The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days).

The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.

The VERABANDTM is a compact, wrist-worn battery-operated wearable device intended for collecting a patient's motion data for assessing patient activity. VERABANDTM is intended to acquire and store data while being worn during normal activities and/or during sleep. The device consists of a wearable band with compact housing for battery-powered on-board electronics with an accelerometer. The recorded activity data is timestamped and stored in non- volatile memory for later retrieval. Downloaded VERABANDTM data can be post-processed based on the timestamp and magnitude of acceleration for reporting.

Here's a breakdown of the acceptance criteria and study information for the Veraband™ device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

• Accelerometer shall meet static calibration point accuracy requirement.
• Accelerometer shall meet repeatability and reproducibility requirement. | Pass |
  | Activation Trigger | - Device shall activate at the required light level.
• Device shall not activate while in the packaging. | Pass |
  | Device Donning/Doffing | Device shall be able to survive the required donning and doffing. | Pass |
  | Device Band Separation and Elongation Forces | - Device shall meet force requirements for elongation.
• Device shall meet force requirements for separation. | Pass |
  | Battery Life for Duration of Use | Device shall meet the battery life requirements for Expected Device Life. | Pass |
  | User Cleaning | Device shall maintain function after a required minimum number of cleanings. | Pass |
  | Device Sampling Rate and Full-Scale Dynamic Range | Device shall have a sampling rate and full-scale dynamic range that meets the requirements. | Pass |
  | Device Frequency Response | Device shall be within the requirement of the predicate's bandwidth. | Pass |
  | VERABAND™ Intended Use | Device shall meet repeatability and reproducibility requirements for activity levels. | Pass |
  | VERABAND™ Report Generation Comparison | Device output metrics shall meet the predicate comparison requirements. | Pass |
  | Usability | Device shall meet the related usability requirement survey scores. | Pass |
  | Packaging Testing | Device shall maintain function per requirements after shipping. | Pass |
  | EMC | Device shall meet the related EMC requirements. | Pass |
  | Electrical Basic Safety | Device shall meet the related electrical basic safety requirements. | Pass |
  | Biocompatibility Testing | Device shall meet the related biocompatibility requirements. | Pass |
  | Firmware Verification and Validation Testing | Device shall meet the related Firmware requirements. | Pass |
  | Software Verification and Validation Testing | Device shall meet the related Software requirements. | Pass |

2. Sample Size and Data Provenance (for test set, if applicable)

The document primarily describes non-clinical engineering and performance testing. It does not explicitly state a "test set" in the context of clinical data. For the "VERABAND™ intended use" test, it states "Simulated users wearing the device perform activities at different intensities of motion and wear compliance times." While it implies subjects, no specific sample size is provided. The data is non-clinical/simulated.

3. Number of Experts for Ground Truth and Qualifications (for test set, if applicable)

Not applicable, as the provided data focuses on non-clinical and simulated testing for performance validation rather than expert-derived ground truth for a test set of patient data.

4. Adjudication Method (for test set, if applicable)

Not applicable. The reported tests are primarily objective engineering and performance validations against predefined criteria, not subjective human evaluations requiring adjudication.

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

No. The document explicitly states: "The VERABAND™ did not require clinical studies to support substantial equivalence to the primary predicate device." Therefore, no MRMC study was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

Yes, the majority of the reported testing falls under standalone performance. The "non-clinical testing summary" details various tests (e.g., accelerometer accuracy, battery life, sampling rate, frequency response, report generation comparison) that evaluate the device's technical functionality and performance in isolation or in comparison to a predicate device's output, without human-in-the-loop performance measurement.

7. Type of Ground Truth Used

For the non-clinical tests, the ground truth was based on:

• Established engineering specifications and requirements (e.g., full-range accuracy, required light level, expected device life, minimum number of cleanings, sampling rate, full-scale dynamic range, predicate's bandwidth, repeatability and reproducibility for activity levels, predicate comparison requirements for output metrics).
• Recognized consensus standards (e.g., IEC, ISO, ASTM).
• Simulated motions and user activities.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. The device is described as an activity monitoring device with an accelerometer to acquire and store data, which is then post-processed. It doesn't appear to be an AI/ML-driven diagnostic device that would typically involve a training set for model development.

