ARTHROSCOPE by ELECTRO-BIOLOGY, INC.

The EBI Spinal Endoscopic System is intended as a diagnostic tool to visualize and illuminate the epidural space of the lumbar and sacral spine when assessing disease pathology using a percutaneous posterior approach.

Device Description

The EBI Endoscopic Spinal System is an arthroscope consisting of several components and different accessories for viewing the lumbar and sacral spinal anatomy. This system includes a fiberscope, disposable catheter, and various accessories. The fiberscope is designed to connect to any compatible commercially available endoscopic video imaging system by using a camera coupler and light cord adaptors.

AI/ML Overview

The provided text describes a 510(k) summary for the EBI Spinal Endoscopic System. It does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or the types of quantitative data requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or detailed ground truth types).

The document is a premarket notification for a medical device (arthroscope) stating its intended use and claiming substantial equivalence to predicate devices already on the market. It mentions "bench testing demonstrates that the device meets its functional requirements" but does not elaborate on what those functional requirements are or present the results of such testing.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text.

However, I can provide what information is available about the "study" (bench testing) and general claims:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Requirements (specifics not provided)	Bench testing demonstrates the device meets its functional requirements.

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (implied to be internal company bench testing).

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

Not applicable/Not specified. This was bench testing, not a clinical study involving expert assessment of patient data.

4. Adjudication method for the test set

Not applicable/Not specified.

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

No, an MRMC study was not done. This device is an arthroscope, not an AI diagnostic tool for image interpretation.

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

Not applicable. This is a physical endoscopic system, not an algorithm.

7. The type of ground truth used

For "functional requirements," ground truth would typically be engineering specifications, measurements, or established performance benchmarks for similar devices, which are not detailed here.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model requiring a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Electro Biology Inc. The logo consists of the letters "EBI" in large, bold font on the left side of the image. To the right of the letters, the words "Electro Biology" are written in a smaller, italicized font. A horizontal line is located underneath the entire logo.

K971083 JUN 23 1997

Enhancing Bone Healing through Applied Science

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI Spinal Endoscopic System is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

1. Submitter: Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054
  Contact Person:Jon Caparotta Telephone: (201) 299-9022

Date prepared: March 24, 1997

EBI Spinal Endoscopic System 2. Proprietary Name: Arthroscope Common Name: Arthroscope and Accessories (888.1100) Classification Name:
1. Predicate or legally marketed devices that are substantially equivalent: ·Myelotec Myeloscope System - Myelotec Inc. "Danek Spinal Endoscopic System - Sofamor Danek USA · Nucleotome EndoFlex - Surgical Dynamics Inc. "Steerable Working Channel Scope - Surgical Dynamics Inc.
1. Description of the device:The EBI Endoscopic Spinal System is an arthroscope consisting of several components and different accessories for viewing the lumbar and sacral spinal anatomy. This system includes a fiberscope, disposable catheter, and various accessories. The fiberscope is designed to connect to any compatible commercially available endoscopic video imaging system by using a camera coupler and light cord adaptors.

Intended Use:The EBI Spinal Endoscopic System™ is intended as a diagnostic tool to visualize and illuminate the epidural space of the lumbar and sacral spine when assessing disease pathology using a percutaneous posterior approach.

1. Materials:The catheter is the patient contacting portion of the system. It is manufactured from medical grade polyurethane. The outer jacket of the fiberscope is made out of polyimide.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI Spinal Endoscopic System and other spinal arthroscopes currently on the market. It is substantially equivalent* to the predicate devices in design, materials and intended use. Also, bench testing demostrates that the device meets its functional requirements.

*Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1997

Mr. Jon Caparotta Manager, Regulatory Affairs Electro-Biology, Inc. ... .. .. .. .. ... ...... 6 Upper Pond Road Parsippany, New Jersey 07054-1079

Re: K971083 Trade Name: Spinal Endoscopic System Regulatory Class: II Product Code: HRX Dated: March 24, 1997 Received: March 25, 1997

Dear Mr. Caparotta:

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 requirements , as set forth in the Quality System Regulation (OS) 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. Jon Caparotta

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 vour 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,

Cly W.B.

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:

1971083

Division
Division of
r 971083

Prescription Use (Per 21 CFR 801.109)

(17

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.