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510(k) Data Aggregation
(219 days)
Prior Care Science Technology LTD
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.
Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.
The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).
The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.
The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.
The mainstream gas analyzers are characterized by the following features:
- Low system integration complexity
- Low power consumption
- Fast startup time
- Low weight
The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.
Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.
However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.
1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):
| Parameter | Medical Gas Analyzer (AG200) Reported Performance | Predicate Device (K123043) | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| CO2 Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | Within ±(0.2 vol% + 2% of reading) for 0 to 15 vol% |
| N2O Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | Within ±(2 vol% + 2% of reading) for 0 to 100 vol% |
| Halothane, Enflurane, Isoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 8 vol% |
| Sevoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 10 vol% |
| Desflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 22 vol% |
| CO2 Accuracy (all conditions) | ±(0.3 vol% + 4% of reading) | ±(0.3 vol% + 4% of reading) | Within ±(0.3 vol% + 4% of reading) |
| N2O Accuracy (all conditions) | ±(2 vol% + 5% of reading) | ±(2 vol% + 5% of reading) | Within ±(2 vol% + 5% of reading) |
| Agents Accuracy (all conditions) | ±(0.2 vol% + 10% of reading) | ±(0.2 vol% + 10% of reading) | Within ±(0.2 vol% + 10% of reading) |
| Respiration Rate Range | 0 to 150 breaths/min | 2 to 150 breaths/min | 0 to 150 breaths/min (implied by compliance with ISO 80601-2-55 despite difference in predicate's lower limit) |
| Respiration Rate Accuracy | ±1 breaths/min | ±1 breaths/min | Within ±1 breaths/min |
| Anaesthetic Agents Threshold | 0.2 vol% | 0.15 vol% (with caveats) | 0.2 vol% deemed acceptable as verified by bench test and compliance with ISO 80601-2-55. |
| Warm-up time | 10-180 seconds |
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Shenzhen Fansizhe Science and Technology Co., Ltd.
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF, are a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the power adapter and its IPL emission activation is by a switch or auto light emission.
Intense Pulsed Light (IPL) System, all models, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.
Intense Pulsed Light (IPL) System, models: T002AQ, T002AD, T002AF, contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.
Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.
Based on the dual pulse technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has single pulse and dual pulse functions.
The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.
This FDA 510(k) clearance letter and summary describe an Intense Pulsed Light (IPL) System for hair removal. However, it does not contain the detailed acceptance criteria or the specific study outcomes that prove the device meets these criteria in the context of an Artificial Intelligence (AI) enabled device. The provided document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technical specifications and non-clinical performance data (biocompatibility, electrical safety, eye safety, and general software V&V).
The request specifically asks about acceptance criteria and study data for an AI-enabled device. This document describes a traditional medical device (IPL) and lists "Software Verification and Validation" as a performance data point, but this typically refers to the functional soundness of the device's embedded software, not necessarily an AI algorithm. There is no mention of deep learning, machine learning, or algorithms that would perform diagnostic or treatment-related AI-driven functions.
Therefore, I cannot extract the requested information regarding AI acceptance criteria, specific study performance metrics for an AI component, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, because this information is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance (Non-AI Focused)
Since the document doesn't detail AI-specific acceptance criteria or performance metrics, the "acceptance criteria" can be broadly inferred from the tests performed to demonstrate substantial equivalence to the predicate device. The "reported device performance" is the successful completion of these tests.
| Acceptance Criteria (Inferred) | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility (cytotoxicity, skin sensitization, skin irritation) | Passed ISO 10993-5, ISO 10993-10, ISO 10993-23 |
| Electrical Safety and EMC | Passed IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83 |
| Eye Safety | Passed IEC 62471 |
| Software Functionality and Hazard Mitigation | All software requirement specifications met, and all software hazards mitigated to acceptable risk levels. Consistent with moderate level of concern. |
Missing Information Regarding AI-Enabled Device Performance
The following information cannot be provided as it is not present in the provided FDA 510(k) clearance letter and summary for an AI-enabled device. This document describes a standard IPL device.
- Sample sizes used for the test set and the data provenance: Not applicable/Not provided for an AI test set. The document refers to non-clinical tests (biocompatibility, electrical safety, etc.), which don't involve test sets of patient data in the context of AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment with experts is a key component of AI algorithm validation, which is not described here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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/Not provided. The device is not described as providing AI assistance to human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
- The sample size for the training set: Not applicable/Not provided. Training sets are relevant for AI algorithms.
