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510(k) Data Aggregation
(507 days)
The intended use is to provide muscle relaxation therapy by delivering a soothing massage.
Legacy-500 Massage Table is an electrically powered, motorized, multifunctional physical therapy table. The intended use is to provide muscle relaxation therapy by delivering a soothing massage. It is designed to travel throughout the back area in a smooth transition but can also stop in one specific area. Pressure of the massage can be adjusted from one (lowest setting) to six (highest setting) and is displayed by six lights. Rollers can massage clockwise or counter-clockwise and the indicator displays the position on the back. The timer allows the table to run from one to thirty minutes shutting power off after treatment time and returning the pressure of the rollers to the lowest setting, at any time during treatment the timer can be manually shut off to stop the table by user or patient. The only patient contacting component is the table top that the patient lays on covered in vinyl upholstery.
This document is a 510(k) summary for a massage table, not a clinical study report for an AI/ML powered medical device. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance metrics is not applicable.
Here's an attempt to address the questions based on the provided text, noting where the information is absent:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or device performance in the context of an AI/ML algorithm. Instead, it demonstrates "substantial equivalence" to predicate devices, which is the regulatory standard for 510(k) submissions. The "performance" is implied by matching features and intended use with already cleared devices.
| Feature (from Comparison Table) | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Legacy-500) |
|---|---|---|
| Intended use: Designed to release muscle tension and deliver a soothing massage. | Yes | Yes |
| Substantially same size and shape. | Yes | Yes |
| Achieve the same physiological effects. | Yes | Yes |
| Three six-inch diameter massage rollers. | Yes | Yes |
| Clockwise and counter-clockwise roller rotation. | Yes | Yes |
| Adjustable roller pressure (varying degrees of pressure on muscles on back). | Yes | Yes |
| Height of rollers can adjust three inches above baseline table surface. | Yes | Yes |
| 30-minute timer that shuts power off after cycle time and is also used as the safety shut off. | Yes | Yes |
| Have the same type of frame construction. | Yes | Yes |
| Have steel roller carriage. | Yes | Yes |
| Can massage full back or selectable area. | Yes | Yes |
| Have lighted height indicator. | Yes | Yes |
| Have same style electrical components and motors. | Yes | Yes |
| Ten (10) minute recommended treatment time. | Yes | Yes |
| Covered in vinyl upholstery. | Yes | Yes |
| One control / indicator panel at head end of table to prevent patient from kicking controls when getting on. | Variation from predicates accepted | Yes (Difference noted but accepted for SE) |
| Indicator panel at head end and control panel at foot end of table. | Predicates have this | No (Device differs here) |
| Has optional hand-held control and heat option. | One predicate has this | No (Device differs here) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The document describes a physical medical device (massage table), not an AI/ML algorithm tested with a data set. The "test set" in this context would be the physical device itself and its adherence to design specifications compared to predicate devices. There is no mention of data or data provenance.
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 applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images or medical records) is not relevant here. The "ground truth" for a massage table's substantial equivalence is its intended use, design features, and safety compared to established predicate devices, as evaluated by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no mention of an adjudication method as would be used for expert review of data in an AI/ML context. The FDA's review process is an assessment against regulatory requirements and comparison to predicates.
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 applicable. No AI component is described or evaluated in this 510(k) submission. Therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm or software component described in this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable in the typical AI/ML sense. The "ground truth" for this medical device submission is effectively the established characteristics, safety, and effectiveness of the legally marketed predicate devices (K010252, K002390, K993461). The manufacturer is demonstrating that their device shares these fundamental characteristics.
8. The sample size for the training set
This information is not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set or corresponding ground truth establishment process described.
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