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

Not applicable, as there is no mention of a "training set" for an AI/ML model. The device's operation relies on sensor data acquisition and processing based on established algorithms and engineering principles, not on a trained machine learning model.

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This device is intended to be used as a stress test device in a medical environment. The main goal of the devices is to create reproducible stress tests. With cycling ergometers typically workload (watt) is imposed. This product is designed both for manual operation and for control by external software. This device will be used in conjunction with another medical device to obtain other important physiological data, allowing a physician to evaluate a test subjects physical status.

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

The provided text is a 510(k) summary for a medical device (MR Ergometers) and does not contain information about acceptance criteria or a study proving that the device meets such criteria. It primarily focuses on the FDA's regulatory review and determination of substantial equivalence for the device.

Therefore, I cannot provide the requested information based on the given input.

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The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals.

The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults:

• Pulse Rate
• Respiratory Rate
• Sleep/Wake Behavior
• Activity associated with Movement

The Spire Health Remote Patient Monitoring System is intended only for general, non-diagnostic sleep and wake behavioral monitoring. It is not intended to assess sleep staging nor diagnose sleep disorders.

The Spire Health Remote Patient Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Spire Health Remote Patient Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG.

The Spire Health Remote Patient Monitoring System is not a substitute for an ECG monitor.

The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data and share this data with healthcare providers with a view to improving patient health and outcomes. The RPM is intended for longitudinal monitoring of pulse rate, respiratory rate, sleep/wake behavior, and activity associated with movement.

The RPM solution is comprised of four components - a Medical Health Tag (MHT), a Spire Mobile Application (Mobile App), a Cloud Platform (Platform) and a Healthcare Professional Dashboard (HPD). The patient facing components of the MHT and Mobile App) are intended for daily use in professional healthcare facilities or in the home. The MHT is a component designed to be affixed semi-permanently via an adhesive backing to the patient's first layer of clothing (e.g. underwear, bras, or pajamas), passing through laundry cycles without detaching. It does not require charging by the user.

The Spire Health Remote Patient Monitoring System was evaluated for various performance metrics, including Pulse Rate and Respiratory Rate Validation, and Activity associated with Movement Validation.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide specific details on the sample sizes used for the test sets for Pulse Rate, Respiratory Rate, or Activity associated with Movement Validation. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts used to establish the ground truth for any of the test sets, nor does it detail their qualifications.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the test sets.

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

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size of human readers improving with AI vs. without AI assistance. This type of study appears to be not applicable to the reported performance evaluations which focus on device accuracy for physiological parameters and activity.

6. Standalone Performance:

Yes, a standalone performance evaluation was done for the algorithm (device itself) without human-in-the-loop performance, as indicated by the "Pulse Rate Validation," "Respiratory Rate Validation," and "Activity associated with Movement Validation" tests. These tests assess the intrinsic accuracy and functionality of the device's measurements.

7. Type of Ground Truth Used:

• Pulse Rate Validation: Ground truth was established by comparison to the standards outlined in ISO 80601-2-61.
• Respiratory Rate Validation: Ground truth was established through a clinical comparison to end-tidal CO2.
• Activity associated with Movement Validation: Ground truth was established through clinical testing to confirm accuracy, though the specific reference method is not detailed.

8. Sample Size for the Training Set:

The document does not provide details on the sample size used for any training set for the device's algorithms.

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

The document does not provide information on how ground truth was established for any training set.

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A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity with audiovisual feedback & graphic movement representations for patients as well as videos of the patients performing the exercises which can be remotely accessed by the clinician. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

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This FDA 510(k) clearance letter for the Vera device does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specifics of the study that proves the device meets those criteria. The letter primarily confirms the device's substantial equivalence to predicate devices and outlines regulatory obligations.