- How the ground truth for the training set was established: Not applicable/Not provided.
Conclusion: The provided FDA 510(k) document is for a non-AI medical device (Intense Pulsed Light System). While it includes software verification and validation, this refers to the functional and safety aspects of embedded device software, not a sophisticated AI algorithm for interpretation or assistance that would require the detailed clinical validation metrics requested in the prompt.
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(74 days)
Science & Bio Materials (S.B.M.) SAS
The PULLUP®, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament.
- PULLUP®, PULLUP® CLIP, PULLUP® TEX CLIP must be used with a Soft Tissue Transplant.
- BT LOOP® must be used with a Bone Tendon Bone Transplant.
The RIGIDLOOP™ T, RIGIDLOOP™ BTB, RIGIDLOOP™ Clip and RIGIDLOOP™ Suture Loop cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament.
- RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ Suture Loop must be used with a Soft Tissue Transplant.
- RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant.
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PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft. Standard and XL sizes.
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BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary split suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that can be mounted on the GraftTech® preparation station. Standard and XL sizes.
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PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device. Standard and XL sizes.
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PULLUP® TEX CLIP: Comprises a nonabsorbable braided loop. One size only.
Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm.
The implants are supplied sterile, individually packaged, ready to use.
The PULLUP®, PULLUP® CLIP, BT LOOP® and PULLUP® TEX CLIP devices are also sold under the trade names RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ BTB and RIGIDLOOP™ Suture Loop respectively.
I apologize, but based on the provided FDA 510(k) Clearance Letter (K250844), the device in question is a bone fixation fastener, specifically for anterior cruciate ligament (ACL) reconstruction.
The document describes non-clinical tests performed to demonstrate substantial equivalence, such as:
- Ultimate failure load (post-fatigue tensile strength) and fatigue displacement
- Biocompatibility testing (ISO 10993-1:2018)
- Bacterial endotoxin testing (ISO 11737-3:2023)
- Shelf-life, storage, and stability testing (ISO 11607-1:2019 for packaging)
- Sterile adoption (ISO 11137-1:2006)
- MRI safety evaluation (ASTM F2503 - 20, IEC 62570:2014, FDA guidance)
The provided text explicitly states "Not Applicable" for clinical tests and indicates that "Changes in design are minor, and do not raise new or different questions of safety and effectiveness compared with the predicate device." This means that no human clinical study was conducted or reported in this 510(k) submission to assess the device's performance in terms of diagnostic accuracy or human-AI interaction.
Therefore, I cannot provide the information requested regarding:
- A table of acceptance criteria and reported device performance directly related to AI or diagnostic accuracy.
- Sample size for a test set (as no clinical test set for AI performance was mentioned).
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone AI performance.
- Type of ground truth used (in an AI context).
- Sample size for a training set (AI model training).
- How ground truth for a training set was established (AI model training).
The 510(k) summary focuses on the mechanical, material, and safety aspects of the physical implant device, demonstrating its equivalence to existing predicate devices through bench testing and material science principles, not through AI performance or diagnostic accuracy studies.
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(218 days)
Beijing Rongrui-Century Science & Technology Co., Ltd.
SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.
SpO2 Extension Cable consists of two parts: the SpO2 patient cable and the adapter. The SpO2 patient cable is used for connecting the monitors, and the adapter is used for connecting the SpO2 patient cable and the SpO2 sensor.
The SpO2 Extension Cable is the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.
By using the same types of construction and technological characteristics to the compatible patient monitor and SpO2 sensor, the SpO2 Extension Cable can avoid measured data corrupted.
The proposed device was modification from the legally marketed (existing) device "SpO2 Extension Cable"/K222370, manufactured by "Beijing Rongrui-Century Science & Technology Co., Ltd.", same as the sponsor of this submission.
Compared to the initial product (K222370), only the structure of the SpO2 Extension Cable has changed. Originally a non-separable complete extension cable, now an extension cable can be separated into two parts, called the SpO2 patient cable and the adapter.
