Search Results
Found 27 results
510(k) Data Aggregation
(60 days)
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
Intended Purpose: The K-Pack Embrace™ Active Safety Needle, being a hypodermic needle with safety shield, is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The safety shield shall be manually locked (activated), after use, to cover the needle to minimize the risk of accidental needle stick.
Indications: The K-Pack Embrace™ Active Safety Needle is for general application – for treatment (injection of fluids) or diagnosis (withdrawal of fluids).
The K-Pack Embrace™ Active Safety Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Embrace™ Active Safety Needle is compatible for use with standard luer slip and luer lock syringes. The K-Pack Embrace™ Active Safety Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label.
This device features a hinged safety shield, made of polycarbonate, attached to the needle hub. The safety feature is activated when the safety shield is manually pressed over the needle immediately after use and prior to disposal to minimize the risk of accidental needle stick injuries. The safety shield is activated with a one-handed operation, using the finger, thumb, or surface activation.
The K-Pack Embrace™ Active Safety Needle is sterilized by ethylene oxide.
I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the K-Pack Embrace™ Active Safety Needle does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way you've requested (e.g., details about AI studies, sample sizes for training/test sets, expert adjudication, MRMC studies, and nuanced ground truth establishment).
The document is a standard 510(k) clearance letter for a medical device (a hypodermic needle with a safety shield) that demonstrates substantial equivalence to a predicate device. The "Non Clinical Test" section focuses on:
- Performance testing: Verification of the device's design against recognized international standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 6009, ISO 23908, ISO 11607-1, USP , and FDA guidance on sharps injury prevention). These standards define various physical and functional requirements for hypodermic needles and their safety features.
- Biocompatibility testing: Evaluation of the materials in contact with the body according to ISO 10993.
- Sterilization and shelf-life testing: Validation of the sterilization method (Ethylene Oxide) according to ISO 11135 and shelf-life studies according to ASTM F1980.
The document does not describe an AI/ML-based device or a study involving human readers, AI assistance, ground truth established by experts, or any of the elements typically associated with the kind of acceptance criteria you've detailed in your prompt (e.g., sensitivity, specificity, AUC for an AI model).
Therefore, I cannot populate the table or answer the specific questions related to AI/ML study design and expert review methodology based on the provided text. The device described is a physical medical device, not a diagnostic AI system.
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(268 days)
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.
The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:
- Pulse Rate,
- Blood Oxygen Saturation under no-motion conditions,
- Respiratory Rate under no motion conditions,
- Peripheral Skin Temperature,
- Electrodermal Activity,
- Activity associated with movement during sleep
The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.
The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.
The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.
The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy, and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.
The Empatica Health Monitoring Platform is a wearable device and software platform composed by:
- A wearable medical device called EmbracePlus,
- A mobile application running on smartphones called "Care App",
- A cloud-based software platform named "Care Portal".
The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or WiFi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.
The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO2), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.
The provided FDA 510(k) clearance letter and its attachments describe the acceptance criteria and study that proves the Empatica Health Monitoring Platform (EHMP) meets those criteria, specifically concerning a new Predetermined Change Control Plan (PCCP) for the SpO2 quality indicator (QI) algorithm.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are outlined for the proposed modification to the SpO2 Quality Indicator (QI) algorithm. The reported device performance is presented as a statement of equivalence to the predicate device, implying that the acceptance criteria are met, as the 510(k) was cleared.
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 QI Algorithm - Bench Testing | Sensitivity, Specificity, and False Discovery Rate of the modified SpO2 QI algorithm in discriminating low-quality and high-quality data are non-inferior to the SpO2 QI in the FDA-cleared SpO2 algorithm. | Implied to have met criteria, as the device received 510(k) clearance. Full performance metrics are not explicitly stated in this document but are described as being non-inferior. |
| SpO2 Algorithm - Clinical Testing (Arms Error) | The Arms error of the modified SpO2 algorithm is lower or equivalent to the FDA-cleared SpO2 algorithm. | Implied to have met criteria, as the device received 510(k) clearance. Full performance metrics are not explicitly stated in this document but are described as being lower or equivalent. |
| SpO2 QI Algorithm - Clinical Testing (Percent Agreement) | The percent agreement between the modified SpO2 QI outputs and the FDA-cleared SpO2 QI outputs must be equal to or higher than 90%. | Implied to have met criteria, as the device received 510(k) clearance. Full performance metrics are not explicitly stated in this document but are described as being equal to or higher than 90%. |
| Software Verification Tests | All software verification tests linked to requirements and specifications must pass. | Implied to have met criteria, as the device received 510(k) clearance. |
Note: For the pre-existing functionalities (Pulse Rate, Respiratory Rate, Peripheral Skin Temperature, Electrodermal Activity, Activity and Sleep), the document states that "no changes to the computation... compared with the cleared version" have been introduced, implying their previous acceptance criteria were met and remain valid.
