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510(k) Data Aggregation
(107 days)
G-Trainer™
Common Name:
Treadmill Unweighing System
Classification Name:
Powered Exerciser (21 CFR 890.5380
O'Brien Drive Menlo Park, CA 94025
Re: K072887 Trade/Device Name: G-Trainer Regulation Number: 21 CFR 890.5380
The Alter-G G-Trainer is indicated for use in the following conditions:
Aerobic conditioning Weight control and reduction Sport specific conditioning programs Gait training in neurologic patients Strengthening and conditioning in older patients Rehabilitation following injury or surgery of the lower extremity Rehabilitation following injury or surgery of the hip, knee, ankle or foot. Rehabilitation after total joint replacement
The G-Trainer is designed to provide an adjustable weight support while the user exercises on the incorporated treadmill. The G-trainer is comprised of a standard exercise treadmill with an integrated unweighting component that can effectively reduce the body weight of an individual while they exercise. A bag that looks much like a small tent is placed over the running surface of the treadmill and sealed in such a manner that an electric blower can inflate the bag. The subject wears a special pair of shorts that zip into the top and center of the bag much like the skirt used on a kayak. The subject zips into the bag and stands on the surface of the treadmill. Using a touch screen control panel, the subject is able to increase or decrease the pressure in the bag. The pressure in the bag provides weight support for the user. By this method. the effective weight of the subject on the treadmill surface can be precisely controlled while they exercise.
The G-Trainer is comprised of a base frame, a treadmill, an upper support frame, the inflatable bag, a pressure source and regulation system, control electronics and a control console.
The provided text describes the G-Trainer, a treadmill unweighing system, and its clinical validation. However, it does not contain typical "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, accuracy, or F1-score, which are common for AI-driven diagnostic devices. Instead, the document focuses on demonstrating the device's functional equivalence to predicate devices and its safety and effectiveness through various studies.
Here's an analysis based on the information provided, framed to address your requested points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit "acceptance criteria" with numerical thresholds are not present in this document. Instead, the performance is described qualitatively in relation to its intended use and comparison to predicate devices. The primary functional claim demonstrated is the ability to accurately adjust effective body weight.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy in adjusting effective body weight | "highly accurate in adjusting the effective body weight of an exercising subjects." "A highly correlated, linear relationship between %body weight and measured body weight could be demonstrated." "The results of this study indicate the G-Trainer to be as effective as the predicate devices in adjusting effective body weight." (Non-Clinical Performance Data) "A linear relationship was found between ground reaction force and % body weight reduction." (Third VA study) "Reduction in ground reaction force showed good correlation with the reduction in body weight." (First UCSD study) "Ground reaction force was observed to decrease linearly with increasing weight support." (University of Colorado study) |
| Safety for use (e.g., cardiovascular response, adverse events) | "Changes in heart rate and blood pressure were of the same magnitude as the change seen when moving from a standing to a supine position." (First VA study) "No significant difference in cardiovascular response was seen between full body weight and unweighted (75% reduction) exercise. The authors concluded that walking with air pressure support appeared to be safe for individuals with stable cardiovascular conditions." (Second VA study) "The authors concluded that neither cardiovascular parameters nor gait characteristics change significantly with lower body positive pressure exercise. They suggest that lower body positive pressure exercise is a potentially new and safe rehabilitation tool..." (Second UCSD study) "The clinic reported no adverse incidents while using the G-Trainer and concluded it to be a safe and effective tool in the clinical setting." (Device Design Validation Trial) "No adverse events were reported in more than 500 individuals cited in these studies, testament to the safety of the G-Trainer..." (Clinical Performance Data Summary) |
| Effectiveness in rehabilitation/gait mechanics | "Pain while exercising was significantly reduced in the ACL patients. The authors concluded that lower body positive pressure exercise is effective at reducing ground reaction forces, while facilitating gait postoperatively." (First UCSD study) "Gait and EMG activity were largely unaffected except at 20% of body weight." (First UCSD study) "Gait kinematics to be only marginally effected at the lower body weights." (University of Colorado study) "Clinical experience clearly indicates the utility of the G-Trainer in the rehabilitation of a wide variety of orthopedic patients." (Clinical Performance Data Summary) "The clinic... concluded it to be a safe and effective tool in the clinical setting." (Device Design Validation Trial) |
| Substantial equivalence to predicate devices | "The G-Trainer has the same intended use as the predicate devices. The treadmills used in both the predicate and G-Trainer devices have the same performance and safety characteristics. The unweighting system used in the G-Trainer, although technologically different from the predicate devices, has been demonstrated through verification and validation testing, as well as clinical experience, to be as effective at reducing effective body weight as those systems used by the predicate devices." (Substantial Equivalence Conclusion/Summary) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document describes several studies, which cumulatively serve as the "test set" for validating the device's performance, safety, and effectiveness. There isn't a single "test set" in the sense of a machine learning evaluation.