The type of instrument connector (which connects one end of the monitoring device) for the SpO2 patient cable is 20pin, there are four types pairing interfaces between SpO2 patient cable and adapter, the pairing interfaces name for the SpO2 patient cable and adapter connection is DB9F-LNCS, MLNCS-MLNCS, LNOP-LNOP, RD-RD and the other end of the adapter connecting to SpO2 sensor is DB9F. Adapters are divided into two categories: with cable and without cable. Adapters for each type of interface are available with and without cables.
The provided FDA 510(k) Clearance Letter for the "SpO2 Extension Cable" is for a Class II medical device, specifically an extension cable used to connect SpO2 sensors to monitoring devices. Based on the content of the letter, the submission is about demonstrating substantial equivalence to a predicate device, not necessarily proving that an AI/ML algorithm meets specific performance criteria.
Therefore, many of the requested points, such as AI/ML specific acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI/ML, are not applicable to this type of device clearance. This clearance focuses on electrical safety, EMC, biocompatibility, and functional compatibility of a hardware component.
Here's a breakdown of the requested information based on the provided document, highlighting what is applicable and what is not:
Analysis of Acceptance Criteria and Study for SpO2 Extension Cable (K242986)
This submission (K242986) pertains to an SpO2 Extension Cable, which is a hardware component. The clearance is based on demonstrating substantial equivalence to a previously cleared predicate device (K222370), rather than establishing performance of an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study details associated with AI/ML devices are not relevant here.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of hardware device are primarily based on compliance with recognized consensus standards and functional compatibility. The "performance" here refers to meeting these engineering and safety specifications, rather than clinical accuracy metrics typically seen for diagnostic algorithms.
| Acceptance Criterion (Standard Compliance / Test) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility: | |
| ISO 10993-5: In Vitro Cytotoxicity | Meets standard |
| ISO 10993-10: Irritation and Skin Sensitization | Meets standard |
| Electrical Safety & Performance: | |
| IEC 60601-1 (Edition 3.2): General requirements | Complies |
| ISO 80601-2-61: Pulse Oximeter Equipment specifics | Complies |
| ANSI AAMI EC53: ECG trunk cables/leadwires (likely for general cable integrity/materials, given context) | Complies |
| Electromagnetic Compatibility (EMC): | |
| IEC 60601-1-2 (Edition 4.1): EMC requirements | Complies |
| Functional Performance: | |
| Compatibility testing (no measured data corrupt during communication between SpO2 sensors and host monitors) | Performance accuracy evaluated and proven |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a "test set" like in AI/ML validation. Compliance is shown through testing of engineering samples of the device itself and its components against the specified standards.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML algorithm. The "data" here comes from laboratory testing of the physical cable. The device manufacturer is Beijing Rongrui-Century Science & Technology Co., Ltd. in China. The testing would have been conducted in a controlled lab environment.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. Ground truth, in the sense of expert annotation for clinical data, is not established for this type of hardware device. The device's performance is verified against engineering standards and functional specifications.
4. Adjudication Method for the Test Set
- Not Applicable. As there's no "ground truth" derived from expert consensus on clinical cases, no adjudication method is relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. An MRMC study is designed to assess the impact of an AI algorithm on human reader performance. This device is an extension cable, not an AI algorithm.
6. Standalone (Algorithm Only) Performance
- Not Applicable. This is a physical cable, not a software algorithm.
7. Type of Ground Truth Used
- Not Applicable. The "ground truth" for this device's acceptance is its adherence to recognized engineering, electrical, biocompatibility, and functional performance standards. This is established through non-clinical testing results, not clinical outcomes data or expert consensus on patient cases.
8. Sample Size for the Training Set
- Not Applicable. No training set exists as this is a hardware product, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set or associated ground truth for training.
Summary of the K242986 Submission's Core Argument:
The core of the K242986 submission is to demonstrate that the modified structure of the SpO2 Extension Cable (now separable into two parts) does not negatively impact its safety and effectiveness when compared to the predicate device (K222370), which was a non-separable cable. This is achieved by showing continued compliance with relevant performance, safety, and compatibility standards. The primary difference noted is a structural change, and the manufacturer successfully demonstrated that this change "will not affect the safety and effectiveness of the proposed device" through non-clinical testing.
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(211 days)
Sight Sciences, Inc.
The TearCare MGX System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.