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not explicitly stated for the SpO2 algorithm modification. The document only mentions "enhancing the development dataset with new samples" for the ML-based algorithm and clinical testing was "conducted in accordance with ISO 80601-2-61... and ... FDA Guidelines for Pulse Oximeters." These standards typically require a certain number of subjects and data points, but the exact numbers are not provided in this public summary.
- Data Provenance: Not specified in the provided document. It does not mention the country of origin, nor whether the data was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document states the platform is "intended to be used by trained healthcare professionals or researchers," and later discusses "professional users" and "clinical interpretation," implying that the ground truth for clinical studies would likely involve such experts, but their specific roles, numbers, and qualifications for establishing ground truth are not detailed.
4. Adjudication Method for the Test Set
The adjudication method for establishing ground truth for the test set is not explicitly mentioned in the provided document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being conducted, nor any effect size regarding human readers improving with AI vs. without AI assistance. The device is for "retrospective remote monitoring" by healthcare professionals, implying an AI-driven data collection/analysis with human review, but not necessarily human-AI collaboration in real-time diagnostic interpretation that an MRMC study would evaluate.
6. Standalone (Algorithm Only) Performance
The acceptance criteria for the SpO2 QI algorithm include "Bench testing conducted using a functional tester to simulate a range of representative signal quality issues." This falls under standalone performance, as it tests the algorithm's ability to discriminate data quality without direct human input. Clinical testing also evaluates the algorithm's accuracy (Arms error) in comparison to an established standard, which is also a standalone performance measure.
7. Type of Ground Truth Used
- For the SpO2 QI ML algorithm: The ground truth for low-quality and high-quality data discrimination seems to be an internal standard/reference based on the "FDA-cleared SpO2 algorithm" and potentially expert labeling of data quality during the "enhancing the development dataset."
- For the SpO2 Accuracy (Arms Error): The ground truth for SpO2 values would be established in accordance with ISO 80601-2-61, which typically involves comparing the device's readings against a laboratory co-oximeter or a reference pulse oximeter for arterial oxygen saturation.
8. Sample Size for the Training Set
The document mentions "enhancing the development dataset with new samples" for the ML-based algorithm but does not specify the sample size for the training set.
9. How Ground Truth for Training Set was Established
The ground truth for training the ML-based SpO2 QI algorithm was established by "enhancing the development dataset with new samples." It also mentions performing "feature extraction and engineering on window lengths spanning a 10-30-second range." While it doesn't explicitly state the methodology, given the context of a "binary output" (high/low quality), it implies a labeling process, likely by human experts or based on predefined criteria derived from the previous FDA-cleared algorithm's performance on various data types. For the SpO2 accuracy, the ground truth would typically be established by a reference method consistent with the mentioned ISO standard and FDA guidance.
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(182 days)
LINK Embrace Shoulder System - Reverse Configuration
General Indications:
The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.
Indications:
Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically and structurally suited to receive the implants.
The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.
The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.
The Humeral Stems Standard without CaP (HX) are intended for cemented or cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for cemented or cementless fixation.
The Modular Stems 75mm are intended for cemented or cementless fixation.
The Modular Stems, fully corundum blasted, are intended for cementless fixation.
The Modular Stems, fully polished, are intended for cemented fixation.
This Line Extension portfolio includes:
- Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutral designs and in wedged (10°, 15° and 20°) and lateralized variants (+3mm and +6mm). The new 25mm Ø RGB components include new peripheral 4.5mm Ø cortical screws in lengths of 20-60mm with a reduced head diameter as compared with the predicate 4.5mm Ø cortical screws cleared in K200368. The screws are available in standard and angle-stable/locking versions.
- Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mm and +6mm lateralization.
- Humeral Reverse Tray in a neutral (concentric) version with extended +5mm height.
The provided document is a 510(k) summary for a medical device called the "LINK Embrace Shoulder System - Reverse Configuration." It is a premarket notification to the FDA for a new component (25mm diameter reverse glenoid baseplates, glenospheres, and a humeral reverse tray) to an existing shoulder replacement system.
Based on the information provided in the document, here's a breakdown of the requested points:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria or specific numerical performance results in a table format for this specific device modification. The performance testing section states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Suitable for intended purpose and Substantially Equivalent to predicate or reference devices with respect to non-clinical performance and design. | "The results of non-clinical performance testing and evaluations demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicate or reference devices." |
The tests performed were:
- Range of Motion analysis (ASTM F1378)
- Bone screw testing
- Wear testing rationale for no new worst case
- Glenoid fretting fatigue rationale for no new worst case
- Humeral fatigue test rationale for no new worst case
- Micromotion test (ASTM F2028)
- Biocompatibility Evaluation
It's important to note that this 510(k) is for an addition/modification to an already cleared device, and the evaluation relies heavily on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing and rationales, rather than establishing entirely new performance benchmarks.