However, based on the provided text, I can infer some information and highlight what is explicitly missing.

Information that CAN be extracted or inferred:

• Device Name: Vera
• Intended Use: A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults (upper extremity, trunk, and lower extremity) in the clinic and at home, with audiovisual feedback, graphic movement representations for patients, and remote access to patient exercise videos for clinicians. Patient assessment, exercise guidance, and approval by a medical professional are required prior to use.
• Regulatory Status: Cleared as a Class II medical device (Product Code LXJ), Regulation Number 21 CFR 890.5360 (Measuring Exercise Equipment).
• Use Type: Prescription Use.

Information that is NOT present in the provided text and is crucial for your request:

1. A table of acceptance criteria and the reported device performance: This detailed information is typically found in the 510(k) summary or the full submission, not in this clearance letter.
2. Sample sizes used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: Not mentioned, and generally less common for this type of device (measuring exercise equipment).
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned, though the device has a standalone component (the software system itself). The performance metrics for this standalone component are what's missing.
7. The type of ground truth used: Not mentioned. For a rehabilitation device, this could involve motion capture systems, clinical assessments, or expert observation.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

To obtain the specific information you are looking for (acceptance criteria, study details, performance metrics, ground truth methods, sample sizes), you would need to access the full 510(k) submission for K192474, which may be available through the FDA's website or by filing a Freedom of Information Act (FOIA) request. The public 510(k) summary, if available, would be the most likely place to find a high-level overview of the performance data.

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The provided text is an FDA 510(k) clearance letter for the device "Vera" by Reflexion Health, Inc. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance data, study design parameters (sample size, data provenance, expert qualifications, adjudication methods), or details about training sets or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text. The document is essentially a regulatory clearance notice, not a clinical study report or a technical performance specification document.

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The REAL Immersive System is an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a seated position in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.

REAL Immersive System is a digital hardware and software medical device platform using a combination of virtual environments and full presence tracked avatars for visual feedback. It is designed for use in healthcare and focusing on physical and neuro rehabilitation. The use of the device is intended to be in a clinical environment supervised by a medical professional trained in rehabilitation therapy.

REAL Immersive System contains the following components:

• . All-in-One HMD with Software Application
• . HMD Controller
• Wireless Transmitter Module (WTM or Large Sensor) .
• Wireless Sensor Module (WSM or Small Sensor) .
• . Tablet with Software Application
• . Sensor Charger (charging station)
• Router ●
• Router Battery ●
• Sensor Bands .

The provided text is a 510(k) premarket notification letter for the Penumbra REAL Immersive System. This type of FDA submission seeks to establish substantial equivalence to a legally marketed predicate device, rather than proving novel claims or establishing new general acceptance criteria through a full clinical trial. Therefore, the document does not describe specific acceptance criteria a device must meet in a traditional sense, nor does it present a study that proves the device meets those criteria for novel claims.

Instead, the submission demonstrates that the REAL Immersive System is substantially equivalent to a predicate device (MindMotion Pro) based on:

1. Similar intended use.
2. Similar technological characteristics.
3. Non-clinical performance data (biocompatibility, electrical safety/EMC, software verification & validation, bench-top performance) that shows the device functions as intended and does not raise new questions of safety or effectiveness compared to the predicate.

Given this context, I will address your request by interpreting "acceptance criteria" as the types of testing and successful results deemed sufficient by the FDA for establishing substantial equivalence for this type of device, as outlined in the provided 510(k) summary. "Reported device performance" will refer to the summary of results presented.

Here's an analysis based on the provided document:

1. Table of "Acceptance Criteria" (interpreted as required testing categories for 510(k) SE) and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of a clinical trial with a defined test set of patient data. The "test set" here refers to the device itself undergoing various engineering and biological safety tests. The document does not specify a numerical sample size for components tested, but rather indicates that the required tests were performed on "the device."
• Data Provenance: The data is generated internally by Penumbra, Inc. through their engineering and quality control processes to ensure compliance with relevant standards. It is not patient or clinical data in this context. The provenance is therefore the device manufacturer's internal testing.