The TearCare MGX System is designed to deliver controlled, precise heat to the tarsal plates and underlying meibomian glands of the eyelids for 15 minutes, followed by an optional warming hold time of up to 10 minutes to allow for manual expression. The TearCare MGX System is comprised of a reusable SmartHub, SmartCable, Charging Nest and charging adapter, and single use SmartLids.
The TearCare MGX System is operated by an eye care practitioner, who affixes the SmartLids to the patient's eyelids, connects the SmartLids to the SmartHub with the SmartCable, and initiates the therapy session on the SmartHub. In the same manner as the predicate device, the system increases the temperature from the lowest warmth setting (41°C) to the highest warmth setting (45°C) when the therapy starts. The SmartHub controls the temperature until the 15-minutes of therapy are complete, at which time the system visually and audibly signals the end of therapy. At the end of the 15-minute core therapy, the TearCare MGX System transitions to an optional Warming Hold Time (WHT) that may last up to a maximum of 10 minutes. WHT holds the temperature at the lowest warmth setting (Warmth setting 1 and temperature set point of 41°C) allowing the eye care practitioner to individually express each eyelid while the lids are warm. To complete the TearCare MGX procedure, the eye care practitioner removes the SmartLid devices one at a time from the patient, then uses the separately available meibomian gland expression forceps (Clearance Assistant) to manually express the meibomian glands immediately following the eyelid heat therapy. Heat is discontinued once the SmartLid is removed prior to expression, at the end of the optional 10-minute WHT, or at any time the eye care practitioner utilizes the SmartHub control to interrupt (pause or stop) treatment.
The subject TearCare MGX System is technologically the same as the predicate TearCare MGX System cleared under 510(k) K231084. Notably, there are no changes to the system impacting thermal exposure and limits regarding temperature control and regulation. The subject device of this submission proposes changes to the TearCare MGX System that impact the Instructions for Use (IFU), rather than a device technological change. The procedural instructions for use are updated with additional instruction for the application of the SmartLids including an earpiece fitment check to assess whether the ear loop requires further support.
The provided FDA clearance letter for the TearCare MGX System (K242786) focuses on demonstrating substantial equivalence to a predicate device (K231084). The core of this submission is a change to the Instructions for Use (IFU) to improve the fitment of the SmartLids, rather than a change to the device's technological characteristics or its core therapeutic performance.
Therefore, the primary "study" described in this document is a clinical validation study of the updated IFU for SmartLids fitment, not a study exploring the therapeutic effectiveness of the device itself or its standalone performance in a medical diagnosis context. The acceptance criteria and device performance listed below directly relate to this fitment validation.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Earloop components remain affixed to the ears for the duration of the simulated treatment (25 minutes). | All earloop components remained affixed to the ears in all subjects for the duration of the 25-minute simulated treatment. The study validated the updated instructions for use, which include steps to "check for earpiece fitment" and a recommendation to use surgical tape if a "loose" fitment is identified. |
| SmartLid devices remain securely affixed to the eyelid throughout the simulated treatment. | The study demonstrates that the TearCare MGX device components (including SmartLids) remain securely affixed to the eyelid throughout a simulated 25-minute treatment when applied according to the updated instructions for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 21 subjects
- Data Provenance: The document does not explicitly state the country of origin, but it is a clinical validation study performed to address a specific usability/fitment aspect of the device. The study is prospective, as it was conducted to validate new instructions for use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The study described is a clinical validation of device fitment, not a diagnostic accuracy study requiring expert adjudication of medical images or conditions. The "ground truth" was whether the device remained affixed. This was directly observed during the study.
- Number of Experts: Not applicable in the context of diagnostic "ground truth" establishment. The assessment of whether earloop components remained affixed would have been performed by the study staff (e.g., eye care practitioners or study coordinators) as part of the observation.
- Qualifications of Experts: Not specified or applicable for a fitment validation. The study involved eye care practitioners applying the device, but their role was in applying the device and observing its fit, not in establishing a medical "ground truth."