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." Therefore, there was no clinical "test set" in the sense of human patient data. The "test set" consisted of components tested in laboratory/benchtop settings. The document does not specify the sample sizes (e.g., number of screws tested, number of components for micromotion) for each of the non-clinical tests.
Data Provenance: The testing was non-clinical (laboratory/benchtop). The manufacturer, Waldemar Link GmbH & Co. KG, is based in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Since no clinical testing was performed, there was no human "ground truth" to establish for a clinical test set. The "truth" for the non-clinical tests is derived from engineering and materials science principles, and standards (e.g., ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical implantable medical device (shoulder replacement components), not an AI/software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implantable medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" is based on:
- Engineering design specifications
- Performance requirements outlined in relevant ASTM standards (e.g., ASTM F1378 for Range of Motion, ASTM F2028 for Micromotion)
- Material properties and biocompatibility standards.
- Comparisons to the performance characteristics of predicate devices.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize a training set or machine learning.
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(251 days)
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.
The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:
• Pulse Rate,
- · Blood Oxygen Saturation under no-motion conditions,
- · Respiratory Rate under no motion conditions,
- · Peripheral Skin Temperature,
- · Electrodermal Activity,
- · Activity associated with movement during sleep
The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.
The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.
The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.
The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy. and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.
The Empatica Health Monitoring Platform is a wearable device and software platform composed by:
- A wearable medical device called EmbracePlus,
- A mobile application running on smartphones called "Care App", ●
- A cloud-based software platform named "Care Portal". ●
The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.
The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO-), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.
Here's a summary of the acceptance criteria and the study details for the Empatica Health Monitoring Platform, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Subject Device) | Reported Device Performance | Comments |
|---|---|---|---|
| Pulse Rate (PR) | |||
| PR Range | 24 – 240 bpm | 24 – 240 bpm | Matches range |
| PR Resolution | 1 bpm | 1 bpm | Matches resolution |
| PR Accuracy (no-motion) | ≤ 3 bpm Arms | ≤ 3 bpm Arms | Meets criteria, tested against ECG |
| PR Accuracy (motion) | ≤ 5 bpm Arms | ≤ 5 bpm Arms | Meets criteria, tested against ECG |
| Respiratory Rate (RR) | |||
| RR Range | 6 - 40 brpm | 6 - 40 brpm | Matches range |
| RR Resolution | 1 brpm | 1 brpm | Matches resolution |
| RR Accuracy (no-motion) | ≤ 3 brpm Arms | ≤ 3 brpm Arms | Meets criteria, tested against capnography. Not intended for motion conditions. |
| Blood Oxygen Saturation (SpO2) | |||
| SpO2 Range | 70-100% | 70-100% | Matches range. Not intended for motion or low perfusion conditions. |
| SpO2 Resolution | 1% | 1% | Matches resolution |
| SpO2 Accuracy | 3% Arms | 3% Arms | Meets criteria (implies compliance with ISO 80601-2-61 and FDA Guidance for Pulse Oximeters). No additional clinical data provided for this submission, relying on prior clearance K221282. |
| Peripheral Skin Temperature (TEMP) | |||
| Temperature Range | 0°C to 50°C | 0°C to 50°C | Matches range |
| Temperature Resolution | 0.1°C | 0.1°C | Matches resolution |
| Temperature Accuracy | ± 0.1ºC within 30.0ºC - 45.0ºC range | ± 0.1ºC within 30.0ºC - 45.0ºC range | Meets criteria. No additional bench tests provided for this submission, relying on prior clearance K221282. |
| Electrodermal Activity (EDA) | |||
| EDA Range | 0.01 μS – 100 μS | 0.01 μS – 100 μS | Matches range. No additional data or documentation provided for this submission, relying on prior clearance K221282. |
| EDA Resolution | 1 digit ~ 55 pS | 1 digit ~ 55 pS | Matches resolution |
| Activity/Sleep | Bench testing confirmed equivalence for activity counts and sleep detection with the predicate device. No additional bench testing provided for this submission, relying on prior clearance K221282. |
2. Sample Size Used for the Test Set and Data Provenance
- Pulse Rate:
- Study 1: 12 healthy adult subjects.
- Study 2: 85 healthy adult subjects.
- Study 3: 49 adult subjects (healthy, PVCs, other comorbidities).
- Total N = 146 adult subjects.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective in nature for regulatory submissions. Country of origin not specified.
