(169 days)
The AMES Therapy Device is a rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion. It also uses muscle vibration for muscle relaxation.
The AMES Therapy Device is an electromechanical physical therapy device that combines 3 motion assemblies (one for the ankle, one for the wrist, and one for the thumb-and-fingers), 5 therapeutic vibrators, and a visual feedback unit, all contained in one device. The patient is seated in a separate conventional chair or wheelchair so that the appropriate limb can be attached to the AMES Therapy Device for therapy. The AMES Therapy Device includes assisted movement to the limb being treated and applies simultaneous vibration to the antagonist muscle. The device provides visual feedback to the patient to indicate whether he/she is producing the requisite force (torque) in assisting the device's motion and encourages the patient to keep working the agonist muscle. The feedback also includes a force (torque) "target," set to a level by the the patient can achieve repeatedly during therapy without becoming too fatigued, but that is also moderately challenging. The torque produced by the patient is indicated on the video touch screen. Testing and reporting on the patient's therapy and functional status can be performed at each therapy session prior to or following administration of therapy. Data for each session include therapy delivery (date, duration, performance) and test results. Two tests are carried out during the treatment session to measure: 1) active range-of-motion, and 2) strength. These test scores permit the therapist: (i) to determine each patient's baseline status at the time that the patient first receives the AMES therapy, and (ii) to monitor changes in rehabilitation status during the course of the patient's therapy. This testing enables therapists to modify the treatment regimen in response to observed improvements and to determine when is no longer benefitting from the therapy. The AMES Therapy Device is non-invasive and there is no electrical stimulation involved in the device, nor any recording of bioelectric potentials. No heat is applied by the AMES Therapy Device.
Here's an analysis of the AMES Therapy Device's acceptance criteria and studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it focuses on demonstrating that the device performs as designed and is substantially equivalent to predicate devices. The "performance" described is largely qualitative or pertains to general safety and functionality.
| Acceptance Criterion (Implicit) | Reported Device Performance (from Non-Clinical & Clinical Testing) |
|---|---|
| Electrical Safety | Meets UL 60601-1 and IEC 60601-1-2 (EMC) standards. |
| Biocompatibility | Patient-contacting materials are not irritating, sensitizing, or cytotoxic. |
| Design Functionality | Performs as designed and met its specifications (Design Verification Testing). |
| Clinical Safety (Skin Integrity) | Safety data from clinical evaluations evaluated safety with respect to skin integrity. |
| Substantial Equivalence | Demonstrated substantial equivalence in intended use, indications for use, and device function/features to predicate devices (System 4 and Vibracussor). |
Regarding the Absence of Detailed Performance Criteria:
It's crucial to understand that for a 510(k) submission, particularly for devices with well-established predicate technology, the primary goal is often to demonstrate substantial equivalence rather than to prove novel efficacy against specific, high-bar performance criteria. The "acceptance criteria" here are more about meeting recognized safety standards, demonstrating intended functionality, and showing comparability to legally marketed devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical evaluations" and "safety data from clinical evaluations" but does not specify the number of participants or the size of these evaluations.
- Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data. It implies the data is prospective as it refers to "clinical evaluations" of the AMES Therapy Device itself, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document.
4. Adjudication Method 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, and the Effect Size
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating the device's own safety and functionality, and its substantial equivalence to predicate devices, not on comparing the efficacy or improvement of human readers (or therapists in this context) with or without AI assistance. The AMES Therapy Device is described as a standalone physical therapy device, not an AI-assisted diagnostic or interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The AMES Therapy Device is a physical therapy device with a human (patient) interacting directly with it, guided by a therapist. It's not an algorithm-only device in the diagnostic or imaging sense. The device itself is "standalone" in the sense that its performance evaluation (safety, functionality) does not involve a human interpreting its output for diagnostic purposes. However, a human is inherently "in-the-loop" as a patient receiving therapy and a therapist managing the treatment.
7. The Type of Ground Truth Used
Given the nature of the device (physical therapy), "ground truth" in the typical AI/diagnostic sense (e.g., pathology, expert consensus on imaging) is not directly applicable. For the AMES Therapy Device, the "ground truth" during its "clinical evaluations" would likely relate to:
- Observed clinical safety outcomes: Was there skin irritation? Were there adverse events?
- Device functionality: Did the device perform its movements, provide vibration, and measure torque/ROM as designed?
- Patient feedback/clinical assessment: Did the patient tolerate the therapy? Did therapists observe expected changes in patient status during the course of therapy (as the device aids in monitoring ROM and strength, but doesn't "diagnose").
The document primarily highlights "Safety data from clinical evaluations... to evaluate the safety of the device with respect to skin integrity." This suggests observed clinical safety outcomes were a primary "ground truth" during its human-use testing.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The AMES Therapy Device, as described, is an electromechanical physical therapy device. It does not appear to employ machine learning or AI algorithms that would require a "training set" in the context of typical AI device development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 890.1925 Isokinetic testing and evaluation system.
(a)
Identification. An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.