4. Adjudication Method for the Test Set
Not applicable. This was a direct observation study of device fitment and retention, not a study requiring adjudication of expert interpretations for a ground truth. The success criterion was whether the device remained affixed, which is a binary, observable outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided document describes a clinical validation study focused on the fitment and retention of the TearCare MGX System's earloop components and SmartLids, specifically for the purpose of validating updated Instructions for Use. It is not a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the therapeutic effectiveness of the device or human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. The TearCare MGX System is an Eyelid Thermal Pulsation System, a physical device intended for localized heat therapy. It is not an AI algorithm or a diagnostic software that would have "standalone" performance in the sense of processing data without human involvement for diagnosis. The closest equivalent to "standalone" performance for such a device would be its ability to maintain therapeutic temperature or its physical function, which is assessed through bench testing (e.g., thermal safety, electrical safety, EMC). The clinical validation study described is about the usability and fitment of its components when applied by a human practitioner.
7. The Type of Ground Truth Used
The ground truth for the clinical validation study was direct observation of device fitment and retention. Specifically, whether the earloop components and SmartLids remained securely affixed to the ears and eyelids, respectively, for the duration of the simulated treatment.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a physical medical device (Eyelid Thermal Pulsation System) and a clinical validation of updated instructions for its use. There is no "training set" in the context of machine learning or AI algorithms for this device. The development of the device itself would involve engineering design, testing, and simulated use, but not typically a "training set" like in software development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of AI or machine learning for this device.
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(469 days)
Makani Science, Inc.
The Makani Science™ Respiration Monitoring System is indicated for continuous, non-invasive, and real-time monitoring of a patient's breathing. It graphically displays respiration versus time and reports the respiratory rate value.
The Makani Science™ Respiration Monitoring System is intended to be used by healthcare professionals in healthcare facilities and dental offices on adult patients aged 22 or older. It is not intended to be used as an apnea monitor.
The Makani Science™ Respiration Monitoring System (Makani Science RMS) is a respiration rate (RR) monitoring system that consists of a pair of identical, battery-powered, wireless, Makani Science Ahe™ Respiration Sensors (Ahe Sensors - piezo-resistive strain sensors) and the Makani Science Ahe™ App (Ahe App), which is deployed and runs on an Apple® iPad®. The two (2) small and lightweight Ahe Sensors are paired to the Ahe App using Bluetooth Low Energy (BLE) 5.0 technology. The Makani Science RMS is intended to be used by trained healthcare providers (HCPs) in the management of their patients. The Ahe Sensors are single-patient use sensors and can be used up to 24 hours of continuous use. The sensors are applied to the patient's intact skin using an adhesive tape built into the sensors and are made to be retained on the skin in nonambulatory use situations, such as supine on a procedure room table or semi-recumbent in a dental chair. One sensor is applied to the patient's thoracic region and the other sensor is applied to the abdomen region. Correct placement of these sensors is important to the effectiveness of the device, and specific guidance is provided to the user in the labeling on where to place the sensors. The Ahe App is a software application, which guides the user through system setup and monitoring using display screens. During use, the iPad is forced into guided access, or "kiosk" mode, which prevents the user from using any other applications during the monitoring session. Once setup is complete and monitoring initiated, the Ahe App displays a graphical rendition and numerical value of the patient's RR. Low and high RR alarm thresholds provide a visual and audible notification if the patient's RR violates the user-determined alarm thresholds. Monitoring continues until the user terminates the monitoring session, at which time the Ahe App can save a report of the monitoring session to an external memory card, if desired by the user. No patient health information (PHI) is retained by the Ahe App after completion of the monitoring session. The Makani Science RMS does not interact with any third-party medical or non-medical devices other than a memory card that is used to store a report of the patient's monitoring session.
The Makani Science™ Respiration Monitoring System is designed for continuous, non-invasive, and real-time monitoring of a patient's breathing, graphically displaying respiration versus time and reporting the respiratory rate value. It is intended for use by healthcare professionals in healthcare facilities and dental offices on adult patients aged 22 or older.
Acceptance Criteria and Reported Device Performance
Although specific numerical acceptance criteria are not explicitly listed in the provided text, the document states that the device was evaluated against performance requirements, applicable standards, and guidance documents. The key performance metric mentioned is Respiratory Rate (RR) Accuracy.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| RR Accuracy | ± 3 BPM |
This reported accuracy is directly compared to the predicate device's accuracy (PMD Solutions / RespiraSense, K220111), which also has an RR Accuracy of ± 3 BPM, indicating that the Makani Science™ RMS meets the established performance benchmark for respiration rate accuracy.