- Respiratory Rate:
- Study 1: 14 healthy adult subjects.
- Study 2: 46 healthy adult subjects.
- Study 3: 17 adult subjects with various health conditions.
- Study 4: 40 adult subjects with various health conditions.
- Total N = 117 adult subjects.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective in nature for regulatory submissions. Country of origin not specified.
- SpO2, Temperature, EDA, Activity/Sleep: For these parameters, the submission relies on previous clearance (K221282), indicating no new clinical test data was provided for this specific submission. The reported performance for these parameters is thus based on the studies supporting K221282. Sample sizes and provenance for those underlying studies are not detailed in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not mention the use of human experts to establish ground truth for the test sets.
- Instead, for Pulse Rate, the ground truth was established using a reference electrocardiogram (ECG).
- For Respiratory Rate, the ground truth was established using a capnography reference device.
4. Adjudication Method for the Test Set
- Not applicable as the ground truth was established against reference medical devices (ECG, capnography) rather than human expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies described are focused on the standalone performance of the device against reference standards.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, standalone studies were performed. The clinical data presented for Pulse Rate and Respiratory Rate directly evaluate the accuracy of the device's computed values against reference standards, without human intervention in the measurement process. The device itself is described as a "platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring," implying that the data collection and parameter computation are algorithmic, and review is done by humans.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)
- Pulse Rate: Reference Electrocardiogram (ECG).
- Respiratory Rate: Reference Capnography device.
- SpO2: Based on the technology description, it would typically be a co-oximeter or a clinically validated pulse oximeter meeting ISO standards. The document notes that no new clinical data for SpO2 was provided, relying on K221282, which would have established ground truth similarly.
8. The Sample Size for the Training Set
- The document does not provide details about the sample size for the training set used for the device's algorithms. It focuses entirely on the clinical validation (test set) data.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide details on how the ground truth for the training set was established. This information is typically not included in a 510(k) summary, which focuses on the validation of the final product.
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(59 days)
LINK® Embrace Shoulder System - Reverse Configuration
General indications: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.
Indications: Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically suited to receive the implants.
The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.
The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.
The Humeral Stems Standard without CaP (HX) and Short without CaP (HX) are intended for cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for cementless fixation.
The Modular Stems 75mm are intended for cemented or cementless fixation.
The Modular Stems, fully corundum blasted, are intended for cementless fixation.
The Modular Stems, fully polished, are intended for cemented fixation.
This system adds modular humeral stem components to the LINK Embrace Shoulder System – Reverse Configuration, comprised of Proximal Bodies and Modular Stems. The modular Proximal Bodies (Ti6A4V) are available in several sizes and heights. The Proximal Bodies feature a spiked surface, and m-l and a-p holes for suture fixation. The Proximal Bodies feature a proximal modular taper connection for assembly to the existing Reverse Tray components. The Proximal Bodies feature a distal modular taper connection for assembly to a modular stem.
The modular stems (Ti6Al4V) are available in different diameters and lengths as well as different surface options for cemented or cementless fixation.
The provided text is a 510(k) summary for the LINK® Embrace Shoulder System - Reverse Configuration. This document describes a medical device, specifically a shoulder prosthesis, and its substantial equivalence to previously cleared devices. It does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device or any study that proves such a device meets acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them, as this information is not present in the provided text.
The document focuses on:
- Device Description: A shoulder joint replacement system, specifically an update adding modular humeral stem components.
- Indications for Use: When and for whom the device is intended.
- Comparison to Predicate Devices: Demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices, primarily by comparing materials,
sterilization, packaging, and general design principles. - Performance Testing: Mentioning non-clinical performance tests (Range of Motion analysis, Fatigue testing with Fretting/Corrosion assessment, and post-fatigue disassembly tests)
to show mechanical safety and performance, but these are for the physical implant, not an AI component. - No Clinical Testing: Explicitly states that clinical performance testing was not required to demonstrate substantial equivalence for this device.
In summary, the provided text describes a conventional physical medical implant, not an AI/ML-driven device.
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(87 days)
LINK Embrace Shoulder System- Anatomical Configuration
General indications: The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty.
Indications:
• A severely painful and/or disabled shoulder joint resulting from osteoarthritis or theumatoid arthritis
- · Avascular necrosis of the humeral head
- · Deformity and/or limited motion
· Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
· Revision of a failed primary component - · Ununited humeral head fractures
- · Cuff tear arthropathy (CTA Heads only)
The All Poly Glenoid Components are intended for cemented use.
The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.
The Humeral Stems Standard without CaP (HX) and Short without CaP (HX) are intended for cementless fixation.
The Humeral Fracture Stems are intended for cementless fixation.
