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Locking Screw: The locking screws, in combination with the appropriate locking plate, are indicated for fixation of fractures, non-unions, replantations, and fusions of small bone fragments, particularly in osteopenic bone of the hand, wrist, foot, and ankle.
Cortex Screw: The Cortex Screw is indicated to be used with the APS Metal Plate & Screw System for the fixatures, osteotomies, non-unions, replantations, and fusions involving small bone fragments, especially in osteopenic conditions. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Star Cancellous Screw: The Star Cancellous Screw is indicated for the fixation of fractures, and non-unions involving the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, and distal tibia, fibula, particularly in osteopenic bone.
APS HLR Screw: The APS HLR Screw is indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments, including joint fusions (arthrodesis) in the foot and fixation of intra-articular fractures of the humerus, femur, and tibia.
Distal CAS Locking Plate: The Distal CAS Locking Plate is indicated for fixation of fractures, malunions, and osteotomies of the distal (lateral) clavicle.
Distal Clavicle Hook Locking Plate | Clavicle Anatomical Midshaft Locking Plate: The Distal Clavicle Hook Locking Plate and Clavicle Anatomical Midshaft Locking Plate are indicated for the fixation of distal (lateral) clavicle fractures, mid-shaft clavicle fractures, and dislocations of the acromioclavicular joint.
Distal Medial Humeral Locking Plate | Proximal Humeral Locking Plate: The Distal Medial Humeral Locking Plate and Proximal Humeral Locking Plate are indicated for fracture dislocations, osteotomies, and non-unions of the distal (medial) and proximal humerus, particularly in osteopenic bone.
Small ABS Locking Plate | Dynamic Compression Locking Plate: The Small ABS Locking Plate and Dynamic Compression Locking Plate are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
Distal Radial Locking Plate | Trident Distal Radial Locking Plate: The Distal Radial Locking Plate and Trident Distal Radial Locking Plate are indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Distal Lateral Femoral Locking Plate: The Distal Lateral Femoral Locking Plate is indicated for buttressing distal femur fractures, including supracondylar, intra-articular and extra-articular condylar, peri-prosthetic fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Large ABS Locking Plate: The Large ABS Locking Plate is indicated for fixation of various lones, such as the humerus, femur, and tibia. It is also for use in the fixation of osteopenic bone and fixation of non-unions or mal-unions.
Distal FDH Locking Plate: The Distal FDH Locking Plate is indicated for fractures, osteotomies, and non-unions of the metaphyseal region of the distal fibula, especially in osteopenic bone.
Distal Tibia Locking Plate System (Antero Lateral Distal Tibial Locking Plate, Distal Medial Tibial Locking Plate): The Distal Tibia Locking Plate System is indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone.
Proximal Medial Tibial Locking Plate: The Proximal Medial Tibial Locking Plate is indicated for buttressing metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, and medial split fractures with associated depression fractures of the medial tibial plateau.
Calcaneal Locking Plate: The Calcaneal Locking Plate is indicated for addressing complex of the calcaneus, including, but not limited to, extra-articular, joint depression, tongue-type, and severely comminuted fractures.
Distal RAF Locking Plate: The Distal RAF Locking Plate is indicated for fixation of complex intra- and extra-articular fractures of the distal radius and other small bones.
Mini Locking Plate System: The Mini Locking Plate System is indicated for fixation of fractures, non-unions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

The APS Metal Plate & Screw System provides anatomically contoured plates designed for use with both non-locking and locking screws. These plates are equipped with locking holes as well as holes for cortex screws, enhancing compression pressure. The combination of locking and compression technologies ensures the implants provide sufficient stability. The system is provided non-sterile and is sterilized in the user facility.

The provided text is a 510(k) summary for the APS Metal Plate & Screw System, a medical device for bone fixation. It focuses on demonstrating substantial equivalence to predicate devices, primarily through materials and mechanical performance testing, rather than clinical performance based on AI or diagnostic capabilities.

Therefore, the document does not contain the information requested regarding acceptance criteria and study details for an AI-powered device, specifically:

• No acceptance criteria table: There's no mention of performance metrics like sensitivity, specificity, or AUC for a diagnostic or AI device.
• No study proving device meets acceptance criteria for AI: The "Performance Data" section discusses biocompatibility and mechanical testing (ASTM F543 and ASTM F382) to establish equivalence for the physical hardware, not the performance of a diagnostic algorithm or AI.
• No sample sizes, data provenance, expert numbers, adjudication methods, MRMC studies, standalone performance, or ground truth details: These are all concepts relevant to the evaluation of AI models or diagnostic devices, which are not discussed in this 510(k) summary.

