(106 days)
The AposTherapy System is intended to be used by trained professionals for adjusting the distribution of weight/force(s) that is being applied to a lower limb. The AposTherapy System is intended for patients with knee osteoarthritis, to help temporarily reduce knee pain and improve lower extremity function during activities of daily living.
The AposTherapy System consists of a pair of shoe-like uppers with two convex units (Pertupods) on the sole of each shoe, a screw fixation mechanism for securely attaching the Pertupod to the track and, if required, soft spacers, weight discs, hard spacers, and wedge spacers. Legally marketed gait analysis software may be used by practitioners to help inform their calibration of the biomechanical device, but the software is not supplied with the device.
The device is worn over socks, so it has no direct contact with the patient. Based on a preliminary evaluation of pain, function, and quality of life, a personalized therapy program is created to meet the patient's treatment needs using the personally calibrated device. Practitioners may use basic, legally marketed gait analysis software (not provided with the device) to collect measurements from various movements (e.g., velocity, step length, single limb support) as part of the treatment program. The patient's progress is assessed periodically; the device is then further adjusted and the therapy program updated as needed to achieve the pre-defined goals. The device is intended to be worn only during the time scheduled by the practitioner (e.g., 30 minutes a day).
The provided text describes the AposTherapy System, a limb orthosis intended for patients with knee osteoarthritis to temporarily reduce knee pain and improve lower extremity function during activities of daily living. Here's a breakdown of the acceptance criteria and study information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended in non-clinical testing. | In all instances, the AposTherapy System functioned as intended, and each test's success criteria were met. |
| Temporarily reduces knee pain in knee OA patients. | WOMAC global scores at week 24: 1.37 ± 1.15 in the AposTherapy arm vs. 2.47 ± 1.80 in the sham arm (1.10 mean difference, Cohen's d of 0.73). |
| 50% change in WOMAC 24: 83% of the AposTherapy arm (95% CI: 74% - 89%) vs. 42% of the sham arm (95% CI: 33% - 52%) achieved this (adjusted odds ratio: 6.67 (95% CI: 3.54-12.58) and adjusted Mantel-Haenszel risk difference of 0.42 (95% CI: 0.28 – 0.52)). This indicates significant pain reduction in the AposTherapy group compared to sham. | |
| Improves lower extremity function during ADLs in knee OA patients. | WOMAC global scores at week 24: (as above, WOMAC assesses both pain and function). The significant improvement in WOMAC global scores implies improved function. |
| Device is as safe and effective as other legally marketed lower limb orthoses. | The conclusion states that "bench and clinical data demonstrate that the AposTherapy System is as safe and effective as other legally marketed lower limb orthoses." This is a general statement rather than specific performance metrics against a predicate device in the text provided. |
2. Sample size used for the test set and the data provenance:
- Sample size: 220 knee OA patients (110 in AposTherapy arm, 110 in sham arm, assuming equal distribution based on text).
- Data provenance: Prospective, randomized, sham-controlled clinical trial. The country of origin is not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The study design described is a clinical trial assessing patient-reported outcomes (WOMAC scores) rather than an evaluation by experts.
4. Adjudication method for the test set:
- This information is not applicable/provided in the context of this clinical trial focusing on patient-reported outcomes. Adjudication methods are typically used for expert review of images or clinical events, not for standardized questionnaire results.
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. The device is a physical orthosis, not an AI-powered diagnostic or assistive tool, and the study did not involve human readers interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The AposTherapy System is a physical medical device, not a standalone algorithm.
7. The type of ground truth used:
- The ground truth in this study was based on patient-reported outcomes, specifically the WOMAC (Western Ontario and McMaster Universities Arthritis Index) global scores, which is a widely accepted measure for assessing pain, stiffness, and physical function in patients with osteoarthritis.
8. The sample size for the training set:
- This information is not applicable/provided. This was a clinical trial validating a physical device, not an AI/machine learning model that typically has a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable/provided for the same reasons as point 8.
§ 890.3475 Limb orthosis.
(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.