ACTAEON PROBE by OSTEOBIOLOGICS, INC.

The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic in vivo point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.

Device Description

The ACTAEON™ Probe is a hand-held device which when activated by the user measures the reaction force (resistance) of articular cartilage against a known rate and force of indentation applied by the disposable indenting tip of the device.

AI/ML Overview

This document does not contain the detailed information necessary to complete all sections of your request. The provided text is a 510(k) summary for the ACTAEON™ Probe, which focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a detailed study report describing acceptance criteria and device performance.

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

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

Unfortunately, the provided text does not include a table of acceptance criteria or specific reported device performance metrics. The summary states that "The ACTAEON™ Probe is designed to meet and comply with all sections of IEC 60601," which refers to electrical safety standards, not performance criteria for measuring cartilage stiffness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. A 510(k) summary primarily focuses on demonstrating substantial equivalence, and often such detailed clinical study information is not included in this document type unless a specific performance study was required.

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)

This information is not available in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text.

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

The ACTAEON™ Probe is described as an "arthroscopic cartilage stiffness tester," which is a physical measurement device, not an AI or imaging diagnostic tool that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC study as you've described it is not applicable to this device.

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

This concept is not applicable to this device. The device is a physical probe that measures stiffness; it's not an algorithm operating in a standalone capacity. The human user operates the device.

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

This information is not available in the provided text. For a device measuring stiffness, ground truth would typically come from comparative mechanical measurements or correlation with pathological findings, but the document does not elaborate on this.

8. The sample size for the training set

This information is not available in the provided text. Since this is not an AI/machine learning device, the concept of a "training set" for an algorithm, as commonly understood in modern AI development, is not applicable here. If "training set" refers to calibration or development data for the physical probe, that information is not provided.

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

This information is not available in the provided text and is not applicable in the context of AI/ML training as defined by your request.

Summary of what is available from the document:

Device: ACTAEON™ Probe, an arthroscopic cartilage stiffness tester.
Intended Use: For arthroscopic in vivo point measurement of articular cartilage stiffness in humans, usable arthroscopically or in open joint procedures.
Predicate Device: Artscan 200 Arthroscopic Cartilage Stiffness Tester from Artscan Oy. Helsinki. Finland.
Regulatory Basis: Substantial equivalence to the predicate device.
Stated Compliance: Designed to meet and comply with all sections of IEC 60601 (electrical safety).

The provided text serves as a regulatory summary for device clearance, not a detailed technical report of a performance study.

Summary

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JAN 1 1 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Act of 1990 and 21 CFR 807.92, In accordance with the requirements of the 510(K) Summary of Safety and OstooDiologics, 210. Inc. 25 accory Probe, 510(k) Number______________________________________________________________________________________________________________________

Submitter:	OsteoBiologics, Inc.University Business Park12500 Network, Suite 112San Antonio, TX 78249-3308Tel: (210) 690-2131 Fax: (210) 690-2559
Contact Person:	Mark Q. Niederauer, Ph.D., Director of Operations
Date (summary prepared):	October 15, 2001
Trade Name:	ACTAEON™ Probe
Common Name:	Arthroscopic Cartilage Stiffness Tester
Description of Device:	The ACTAEON™ Probe is a hand-held device whichwhen activated by the user measures the reaction force(resistance) of articular cartilage against a known rateand force of indentation applied by the disposableindenting tip of the device.
Indications for Use:	The ACTAEON™ Probe arthroscopic cartilage stiffnesstester is indicated for an arthroscopic in vivo pointmeasurement of articular cartilage stiffness in humans.The ACTAEON™ Probe can be used arthroscopicallyor in open joint procedures.
Testing Summary:	The ACTAEON™ Probe is designed to meet andcomply with all sections of IEC 60601.
Predicate Device:	Artscan 200 Arthroscopic Cartilage Stiffness TesterArtscan Oy. Helsinki. Finland

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2002

OsteoBiologics, Inc. Mark Q. Niederauer, Ph.D. Director of Operations University Business Park 12500 Network, Suite 112 San Antonio, Texas 78249-3308

Re: K013429

Trade Name: ACTAEONTM Probe Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: NGR Dated: October 15, 2001 Received: October 16, 2001

Dear Dr. Niederauer:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. Mark Niederauer:

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark A. Mulkern

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

Enclosure

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INDICATIONS FOR USE (FORM) 2.4

INDICATIONS FOR USE

510(k) Number (if known): (not known) [K013429](https://510k.innolitics.com/search/K013429)
Device Name: ACTAEON™ Probe

Indications For Use:

The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic in vivo point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Melber
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number [K013429](https://510k.innolitics.com/search/K013429)

Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)

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.