In summary, the provided document describes a traditional medical device (metal plates and screws) and its evaluation through material and mechanical testing, not a device involving Artificial Intelligence or diagnostic capabilities that would require the typical performance study details asked in the prompt.

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The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Procedure Masks / Surgical Masks with Polyethylene nose wire can be used in MRI environment.

Procedure Mask / Surgical Mask, Ear loops and Tie-On. This is a single use, disposable device(s), provided non-sterile.

The provided text is a U.S. FDA 510(k) clearance letter for a Procedure Mask/Surgical Mask. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain any information regarding the acceptance criteria, device performance testing (including details on sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details) for an AI/ML-driven device.

This document pertains to traditional medical device clearance (a surgical mask), which goes through a different evaluation process than AI/ML-driven software as a medical device (SaMD). The questions you've asked are highly relevant to the regulatory clearance of AI/ML-driven medical devices, but the provided text does not offer this information.

Therefore, I cannot fulfill your request using the given input, as the necessary information is absent.

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The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

The Rumble Tuff electrically powered breast pumps (models PA219DM and PA210DM) are intended for multi-user use to extract milk from lactating breasts. The PA209DM model is powered by a 9V AC/DC Power Adaptor and/or built-in 7.4V Li-lon battery. The PA210DM model is powered by a 12V AC/DC Power Adaptor and does not have a batter powered option. Pumping can be performed on one breast (single pumping) or on both breasts (double pumping). The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontrolled DC electric motor. The controlling program consists of 3 phases of speed control (Reflex, Swift, and Natural) and various suction settings. The subject devices utilize an LCD screen as a user interface. All patient-contacting and breast milk-contacting materials are identical to the predicate device.

This document is a 510(k) Premarket Notification for a Rumble Tuff Electric Breast Pump (models PA209DM and PA210DM). It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device (Rumble Tuff Electric Breast Pump K113315).

Let's break down the information to address your specific points about acceptance criteria and the study proving the device meets them.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria for a novel AI/software medical device. Therefore, many of your requested points regarding AI/algorithm performance, ground truth establishment, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a breast pump.

Instead, the "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate, and that any technological differences do not raise new questions of safety or effectiveness. The "study" proving this largely relies on non-clinical tests comparing the new devices to the predicate and compliance with relevant voluntary standards.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical device (breast pump), the "acceptance criteria" are primarily related to meeting performance specifications similar to the predicate and complying with relevant safety and performance standards. There isn't a table of specific AI algorithm acceptance criteria and reported AI performance as one might expect for a software-as-a-medical-device (SaMD) submission.

However, we can infer some comparative performance points:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in the context of a clinical test set with human subjects for performance evaluation like an AI model would have. For physical devices, "testing" usually refers to bench testing, engineering validation, and compliance verification. The tests listed are non-clinical (e.g., electrical safety, vacuum performance, use life).
• Data Provenance: Not applicable in the context of clinical data for an AI/algorithm system. The "data" here would be test results from physical device measurements. No explicit mention of country of origin or retrospective/prospective for these non-clinical tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This submission does not involve AI model performance evaluation requiring expert-established ground truth from medical images or clinical data. The tests are for the physical and functional aspects of a breast pump.

4. Adjudication Method for the Test Set

• Not applicable. There is no adjudication process described as it's not a clinical study involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This is a breast pump, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This device is a physical breast pump. While it has a "microcontrolled DC electric motor" and a "controlling program," the submission focuses on its overall functional safety and equivalence, not on the standalone performance of its internal software/algorithm in the way one would evaluate a diagnostic AI.

7. The Type of Ground Truth Used

• Not applicable / Engineering and Regulatory Standards. The "ground truth" for this device's performance would be defined by engineering specifications, validated test methods, and compliance with the limits set by voluntary standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management). For comparison to the predicate, the predicate's established performance serves as a reference.

8. The Sample Size for the Training Set

• Not applicable. This refers to machine learning models. This document describes a physical medical device.

9. How the Ground Truth for the Training Set was Established

• Not applicable. This refers to machine learning models.

Summary of the "Study that Proves the Device Meets the Acceptance Criteria"

The "study" in this context is a series of non-clinical tests and demonstrations of compliance with voluntary standards that support the claim of substantial equivalence.

