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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 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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ActiSpec® is a small limb worn activity monitor designed for documents associated with applications in physiological monitoring. The device intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.

ActiSpec® consists of a pair of toe bands containing firmware within the toe band housing, and an offline data download, scoring, and report generation tool. The ActiSpec® toe band is a small, battery-operated activity monitor worn on the big (great) toe. ActiSpec® typically is packaged as a pair of toe bands, one for each big toe.

ActiSpec® measures, records, and scores movements caused by the contraction of the tibialis anterior muscle responsible for movement of the big toe and dorsiflexion of the ankle and foot. These movements are detected by the accelerometer.

The intention is for the patient to wear the toe bands only while sleeping for five (5) consecutive nights. After the fifth night, the patient returns the toe bands to Sleep Modus and a report is generated for the care provider.

The generated report contains statistical information regarding the movements of the patient each night including a graph showing those movements. The report is in the form of a PDF document emailed to the care provider.

ActiSpec® has a 2-year shelf life in addition to a 120-hour active data collection period. Device activation occurs upon removal of the toe bands from the light-proof packaging.

The provided text discusses the ActiSpec Activity Monitor, its intended use, and its equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test and training sets, or information about expert adjudication, MRMC studies, or ground truth establishment relevant to performance metrics. The document is a 510(k) summary focused on demonstrating substantial equivalence rather than a detailed clinical study report.

Therefore, much of the requested information cannot be extracted directly from this document. I will highlight the information that is present and explicitly state where the requested details are not available.

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document states, "Testing has been performed to demonstrate that the ActiSpec® meets the predetermined specifications." However, it does not detail what those specifications are (acceptance criteria) or present a table of results against them. It only mentions a "bench comparison was performed between ActiSpec® and the predicate ActiTrainer device."

2. Sample sized 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 in the document. The document mentions "bench comparison" but does not specify the sample size or data provenance for any 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)

This information is not provided in the document. The type of testing described (bench comparison to a predicate device) does not typically involve expert-established ground truth in the way a clinical study for diagnostic accuracy would.

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

This information is not provided in the document.

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 in the document. An MRMC study is not mentioned. The device, an activity monitor, is not described as having an "AI" component that would assist human readers in interpretation; it records and scores movements.

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

The document describes the ActiSpec® as a device that "measures, records, and scores movements" and generates a report. This suggests a standalone, algorithm-only performance, as it is designed to objectively quantify activity. The core function is automated measurement and scoring. The report is then provided to a "care provider." The document states, "comparison testing demonstrates that the event recording capabilities of the devices are substantially equivalent" to the predicate ActiTrainer. This comparison would implicitly be of the standalone performance of the ActiSpec's recording capabilities.

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

The document implies that the ground truth for "event recording capabilities" was established by comparison to the predicate device, ActiTrainer. The specific mechanism of how "ground truth" was defined during this bench comparison (e.g., a reference standard for movement detection against which both devices were measured, or if accuracy was defined solely by agreement with the predicate) is not detailed. It is mentioned that "ActiSpec shares the same acceleration sensitivity with the predicate ActiTrainer but utilizes a fixed acceleration threshold of 0.1g while the ActiTrainer allows the user to define the movement threshold," indicating a comparison of their acceleration detection and scoring.

8. The sample size for the training set

This information is not provided in the document. The document describes the device, not the development process with training sets.

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

This information is not provided in the document, as no training set is discussed.

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Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.

The Ergoselect is the result of long-standing experience and its consequent implementation. The system is convincing thru the optimal, and therefore, cost-effective configuration of the ergometer according to in medical ergometer specific requirements. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect / GE measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. Ergoselect / GE ergometer includes following models (P/K versions): Ergoselect 50, Ergoselect 100 / 200, Ergoselect 600, Ergoselect 1000, Ergoselect 1200, Optibike 50 med, Optibike med.

This document describes the Ergoline Ergoselect / GE device, an exerciser for physiotherapy. Since this is a very basic device, the provided information does not contain the typical sections found in a submission for an AI/ML-powered medical device regarding acceptance criteria and detailed study results. The content focuses on demonstrating substantial equivalence to a predicate device and compliance with general safety and performance standards.

Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document.

Here's an assessment based on the provided text:

1. A 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)

Not applicable. This device is a physical exerciser, not an AI/ML diagnostic or prognostic device that uses a "test set" of patient data in the typical sense. The "performance data" refers to non-clinical performance and compliance with standards rather than clinical trial data on patient outcomes for an algorithm. The text states "All models that are covered by this 510(k) premarket notification have been on the market in Europe for years with no device failures." suggesting real-world usage experience, but it doesn't specify a sample size or provenance for this.

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)

Not applicable. "Ground truth" in the context of expert consensus is not relevant for this type of medical device as it does not perform diagnostic interpretations.

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

Not applicable, as there is no "test set" in the context of diagnostic performance 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, as this device is an exerciser, 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 is not an algorithm-only device.

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

Not applicable. The "ground truth" for this device's performance would be its adherence to established engineering, safety, and performance standards for exercise equipment, and its ability to function reliably for its indicated uses (physiotherapy, muscle redevelopment, obesity adjunct treatment).

8. The sample size for the training set

Not applicable. This device does not have an AI/ML component that requires a "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

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

The ActiTrainer is housed in a polycarbonate plastic housing. It is 8.5 cm long by 3.4 cm wide by 1.6 cm thick and it weights 51 grams. It also has an optional Polar heart strap. Data is downloaded into a PC via a USB plug and the data is displayed with ActiGraph LLC's ActiLife software.

This document describes the ActiTrainer, an activity monitor, and its substantial equivalence to a predicate device, the Actigraph. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria with numerical performance values for parameters like sensitivity, specificity, accuracy, or other commonly used metrics in medical device studies.

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, which is a common pathway for 510(k) clearance.

Therefore, many of the requested sections regarding acceptance criteria and performance study details cannot be fully answered from the provided text.

Here is an attempt to answer based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, the "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics. The performance is assessed by comparing the ActiTrainer's specifications to those of the Actigraph (K040554).

Study Details (as much as can be inferred from the document):

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 describe a "test set" in the context of a performance study with human subjects or a dataset for algorithm validation. The comparison is based on the specifications of the new device (ActiTrainer) against the specifications of the predicate device (Actigraph). This is a technical comparison, not a clinical trial or algorithm validation study. Therefore, there is no sample size for a test set or data provenance in the traditional sense.

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 is not applicable as there was no "test set" requiring ground truth establishment by experts for performance evaluation. The ground truth for proving substantial equivalence lies in the technical specifications and intended uses being comparable.

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

Not applicable, as no test set was described that would require 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. The ActiTrainer 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

This refers to the device's inherent function. The ActiTrainer operates as an algorithm-only device (it records and processes physical movement data without continuous human intervention during data collection). The "study" presented is a comparison of its technical specifications to a predicate, not an evaluation of its standalone performance in a clinical setting with numerical outcomes.

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

For the purpose of 510(k) clearance in this context, the "ground truth" is primarily the established technical specifications and intended use of the legally marketed predicate device (Actigraph K040554). The ActiTrainer's specifications and intended use are compared against these predicate "truths" to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This document describes a 510(k) submission for a physical activity monitor, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for an AI/machine learning algorithm.

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Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.

The Ergoselect 100 K/P; Ergoselect 200 K/P ergometer has been designed to meet the medical and ergonomic requirements for an efficient and relevant stress test of the cardiovascular system. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.

The ergometry system Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P consists out of the following components: Basic unit: Ergoselect 100: Ergoselect 200 Control panel type P / K Control unit: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.

The provided text is a 510(k) summary for the Ergoline Ergoselect 100 K/P and Ergoselect 200 K/P ergometers. It states that the device is deemed "substantially equivalent" to a predicate device (K851097), which means it has similar intended use and technological characteristics, and therefore does not raise new questions of safety or effectiveness.

Crucially, this type of submission (510(k)) for substantial equivalence typically does not involve a new stand-alone clinical study with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies of the kind you've asked for. Instead, the manufacturer demonstrates that their device is as safe and effective as a legally marketed predicate device.