- Study 1 (Feasibility - VA): Eight healthy male subjects (29 to 52 years of age). Prospective. Data provenance not specified beyond "Veterans Administration Rehabilitation Research and Development Center in Palo Alto, California."
- Study 2 (Cardiopulmonary Response - VA): Nine subjects with stable cardiovascular or respiratory disease. Prospective. Data provenance as above.
- Study 3 (Ground Reaction Force - VA): Ten healthy individuals. Prospective. Data provenance as above.
- Study 4 (ACL/Meniscectomy - UCSD): Fifteen patients that had undergone ACL reconstruction or arthroscopic meniscectomy. Prospective. Data provenance not specified beyond "University of California, San Diego."
- Study 5 (Cardiovascular/Gait Changes - UCSD): Nine subjects (for cardiovascular response), six of whom were also studied for gait changes. Prospective. Data provenance as above.
- Study 6 (Runners - University of Colorado): Ten healthy recreational runners. Prospective. Data provenance "University of Colorado, Department of Integrative Biology."
- Study 7 (Device Design Validation Trial - Ergo-Rehab): 470 clients (375 orthopedic problems, 95 general cardiovascular conditioning). Prospective/Retrospective observation. Data provenance "physical therapy clinic, Ergo-Rehab, of Fremont, CA". This was an 18-month observational period.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is not an AI diagnostic tool and does not rely on "ground truth" derived from expert image interpretation in the typical sense. Instead, the studies involved medical professionals and researchers to conduct and interpret physiological measurements and clinical outcomes.
- First VA Study: Dr. Robert Whalen (inventor, likely a researcher/engineer) and collaborators from the Veterans Administration Rehabilitation Research and Development Center.
- Second and Third VA Studies: Researchers from the Veterans Administration Rehabilitation Research and Development Center.
- UCSD Studies: Dr. Alan Hargens (co-inventor, researcher at University of California, San Diego) and his laboratory.
- University of Colorado Study: Researchers from the Department of Integrative Biology.
- Device Design Validation Trial (Ergo-Rehab): The clinic provided monthly reports of patient use, pathologies rehabilitated, and comments. This implies clinical assessment by therapists/clinicians at the clinic, but specific "experts" for ground truth establishment are not detailed. The "System operators will be trained medical practitioners operating from clinics, hospitals and research facilities."
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are not applicable to the physiological and clinical outcome measurements described for the G-Trainer. These studies involved direct measurements and clinical observation, not subjective interpretations requiring adjudication among multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed because the G-Trainer is a physical device for rehabilitation, not an AI system assisting human readers in diagnostic tasks. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not relevant.
6. Standalone (Algorithm Only) Performance
The G-Trainer is not an algorithm, but a physical medical device. The "Non-Clinical Performance Data" section describes "verification testing" where the device's accuracy in adjusting body weight was directly measured without human intervention beyond operating the control panel. This could be considered a form of "standalone" performance for the core mechanical function.