The LINK Embrace Shoulder System offers diverse fixation options suitable for the majority of patient populations and indications. A wide range of stems in different configurations allows for cemented and cementless fixation.
Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to head adapters. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phosphate coated versions. Humeral Fracture Stems are also available. The Humeral Stems have been previously cleared for use with the LINK Embrace Shoulder System – Reverse [K200368].
Humeral Heads (CoCrMo) are available in several sizes with a female taper for connection to the Head Adapters.
CTA Heads (CoCrMo) are available in neutral and different offset versions and feature a male taper for connection to Humeral Stems.
The Cemented All Poly Glenoids are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur).
The LINK Embrace Shoulder System is supported by a streamlined, lightweight and ergonomic instrument set.
Here's a breakdown of the acceptance criteria and study information, based on the provided text:
Important Note: The provided document is an FDA 510(k) clearance letter and a 510(k) Summary for a medical device (LINK Embrace Shoulder System - Anatomical Configuration). This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria for a novel AI/software function. Therefore, the questions related to AI/software performance metrics, ground truth, experts, and reader studies are not applicable to this document, as it describes a physical shoulder implant, not an AI-powered diagnostic or therapeutic tool.
The "acceptance criteria" in this context refer to the successful completion of non-clinical performance tests and analyses to demonstrate the device's safety and effectiveness compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Range of Motion analysis (ASTM F1378) | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Glenoid loosening (ASTM F2028) | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Fatigue testing with Fretting/Corrosion assessment | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Static and post-fatigue evaluation of component Locking Mechanisms (ASTM F2009) | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Wear Rationale | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Characterization of UHMWPE sterilized EO (reference K200368) | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Biocompatibility evaluation | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Overall Substantial Equivalence | The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicates. |
Regarding the other questions related to AI/Software Performance:
Since this document describes a physical medical implant (shoulder prosthesis) and not an AI/software device, the following questions are not applicable (N/A). The concept of "test set," "training set," "ground truth experts," and "reader studies for AI" do not apply in this context.
- Sample size used for the test set and the data provenance: N/A (Not an AI/software device)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/software device)
- Adjudication method for the test set: N/A (Not an AI/software device)
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (Not an AI/software device)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/software device)
- The type of ground truth used: N/A (Not an AI/software device)
- The sample size for the training set: N/A (Not an AI/software device)
- How the ground truth for the training set was established: N/A (Not an AI/software device)
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(357 days)
LINK Embrace Shoulder System - Reverse Configuration
The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.
Indications:
Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically and structurally suited to receive the implants.
The Reverse Baseplate is intended for cementless fixation with the addition of bone screws.
The Humeral Stems, Standard with CaP (HX) and Short with CaP (HX), are intended for cementless fixation.
The Humeral Stems, Standard without CaP (HX) and Short without CaP (HX), are intended or cementless fixation.
The Humeral Fracture Stems are intended for cementless fixation.
Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to reverse tray components for rTSA configurations. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phospate coated versions. Humeral fracture stems are also available.
The Reverse Glenoid Baseplate (Ti6Al4V) hosts a central Bone Screw and up to 4 peripheral Bone Screws. The system includes anglestable (locking screws), polyaxial anglestable and standard screw fixation with cortical and cancellous thread designs. The baseplate's backside and central peg feature a porous titanium surface for biologic fixation. The Reverse Glenoid Baseplate is assembled with a CoCrMo Glenosphere for rTSA.
The LINK Embrace Shoulder System - Reverse Configuration offers Glenospheres in several diameters. And neutral and eccentric designs. The Embrace Glenospheres are connected to the Reverse Baseplate by means of a taper and locking screw.
Reverse Trays (CoCrMo) are available in neutral, inclined and offset versions, which are combined with Reverse Inserts (polyethylene) in neutral and 10° & 20° inclined versions, enabling the surgeon to adjust the mechanical parameters in different spatial planes (e.g. retroversion and inclination) independently from each other. In addition, different Insert heights are available.
The reverse inserts are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur®).
The LINK Embrace Shoulder System – Reverse Configuration is supported by a streamlined, lightweight and ergonomic instrument set.
The provided text is an FDA 510(k) summary for a medical device called the "LINK Embrace Shoulder System - Reverse Configuration." This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than proving the device meets specific performance criteria through clinical studies, AI algorithm validation, or human-in-the-loop performance evaluation.
Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I answer questions related to AI performance, sample sizes for test/training sets, expert consensus, or MRMC studies. The document explicitly states:
"Clinical Testing: Clinical performance testing was not required to demonstrate the substantial equivalence of this device."
Instead, the submission relies on non-clinical performance testing and analysis to demonstrate that the device is suitable for its intended purpose and substantially equivalent to predicate devices. These tests are primarily mechanical and material characterization tests, not studies assessing clinical outcomes or AI algorithm performance.