These include:

• Risk Analysis: Developed in accordance with EN ISO 14971:2012.
• Electrical Safety Testing: In accordance with IEC 60601-1:2005-1:2005+CORR.2.2007+AM1:2012.
• Electromagnetic Compatibility Testing (EMC): In accordance with IEC 60601-1-2:2014.
• Safety Testing for Home Setting Use: In accordance with IEC 60601-1-11:2015.
• Software Verification and Validation Testing: Adhering to FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
• Backflow Protection Testing
• Vacuum Performance Testing
• Use Life Testing

The conclusion (Section 8) explicitly states: "The performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence." This statement is the qualitative proof that the device meets the implicit acceptance criteria for substantial equivalence to its predicate.

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Cardiovascular surgery - closure of the sternum following sternotomy.

The Sternal Cable System is an alternative over traditional monofilament sternal wire used for cardiovascular sternal closure following sternotomy. The system consists of multi-strand stainless steel and titanium cables and crimps, which are tensioned and secured around the bone using a tensioner/crimper instrument. Multiple "figure 8" constructs work as one unit to provide stabilization.

Cables are manufactured from titanium 6Al-4V ELI alloy (ASTM F136) or 316L stainless steel (ASTM F138); CP titanium (ASTM F67) or 316L stainless steel (ASTM F138) crimps are provided to match the corresponding cable materials. However, the different metals are never to be mixed. Non-implantable leaders are manufactured from 316L stainless steel (ASTM F138) or titanium 3Al/2.5V Alloy (ASTM B863) and needles are 420 or 470 stainless steel.

The implants are provided sterile for single-use but must never be re-sterilized; reusable instruments are supplied non-sterile and must be steam sterilized by the user prior to use in accordance with the instructions for use. Cases are supplied for sterilization and transport of the instruments.

The provided document is a 510(k) summary for the A&E Medical Corporation Sternal Cable System. It primarily discusses the device's substantial equivalence to a predicate device and its indications for use.

Based on the content of this document, no information is available regarding specific acceptance criteria for device performance, nor details of a study proving the device meets such criteria in terms of clinical or algorithmic performance. The document focuses on regulatory clearance based on substantial equivalence, materials, manufacturing processes, and general mechanical performance similarities to a predicate device, rather than detailed performance metrics.

Specifically, the following points pertinent to your request are addressed by the document:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states, "This submission presents no changes to the devices which required new non-clinical or clinical evidence." It only mentions "Same mechanical performance" when comparing to the predicate, but no specific metrics or acceptance criteria are given.
• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided. As no new non-clinical or clinical evidence was required or presented for performance evaluation, there is no test set in this context.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided.
• 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: This information is not provided. The device is a physical medical device (Sternal Cable System), not an AI algorithm for diagnostic reading.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided. The device is a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.
• 8. The sample size for the training set: This information is not provided.
• 9. How the ground truth for the training set was established: This information is not provided.

The document mentions a "Pyrogenicity evaluation" for endotoxin levels, which can be considered a performance test.

• Acceptance Criteria for Pyrogenicity: Endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
• Reported Device Performance for Pyrogenicity: The device was tested to ensure the endotoxin level meets this requirement. However, the exact measured endotoxin level is not stated.

In summary, the document does not contain the detailed performance study information you are seeking for a medical device that would describe specific acceptance criteria and the results of a study demonstrating these criteria were met, particularly in the context of diagnostic performance or AI systems. The focus of this 510(k) submission is on demonstrating substantial equivalence to a predicate device based on similar technological characteristics, materials, and intended use, rather than presenting a de novo performance study with quantitative acceptance criteria and results.

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This device is a ceramic blank for fabrication of dental restoration in anterior and posterior locations. This device is used for fabricating copings, crowns, inlays, veneers and bridges.

The device is a strong and esthetic dental ceramic blank that is used by dental laboratories for fabrication of dental prosthetics such as copings, crowns and bridges. The device is comprised mainly of zirconium oxide powder and is used by dental CAD/CAM systems currently available in the market. The device is initially manufactured in a partially sintered state and is milled to specifications using standard CAD/CAM milling machines by dental technicians. The milled units are then sintered fully to the final state that is capable of being used in dental restoration procedures by dentists.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.

