The LEADfix Bioresorbable Membrane Pin System is intended to be used to fixate and stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity. The LEADfix membrane pin is similar in intended use to other marketed membrane screws, including the IMZ Membrane Tack System and the Memfix screws, which are intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity.
The LEADfix Bioresorbable Membrane Pin System is designed to fixates he itAbilize resorbable barrier membranes during the healing process all stabilize resorbable barrism membrane to resident and of providing an accacinent mossite. The LEADfix membrane pin is aljacent bone at the burghour biro.
Indicated for use with absorbable guided tissue and guided bone regeneration membranes.

Device Description

The LEADfix Bioresorbable Membrane Pin System consists of components and instruments designed to fixate and stabilize bioresorbable barrier membranes in the oral cavity during the healing process following dental surgery. The system provides an anchoring mechanism for the membranes to resident and adjacent bone at the surgical site. The LEADfix membrane pin is fabricated from a bioresorbable polymer. The pin has a low profile, round, lens shaped head and a shaft with two circular ribs. The system also consists of stainless steel instrumentation designed to place the pin at the surgical site.

AI/ML Overview

The provided 510(k) summary for the LEADfix® Bioresorbable Membrane Pin System describes a medical device, not a software-driven AI device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI performance metrics (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance), is not applicable to this document.

The document discusses the substantial equivalence of the LEADfix system to predicate devices based on its intended use, design, materials, and non-clinical/clinical conclusions.

Here's an analysis of the provided text in the context of device approval, though not for AI:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" in a quantitative manner as one would expect for AI performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is described qualitatively:

Acceptance Criterion (Implicit)	Reported Device Performance
Sufficient strength to fix an absorbable membrane material to bone. (Nonclinical)	"Pull force testing of the LEADfix Bioresorbable Membrane Pin demonstrate that the pin has sufficient strength to fix an absorbable membrane material to bone. Results showed that the absorbable membrane material does not possess the strength to pull the implanted LEADfix pin out of bone without compromising itself in the process."
Effectively assists clinicians to fixate membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration. (Clinical)	"Clinical use of the LEADfix pin in conjunction with absorbable barrier membranes demonstrate that the LEADfix pin effectively assists clinicians to fixate membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration."
Safety and effectiveness comparable to predicate devices.	"Both in vitro and in vivo examination and use of this material do not raise new questions of safety or effectiveness as compared to predicate devices.""The device does not raise new issues or questions of safety and effectiveness as compared to predicate devices."

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified. The document mentions "Pull force testing" (nonclinical) and "Clinical use" (clinical) but does not provide numbers for participants or specimens.
Data Provenance: Not specified. Given the applicant is from Germany, it's possible some data originated there, but no details are provided. The studies appear to be proprietary tests conducted by the manufacturer, rather than large-scale population data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. Clinical use would implicitly involve dental professionals, but no details are given.

4. Adjudication method

Adjudication Method: Not applicable/Not specified. The assessment appears to be based on direct measurement (pull force) and clinical observation/outcomes, rather than expert adjudication of a diagnostic output.

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

MRMC Study: No, this is not an AI device. This type of study is not relevant.

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

Standalone Study: No, this is not an AI device. The device is a physical pin system, not an algorithm.

7. The type of ground truth used

Type of Ground Truth:
- For non-clinical performance (pull force), the ground truth would be quantitative measurements of various mechanical properties (e.g., force required to pull out, material integrity).
- For clinical performance, the ground truth would be observed clinical outcomes, such as successful membrane fixation, predictable bone/tissue regeneration, and absence of new health risks.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is not an AI device that requires training data in the machine learning sense. The device's design and material properties are based on scientific principles and engineering, not iterative training on a dataset.

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

Ground Truth for Training Set Establishment: Not applicable.

In conclusion, the provided document is a 510(k) summary for a physical medical device, not an AI software. As such, the specific criteria and study details requested, particularly those related to AI algorithm performance evaluation, are not present or relevant in this context. The document focuses on demonstrating substantial equivalence through non-clinical testing and clinical observation.

Summary

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JAN 3 0 1998

K974392

510(k) SUMMARY

1. Applicant's Name and Address

Company Name:	Biovision GmbH
Address:	Merzhauser Straße 112, D-79100 Freiburg, Germany
Telephone Number:	49-761/45 84-344
Facsimile Number:	49-761/45 84-541
Contact Person:	Michael Nagel, Clinical Research Manager
Date Summary Prepared:	October 24, 1997

2. Device Name

Trade Name:	LEADfix® Bioresorbable Membrane Pin System
Common/Usual Name:	Membrane fixation pin
Classification Name:	Screw, fixation, intraosseousper Dental Products Panel 21 CFR section 872.4880

3. Predicate Devices

IMZ Membrane Tack System (K960945) MemFix™ System (K955369)

4. Device Description

5. Intended Use

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6. Technological Characteristics

The LEADfix® Bioresorbable Membrane Pin System is similar in design and principles of operation to the predicate systems. The membrane pin, however, does not require subsequent removal after the completion of the membrane treatment and healing phase.

Materials of construction for the pin differs from the predicate devices. The LEADfix® pin is composed of a Polylactid copolymer. The Polylactid copolymer is absorbable while the predicate systems are non-absorbable metals that must be removed at the completion of the membrane treatment and healing phase. Both in vitro and in vivo examination and use of this material do not raise new questions of safety or effectiveness as compared to predicate devices.

7. Nonclinical Test Conclusions

Pull force testing of the LEADfix Bioresorbable Membrane Pin demonstrate that the pin has sufficient strength to fix an absorbable membrane material to bone. Results showed that the absorbable membrane material does not possess the strength to pull the implanted LEADfix pin out of bone without compromising itself in the process.

8. Clinical Use Conclusions

Clinical use of the LEADfix pin in conjunction with absorbable barrier membranes demonstrate that the LEADfix pin effectively assists clinicians to fixate membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration.

9. Conclusions

In summary. Biovision believes that the LEADfix Bioresorbable Membrane Pin System is substantially equivalent to currently marketed predicate devices. The device does not raise new issues or questions of safety and effectiveness as compared to predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 30 1998

Mr. Foster Boop Requlatory Affairs Associate Biovision GmbH C/O Sulzer Calcitek, Incorporated 2320 Faraday Avenue Calrsbad, California 92008-7216

Re: K974392 Leadfix Bioresorbable Membrance Pin System Trade Name: Requlatory Class: II Product Code: DZL October 24, 1997 Dated: November 21, 1997 Received:

Dear Mr. Boop:

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 requlations affecting your device can be found in the Code of Federal Requlations, - 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

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Page 2 - Mr. Boop

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 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,

Timothy Glatowski

Timoth Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation ... Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

K974892

IEADfix Bioresorbable Membrane Pin System Device Name:

Indications For Use:

The LEADfix Bioresorbable Membrane Pin System is designed to fixates he itAbilize resorbable barrier membranes during the healing process all stabilize resorbable barrism membrane to resident and of providing an accacinent mossite. The LEADfix membrane pin is aljacent bone at the burghour biro.
Indicated for use with absorbable guided tissue and guided bone regeneration membranes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russer

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_19-2429

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

000008

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.