7. Type of Ground Truth Used
The "ground truth" for the G-Trainer's validation included:
- Physiological Measurements: Measured body weight on a calibrated scale, ground reaction force (measured using force plates), heart rate, blood pressure.
- Clinical Outcomes/Observations: Reduction in pain, gait changes, EMG activity, and general clinical effectiveness and safety as observed by physical therapy clinics.
- Metabolic Demand: Measured during exercise.
These are objective or semi-objective measurements and clinical assessments, not expert consensus on qualitative data like images.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as the G-Trainer is a physical device and not an AI/machine learning algorithm that requires training data. The development prototypes and early iterations could be considered analogous to a design and refinement process, but not a data-driven "training" in the ML sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this question is not applicable. The device's design was based on scientific principles (air pressure differential technology) initially conceived at NASA and refined through the studies mentioned.
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(219 days)
Name: Active Elbow Brace
Classification Name:
890.1375, EMG-triggered powered exercise equipment OAL 890.5380
the following product codes have been adopted under Section 514 of the Food Drug and Cosmetic Act: 890.5380
The Myomo e100 is indicated for use by stroke patients undergoing rehabilitation to facilitate the following:
. Stroke rehabilitation by muscle re-education
. Maintaining or increasing range of motion .
The Myomo e100 is an electromechanically powered device intended to facilitate movement and increase range of motion for stroke patients. This device would be included as part of prescribed physical therapy to enable stroke patients to exercise that would otherwise be unable to independently do so. The Myomo e100 is an automatic strength amplifier using the detected electromyograph (EMG) as an indication of residual muscle strength. In the case of a patient who is unable to move his/her arm, the addition of strength amplification allows him/her to perform standard physical therapy exercises.
The Myomo e100 is available in left and right arm configurations. Foam pad inserts of various shapes are provided for fitting the brace for individual patients. Placement of the EMG sensors is configured for the individual patient allowing placement on either the tricep or bicep depending on the prescribed exercise. Optional adjustments for bicep and tricep gain are set and stored as part of the customization.
As pictured in Figure 1, adjustable straps are used to attach the brace to the arm. Once the brace is properly fitted to the arm the Myomo e100 is turned on using the "Control User Interface". The EMG signals are calibrated in the resting position and then the brace is ready for operation. The battery pack attaches to the "Control User Interface" and is not in contact with the patient.
The prescribing health care provider incorporates use of the Myomo e100 as part of a patient's physical therapy regimen. Progress can be monitored through the prescribed therapy using a goniometer, Fugl-Meyer testing, or other conventional evaluation techniques.
The Myomo e100 consists of three main elements:
- Brace: provides support for the forearm during lift. 4.1
- 4.2 EMG Sensors: B & L Electrodes
- Control User Interface: provides the signal processing function and the motor 4.3 mechanism and controls for operation of the Myomo e100.
The Myomo e100 510(k) submission (K062631) does not contain the type of acceptance criteria and performance study details typically associated with AI/ML-based medical devices or diagnostics. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technical characteristics, and compliance with general safety and performance standards.
The document explicitly states: "Neither bench, animal nor clinical testing were assessed." and "Performance Testing: Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30." This means a formal clinical performance study, as would be expected for AI/ML devices, was not required or submitted for this particular device.
Therefore, many of the requested categories in your prompt cannot be answered from the provided text. I will provide the information that is available.
Description of Acceptance Criteria and Reported Device Performance
The submission for the Myomo e100 does not present a table of specific acceptance criteria for a diagnostic or AI/ML performance study, nor does it report device performance in terms of metrics like sensitivity, specificity, or accuracy.
Instead, the "Performance Data" section primarily addresses:
-
Compliance with recognized standards:
- IEC 60601-1-1 (Thermal, Electrical, Mechanical Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- FDA's "Reviewer Guidance for the Content of Premarket Submission for Software Contained in Medical Devices", May 11, 2005
- FDA's "Guidance for Off-The-Shelf Software Use in Medical Devices"
- ISO 14971:2000 (Risk Analysis)
- ISO 10993-1:2003 (Biocompatibility)
- Title 21 CFR Part 898 Performance Standard for Electrode Lead (demonstrated by conformity to IEC 60601-1-1).
