THE BAGNOLI-8 EMG SYSTEM by DELSYS, INC.

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.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Mr. Gianluca De Luca Research Engineer Delsys, Inc. P.O. Box 15734 Boston, Massachusetts 02215

Re: K990356 Trade Name: The Bagnoli-8 EMG System Regulatory Class: II Product Code: HCC and IRC Dated: January 27, 1999 Received: February 5, 1999

Dear Mr. De Luca:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gianluca De Luca

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known)	K 990356
Device Name:	Bagnoli-8 EMG System

Indications For Use:

This device is to be used for biofeedback applications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dcoee/s

(Division Sign-Off) Division of General Restorative Devices

510(k) Number

Prescription Use
Per 21 CFR 801.109 OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

Regulation Number and Section

§ 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.