(30 days)
The Speed Hound ProPerformance Recovery System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Speed Hound Recovery System simulates kneading and stroking of tissues by using an inflatable garment.
This submission is for the Speed Hound ProPerformance Recovery System. The Speed Hound ProPerformance Recovery System is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase in circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health.
The device is a Class II, type BF applied part that receives power through a non-detachable power cord
The ProPerformance Recovery System consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment A description of each of these components is provided below.
The hardware and software of this device is identical to the model PT1003 by Xiamen Senyang Co., Ltd., cleared under 510(k) K181409
The "garments" (leg, arm and hip) and the plastic air tubing are of identical materials to the components of the FDA-cleared PT1003 (K181409).
The provided text is a 510(k) summary for the ProPerformance Recovery System, a powered inflatable tube massager. This device is seeking clearance based on substantial equivalence to a predicate device.
The context of this document is a regulatory submission for a medical device that does not involve an AI/ML algorithm. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI/ML device meets acceptance criteria are not applicable in this case. The device is a physical product, and its performance is assessed through bench testing and comparison to a legally marketed predicate, not through evaluation of an AI's diagnostic or predictive capabilities.
Here's an analysis based on the provided document, addressing the relevant points and explicitly stating N/A for those that are not applicable to this type of device:
Analysis of ProPerformance Recovery System Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of "acceptance criteria" in the sense of accuracy metrics for an algorithm. Instead, it demonstrates performance by showing equivalence to a predicate device and compliance with recognized voluntary standards through bench testing.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Indications for Use: | Identical to predicate: Temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas in good health, simulating kneading and stroking of tissues using an inflatable garment. |
| Classification: | Identical to predicate: Class II Device, IRP (21 CFR 890.5650). |
| OTC or Prescription Use: | Identical to predicate: Over-The-Counter (OTC). |
| Environment of Use: | Identical to predicate: Clinics, hospital, athlete training, and home environments. |
| Compliance with Voluntary Standards: | Meets and exceeds predicate's compliance: AAMI ANSI ES60601-1 (replaced IEC 60601-1), IEC 60601-1-2 (Electromagnetic Disturbances), and additionally IEC 60601-1-11 (Home Healthcare Environment) which the predicate did not explicitly declare. Bench testing was performed to confirm compliance with these standards (Sections 16, 17, and 18 for test reports). |
| Mode of Operation: | Identical to predicate: Sequential/Peristaltic, with "A" and "B" modes as described. |
| Power: | Equivalent to predicate: 110-125Vac 60Hz. Predicate is 110V, 60Hz. |
| Device Pressure Range: | Identical to predicate: 20-200 mmHg. |
| Treatment Time: | Identical to predicate: User-determined, choices of 10, 20, or 30 minutes, with option to add 10 minutes. |
| Garment Contact Surface Material: | Identical to predicate: Nylon with a Polyurethane laminate. Identical to reference device K181409. |
| Attachments (Leg, Arm, Hip): | Identical in size and construction to predicate (Yes for all). |
| Number of Inflatable Appliance Segments: | Identical to predicate: 4. |
| Weight: | Similar to predicate: 5.7 pounds (new device) vs. 5.8 pounds (predicate). |
| Dimensions (W x H x D): | Similar to predicate: 11.25" x 5.1" x 6.7" (new device) vs. 10" x 6.5" x 5" (predicate). |
| Housing Materials and Constructions: | Identical to predicate: Molded ABS enclosure. |
| Patient Contact: | Identical to predicate: Non-conductive appliances. |
| Safety Features: | Identical to predicate: Button on display allows user to stop or pause therapy session at any time. |
| Functionality (Controls, Indicators, Performance testing): | Tested to ensure all requirements met. Verified through internal testing (Sections 16, 18). This includes confirmation of basic operational functionality in line with stated design. |
| No New Safety/Efficacy Concerns: | No differences between the proposed device and the predicate device that raise new safety and efficacy concerns. This is a core conclusion for 510(k) substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not applicable in the context of an AI/ML test set. The performance evaluation for this physical device relies on bench testing for compliance with electrical safety, EMC, and home use standards, and on direct comparison of specifications and features to a predicate device. The document mentions "Testing of all controls," "Testing of all indicators," and "Testing of performance" without specifying a sample size for these physical tests, which are typically product-level validations.
- Data Provenance: The data comes from internal "bench" performance testing conducted by the manufacturer/applicant to demonstrate compliance with voluntary standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11). It is retrospective in the sense that the test results are submitted after completion. The country of origin of the data is implicitly the country where the testing was performed, likely related to the applicant's location (Menlo Park, CA) or their manufacturing partner (Xiamen Senyang Co., Ltd., China, for the identical hardware/software model).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This pertains to AI/ML ground truth establishment. For a physical device, "ground truth" is typically defined by engineering specifications, regulatory standards, and physical measurements. The "experts" involved are likely engineers, quality assurance personnel, and regulatory professionals.
4. Adjudication Method for the Test Set:
- Not applicable. This applies to multi-reader evaluations in AI/ML studies. Performance validation here involves meeting predefined engineering and regulatory specifications through testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted device. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical product, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used:
- For this device, the "ground truth" is based on:
- Engineering Specifications: The device's design and operational parameters (e.g., pressure range, modes, dimensions).
- Regulatory Standards: Compliance with recognized international and national consensus standards for medical electrical equipment (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11).
- Predicate Device Equivalence: The specifications and performance of the legally marketed predicate device (K182668 - Rapid Reboot Compression Therapy System) and a reference device (K181409 - Pressure Therapy System PT1003).
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no AI/ML training set, this question is irrelevant.
In summary, the ProPerformance Recovery System is a conventional medical device. Its "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant safety and performance standards through bench testing, rather than through clinical studies or AI/ML performance evaluations.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).