Series of dilators, tubular retractors of various lengths and guide wire for use in providing access to the spine for minimally invasive discectomy procedures.

AI/ML Overview

The provided text describes a medical device, the Bright Medical Dilation Retractor System, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving device performance using a test set, ground truth, expert involvement, or specific performance metrics.

Here's what can be extracted and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided K992898 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the Sofamor Danek MicroEndoscopic Discectomy Retractor System, rather than presenting a performance study with specific acceptance criteria and a test set like those typically seen for AI/software devices.

The underlying "acceptance criterion" for this submission appears to be that the device functions in a manner that is "as safe and effective" as its predicate. This is a qualitative assessment based on material equivalence, similar dimensions, and achieving the same surgical objectives.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness: Functions in as safe and effective a manner as the predicate device.	"When used as designed, the Dilation Retractor System functions in as safe and effective a manner as the predicate device."
Technological Characteristics: Equivalent materials, similar dimensions, same surgical objectives as the predicate.	"The Bright Medical Dilation Retractor System is manufactured from equivalent materials, with similar dimensions, to achieve the same surgical objectives as the predicate MED MicroEndoscopic Discectomy System."

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This document does not describe a performance study involving a test set, rather it asserts substantial equivalence based on design and material characteristics compared to a predicate device.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. No "ground truth" establishment using experts for a test set is described.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No test set or related 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

MRMC Study: No. This is a mechanical surgical device, not an AI/software device. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: Not applicable. This is a mechanical surgical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable. No specific "ground truth" as typically understood for performance studies (e.g., pathology, outcomes) is mentioned. The "truth" in this submission relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable.

Summary of Missing Information:

The provided document is a 510(k) summary for a surgical retractor system. It focuses on demonstrating "substantial equivalence" to a predicate device rather than detailing a performance study with quantitative acceptance criteria, test sets, ground truth establishment, or expert reviews as would be relevant for devices that require such validation (e.g., diagnostic software, AI/ML devices). Therefore, many of the requested details about performance studies, sample sizes, and expert involvement are not present in this document.

Summary

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OCT 21 1999

Page 10

K992898

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SECTION 6 510(k) SUMMARY

Submitter's Name:	Bright Medical Instruments
Submitter's Address:	799 N.E. 71st StreetBoca Raton, Florida 33467
Contact Person:	Robert E. Simonson
Telephone:	877-527-4448
Facsimile:	561-998-8224
Date Prepared:	July 30, 1999
Device Trade Name:	Dilation Retractor System
Device Common Name:	Surgical Retractor
Classification Name:	Self-Retaining Retractor for Neurosurgery
Predicate Device:	Sofamor Danek MicroEndoscopicDiscectomy Retractor System
Device Description:	Series of dilators, tubular retractors ofvarious lengths and guide wire for use inproviding access to the spine forminimally invasive discectomyprocedures.
Intended Use:	To provide the surgeon with minimallyinvasive surgical access to the spine byensuring the placement/positioning of theretractor, down to the lamina, with itsattachment to a flexible arm to provide aself locking method of access to thespinal site through which a microscopeand surgical instruments can bemanipulated.

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Technological Characteristicsand Comparison to Predicate	The Bright Medical Dilation RetractorSystem is manufactured from equivalentmaterials, with similar dimensions, toachieve the same surgical objectives asthe predicate MED MicroEndoscopicDiscectomy System.
Performance Data:	When used as designed, the DilationRetractor System functions in as safeand effective a manner as the predicatedevice.
Conclusion:	The Bright Medical Dilation RetractorSystem is safe and effective and issubstantially equivalent to the predicatedevice.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three wavy lines, resembling a bird in flight or a symbolic representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1999

Mr. Robert E. Simonson President Bright Medical Instruments 799 North East 71st Street Boca Raton, Florida 33487

Re: K992898

Trade Name: Bright Medical Dilation Retractor System Regulatory Class: II Product Code: GZT Dated: July 29, 1999 Received: August 27, 1999

Dear Mr. Simonson:

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. Robert E. Simonson

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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K992898

SECTION 5

INDICATIONS FOR USE

Bright Medical Dilation Retractor System

Provide a self-locking device to hold the edges of a wound open for neurosurgical procedures.

Prescription Use __

Over the Counter _______________

Poole Jo

(Division Sign-Off) Division of General Restorative Devices 128 510(k) Number

Regulation Number and Section

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).