Study Proving Device Meets Acceptance Criteria
A clinical performance study was conducted to validate the respiration rate accuracy of the Makani Science™ Respiration Monitoring System.
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Sample Size and Data Provenance:
- Test Set Sample Size: 29 human subjects.
- Data Provenance: The document does not explicitly state the country of origin, but it is clear the data is from human subjects from the "intended use population," implying a clinical setting. The study appears to be prospective, as it involved actively testing subjects with the device.
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Experts for Ground Truth Establishment:
- The document does not detail the number or qualifications of experts used to establish the ground truth beyond stating "manually counted end-tidal CO2." It is implied that healthcare professionals or trained personnel performed the manual counting.
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Adjudication Method:
- No adjudication method is described. The ground truth was established by "manually counted end-tidal CO2 using an FDA-cleared capnogram," suggesting a direct, objective measurement rather than subjective interpretation requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned or performed. The study focused on the device's accuracy against a "gold standard" rather than comparing human reader performance with and without AI assistance.
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Standalone Performance:
- Yes, standalone (algorithm only) performance was assessed. The accuracy of the Makani Science™ RMS was validated against a gold standard method, specifically "manually counted end-tidal CO2 using an FDA-cleared capnogram." This evaluates the device's ability to accurately measure respiratory rate independently.
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Type of Ground Truth Used:
- "Gold standard, manually counted end-tidal CO2 using an FDA-cleared capnogram." This represents a direct, objective physiological measurement.
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Training Set Sample Size:
- The document does not specify the sample size for the training set. The clinical study mentioned is for performance validation, not for training the algorithm.
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Ground Truth Establishment for Training Set:
- The document does not explicitly describe how the ground truth for the training set was established. However, given the nature of the device (respiration monitoring), it can be inferred that training data would likely involve various respiration patterns with corresponding accurate respiratory rate measurements, potentially derived from similar gold standard methods as used for the test set.
Additional Performance Testing Details:
The clinical testing also included:
- RR validation in all four available postures (supine, right side, left side, and reclined).
- Sub-group analysis to demonstrate maintained RR accuracy regardless of patient demographics (sex, BMI (healthy, overweight, and obese), Fitzpatrick skin type).
- Accuracy maintained in the presence of comorbidities.
- Accuracy maintained in the presence of artifacts (e.g., coughing).
- Accuracy maintained following positional change (e.g., supine → reclined position).
- Successful demonstration that RR accuracy was maintained over 24 hours of continuous use in bench testing.
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(171 days)
Qingdao Kingon Medical Science and Technology Co., Ltd
The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen.
The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.
The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.
The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode" .
In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.
The provided text describes a 510(k) premarket notification for a Portable Oxygen Concentrator (P2-TOC). It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence. However, the document does not contain information related to an AI/ML-enabled device or a study involving human experts, ground truth establishment, or comparative effectiveness with AI assistance.
Therefore, I cannot fulfill most of the requested points as the provided document is for a physical medical device (portable oxygen concentrator) and not an AI/ML diagnostic or therapeutic device.
The document primarily focuses on:
- Device Description and Indications for Use: What the portable oxygen concentrator does.
- Principle of Operation: How it separates oxygen from air.
- Comparison with Predicate Devices: Demonstrating similarity in function and safety to already-marketed oxygen concentrators.
- Non-Clinical Tests Performed: This section lists various engineering and safety standards (electrical safety, EMC, software verification, biocompatibility) that the device complies with. These are standard tests for medical devices to ensure quality and safety, not AI model performance.
- Absence of Clinical Accuracy Testing: Explicitly states "There was no clinical testing performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.
Here's what I can extract from the provided text regarding acceptance criteria and performance, focusing on what is relevant for a physical medical device:
The "acceptance criteria" for a physical device like a Portable Oxygen Concentrator are typically defined by compliance with recognized consensus standards and performance specifications. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to show compliance with these standards and performance specifications.