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

• Not applicable. The ground truth for these types of engineering and biocompatibility tests is adherence to established international and national standards (e.g., ISO 10993, ANSI/AAMI 60601-1, IEC 60601-1-2, FCC). There isn't a "ground truth" established by human experts in the sense of clinical annotations or pathological diagnoses for this type of submission.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus-building among multiple human evaluators, typically in clinical studies, to establish ground truth or assess outcomes. These are not relevant for demonstrating compliance with engineering and safety standards.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this 510(k) submission. The document explicitly states: "No clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."
• Effect size: Therefore, there is no reported effect size for human readers improving with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not directly applicable in the terms usually associated with AI/ML algorithms. The REAL Immersive System is essentially an "algorithm only" system in the sense that its software processes inputs and provides outputs. The performance here is evaluated against its functional specifications and compliance with standards, not generally as a standalone diagnostic or interpretative AI performance for clinical decision-making. The system's performance is demonstrated through the verification and validation (V&V) of its software.

7. The Type of Ground Truth Used

• The "ground truth" for the various tests conducted is defined by compliance with established industry standards and regulatory requirements.
  • For biocompatibility: ISO 10993-1.
  • For electrical safety/EMC: ANSI/AAMI 60601-1, IEC 60601-1-2, 60601-1-6, IEC 62366, FCC regulations.
  • For software: FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
  • For bench-top performance: Manufacturer's internal design specifications and functional requirements.

8. The Sample Size for the Training Set

• Not applicable. This device is not described as utilizing machine learning or AI that requires a "training set" of data in the common sense for deriving algorithms or predictions. The software is developed using traditional engineering principles and verified against its specifications.

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

• Not applicable, as there is no "training set."

In summary, the provided document is a 510(k) notification focused on demonstrating substantial equivalence through non-clinical performance data and compliance with established standards, not a report on a clinical study with traditional acceptance criteria for diagnostic accuracy or clinical outcomes.

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DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and the like.

DARI Health is a "markerless," three-dimensional human motion capture and analytical software system that uses off-the-shelf video cameras, off-the-shelf computer hardware, off-theshelf motion analysis software, and proprietary DARI Health Software (consisting of DARI Connect, DARI Capture plug-in, DARI Insight Engine, and DARI Rerort Engine) or DARA quantify, and document full-body human kinematics and kinetics during patient movement. Motions are recorded in real-time, using a digital "skeleton" to identify joint center and segment data for the cervical spine, upper extremity, trunk, and lower extremity of the paint. The captured video can be viewed after recording has ended or at some later point. During movement, the DARI Health interfaces with the capture software (off-the-shelf, Captury Live) tracks all segments and joint centers as they move in all planes of more the with resulting output is sent to The DARI Insight Engine processing software-either housed it ally on the computer used for capture or in a security-compliant, cloud-based server-where thered drant can be used to calculate all kinetic data produced during the revor d more one more one Such data is then displayed in different report formats-from large, raw datasets to simple, grahital reports that track key biomechanical metrics. Healthcare providers can access patient biomechanical data remotely through a secure webportal or locally on the computer database application to monitor patient progress and view prior or current motion analyses. There is no direct contact with the patient by the DARI Health system, and no energy is delivered to the subject at any point during the usage of the system.

The DARI Health device is a "markerless," three-dimensional human motion capture and analytical software system that uses off-the-shelf video cameras, computer hardware, motion analysis software, and proprietary DARI Health Software to quantify and document full-body human kinematics and kinetics during patient movement.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are not explicitly stated in a defined "acceptance criteria" section with specific numerical thresholds. Instead, the document discusses the device's performance in relation to predicate devices and industry standards. Therefore, I will derive the implicit acceptance criteria from the performance claims made in the "Summary of Performance Data" section and present the reported device performance.

