The Myeloscope is intended to be used by physicians for the illumination and The Mydlescope is intenthe epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.

Device Description

The Myelotec Myeloscope is a flexible fiberoptic system that includes a video guided catheter that allows steering of the fiberoptic scope. The fiberoptic scope is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The video guided catheter is a sterile, disposable device.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called Myeloscope. It does not contain acceptance criteria or a detailed study proving the device meets acceptance criteria.

The 510(k) summary only briefly mentions some performance and safety testing. Therefore, I cannot complete the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted from the text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in document	Catheter is capable of flexing the Myeloscope optics 30 degrees to the right and left for 250 cycles without damage to the tip bonds or steering mechanism.
Not specified in document	Biocompatibility for patient contacting materials demonstrated.
Not specified in document	Optical and mechanical performance and materials are similar to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set or the data provenance. It only mentions "performance testing of the video guided catheter."

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 mentioned in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the 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
No MRMC study was mentioned. The device described is a physical scope, not an AI system for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not specified. The performance testing appears to be functional and safety testing of the device itself (e.g., flexibility, biocompatibility), not related to diagnostic accuracy against a ground truth for disease.

8. The sample size for the training set
Not applicable. No training set is mentioned as this is a physical device subject to performance and safety testing, not an AI/ML model that requires training.

9. How the ground truth for the training set was established
Not applicable (see point 8).

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 1996

Myelotec, Inc. c/o Ms. Carolann Kotula Official Correspondent MDI Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

Re : K960194 Trade Name: Myeloscope Regulatory Class: II Product Code: HRX Dated: July 12, 1996 Received: July 16, 1996

Dear Ms. Kotula:

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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requiations, Title 21, Parts 800 to 895. rt substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - Ms. Carolann Kotula

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 at (301) 443-6597.

Sincerely yours,

n 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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5 IO(k) Number (if known): X960194

Myeloscope Devico Name:

Indications For Usc:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED)

Concurence of CDRH, Office of Device Evaluation (ODE)

the Rhodes
(Division Sign-Off)

Division of Gueral Resultative Devices

510(k) Number .

Prescription Usc (Per 21 CFR 801.109)

Over-The-Country Use

(Optional Formel 1-2-96)

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d i

K960194

ATTACHMENT 1 Page 1 of 2

sport - 4 1004

510(K) SUMMARY MYELOTEC MYELOSCOPE SYSTEM

Submitter Information:

Edward J. Lortie President Myelotec, Inc. 1005 Alderman Drive, Suite 101 Alpharetta, GA 30202 Telephone # (770)-664-4656

510(K) Summary Prepared: June 28, 1996

Name of the Device:

Trade or Proprietary Name: Myelotec Myeloscope

Common Name: Flexible fiberoptic scope with guiding catheter

Classification Name: Arthroscope and Accessories (21 CFR Part 888.1100)

Identification of Legally Marketed Devices To Which The Submitter Claims Equivalence:

The Myelotec, Inc. Myeloscope is similar in design and/or intended use to several legally marketed flexible fiberscope endoscopes. These include the Danek Spinal Epidural Endoscope Systems (K930191) and the Ultra-Vu Endoscope Systems (K913129). These are flexible fiberoptic systems used for "micro-endoscopic" applications in small body cavities and spaces.

Description of the Subject Device:

The optical performance characteristics of the Myeloscope are similar to the predicate devices.

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Image /page/4/Picture/0 description: The image contains four lowercase letters: 'm', 'd', and two 'i's. The letters are arranged horizontally from left to right. The letters are outlined in black, with a white fill.

Performance testing of the video guided catheter shows that the catheter is capable of flexing the Myeloscope optics 30 degrees to the right and left for 250 cycle without damage to the tip bonds or steering mechanism.

Safety testing included biocompatibility for patient contacting materials.

Intended Use of the Subject Device

The Myeloscope is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.

Technological Characteristics of the Subject Device:

There are no significant technological characteristics between the Myelotec Myeloscope and the predicate devices. Optical and mechanical performance and materials are similar.

Non-clinical testing on the Myelotec Myeloscope included optical, mechanical, sterilization assurance and re-use validations.

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.