(176 days)
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
The Ergoselect 100 K/P; Ergoselect 200 K/P ergometer has been designed to meet the medical and ergonomic requirements for an efficient and relevant stress test of the cardiovascular system. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
The ergometry system Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P consists out of the following components: Basic unit: Ergoselect 100: Ergoselect 200 Control panel type P / K Control unit: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
The provided text is a 510(k) summary for the Ergoline Ergoselect 100 K/P and Ergoselect 200 K/P ergometers. It states that the device is deemed "substantially equivalent" to a predicate device (K851097), which means it has similar intended use and technological characteristics, and therefore does not raise new questions of safety or effectiveness.
Crucially, this type of submission (510(k)) for substantial equivalence typically does not involve a new stand-alone clinical study with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies of the kind you've asked for. Instead, the manufacturer demonstrates that their device is as safe and effective as a legally marketed predicate device.
Therefore, many of your requested points are not applicable to the information contained in this 510(k) summary. I will answer the applicable parts and indicate where information is not present.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission does not present a de novo clinical study with specific acceptance criteria and detailed performance metrics as you typically find for novel devices. Instead, a substantial equivalence determination is made against a predicate device. The "acceptance criteria" here are met by demonstrating that the new device is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate K851097) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Intended Use: Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity. | Intended Use: Identical. "Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity." |
| Technological Characteristics: No technical characteristics existing that would raise new questions regarding safety and effectiveness. | Technological Characteristics: "The implemented technology of the Ergoline Ergometers is identical or similar following the Substantial Equivalence comparison rational. No technical characteristics in terms of similarity/differences are existing that would raise new questions regarding safety and effectiveness." Cardiac monitor meets AAMI/ANSI EC13:1992. |
| Safety and Effectiveness: Demonstrated to be as safe and effective as the predicate device. | Safety and Effectiveness: "it is concluded that the Ergoline Ergometers are safe and effective for their Intended Use and that Substantial Equivalence is verified and justified in comparison to the Predicate Device." |
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 for this 510(k) submission. The submission relies on a comparison to a predicate device, not a new clinical study with a test set of patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable for this 510(k) submission. No independent expert review of a new test set was conducted for this substantial equivalence determination.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this 510(k) submission. No test set requiring adjudication was used.
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 for this device (ergometer) or this type of submission (510(k) for substantial equivalence). This device is an ergometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable for this device (ergometer) or this type of submission. This device is an ergometer; it does not involve algorithms for standalone performance measurement in the context of diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate device (K851097). The new device is compared against this predicate.
8. The sample size for the training set
- Not applicable for this 510(k) submission. This device is an ergometer, not an AI-driven system that requires a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable for this 510(k) submission. As there is no training set for an AI algorithm here, no ground truth needed to be established in that manner. The "ground truth" for the submission is the regulatory acceptance of the predicate device.
§ 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.