Here's what I can extract from the provided text regarding the non-clinical testing:
Summary of Non-Clinical Performance Testing (as provided in the document):
| Test Type | Relevant Standard (if mentioned) | Purpose as Stated in Document |
|---|---|---|
| Range of Motion analysis | ASTM F1378 | To assess the device's range of motion characteristics. |
| Fatigue testing with Fretting/Corrosion assessment | N/A | To evaluate the device's durability and resistance to wear and corrosion under cyclic loading. |
| Glenoid baseplate loosening | ASTM F2028 | To assess the stability of the glenoid baseplate fixation. |
| Reverse Baseplate/Glenosphere Component Disassociation/Taper Connection Test | ASTM F2028 | To ensure the robust connection and prevent disassociation of these components. |
| Reverse baseplate and insert disassembly (lever-out, push-out, torque-out) testing | ASTM F1820 | To evaluate the mechanical integrity and resistance to disassembly of the baseplate and insert. |
| Bone screw testing | ASTM F543 | To assess the strength and performance of the bone screws used for fixation. |
| Wear rationale | N/A | To analyze and justify the wear characteristics of the device materials. |
| Impingement Testing | ASTM F2582 | To assess potential impingement phenomena within the shoulder system. |
| Characterization of UHMWPE sterilized by EO | N/A | To ensure the properties of the Ultra-High Molecular Weight Polyethylene are maintained after ethylene oxide sterilization. |
| Characterization of TrabecuLink porous surfaces | N/A | To assess the features and properties of the porous titanium surfaces for biologic fixation. |
Study Details from the provided document (where applicable):
- Sample sizes: Not specified for any of the non-clinical tests. These would typically be determined by the specific ASTM standards or internal validation protocols.
- Data provenance: Not explicitly stated, but these are laboratory-based, non-clinical tests likely conducted by the manufacturer or a contracted testing facility.
- Experts and Ground Truth: Not applicable in the context of this 510(k) summary, as it describes non-clinical mechanical testing, not clinical studies or AI algorithm validation requiring human expert consensus.
- Adjudication method: Not applicable.
- MRMC Comparative Effectiveness Study: Not performed (as per "Clinical performance testing was not required").
- Standalone Performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable for non-clinical, mechanical testing. The "ground truth" would be the measured physical properties and performance against specified engineering criteria.
- Training Set Sample Size & Ground Truth Establishment: Not applicable, as this document does not describe the development or validation of an AI algorithm.
Conclusion stated in the document: The results of the non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicate devices.
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(161 days)
Embrace
The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional.
The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTCS). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a likely GTCS is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers. The device also enables patients to manually record seizure events, and provides contextual information related to activity and sleep.
The provided document describes the FDA 510(k) clearance for the Empatica Embrace device, a non-EEG physiological signal-based seizure monitoring system. The information below is extracted and organized to answer your request.
1. Table of Acceptance Criteria and Reported Device Performance
While the document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for clearance, the performance results presented indicate the observed efficacy. The implicit acceptance criteria would be for the device to perform well enough to demonstrate substantial equivalence to the predicate device and ensure safety and effectiveness.
| Performance Metric | Implicit Acceptance Criteria (based on predicate equivalence and clinical utility) | Reported Device Performance (Embrace) |
|---|---|---|
| Positive Percent Agreement (PPA) - All Patients | High PPA to ensure most GTCS events are detected, comparable to predicate. | 0.9815 (53 out of 54 GTCS detected) with 95% CI of [0.9028; 0.9702] |
| False Alarm Rate (FAR) - Overall | Low FAR to minimize non-actionable alerts for caregivers. | 0.94 false alarms per 24 hours with 95% CI of [0.71, 1.21] |
| Mean FAR - Overall | Low mean FAR for individual patients. | 1.25 (average of FARs across patients) |
| PPA (6-12 years) | High PPA for pediatric subgroup. | 0.917 (corrected PPA: 0.799) with 95% CI of [0.601, 0.895] |
| PPA (13-21 years) | High PPA for adolescent subgroup. | 1.0 (corrected PPA: 0.915) with 95% CI of [0.889, 0.934] |
| PPA (Adults, >21 years) | High PPA for adult subgroup. | 1.0 (corrected PPA: 0.924) with 95% CI of [0.910, 0.931] |
| FAR (6-12 years) | Low FAR for pediatric subgroup. | 1.33 false alarms per 24 hours (mean FAR: 1.79) |
| FAR (13-21 years) | Low FAR for adolescent subgroup. | 1.37 false alarms per 24 hours (mean FAR: 1.47) |
| FAR (6-21 years) | Low FAR for combined pediatric subgroup. | 1.35 false alarms per 24 hours (mean FAR: 1.63) |
| FAR (Adults, >21 years) | Low FAR for adult subgroup. | 0.67 false alarms per 24 hours (mean FAR: 0.76) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 141 patients diagnosed with epilepsy.