The document is a 510(k) premarket notification letter from the FDA to A&D Dental Innovations, LLC regarding their PRISM Zirconia device. It primarily focuses on:

• FDA's substantial equivalence determination: Stating that the device is substantially equivalent to a legally marketed predicate device (Prismatik™ Clinical Zirconia, K060104).
• Regulatory information: Such as trade name, regulation number, classification, and general controls.
• Indications for Use: What the device is intended for.
• Device Description: General information about the device's material and manufacturing process.
• Substantial Equivalence justification: Briefly mentioning that performance testing (flexural strength, thermal expansion, solubility) was performed to establish substantial equivalence.

However, the document does not elaborate on:

• Specific acceptance criteria values for the performance tests.
• The actual reported device performance values against those criteria.
• Details about the study design: Such as sample size for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.
• Information about training sets (sample size, ground truth establishment).

To answer your question thoroughly, I would need a more detailed study report or technical document that outlines the specific testing conducted, the quantitative results obtained, and the predefined acceptance criteria.

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The UA-767F and UA-767FAC are designed to be used by users who are older than twelve (12) years at home or clinics to monitor their blood pressure (systolic and diastolic) and pulse rate. The arm circumference range shall be between 8.7 inches (22.0 cm) and 17.7 inches (45.0 cm).

UA-767F and UA-767FAC have the same design except UA-767FAC having an AC plug for an external AC adapter connection. Both devices use an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is inflated automatically by an internal pump of UA-767F and UA-767FAC. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300mmHg. UA-767F and UA-767FAC will not inflate the cuff higher than 300mmHg. UA-767F and UA-767FAC will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.

This document is a 510(k) K141201 premarket notification from A&D Engineering, Inc. for their UA-767F and UA-767FAC Digital Blood Pressure Monitors. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical trial with specific acceptance criteria and detailed study results as would be found in a PMA.

Therefore, the requested information, particularly regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, and detailed ground truth establishment for training and test sets, is not applicable to this type of regulatory submission and is not provided in the document. This submission primarily relies on compliance with recognized standards and a comparison of technical specifications to predicate devices.

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" in the context of a clinical trial for individual performance metrics, but rather references adherence to recognized standards like ANSI/AAMI/IEC 80601-2-30:2009 for "essential performance." The key performance metrics mentioned are accuracy for blood pressure and pulse rate, which align with the requirements of such standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details of a specific clinical test set with sample size, data provenance, or study design (retrospective/prospective). The submission relies on "design verification and design validation activities based on the comparison... with the predicate devices" and adherence to recognized international standards. This suggests testing was likely internal and focused on meeting technical specifications rather than a full-scale clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The device is a non-invasive blood pressure monitor that directly measures physiological parameters, not an AI or imaging device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document, as it pertains to expert adjudication of ground truth for interpretive devices, which this is not.

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

No. This is not an AI-assisted device and therefore an MRMC study is not relevant or included in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone blood pressure monitor. Its performance is measured directly against reference standards (as implied by adherence to standards like ANSI/AAMI/IEC 80601-2-30), not as an algorithm's output requiring human interpretation as a separate step. The document states, "The systolic and diastolic blood pressures are determined by oscillometric method." The reported accuracy falls under the device's inherent design and measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood pressure monitors, "ground truth" typically refers to measurements obtained through a validated reference method (e.g., auscultation by trained observers using a mercury sphygmomanometer) as part of the testing required by standards like ANSI/AAMI/IEC 80601-2-30. The document does not explicitly state the specific method used for ground truth, but its reliance on these standards implies their methodologies were followed.

8. The sample size for the training set

This information is not applicable and not provided. This device is a hardware-based measurement device, not an AI/machine learning model that typically relies on a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no "training set" in the context of this device.

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Measure blood pressure (systolic and diastolic) and pulse rate.

UA-651 uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is inflated automatically by an internal pump of UA-651. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300mmHg. UA-651 will not inflate the cuff higher than 300mmHg. UA-651 will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.

The provided document is a 510(k) premarket notification for a medical device, the A&D Medical UA-651 Digital Blood Pressure Monitor. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance Study Information:

For a non-invasive blood pressure measurement system like the UA-651, the crucial acceptance criteria revolve around its accuracy in measuring blood pressure and pulse rate. The document indicates that the device's accuracy specifications are unchanged from its predicate devices, which suggests these specifications were previously found acceptable.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document consistently states "No change – the same" for the UA-651's performance characteristics compared to the predicate devices. This implies that the previous clearance of the predicate devices established these as acceptable performance criteria, and the current device meets them due to technological equivalence. The document does not provide new, specific test results for the UA-651 to explicitly prove it meets these criteria in this submission. Instead, it relies on the argument of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide details on a specific clinical test set for the UA-651 itself. Since the submission relies on demonstrating substantial equivalence to predicate devices, it asserts that the modifications (primarily cosmetic changes and removal of certain features) do not affect safety or effectiveness. Therefore, a new, comprehensive clinical study with a dedicated test set and sample size specifically for the UA-651's accuracy is not detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document as there is no description of a new clinical study to establish ground truth for the UA-651.