-
Design Verification and Validation: Bench testing was performed according to FDA's Design Control Requirements (Title 21 Code of Federal Regulations, Part 820.30).
The conclusion states that the Myomo e100 is "substantially equivalent to the afore-mentioned predicate devices with respect to indications for use/intended use, and technical characteristics." This is the primary "acceptance criterion" for a 510(k) premarket notification when formal clinical performance data is not deemed necessary by the FDA.
Information Not Available (and why)
The following information cannot be extracted from the provided text because the submission did not include a clinical performance study as typically seen for AI/ML devices:
- A table of acceptance criteria and the reported device performance: Not applicable in the context of this 510(k) submission.
- Sample size used for the test set and the data provenance: No test set (clinical data) was used or reported in this submission for device performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set with expert-established ground truth was reported.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI/ML diagnostic device and no human reader study was conducted.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as no AI model training was mentioned.
- How the ground truth for the training set was established: Not applicable.
Summary of what is available from the text:
- Device: Myomo e100, an electromechanically powered device for stroke patients undergoing rehabilitation to facilitate muscle re-education and maintain/increase range of motion. It uses detected electromyograph (EMG) as an indication of residual muscle strength to amplify movement.
- Regulatory Pathway: 510(k) Premarket Notification (K062631).
- Basis for Clearance: Substantial equivalence to predicate devices (Kinetec 6080 CPM for Elbow, Biomove 3000, Boston Digital Arm System) based on indications for use/intended use and technical characteristics.
- Performance Data: Focuses on compliance with recognized safety, electrical, EMC, software, risk management, and biocompatibility standards (e.g., IEC 60601-1-1, IEC 60601-1-2, ISO 14971, ISO 10993). Bench testing for design verification and validation was performed as per FDA Design Control Requirements (21 CFR Part 820.30).
- Absence of Clinical Studies: The submission explicitly states that "Neither bench, animal nor clinical testing were assessed" for the comparison of the Myomo e100 to predicate devices. This indicates that a separate, formal clinical performance study was not required by the FDA for this particular 510(k) clearance, as the device was deemed substantially equivalent through other means (design documentation, technical characteristics, and standards compliance).
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(260 days)
Dominion Court McLean, Virginia 22102
Re: K022417
Trade Name: Care™ Stim Regulation Number: 21 CFR 890.5380
The Classic Stim is recommended for use for the following conditions:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical simulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
A portable NMS device for muscle re-education.
This document describes the 510(k) summary for the CARE STIM™ muscle stimulator, and it declares non-clinical testing was sufficient to show substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (CARE STIM™) |
|---|---|
| Output characteristics of the predicate device (Ortho Dx muscle stimulator). | Output characteristics are substantially equivalent. |
| Intended Use of the predicate device. | Intended Use is substantially equivalent. |
| Labeling of the predicate device. | Labeling is substantially equivalent. |
| No new questions of safety and effectiveness compared to the predicate device. | No new questions of safety and effectiveness are posed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The study relies on bench testing comparisons to a predicate device, not a human test set.
- Data Provenance: Bench testing data comparing the output characteristics of the CARE STIM™ to the Ortho Dx. The country of origin and whether it's retrospective or prospective are not specified, but it would inherently be a prospective bench test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth for device characteristics was established via engineering bench testing, not expert clinical assessment.
4. Adjudication Method for the Test Set
- Not applicable. This was a technical comparison, not a clinical study requiring adjudication of expert opinions.
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 a muscle stimulator, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm. Bench testing was done on the device's electrical output.
7. The Type of Ground Truth Used
- Bench Test Comparison Records: The "ground truth" for the CARE STIM™ was the established output characteristics, intended use, and labeling of the predicate device (Ortho Dx). This was determined through non-clinical (bench) testing.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning device and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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