Made from surgical grade PLL (homopolymer poly (L(-) -lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LM Anchor, formatted as requested:

Acceptance Criteria and Study for LM Anchor

The provided 510(k) summary for the Li Medical RotorBlade™ (LM Anchor) focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel safety and effectiveness through a rigorous performance study with predefined acceptance criteria. The primary evidence presented is preclinical testing showing substantial equivalence in pullout strength.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Premarket Definition: The new device (LM Anchor) must be substantially equivalent to the predicate device (Li Medical RotorBlade™ K983435) in terms of safety and effectiveness, specifically regarding pullout strength.	The study found that "the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the predicate device." No specific quantifiable metric (e.g., within X% of the predicate mean, or exceeding a certain force threshold) is provided as an acceptance criterion.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text. The summary only mentions "Pre-clinical testing."
Data Provenance: Not explicitly stated. However, "Pre-clinical testing" typically implies laboratory or ex-vivo testing rather than in-vivo human data. It's likely conducted in a controlled lab setting, not geographically specific patient data. It is retrospective in the sense that it aims to compare against an already marketed predicate, but the testing itself would have been newly performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study described is a pre-clinical, mechanical comparison of pullout strength. Ground truth in this context would likely be defined by physical measurements and engineering standards, not expert medical opinion.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is a pre-clinical, mechanical comparison. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints. Physical measurements for pullout strength would be objective and not require adjudication by human experts in the medical sense.

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 comparative effectiveness study was not done. This device is a mechanical surgical anchor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, questions regarding AI assistance and human reader improvement are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not an AI algorithm. It is a physical medical device (suture anchor). Therefore, the concept of standalone algorithm performance is not applicable. The performance evaluated was the mechanical pullout strength of the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the pre-clinical pullout strength testing would have been objective physical measurement of the force required to pull the anchor out of the test substrate (likely bone or a bone substitute). This is a direct physical property measurement, not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device subject to mechanical testing, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a physical device.

Summary

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SEP 2 3 1999

1499293B

510(K) SUMMARY

Device Sponsor:

Contact: Date:

Classification Name: Common Name: Proprietary Name:

Predicate Device:

Device Description:

Intended Use:

Technical Comparison:

Performance Data:

Li Medical, 4 Armstrong Road, Shelton, CT 06484.

Rhodemann Li, Vice President August 30, 1999

Unclassified Bone anchor Li Medical RotorBlade™

Li Medical RotorBlade™ (K983435)

Shoulder - rotator cuff repair

The LM Anchor is identical to the predicate devicein its intended use, and similar in safety and effectiveness. The only difference between the new anchor and the predicate device is that the dimensions have been increased slightly in areas of stress and the suture eyelets have been widened to accommodate up to two (2) USP #2 sutures.

Pre-clinical testing showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullour strength of the predicate device.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare, with a single snake entwined around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

Mr. Rhodemann Li Vice President Li Medical Technologies Inc. 4 Armstrong Road Shelton, Connecticut 06484

Re: K992938

Trade Name: RotorBlade™ Suture Anchor Regulatory Class: II Product Code: MAI and GAS Dated: August 19, 1999 Received: August 31, 1999

Dear Mr. Li:

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 (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. Rhodemann Li

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) 594-4659. 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" (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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
J cotella

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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Page 1 of 1

510(k) Number (if known); K992938

Device Name:

LM Anchor

Indications For Use: rotator cuff repair Shoulder:

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

NEWS (CONTINE SECTION) (VEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jocelle Jo

(Division Sign-Off)
Division of General Restorative Devices K992938
510(k) Number

11/2 Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.