1. Table of Acceptance Criteria and Reported Device Performance (Based on "Comparison with predicate device" and "Non-Clinical Tests Performed"):
| Acceptance Criteria Category | Specific Acceptance Standard/Criterion (Implied or Explicit) | Reported Device Performance / Compliance |
|---|---|---|
| Safety & Electrical | ANSI AAMI ES 60601-1 (General Safety) | Complies with AAMI ANSI ES60601-1 |
| IEC 60601-1-11 (Home Healthcare) | Complies with IEC 60601-1-11 | |
| Electromagnetic Comp. | IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 |
| Performance (Oxygen Conc.) | ISO 80601-2-69 (Oxygen Concentrator Equ.) | Complies with ISO 80601-2-69 |
| ISO 80601-2-67 (Oxygen-conserving Equ.) | Complies with ISO 80601-2-67 | |
| Software | IEC 62304 (Software Verification) | Complies; Software V&V performed per FDA Guidance |
| Usability | IEC 60601-1-6 (Usability) | Complies with IEC 60601-1-6 |
| Alarms | IEC 60601-1-8 (Alarm Systems) | Complies with IEC 60601-1-8 |
| Biocompatibility | ISO 18562-1, -2, -3 (Breathing Gas Pathways) | Complies with ISO 18562-1, -2, -3 |
| ISO 10993-1, -5, -10, -23 (Biological Evaluation - Patient Contact) | Complies with ISO 10993-1, -5, -10, -23 | |
| Battery Safety | IEC 62133-2 (Lithium Batteries) | Complies with IEC 62133-2 |
| Oxygen Concentration | 90%-3%/+6% at all settings (P2-TOC) | "90%-3%/+6% at all settings" (vs. Predicates 90% +/- 3%) - Risk mitigated by ISO 80601-2-67: 2020 testing. |
| Acoustic Noise | ≤ 60dB (A) (Gear 10 of pulse mode/ Gear 5 of continuous mode) | "litter bigger than predicate device Model 1000" but "standard requirements have been met" (ISO 80601-2-69, IEC 60601-1) |
| Physical Dimensions/Weight | (Not a specific standard, but compared to predicates) | Different from predicates but risks mitigated by ISO 80601-2-69, EC60601-1, ISO 80601-2-67 testing. |
| Flow Rates | (Not a specific standard, but compared to predicates) | Continuous: 1.0-3.0 LPM (Same as predicates). Pulse: 5-200 ml Pulse Volumes (differs from predicates, max flow rate is smaller) - risks mitigated by various ISO/IEC testing. |
Regarding the points specific to AI/ML devices, I must state that the document does not provide the requested information for the following reasons:
2. Sample size used for the test set and the data provenance: Not applicable. This document describes testing for a physical device's compliance with engineering standards, not an AI model trained on data. There is no concept of a "test set" from a data perspective. The "testing" refers to bench testing of the physical hardware and embedded software. Data provenance would not be a relevant concept as it pertains to clinical data for AI model training/testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by experts is mentioned. The ground truth for device performance is based on physical measurements against established engineering and medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring expert adjudication.
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 oxygen concentrator, not an AI-assisted diagnostic or therapeutic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to a physical device, not a standalone AI algorithm. While it has embedded software, its "performance" is measured by its physical output (oxygen concentration, flow rate) and adherence to safety standards, not by an algorithm's classification or detection accuracy.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is determined by direct measurement of physical parameters (e.g., oxygen purity, flow volume, noise levels) and compliance with specified engineering and safety standards, as detailed in the "Non-Clinical Tests Performed" section.
8. The sample size for the training set: Not applicable. This is for an AI/ML model, not a physical medical device. The device itself is manufactured; it doesn't "learn" from a training set in the AI sense.
9. How the ground truth for the training set was established: Not applicable. See point 8.
In summary, the provided document is a regulatory submission for a physical Portable Oxygen Concentrator, and therefore, the information requested, which pertains to AI/ML device performance and validation studies, is not present. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this device are based on demonstrating compliance with a comprehensive set of recognized consensus engineering and safety standards through non-clinical bench testing.
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(109 days)
Verily Life Sciences, LLC
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.
Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
The Verily Numetric Retinal Camera (VNRC), the subject device, is a tabletop fundus camera that provides non-mydriatic, color, posterior segment images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. It is a non-contact, high-resolution digital imaging device that is suitable for photographing, displaying, and storing images of the retina to be evaluated under non-mydriatic conditions.
The Verily Numetric Retinal Camera takes images of the fundus in the following manner:
Focusing: The patient interactively focuses an image shown on a microdisplay to the best qualitative focus by turning a knob on an external peripheral device which modulates the camera optics.
