The EndoPearl™ With Threader is used in conjunction with a Invatec 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™ With Threader Bioabsorbable Soft Tissue Device is a cannulated, sterile, sinqle-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will gradually be metabolized by the body. EndoPearl™ comes preloaded on a suture threader (with The nitinol wire) to facilitate the threading of the suture into EndoPearl™ during graft preparation by the the surgeon, resident, PA, or nurse.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "EndoPearl™ With Threader." This submission is a request to market a new device by demonstrating its substantial equivalence to a legally marketed predicate device.

Crucially, a 510(k) submission focuses on demonstrating substantial equivalence rather than proving a device meets specific acceptance criteria through a clinical study for performance.

Therefore, there is no information in the provided text regarding:

Acceptance criteria and reported device performance in a table.
Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
Standalone algorithm performance.
Type of ground truth used for performance evaluation.
Sample size for training sets or how ground truth for training sets was established.

This is because the 510(k) process for a Class II device like this typically relies on non-clinical performance data (e.g., biocompatibility testing, mechanical testing) and a comparison to a predicate device to establish safety and effectiveness, rather than a clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.

Based on the provided text, the core "study" that proves the device meets the criteria for market clearance is the demonstration of substantial equivalence to a legally marketed predicate device.

Here's what can be extracted and inferred from the text regarding this "study" or justification:

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

Not applicable. The provided text does not contain acceptance criteria related to clinical performance metrics or reported device performance against such metrics. The "criteria" here are those for establishing substantial equivalence to a predicate device.

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

Not applicable. There is no "test set" in the context of clinical performance evaluation described here. The submission is a comparison of characteristics to a predicate device.

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 applicable. No expert ground truth establishment for a test set is mentioned.

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

Not applicable. No adjudication method is described.

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:

Not applicable. This device is a bioabsorbable fixation device, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to this submission.

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

Not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" equivalent in a 510(k) context for substantial equivalence is the safety and effectiveness profile of the legally marketed predicate device. The new device is deemed "safe and effective" if it shares similar technological characteristics and intended use with the predicate, and introduces no new questions of safety or effectiveness.

8. The sample size for the training set:

Not applicable. The concept of a "training set" for an algorithm is not relevant to this type of device submission.

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

Not applicable.

Summary of "Study" and "Acceptance Criteria" in the 510(k) Context:

Acceptance Criteria (for 510(k) submission): The device (EndoPearl™ With Threader) must be "substantially equivalent" to a legally marketed predicate device (EndoPearl™). Substantial equivalence means having the same intended use and technological characteristics, or if technological characteristics differ, they do not raise new questions of safety or effectiveness and the information submitted demonstrates that the device is as safe and effective as the predicate device.
"Study" Proving Acceptance: The entire 510(k) submission itself serves as the "proof." The key elements presented are:
- Predicate Device: EndoPearl™ (Linvatec Corporation, 510(K) # K984171)
- Comparison: A "Chart of Similarities and Dissimilarities" (Page 3 of 3) is provided, comparing the new device and the predicate device across categories such as:
  - Company
  - Device Name
  - Intended Use
  - Material
  - Single-Use/Reusable
  - Method of Sterilization
  - Design
- Conclusion: The submission aims to demonstrate that the new EndoPearl™ With Threader is substantially equivalent to the predicate EndoPearl™ because they share the same intended use, similar materials (Poly (L-lactic acid) for the Pearl), similar design sizes (7mm, 8mm, 9mm), and both are single-use and sterilized by ETO. The primary difference is the addition of a "Threader" component (Ultem with Nitinol Wire) to facilitate suture threading, which is presented as an enhancement without altering the fundamental safety or effectiveness of the bioabsorbable fixation component.

In essence, for this 510(k) clearance, the "acceptance criteria" were met by successfully arguing to the FDA that the new device is substantially equivalent to an already cleared device, without presenting new safety or effectiveness concerns.

Summary

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K9913339

DEC I 0 1999

October 4, 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 nereby - Baxaccing - cho Pearl™ With Threader, 510(k) Number

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Laura Seneff Manager, Regulatory Affairs

Device Name C.

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

Predicate/Legally Marketed Devices D.

EndoPearl™ Linvatec Corporation

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Summary of Safety and Effectiveness
EndoPearl™ With Threader 510(k) # K993339 October 4, 1999 Page 2 of 3

E. Device Description

EndoPearl™ comes preloaded on a suture threader (with The nitinol wire) to facilitate the threading of the suture into EndoPearl™ during graft preparation by the the surgeon, resident, PA, or nurse.

F. Intended Use

This device is used in conjunction with a 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.

৫ . Substantial Equivalence

The EndoPearl™ With Threader is substantially equivalent in function and intended use to the EndoPearl™ (Linvatec Corporation) .

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

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Summary of Safety and Effectiveness EndoPearl™ With Threader 510 (k) # ____________________________________________________________________________________________________________________________________________________________________ Page 3 of 3

�

CHART OF SIMILARITIES AND DISSIMILARITIES

Company	Device Name	Intended Use	Material	Single-UseReusableMethod ofSterilization	Design
NEW PRODUCTLinvatec	EndoPearl™With ThreaderBioabsorbableSoft TissueDevice	Used in conjunctionwith a LinvatecBioScrew®bioabsorbableinterference screw, asa back-up tointerference screwfixation of softtissue grafts on thefemoral side of anACL/PCLreconstruction.	EndoPearl: Poly (L-lacticacid)Threader: Ultem with NitinolWire	Single-UseETO	7mm, 8mm, 9mm
PREDICATELinvatecEndoPearl™510(K) #K984171	EndoPearl™	Used in conjunctionwith a LinvatecBioScrew®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

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles an eagle or other bird with its wings spread. The emblem is stylized and appears to be composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1999

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

Re: K993339

Trade Name: EndoPearI™ With Threader Regulatory Class: II Product Code: MAI and HWC Dated: October 4, 1999 Received: October 5, 1999

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 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 (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 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. Laura Seneff

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

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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October 4, 1999

Page 1 of 2

510(k) Number (if known):_K993339

Device Name: EndoPearl™ With Threader

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use___________OR

Over-the-Counter Use_

(Per 21 CFR 801.109)

(Optional Format 1-296)

Acolla

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.