- 80 pediatric patients (ages 6-21 years, median: 13 years)
- 61 adult patients (ages 22-63 years, median: 39 years)
- Data Provenance: The study was conducted in a hospital Epilepsy Monitoring Unit (EMU) setting. While the document doesn't explicitly state the country of origin, the listed submitter address is in Milan, Italy. The data is prospective as patients were enrolled and monitored during their EMU stay for the purpose of this study.
- Observed GTCS: 31 EMU patients experienced a total of 54 generalized tonic-clonic seizures (GTCSs). 110 EMU patients did not experience any seizure.
- Recorded Data: 141 patients provided overall 409 days (9,806 hours) of ACM (accelerometer) and EDA (electrodermal activity) measurements, with a median of 49.2 hours of data per patient.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: A "panel of three readers" was used.
- Qualifications of Experts: The ground truth was established using "the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers." This implies the "readers" were highly qualified medical professionals experienced in epilepsy diagnosis and seizure classification, likely epileptologists, given the standard of care in EMUs. Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
The document states "relative to a panel of three readers." While it doesn't explicitly detail the adjudication method (e.g., majority vote, independent assessment with reconciliation), the phrase "panel of three readers" suggests a consensus or majority agreement approach was used to establish the ground truth from the video-EEG data. It is not explicitly stated as 2+1 or 3+1, but rather that the ground truth was derived from the consensus of these three readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No MRMC comparative effectiveness study was described where human readers' performance with and without AI assistance was evaluated. This study focused on the standalone performance of the device's algorithm in detecting GTCS.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance study was done. The reported PPA and FAR metrics represent the performance of the Embrace device's algorithm in detecting GTCS events based on its internal processing of EDA and motion data, without direct human intervention in the detection process. The device sends an alert when a likely GTCS is detected, which then initiates actions by caregivers. The study evaluates the accuracy of these automated detections.
7. The Type of Ground Truth Used
- The ground truth used was expert consensus based on gold-standard video-Electroencephalogram (EEG) methodology. This is considered a high-fidelity ground truth for seizure detection in an Epilepsy Monitoring Unit (EMU) setting. Every recorded seizure was classified as epileptic.
8. The Sample Size for the Training Set
The document states: "Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTCS). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units."
- The document describes the validation of the algorithm on data from specific sources but does not explicitly state the sample size used for the training set. The 141 patient dataset is specifically described as the "clinical testing" dataset, suggesting it was used for evaluation, not necessarily for training. It's common for validation data to be distinct from training data.
9. How the Ground Truth for the Training Set Was Established
- Similar to the validation set, the description implies that the data used for training (or at least development and refinement) of the algorithm was "labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units." This indicates a high-quality, expert-driven ground truth establishment process for the data used to develop and refine the algorithm.
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(122 days)
Embrace
The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults in home or healthcare facilities during periods of rest. The device is worn on the wrist, and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometers, EDA, and Temperature for subsequent review by a trained healthcare professional.
The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCs in hospital Epilepsy Monitoring Units. When a likely GTC is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Positive Percent Agreement (PPA) | Not explicitly stated but inferred to be clinically acceptable and comparable to prior devices, ensuring effective detection of GTC seizures. Given the reported value, it's expected to be high. | 1.0 (corrected PPA = 0.9334) with a 95% CI of [0.9213, 0.9424] |
| False Alarm Rate (FAR) | Not explicitly stated but inferred to be clinically acceptable and comparable to prior devices, ensuring a manageable number of false alerts for caregivers. Given the reported value, it's expected to be low. | 0.4286 false alarms per 24 hours with a 95% CI of [0.3425, 0.7002], corresponding to a mean FAR of 0.5894 |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for PPA and FAR. Instead, it reports the device's performance metrics and implicitly suggests that these values are deemed acceptable for marketing the device as "substantially equivalent" to a predicate device. The FDA typically relies on a comparison to predicate devices and clinical justification for novel devices.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- 135 patients diagnosed with epilepsy were enrolled.
- Out of these, 22 patients experienced a total of 40 generalized tonic clonic seizures (GTCSs).
- 113 patients did not experience any seizures during the study.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was conducted within an "Epilepsy Monitoring Unit (EMU)" in a "top level 4 epilepsy center," suggesting a clinical setting in a developed healthcare system (likely the US, given the FDA submission).
- Retrospective or Prospective: The study enrolled patients and observed them for seizure events within the EMU, implying a prospective collection of data for the purpose of validating the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Three readers.