Therefore, many of your requested points are not applicable to the information contained in this 510(k) summary. I will answer the applicable parts and indicate where information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission does not present a de novo clinical study with specific acceptance criteria and detailed performance metrics as you typically find for novel devices. Instead, a substantial equivalence determination is made against a predicate device. The "acceptance criteria" here are met by demonstrating that the new device is as safe and effective as the predicate.

1. Table of Acceptance Criteria and 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)

• Not applicable for this 510(k) submission. The submission relies on a comparison to a predicate device, not a new clinical study with a test set of patients or data.

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

• Not applicable for this 510(k) submission. No independent expert review of a new test set was conducted for this substantial equivalence determination.

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

• Not applicable for this 510(k) submission. No test set requiring adjudication was used.

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

• Not applicable for this device (ergometer) or this type of submission (510(k) for substantial equivalence). This device is an ergometer, not an AI-assisted diagnostic tool.

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

• Not applicable for this device (ergometer) or this type of submission. This device is an ergometer; it does not involve algorithms for standalone performance measurement in the context of diagnostic AI.

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

• The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate device (K851097). The new device is compared against this predicate.

8. The sample size for the training set

• Not applicable for this 510(k) submission. This device is an ergometer, not an AI-driven system that requires a "training set" in the context of machine learning.

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

• Not applicable for this 510(k) submission. As there is no training set for an AI algorithm here, no ground truth needed to be established in that manner. The "ground truth" for the submission is the regulatory acceptance of the predicate device.

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The Quinton MedTrack CR Plus Treadmill is intended to be used as a rehabilitation device for cardiovascular conditioning. The intended population are ambulatory patients undergoing exercise rehabilitation.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a treadmill (Quinton MedTrack CR Plus Treadmill). This type of document declares substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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Useful for physiotherapy in redevelopment of muscles or for restoration of motion to joints or for use as an adjunct treatment for obesity. The bicycle would be Class I exempt when sold without measuring capability but is available with ECG and/or blood pressure measuring options thus making it Class II, not exempt. The unit's workload can be controlled by an RS-232 input for connection to ECG stress test systems (supplied by other manufacturers)

Not Found

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification for an exercise bicycle (REHCOR™) and discusses its classification, indications for use, and substantial equivalence to a predicate device, but it does not detail any performance studies with specific acceptance criteria.

Therefore, I cannot fulfill your request for the tables and information regarding acceptance criteria and a study from the provided text.

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Not Found

Not Found

The provided text describes safety criteria for an exercise device but explicitly states, "Penny and Giles Biometrics makes no claims for the effectiveness of this equipment." Therefore, it is impossible to describe acceptance criteria related to a device's effectiveness or a study proving its performance against such criteria.

The information given focuses solely on passive safety and electrical safety without any performance metrics for the device's intended therapeutic or training function.

Here's a breakdown of what can be extracted and what cannot, based on your request:

1. A table of acceptance criteria and the reported device performance

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

• Not applicable. The provided text does not describe any effectiveness testing or a test set in the context of device performance. The safety criteria are likely assessed through engineering tests and analysis rather than a patient-based test set.

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

• Not applicable. No effectiveness ground truth is mentioned or established.

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

• Not applicable. No effectiveness test set 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. No effectiveness study, MRMC study, or AI component is mentioned.

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

• Not applicable. No effectiveness or algorithm performance is mentioned.

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

• Not applicable. No effectiveness ground truth is mentioned. The "ground truth" for the safety criteria would be engineering specifications and safety standards, which are implied to be met by the appendices referenced.

8. The sample size for the training set

• Not applicable. No training set is mentioned as there are no claims of effectiveness or AI/algorithmic performance.

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

• Not applicable. No training set is mentioned.

In summary: The provided document is a safety and regulatory submission, not a performance or effectiveness study. It explicitly disclaims any claims regarding the device's effectiveness, making it impossible to answer most of your detailed questions about performance criteria and related studies.

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