(464 days)
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
The Ergoselect is the result of long-standing experience and its consequent implementation. The system is convincing thru the optimal, and therefore, cost-effective configuration of the ergometer according to in medical ergometer specific requirements. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect / GE measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. Ergoselect / GE ergometer includes following models (P/K versions): Ergoselect 50, Ergoselect 100 / 200, Ergoselect 600, Ergoselect 1000, Ergoselect 1200, Optibike 50 med, Optibike med.
This document describes the Ergoline Ergoselect / GE device, an exerciser for physiotherapy. Since this is a very basic device, the provided information does not contain the typical sections found in a submission for an AI/ML-powered medical device regarding acceptance criteria and detailed study results. The content focuses on demonstrating substantial equivalence to a predicate device and compliance with general safety and performance standards.
Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document.
Here's an assessment based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Ergoselect 100 K/P; Ergoselect 200 K/P, K053078) in terms of: - Design - Operational characteristics - Configurational characteristics - Ergometrical characteristics - Technical characteristics - Safety characteristics | "The features of the subject device are substantially equivalent to the predicate device based on similarities in terms of design, operational, configurational, ergometrical, technical and safety characteristics. In addition, the classification and intended use of the predicate and subject device are the same." |
| "The presented data that was conducted on the Ergoline / GE ergometer shows in its results and in comparison that the products perform as well as or better than the predicate device, safe and effective for their intended use and do not raise any questions regarding safety and effectiveness." | |
| Compliance with relevant medical device standards | "Ergoline certifies compliance with the requirements among others of following device relevant standards: IEC 60601-1: Medical Electrical Equipment, General Requirements for Safety; IEC 60601-1-2: Medical Electrical Equipment, General Requirements for Safety, Electromagnetic compatibility - requirements and tests; ISO 14971: Medical devices -Application of risk management to medical devices; and ISO 10993 Biological evaluation of medical devices." |
| Safety and Effectiveness of the device | "All models that are covered by this 510(k) premarket notification have been on the market in Europe for years with no device failures. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a physical exerciser, not an AI/ML diagnostic or prognostic device that uses a "test set" of patient data in the typical sense. The "performance data" refers to non-clinical performance and compliance with standards rather than clinical trial data on patient outcomes for an algorithm. The text states "All models that are covered by this 510(k) premarket notification have been on the market in Europe for years with no device failures." suggesting real-world usage experience, but it doesn't specify a sample size or provenance for this.
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. "Ground truth" in the context of expert consensus is not relevant for this type of medical device as it does not perform diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" in the context of diagnostic performance requiring expert adjudication.
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, as this device is an exerciser, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance would be its adherence to established engineering, safety, and performance standards for exercise equipment, and its ability to function reliably for its indicated uses (physiotherapy, muscle redevelopment, obesity adjunct treatment).
8. The sample size for the training set
Not applicable. This device does not have an AI/ML component that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.