Alignment: The patient is shown a fixation target on the microdisplay and through an interactive session with position feedback, the patient aligns their pupil to the camera. The pupil location is determined using eye-tracking.
Image Capture: White light from LEDs illuminates the fundus. The light reflection from the fundus is captured by a color CMOS sensor.
The Verily Numetric Retinal Camera has the following acceptance criteria and reported device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resolving power (center) | ≥ 60 line pairs/mm at the center of the field | Pass |
| Resolving power (mid field) | ≥ 40 line pairs/mm at the mid field (r/2) | Pass |
| Resolving power (periphery) | ≥ 25 line pairs/mm at the periphery of the field (r) | Pass |
| Field of view | 45 degrees | Pass |
| Pixel pitch tolerance |
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(90 days)
Apira Science Inc
MEN - The GroWell BT Hair Growth System ("GroWell") is designed to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V. WOMEN - The GroWell is designed to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin classifications of I-II. The GroWell is approved for Fitzpatrick skin types I-IV.
The GroWell BT Hair Growth System consists of 24 proprietary red light diode lasers and 39 proprietary red light super-luminescent diodes configured in a flexible panel which is inserted in an adult, baseball-style cap. The GroWell contains 655nm laser and LED diodes, which generates light after being excited by the internal power supply, the light is controlled and output by the control device, and directly and effectively irradiated to the treatment site, so as to achieve therapeutic effect. The GroWell's conbination of diode lasers and non-laser LED's provides for a full coverage of the head: i.e, the scalp area roughly from the top of the head to the top of the ears. The GroWell session will be "paused" and the light array will automatically turn off if the user removes the GroWell during use, and will resume when it is replaced on the 25 minute session, the lights will turn off and the GroWell will emit two audible beeps to signal that the therapy is complete.
The provided text is a 510(k) summary for the GroWell BT Hair Growth System. It states that non-clinical testing was conducted, but explicitly mentions no clinical data was used for performance verification. Therefore, it is impossible to infer acceptance criteria or details about a study proving the device meets those criteria from the provided document.
The document lists standards that the device complies with, but these cover general safety, electromagnetic compatibility, and biocompatibility, not performance related to hair growth efficacy.
Here's a breakdown of why the requested information cannot be provided from the text and what can be extracted:
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: The document states "The clinical test is not applicable, there's no clinical data." This means there were no clinical performance acceptance criteria established or met.
- Sample sized used for the test set and the data provenance: Not applicable as there was no clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What can be extracted from the text regarding device verification:
The document states: "Non-clinical testing have been conducted to verify that the GroWell meets all design specifications which supports the conclusion that it's substantially equivalent to the predicate demonstrate that the subject device complies with the following standards:"
These standards relate to safety and electrical performance, not efficacy of hair growth.
- IEC 60601-1 Edition 3.2 2020-08: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.1 2020-09: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-1-11 Edition 2.1 2020-07: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 62471 First edition 2006-07: Photobiological safety of lamps and lamp systems.
- IEC 60825-1: 2014: Safety of laser products - Part 1: Equipment classification, and requirements.
- Biocompatibility: Evaluated as per ISO 10993-1 Fifth edition 2018-08, and tested as per ISO 10993-5 Third edition 2009-06-01, ISO 10993-10 Fourth edition 2021-11 and ISO 10993-23 First edition 2021-01.
- Software evaluation: As per FDA guidance "Content of Premarket Submissions for Device Software Functions."
The conclusion provided is based on "analysis and tests" (referring to the non-clinical tests listed) and suggests substantial equivalence to predicate devices because of similar indications for use and technological characteristics (light source, design, wavelength, energy per diode). The differences noted (power supply, number of diodes, dimensions, and weight) were deemed not to raise safety or effectiveness issues due to compliance with international standards and core function (light output) not being affected.
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(223 days)
Zhangzhou Easepal Medical Science And Technology Co., Ltd.
Air compression Leg Massager is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health, it can simulate kneading and stroking of tissues by using an inflatable garment.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "Air compression Leg Massager." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample size for a test set.
- Data provenance for a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is solely an FDA clearance letter based on substantial equivalence, not a detailed report of a performance study. K240373 refers to a Class II device (Powered Inflatable Tube Massager) which typically undergoes a different type of review process than novel AI/ML-driven diagnostic devices that would require such extensive performance data.
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