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

• Sample Size for Kinematic Accuracy Study: Not explicitly stated as a number of subjects or sessions. It refers to "clinically relevant joint angles being measured for investigation" in a comparison to a predicate system.
• Sample Size for Kinetic Accuracy Study: Not explicitly stated as a number of subjects or sessions. It refers to a comparison to "simultaneous measurements derived from a force plate."
• Sample Size for Repeatability Study: "Successive scans of 9,120 bone segments" were analyzed. This implies a significant amount of data, likely from multiple subjects and/or multiple scan sessions.
• Data Provenance: The studies are described as "independent, peer-reviewed studies" and "DARI Health internal studies." The country of origin of the data is not specified, but the submission is to the U.S. FDA. The retrospective or prospective nature of these studies is not explicitly mentioned.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth was established by:

• Predicate marker-based Vicon (Peak Motus) system: For kinematic accuracy.
• Industry-standard force plate output: For kinetic accuracy.
• Successive scans and internal measurements: For repeatability.

Therefore, there were no human experts establishing the ground truth as described in the prompt's question for this type of objective measurement device.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was established by objective measurement systems (Vicon, force plate, internal measurements), there was no human adjudication process involved for the test set.

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

No, an MRMC comparative effectiveness study was not conducted. The studies described are focused on the technical accuracy and repeatability of the device's measurements compared to established objective methods, not on how human readers (clinicians) improve with AI assistance. The DARI Health system is a measurement and analysis tool, not one that directly assists a human reader in making a diagnostic interpretation in the same way an AI for medical imaging might.

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

Yes, the performance studies described are essentially standalone (algorithm only) performance assessments. The DARI Health system's ability to accurately capture, quantify, and analyze human movement (kinematics and kinetics) and its repeatability are evaluated as a standalone system against objective measurement standards. It does not involve human-in-the-loop performance in the context of these validation studies.

7. The Type of Ground Truth Used

• Kinematic Accuracy: Reference data from a predicate marker-based Vicon (Peak Motus) system. This is an instrument-based ground truth.
• Kinetic Accuracy: Reference data from industry-standard force plate output. This is also an instrument-based ground truth.
• Repeatability: Internal measurements of successive scans of bone segments, indicating the device's consistency over time.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. The descriptions focus on performance validation rather than the details of algorithm development or training.

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

The document does not provide any information on how the ground truth for the training set (if any specific training set was used for machine learning models, which is implied by a "markerless" system) was established. The "Summary of Performance Data" focuses solely on the validation/test datasets against established objective measures.

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The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

The Qualisys Clinical System (QCS) is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

In order to achieve this, the QCS utilizes data captured from image sensors (motion capture cameras) to triangulate the 3D-position of one or several reflective markers attached to the patient. This is done by two or more cameras calibrated to provide overlapping field of views from multiple angles. QCS produce data with 3 degrees of freedom for each marker, i.e. positional information. Rotational information (e.g. of a limb) may be retrieved from the relative orientation of three or more markers.

The tracking cameras may record images and identify the position of the markers with a high spatial and temporal resolution to generate high performance motion capture of the markers.

The markers are usually attached directly to the skin. The markers are specially designed to reflect the IR-light flashed from the tracking cameras.

In addition, subsystems may be added to record data in synchronization with the tracking cameras to facilitate the analysis, or for pure documentation purposes. The additional subsystems may be any one of, or a combination of: 1) Ordinary video, 2) EMG data and 3) Force plate data.

Here's an analysis of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., accuracy, precision) that the Qualisys Clinical System (QCS) must meet for regulatory purposes. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device (SMART-D [K131660]) through technical and functional comparisons, along with performance data from non-clinical tests.

The reported device performance is described generally through the successful completion of software and hardware tests, and demonstration of metrological accuracy and reliability.

