The device is a bioresorbable interference screw used for the anterior cruciate ligament (ACL). The Phusis® Absorbable Interference Screw system is made up of two different diameter screws (7.0mm and 9.0mm) available in two lengths for each diameter. The 7.0mm diameter screws are 20 & 25 mm in length and the 9.0mm screws are 25 & 30 mm in length. The thread profile is that of a non aggressive single lead thread (cancellous-type) with a pitch of approximately 12 to the inch. The thread is progressive in nature. That is, the distal end or tip of the screw is tapered slightly to improve ease of insertion.

The cannulation channel serves two purposes, it allows for the insertion of a guide wirelpin and it provides the driver interface. The cannula channel is not round throughout its length, but rather, it is hex in configuration over most of its length. Only the last millimeter near the tip is round. This provides two specific benefits, maximum hex drive interface and excellent insertion when inserted over the guide pine/wire.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study used to prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) Pre-market Notification for the Phusis® Absorbable Interference Screw. In this regulatory context, "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices. The performance is assessed by comparing key features, indications for use, and a clinical summary.

1. Table of Acceptance Criteria and Reported Device Performance

Feature / Acceptance Criteria	Phusis® Absorbable Interference Screw (Reported Performance)	Predicate Device 1 (BioScrew Fixation System, Linvatec, Inc.)	Predicate Device 2 (Acufex Screw, Acufex Microsurgical, Inc.)	Substantially Equivalent (SE)?
Indications for Use (same as predicates)	ACL reconstruction	Same	Same	Yes
Design (cylindrical, headless, cannulated, tapered cancellous thread, interference screw)	Cylindrical headless cannulated, tapered cancellous thread, interference screw	Same	Same	Yes
Sterility Assurance Level (SAL 10-8)	SAL 10-8	Same	Same	Yes
Sterilization Method (compatible with accepted methods)	Hydrogen Peroxide Plasma	Gamma	Unsterile	Yes (Method difference accepted)
Sizes (comparable range)	4 sizes (7.0mm dia. x 20 & 25mm length; 9.0mm dia. x 25 & 30mm length)	Same	Same	Yes
Material (biocompatible and resorbing as intended for absorbable)	PLA98 (98% L-lactic units, 2% D-lactic units - α-hydroxy-acid stereocopolymer)	PLA	Titanium	Yes/No (Difference in material accepted due to class & prior use of PLA)
Accessory Items (specialized surgical instruments available)	Specialized Surgical Instruments (cannulated hex screwdriver, non-cannulated hex screwdriver, conformator, clearance template, gauge, guide wires)	Same	Same	No (Differentiation noted but not deemed to preclude SE)
Manufacturer	Phusis (Tornier S.A.)	Linvatec, Inc.	Acufex Microsurgical	Yes
Product Code	87HWC	Same	Same	Yes
Clinical Performance (equivalent to predicates)	Analysis supports conclusion of performance substantially equivalent to referenced comparison devices	Historical performance of BioScrew	Historical performance of Acufex	Yes

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

The study described is a retrospective review and analysis of European ACL reconstruction clinical results.

Sample Size for Test Set: The specific number of patients (n) included in the retrospective review is not explicitly stated in the provided text, only that "variables such as n" were detailed.
Data Provenance: The data is from European ACL reconstruction clinical results and is retrospective.

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

This document describes a regulatory submission ("510(k)") which typically relies on expert consensus in the medical community and previously established evidence for predicate devices.

Number of Experts: The document does not specify a number of experts specifically used to establish ground truth for this particular retrospective review.
Qualifications of Experts: It is implied that the "peer review literature" referenced, and the "appropriate statistical methodologies applied," would have been reviewed and analyzed by individuals with expertise in orthopedic surgery, clinical research, and statistical analysis, likely including medical doctors and biostatisticians. However, specific qualifications are not detailed for the individuals conducting this specific review. The FDA's review process itself involves experts in device evaluation.

4. Adjudication Method for the Test Set

The document describes a "retrospective review and analysis" of existing clinical results. It does not mention a specific adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth within the reviewed data. The analysis likely involved synthesizing and comparing reported outcomes from various clinical studies and publications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

Was an MRMC study done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The study was a retrospective review of existing clinical data, not a direct comparison of human readers with and without AI assistance.
Effect Size: Therefore, no effect size for human reader improvement with AI assistance is applicable or reported.

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

Was a standalone study done? No, this device is a physical surgical implant (an absorbable interference screw). The concept of "standalone performance" without human-in-the-loop applies to AI/ML algorithms that interpret data or images. This is not applicable to the Phusis® Absorbable Interference Screw.

7. The Type of Ground Truth Used

The ground truth for the comparison was established based on:

Clinical Performance Data: A retrospective review of "European ACL reconstruction clinical results" was undertaken, examining "nine common ACL clinical variables." These variables included symptoms, pivot shift, screw breakage, return to activity, complications, and final outcome.
Peer Review Literature: The clinical performance of the Phusis screw was contrasted with the Linvatec BioScrew and Acufex metallic interference screw "as reported in the peer review literature." This implies a reliance on published clinical outcomes from these predicate devices as a benchmark for comparison.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device (an interference screw), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the device's design and material selection would stem from foundational research in biomaterials and orthopedic surgery, but not a dataset in the AI sense.

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

Not Applicable. (See point 8).

