(277 days)
AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric.
Manual operation systems:
- . Headpiece.
- . Extension of feet.
- Drops. .
- Dorso - lumbar release/breakaway
- Lateral Flexion. ●
Electrical operating systems:
- . Horizontal elevation.
- . Flexion of the lower limb sector.
- Extension or linear movement of the lower limb sector (distraction/traction).
This FDA 510(k) K241193 premarket notification describes the AGILIS - Multi-function Physical Therapy Table. The submission indicates that no clinical studies were performed for this device. Therefore, no information is available regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The submission focuses on demonstrating substantial equivalence to a predicate device (AIR-FLEX WITH AUTO-DISTRACTION, K063034) through non-clinical testing.
Here's a summary of the non-clinical testing for the AGILIS Multi-function Physical Therapy Table:
1. A table of acceptance criteria and the reported device performance
| Test Category | Standard / Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | EN/IEC 60601 -1:2005 + AMD1:2012 + AMD2:2020 - Medical Electrical Equipment - Part I: General Requirements for Basic Safety and Essential Performance. | Compliance with the standard. | Complied with the standard. |
| Electromagnetic Compatibility | IEC 60601-1-2:2014 +AMD1:2020- Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. | Compliance with the standard. | Complied with the standard. |
| Performance Safety Testing | Load Application (static and dynamic) | Not explicitly detailed, but implied to demonstrate safe operation under expected loads. | These tests demonstrate that the proposed device meets the acceptance criteria. |
| Efficacy Testing | Functional Analysis tests | Not explicitly detailed, but implied to demonstrate correct functional operation. | These tests demonstrate that the proposed device meets the acceptance criteria. |
| Operational Control | Operational control on 100% of manufactured tables before release to the market. | Correct functioning, safety, and effectiveness according to established procedures. | Ensures correct functioning, safety, and effectiveness. |
2. Sample sized used for the test set and the data provenance
- No specific sample size for the test set is mentioned beyond a general statement of "operational control is carried out on 100% of the manufactured tables." This refers to manufacturing quality control rather than a specific test set for regulatory submission.
- The data provenance is not specified regarding country of origin or whether it was retrospective/prospective, as these were bench tests and internal operational controls.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical studies with expert-established ground truth were performed.
4. Adjudication method for the test set
- Not applicable, as no clinical studies requiring adjudication were performed.
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 physical therapy table, not an AI-powered diagnostic or assistive 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 therapy table, not a software algorithm.
7. The type of ground truth used
- For the non-clinical tests (electrical safety, EMC, performance), the "ground truth" implicitly refers to the requirements and specifications of the referenced international consensus standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for bench performance testing.
8. The sample size for the training set
- Not applicable, as no machine learning or AI component is mentioned requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).