The EndoPearl is used in conjunction with the Linvatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.

Device Description

The EndoPearl BioAbsorbable Soft Tissue Device is a cannulated, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will gradually be metabolized by the body.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data. The document is a 510(k) summary for the EndoPearl device, primarily focusing on its substantial equivalence to a predicate device. While it mentions "Testing has been done to prove safety and effectiveness of the device," it does not provide the results of these tests in a way that allows for a direct answer to your detailed questions about acceptance criteria and device performance metrics.

However, based on the limited information, here's what can be extracted and inferred:

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

The document does not explicitly state acceptance criteria or report specific performance metrics like accuracy, sensitivity, or specificity. The "performance" described is centered around its intended use and bioabsorbability.

Acceptance Criteria (Inferred)	Reported Device Performance
Material Properties:	Made from a bioabsorbable homopolymer, Poly (L-lactic acid), which will gradually be metabolized by the body.
Fixation Functionality:	Used as a back-up to interference screw fixation of soft tissue grafts. Implied to perform this function safely and effectively.
Biocompatibility:	Implied safe interaction with the body given its bioabsorbable nature and intended use.
Sterility:	Sterile, single-use device.
Sizing:	Available in 7mm, 8mm, 9mm sizes.
Substantial Equivalence:	Deemed substantially equivalent in function and intended use to the EndoButton (Acufex Microsurgical Inc.).

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

This information is not provided in the document. The text only vaguely states "Testing has been done" without details on sample size, data type, or provenance.

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 provided in the document. The general nature of the device (implantable fixator) suggests that "ground truth" would likely be established through biomechanical testing, animal studies, or clinical observations rather than expert consensus on images.

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

This information is not provided 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

This is not applicable to the EndoPearl device. The EndoPearl is a physical medical device (a fixation device), not an AI algorithm or a diagnostic tool that would involve human readers or AI assistance in interpretation.

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

This is not applicable as the EndoPearl is a physical device, not an algorithm.

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

The document does not specify the precise "ground truth" used for testing. For a bioabsorbable fixation device, ground truth would typically relate to:

Biomechanical performance: Strength, degradation rate, load-bearing capacity.
Biocompatibility: Lack of adverse tissue reaction.
Clinical outcomes: Successful fixation, absence of complications, healing process.
However, no details are provided.

8. The sample size for the training set

This information is not provided. As the device is not an AI algorithm, the concept of a "training set" in the context of machine learning is not directly applicable.

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

This information is not provided and is not applicable in the context of a physical medical device.

Summary

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4/29/99

Image /page/0/Picture/1 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three angled lines inside. The word "Linvatec" is written in a bold, sans-serif font.

11311 Concept Boulevard Largo, Florida 33773-4908 727 392-6464

K98417/

February 9, 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the EndoPearl, 510(k) Number K984171.

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Laura Seneff Manager, Regulatory Affairs

c. Device Name

Trade Name:	:	EndoPearl
Common Name	:	EndoPearl
Classification Names	:	None Assigned
Proposed Class/DeviceProduct Code	:	Class II-87 MAI, FastenerFixation, Biodegradable, SoftTissue

D. Predicate/Legally Marketed Devices

EndoButton Acufex Microsurgical Inc.

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Summary of Safety and Effectiveness EndoPearl 510 (k) # K984171 February 9, 1999 Page 2 of 3

E. Device Description

BioAbsorbable Soft Tissue Device is ಡಿ The EndoPearl cannulated, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will qradually be metabolized by the body.

F. Intended Use

This device is used in conjunction with the Linvatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.

G. Substantial Equivalence

The EndoPearl is substantially equivalent in function and intended use to the EndoButton (Acufex Microsurgical Inc.) .

Testing has been done to prove safety and effectiveness of the device.

The similarities/dissimilarities to the predicate are shown in the attached table.

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Summary of Safety and Effectiveness EndoPearl 510(k) # K984171 February 9, 1999 Page 3 of 3

Company	Device Name	Intended Use	Material	Single-UseReusableMethod ofSterilization	Design
NEW PRODUCTLinvatec	EndoPearlBioAbsorbableSoft TissueDevice	Used in conjunctionwith Linvatec'sBioScrew®bioabsorbableinterference screw, asa back-up tointerference screwfixation of softtissue grafts on thefemoral side of anACL/PCLreconstruction.	Poly (L-lactic acid)	Single-UseETO	7mm, 8mm, 9mm sizesDesign is a spherewith a 2mm centralhole.
PREDICATEAcufexMicrosurgicalInc.510 (K) #K922559	EndoButton	Suture fixation in therepair of tendons andligaments.	Titanium Alloy	Single UseGammaRadiationSterilization	Sizes :4mm x 12mm4mm x 16.5mmDesign is a flatrectangular platewith four holesgoing across.

CHART OF SIMILARITIES AND DISSIMILARITIES

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Ms. Laura Seneff Manager, Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

K984171 Re: EndoPearl Trade Name: Regulatory Class: II Product Codes: MAI and HWC Dated: February 9, 1999 February 10, 1999 Received:

Dear Ms. Seneff:

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 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 Regulations, Title 21, Parts 800 to 895. ਰੇ 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 In addition, FDA may publish further announcements action. 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. Laura Seneff

This letter will allow you to begin marketing your device as rnio reed in your 510 k) premarket notification. The FDA ating of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predice actits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in rigro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on obmpriamot as (nd 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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February 9, 1999

Page 1 of 1

510(k) Number (if known): K984171

Device Name: EndoPearl

Indications for Use:

The EndoPearl is used in conjunction with the Linvatec BioSo bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of ACL/PCL reconstruction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off) General Restorative Devices

Prescription Use	Yes	OR
(Per 21 CFR 801.109)

Over-the-Counter Use /

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.