- Qualifications of Experts: They are referred to as a "panel of three readers." Although their specific qualifications (e.g., neurologists, epileptologists, years of experience) are not explicitly detailed in this document, the context of an "Epilepsy Monitoring Unit" and "gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists" strongly suggests they were highly qualified medical professionals specializing in epilepsy and EEG interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document mentions "relative to a panel of three readers" for PPA calculation. This implies that the ground truth was established by consensus (or agreement) among these three readers. The specific adjudication method (e.g., if at least 2 out of 3 had to agree, or if all 3 had to agree, or if a tie-breaking fourth expert was used) is not explicitly stated. However, the use of a "panel" suggests a structured review process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Was an MRMC comparative effectiveness study done? No. The study described focuses on the standalone performance of the Embrace device (i.e., the algorithm's ability to detect seizures) against a human-established ground truth. It does not evaluate how human readers' performance might change with or without the device's assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The performance metrics (PPA and FAR) directly reflect the algorithm's ability to detect GTC seizures based on sensor data. The device "runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC)."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: Expert consensus based on "gold-standard video-Electroencephalogram (EEG) methodology." This is a strong form of ground truth for epilepsy, as video-EEG is the primary method for diagnosing and classifying seizures in clinical practice. The data was "labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists."
8. The sample size for the training set
The document states, "The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCs in hospital Epilepsy Monitoring Units."
However, it does not explicitly state the sample size of the training set. It only describes the validation set (the 135 patients). It's common for regulatory submissions to omit detailed training set information, focusing instead on the independent validation (test) set.
9. How the ground truth for the training set was established
- The ground truth for the training set (implied, as the exact set is not detailed) was established using the "gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center." This indicates that the training data was meticulously labeled by highly qualified experts using the most reliable method for seizure detection.
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(107 days)
Embrace Neonatal MRI System
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The Embrace Neonatal MRI System is a 1Tesla Permanent MRI system producing MR images of Neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.
The provided document is a 510(k) Premarket Notification for the Embrace Neonatal MRI System. It details the device's indications for use, comparison to a predicate device, and the non-clinical testing performed. However, it explicitly states that no clinical studies were conducted to establish substantial equivalence for this device. Therefore, it does not contain the acceptance criteria or study details regarding device performance from a clinical perspective.
Here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
Based on the document, direct clinical acceptance criteria and reported device performance from a clinical study are not available. The document focuses on non-clinical testing and comparison to a predicate device for substantial equivalence.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Compliance with ES/IEC 60601-1 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 60601-1-2 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 60601-2-33 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 60601-2-20 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 60601-1-6 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 62304 | Demonstrated (implied by submission and clearance) |
| Compliance with NEMA MS-1, MS-2, MS-3, MS-5, MS-12 | Demonstrated (implied by submission and clearance) |
| Demonstrated performance via System and Software V&V | Demonstrated (implied by submission and clearance) |
| Demonstrated diagnostic quality images from phantom studies | Demonstrated (stated in "Summary of Clinical Tests" section) |
2. Sample size used for the test set and the data provenance:
- Test set for clinical performance: Not applicable, as no clinical studies were performed.
- Test set for non-clinical performance (phantom images, V&V): Not specified in the document. The provenance of this data is from Aspect Imaging Ltd., likely internally generated during device development.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical studies with expert-established ground truth were performed. The document mentions "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis," but this refers to the intended use of the device, not a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies with adjudication were performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is an MRI system, not an AI diagnostic tool designed to assist human readers. Moreover, no clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is an MRI system, not a standalone algorithm. Its performance is evaluated on its ability to produce diagnostic quality images, which are then interpreted by a human physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for a clinical study. For the non-clinical phantom images, the "ground truth" would be the known properties and geometry of the phantoms themselves, used to assess image quality, resolution, and artifact levels.
8. The sample size for the training set:
Not applicable. This is an MRI system, not an AI model that requires a specific training set in the conventional sense. The "training" of the system would involve engineering and calibration using test data and phantoms.
9. How the ground truth for the training set was established:
Not applicable. As described in point 8, this is an MRI system, not an AI model with a training set. If considering the calibration and engineering process, the "ground truth" would be established through physical measurements, known phantom compositions, and established MRI physics principles.
In summary, the provided FDA 510(k) letter and summary explicitly state that no clinical studies were conducted to support substantial equivalence for the Embrace Neonatal MRI System. The device was cleared based on non-clinical testing, including phantom images, to demonstrate its ability to provide diagnostic quality images, and comparison to a legally marketed predicate device (Wrist 3 MRI System). The rationale given for not performing clinical studies was the "vulnerable patient population" (neonates) and that the "benefits of sample clinical images did not outweigh the risks associated with acquisition of those images."
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