4. Adjudication Method for the Test Set:

This information is not provided in the document as there is no description of a new clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study is not mentioned or implied in this document. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. Blood pressure monitors are automated devices, and their performance is typically assessed through direct comparison to a reference standard, not through human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The blood pressure monitor is an inherently standalone device in terms of its measurement algorithm. It measures blood pressure without direct human real-time intervention in the measurement process itself (though a human initiates the measurement). The accuracy specifications (e.g., +/- 3 mmHg) inherently represent the standalone performance of its oscillometric algorithm. However, the document does not describe a new standalone study conducted for the UA-651. It relies on the standalone performance of its predicate devices.

7. Type of Ground Truth Used:

For blood pressure monitors, the gold standard (ground truth) is typically a sphygmomanometer (manual blood pressure measurement using a stethoscope and cuff), often performed by trained clinicians, or an invasive arterial line measurement. While the document doesn't explicitly state the type of ground truth a reference standard to which the predicate devices were compared, it's implicitly understood that such a reference standard was used in the original validation of the predicate devices to establish their accuracy claims. No new ground truth establishment is described for the UA-651.

8. Sample Size for the Training Set:

The concept of a "training set" is usually associated with machine learning algorithms where data is used to train a model. While the oscillometric method involves algorithms, they are typically based on established physiological principles and signal processing, rather than iterative machine learning training on a large dataset in the modern sense. Therefore, the document does not mention a specific training set size.

9. How the Ground Truth for the Training Set Was Established:

As above, the concept of a "training set" in the context of modern machine learning is not directly applicable or discussed. The underlying algorithms for oscillometric blood pressure measurement would have been developed and validated against established physiological principles and clinical data during the development of the predicate devices, likely using reference methods for ground truth (as described in point 7). The document does not detail this process for the UA-651 or its predicate devices' initial development.

In summary: The submission for the A&D Medical UA-651 hinges on the argument of "substantial equivalence" to its predicate devices. This means that instead of presenting new studies for the UA-651, it asserts that because the core technological and operational characteristics related to blood pressure measurement are unchanged, and the modifications are primarily aesthetic or involve the removal of non-critical features, the UA-651 is presumed to have the same performance as the already-cleared predicate devices. The details about sample sizes, experts, adjudication, and specific ground truth establishment are not provided for the UA-651 itself in this document, as those would have been part of the original predicate device clearances.

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The A&D Medical UB-543 family digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.

UB-543 uses an inflatable cuff which is wrapped around the patient's wrist. After the user pushes the "START" button, cuff is inflated automatically by an internal pump once the condition of the CPG (correct position guidance) algorithm is met. Measurement starts and the systolic and diastolic blood pressures are determined by oscillometric method. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300mmHg. UB-543 will not inflate the cuff higher than 300mmHg. UB-543 will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.

The provided document is a 510(k) summary for a digital blood pressure monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a standalone performance study.

Therefore, many of the requested details about acceptance criteria studies, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance metrics, are not available in this document. The document describes changes from predicate devices and emphasizes that the fundamental scientific technology and intended use have not changed, implying that the established performance of the predicate devices should apply.

Here's a summary of the information that can be extracted from the provided text, along with a statement where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The accuracy criteria for UB-543 are provided as +/- 3mmHg and +/- 5% for pulse. For the predicate, the BP accuracy is +/- 3mmHg or +/- 2%, whichever is greater. While the UB-543 states +/- 3mmHg, it doesn't explicitly state the "whichever is greater" clause, but given the substantial equivalence claim, it's highly likely to adhere to the same underlying standard implying consistency with the predicate. The measurement range for BP is slightly expanded for UB-543 (0-299mmHg vs 20-280mmHg).

