(97 days)
The Able-X is indicated for use by stroke patients undergoing upper limb rehabilitation to facilitate: :
- Stroke rehabilitation by muscle re-education
- Maintaining or increasing range of motion
The Able-X is an exercise system that uses virtual reality to promote therapeutic bilateral movement exercises through use of a wireless hand held game controller and computer games. The Able-X is comprised of a lightweight polymer handlebar with a wireless game controller mounted at one end and a fixed hand vertical hand grip at the other end of the bar. The wireless controller communicates via a USB receiver dongle to a computer installed with therapeutic exercise games. Game play of the therapeutic exercises is controlled through the game controller and displayed in real-time on the computer screen. The Able-X therapeutic exercise games are provide on a CD or can be downloaded directly through the internet. The Able-X does not include a separate console and is intended to be operated directly through a user supplied computer that meets minimum processing and operating system requirements.
The provided text states, "Testing confirms that the Able-X can be used according to its intended use and in an equivalent manner to the predicate devices." However, it does not provide specific acceptance criteria or detailed study results with quantitative performance data. The device is cleared based on substantial equivalence to predicate devices, rather than meeting specific performance metrics from a dedicated study.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the Able-X device itself. The basis for clearance is "substantial equivalence" to predicate devices.
- Reported Device Performance: The text generally states: "Testing confirms that the Able-X can be used according to its intended use and in an equivalent manner to the predicate devices." No specific metrics (e.g., accuracy, sensitivity, range of motion improvement percentage) are provided.
| Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| N/A | N/A (Substantial equivalence to predicates) | "Can be used according to its intended use and in an equivalent manner to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
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)
- Not applicable as no specific test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific test set requiring adjudication is described.
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, an MRMC study is not mentioned. This device is not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is an exercise system; the concept of "standalone performance" as typically applied to algorithms is not directly relevant here. Its performance is inherent in its function as an exercise aid.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no specific ground truth for performance metrics is described. The clearance is based on substantial equivalence, implying that its functional characteristics were deemed sufficiently similar to existing devices.
8. The sample size for the training set
- Not applicable. This device is an exercise hardware/software system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 890.5370 Nonmeasuring exercise equipment.
(a)
Identification. Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.(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.