(83 days)
This device is to be used for biofeedback applications.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Bagnoli-8 EMG System." It indicates that the device has been found substantially equivalent to a legally marketed predicate device. This document primarily focuses on regulatory clearance and does not contain detailed information about acceptance criteria or specific study results for device performance.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth cannot be extracted directly from this document.
However, based on the limited information, here's what can be stated:
1. A table of acceptance criteria and the reported device performance
- Not available in this document. The document is a regulatory clearance letter, not a performance study report. It states the device is "substantially equivalent" to a predicate device, implying its performance is considered acceptable for its stated indications for use, but specific performance criteria or reported performance values are not listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in this document. The document does not describe the specific studies or test sets used to demonstrate substantial equivalence.
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 available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in this document.
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 / Not available in this document. The Bagnoli-8 EMG System is for biofeedback applications, and the document does not suggest it is an AI-powered diagnostic tool that would involve human readers or MRMC studies for comparative effectiveness with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available in this document. Since it's for biofeedback, it inherently involves human interaction, but the document does not detail specific performance studies, standalone or otherwise.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in this document.
8. The sample size for the training set
- Not available in this document.
9. How the ground truth for the training set was established
- Not available in this document.
Summary of available information:
- Device Name: The Bagnoli-8 EMG System
- Indications for Use: This device is to be used for biofeedback applications.
- Regulatory Clearance: K990356, cleared on April 29, 1999, as substantially equivalent to a legally marketed predicate device.
- Regulatory Class: II
- Product Code: HCC and IRC
To obtain the detailed information requested, one would need to refer to the original 510(k) submission (K990356) and any supporting documentation that was provided to the FDA for review, which would describe the performance testing conducted. This document itself is merely the agency's clearance letter.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.