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in this document.
• Data Provenance: Not specified in this document. Given that it's a 510(k) for a modified device claiming substantial equivalence, it's possible that clinical data was not required for the modifications, and performance was inferred from the predicate device and internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a blood pressure monitor, not an AI-assisted diagnostic imaging device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, implicitly. Blood pressure monitors are standalone devices where the algorithm (oscillometric method) determines the blood pressure and pulse rate without human intervention beyond initiating the measurement. The document states: "Measurement starts and the systolic and diastolic blood pressures are determined by oscillometric method."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly stated, but for blood pressure monitors, the "ground truth" or reference standard for accuracy is typically direct intra-arterial measurement or a validated auscultatory method performed by trained personnel according to established protocols (e.g., AAMI, ISO standards). The document refers to "Accuracy: BP : +/- 3mmHg" which indicates a comparison against a reference.

8. The sample size for the training set

• Not applicable/specified. This device uses a traditional oscillometric algorithm, not a machine learning model that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

• Not applicable/specified (see #8).

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Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.

Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.

The document provided outlines the A Plus Medical Babi.Plus™ Neonatal Resuscitation Bag and its substantial equivalence to a predicate device. The primary study presented relates to comparative technological characteristics rather than a clinical study involving human patients or complex AI algorithms.

Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the ISO 10651-4:2002 standard ("Lung ventilators - Part 4: Particular requirements for opered resuscitators") and the predicate device's performance. The "Babi.Plus™" column shows the reported device performance.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a pre-market notification (510(k)) based on substantial equivalence, primarily through a comparison of technical characteristics to a known predicate device and conformity to an international standard (ISO 10651-4:2002).

• Test Set Sample Size: Not applicable. The "study" presented here is a summary of comparative technical specifications, not a clinical trial or performance evaluation using a "test set" in the context of AI/diagnostic device validation. The performance values listed (e.g., oxygen delivery, resistance) would have been determined through engineering tests on a sample of the device, but the sample size for these specific tests is not provided.
• Data Provenance: Not applicable in the sense of clinical data. The performance data is generated through laboratory testing of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study that involves expert ground truth for image interpretation or diagnosis. The "ground truth" for the technical specifications is based on established engineering principles, metrology, and compliance with the ISO standard.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process described or implied for the generation of these technical performance metrics.

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 not an AI-enabled diagnostic device, nor is it a multi-reader study. It is a manual resuscitation bag.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (manual resuscitation bag), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance characteristics (e.g., flow rates, volumes, resistances) is established through physical measurement and testing against the requirements of ISO 10651-4:2002 and comparison with the specifications of the predicate device. It is an engineering "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" or corresponding ground truth establishment described.

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Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Babi.Plus Infant Nasal Cannula System:

The information provided describes a 510(k) premarket notification for a medical device (Babi.Plus Infant Nasal Cannula System), emphasizing its substantial equivalence to a predicate device. The core of the "study" proving acceptance criteria here is a bench testing and dimensional analysis comparison to a legally marketed predicate device, rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantially equivalent performance" to the predicate device. The performance characteristics compared are "Resistance to gas flow in the inspiratory circuit" and "Resistance to gas flow in the expiratory circuit."

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria is met by demonstrating that the "Proposed Device" (Babi.Plus Nasal Cannula) has "substantially equivalent performance" to the "Predicate" device based on the measured resistance to gas flow values. Visually, the reported values for the proposed device are consistently close to, or slightly lower than, the predicate device's values, especially for the inspiratory circuit, indicating comparable or even slightly reduced resistance.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in terms of number of devices tested. The data presented is a series of measurements across different gas flow rates (1 to 12 L/min). It implies measurements were taken for at least one unit of each device type (Proposed and Predicate).
• Data Provenance: The data is generated from bench testing conducted by A Plus Medical. There is no mention of country of origin of the data, nor is it clinical (retrospective or prospective) data. It's engineering performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as the study is a bench test comparing physical performance characteristics (gas flow resistance) of medical devices, not an evaluation requiring expert interpretation of medical images or patient outcomes. The "ground truth" is derived from metrology/measurement techniques, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• None. This concept is not applicable to a bench testing study comparing physical specifications. Adjudication methods are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert interpretation of qualitative data.

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:

• No. An MRMC comparative effectiveness study was not done. This study is a bench comparison of physical device characteristics, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This study does not involve an algorithm or AI. It's a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this study is the measured physical properties (resistance to gas flow) of the predicate device. The proposed device's performance is then compared directly against these established measurements. This is based on objective measurements from a bench test setup, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This study does not involve a training set as it is a bench test comparison of physical devices, not a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable. As there is no training set, this question is irrelevant to the described study.

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