Table 1: Implicit Acceptance Criteria and Reported Device Performance

Study Information

The document describes non-clinical tests rather than a formal clinical study with human subjects for novel device performance claims. The primary "study" is a comparative analysis demonstrating substantial equivalence to a predicate device.

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

• Test Set Sample Size: Not explicitly stated as a number of patients/cases. The "test set" primarily refers to software and hardware testing.
• Data Provenance: Not specified for any dataset related to the performance data. It is focused on demonstrating substantial equivalence through technical and functional comparisons and non-clinical testing.

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)

• Number of Experts: Not applicable. The ground truth for the non-clinical tests and metrological accuracy would be established by engineering standards, calibrated instruments, and scientific literature rather than expert human interpretation of medical data.
• Qualifications of Experts: N/A.

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

• Adjudication Method: Not applicable. This concept typically applies to studies where human readers are interpreting a test set and their discrepancies need to be resolved. The document focuses on technical verification and validation against specified requirements and predicate device characteristics.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a motion capture system, not an AI-assisted diagnostic tool that aids human readers in interpretation.

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

• Standalone Performance: Yes, the described "Non-clinical tests performed on the QCS include software and hardware tests" and "Metrological accuracy and reliability of the raw output of the system (three-dimensional position of reflective markers) has been verified and validated" indicate standalone performance evaluations of the system's components and overall output. The system quantifies and displays movement patterns.

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

• Type of Ground Truth:
  • For metrological accuracy, the ground truth is established by physical standards (e.g., "dimensions of the calibration devices supplied with the system are traceable to a national meter reference").
  • For software and hardware functioning, the ground truth is against predefined technical specifications and requirements.
  • For the relevance of gait assessments, it refers to a "Clinical Evaluation report," implying a review against established clinical understanding and literature on gait analysis.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The document describes a medical device for motion capture, not a machine learning or artificial intelligence system that requires a "training set" in the conventional sense.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning model.

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The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for document associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The Insight watch can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis.

The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral.

The ActiGraph CentrePoint Insight Watch is a wrist-worn activity monitor designed for physiological monitoring, particularly for tracking movement during sleep to analyze circadian rhythms and assess physical motion.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of acceptance criteria and the reported device performance:

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 states that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." Therefore, there is no clinical test set described in this submission. The "test set" in this context refers to devices used for non-clinical bench testing. The sample size for these non-clinical tests is not explicitly mentioned, nor is the provenance of data for these tests beyond being "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set for ground truth establishment is described. The acceptance is based on substantial equivalence to a predicate device through non-clinical bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication is described.

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 device is an activity monitor, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The document describes the device as a standalone activity monitor that records and stores data from an accelerometer. Non-clinical bench testing was performed to demonstrate its performance and reliability in this standalone function. The "study" mentioned is the series of non-clinical bench tests performed to support substantial equivalence.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be established engineering specifications and recognized voluntary consensus standards. For example, accelerometer dynamic range, sampling rate, memory capacity, water resistance, weight, size, and recording time were compared against the predicate device's capabilities and against the device's own internal specifications validated through bench testing. The non-clinical bench tests included:

   • Performance and reliability testing
   • Comparative data analysis
   • Basic safety and essential performance in accordance with AAMI ES60601
   • Electromagnetic compatibility (EMC) in accordance with IEC 60601
   • Biocompatibility and material standards confirms there is no harm to the patient wearing the device.
   • System compatibility with ActiGraph software for data download and collection

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set for model development.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model for this device.

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MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient exercise guidance, and approval by the medical professional is required prior to use.

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This document is an FDA 510(k) clearance letter for the MindMotion™ GO device. It states the device's indications for use but does not contain information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, experts, adjudication), or comparative effectiveness studies. Therefore, I cannot fulfill your request for that specific information based on the provided text.

The closest information provided is the "Indications for Use":

Device Name: MindMotion™ GO

Indications for Use (Describe): MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient exercise guidance, and approval by the medical professional is required prior to use.

Ask a specific question about this device