In summary: The submission relies on demonstrating substantial equivalence to existing legally marketed devices by comparing design features, intended use, materials (with justification for differences), and clinical performance through a retrospective review of European clinical outcomes and comparison to peer-reviewed literature on predicate devices. It is not an AI/ML device, so concepts like training sets, standalone performance, and MRMC studies are not relevant.

Summary

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Tornier S.A.

Phusis® Absorbable Interference Screw

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:
  Phusis® Absorbable Interference Screw Trade Name:

Interference Screw Common Name:

Screw. Fixation, Bone Classification Name:
Establishment Name & Registration Number: सं

Tornier S.A. Name:

8020756 Number:

1. Classification:
  Screw, Fixation, Bone, as categorized under 21 CFR, § 888.3040.

& 888.3040 Smooth or threaded metallic bone fixation fastener. (a) Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstruction, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. (b) Classification. Class II.

Device Class: Class II Classification Panel: Orthopaedic Product Code: 87HWC

4. Company Contact:

Ms. Patricia Abraham, Marketing Manager Tornier, S.A. B.P. 11 - rue Doyen Gosse 38330 - Saint Ismier France 011.334.7652.8000 011.334.7652.0673 - fax

5. Special Controls:

Special Controls do not apply to this device.

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6. Substantially Equivalent Device(s):

1. BioScrew Fixation System. Linvatec, Inc., K933719
1. Acufex Screw, Acufex Microsurgical, Inc., K895711

7. Indications for use:

1. Surgical repair of the anterior cruciate ligament.
1. ACL repair.
1. Arthroscopic ACL repair.

8. Description of the Device:

Materials:

The material used to construct the device is described as an a -hydroxy-acid. Specifically, the material used in the construction of the Plusis® Absorbable Interference Screw is an exclusively lactic stereccopolymer containing PLA98 (98% L-lactic units and 2% D-lactic units. Resorption of PLA98 occurs exclusively by a chemical mechanism known as autocatalytic hydrolysis leading to progressive breaking of the macromolecular chains. The 2% of D-lactic units guarantee permanent hydrolysis of a PLA98 implant until its complete resorption.

Instrumentation:

Specialized instruments are provided as a part of the Phusis® Interference Screw system. There is a cannulated hex screw driver, a non-cannulated hex screw driver, a conformator (thread tap) a clearance template and a gauge. Guide wires of the appropriate diameter are also available with the system.

9. Claims Regarding Device Features, Performance, or Safety:

Surgical technique essentially the same as for metallic interference screws. 1.
1. Ease of use.
1. obviates the need for secondary surgery to remove the screw after healing.
Long history of safe use of Poly L-lactic acid material for same and similar uses. ব
strong initial and intermediate fixation followed by complete resorption. ട്.

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10. Cleaning/Sterilization/Re-sterilization:

The implantable product is supplied sterile from the manufacturer. The device may not be secondarily cleaned or resterilized. Once the product packaging is opened or damaged, the product is no longer considered sterile. Inspect all packaging on arrival for evidence of shipping damage. Damaged packaging renders the product unsafe and it should not be used. Return all shipping damaged product promptly. Subsequently damaged product packaging requires product replacement. Product used in the operating room must be opened and placed into use using accepted operating room sterile technique.

The surgical instruments required to properly use the device are supplied clean only and must be sterilized prior to each use. Remove all shipping and packaging materials before sterilization. Wash all instruments thoroughly prior to sterilization. For the instruments, the recommended method is steam autoclave sterilization. The recommended sterilization cycle is based on AAMI guidelines. The cvcle is saturated steam at 270° F for 30 minutes.

11. Equivalence:

Based on the materials, intended uses, design and clinical technique, the Phusis® Absorbable Interference Screw is substantially equivalent to the above referenced legally marketed BioScrew Fixation System available from Linvatec, Inc.

FEATURE	Phusis Screw	BioScrew	Acufex	SE?
Indications for Use(s):	ACL reconstruction	same	same	Yes
Design:	cylindrical headless cannulatedtapered cancellous threadinterference screw	same	same	Yes
Sterility Assurance Level	SAL 10-8	same	same	Yes
Sterilization Method:	Hydrogen Peroxide Plasma	Gamma	Unsterile	Yes
Sizes	4	same	same	Yes
Material:	PLA98	PLA	Titanium	Yes/no
Accessory Items:	Specialized Surgical Instruments	same	same	No
Manufacturer:	Phusis	Linvatec, Inc.	Acufex Microsurgical	Yes
Product Code:	87HWC	same	same	Yes
K - Number	Pending	K933719	K895711	Yes

12. Feature Comparison Table:

13. Clinical Summary:

A retrospective review and analysis of European ACL reconstruction clinical results using the Phusis screw was undertaken. The purpose of the review was to examine clinical performance of the Phusis screw and contrast it with the Linvatec BioScrew and the Acufex metallic interference screw as reported in the peer review literature. Nine common ACL clinical variables were identified and matched for comparison. Appropriate statistical methodologies were applied.

The comprehensive report detailed variables such as n, average follow-up, symptoms, pivot shift, breakage of the screw on insertion, return to activity, intra-operative and post-operative complications, and final outcome was completed. The analysis supports the our conclusion that the performance of the Phusis screw is substantially equivalent to the referenced comparison devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying a sense of authority and trustworthiness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1998

Mr. David W. Schlerf Buckman Company, Inc. Representing Tornier S.A. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

K970829 Re: Phusis® Absorbable Interference Screw Requlatory Class: II Product Codes: MAI and HWC November 3, 1998 Dated: Received: December 7, 1998

Dear Mr. Schlerf:

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, Druq, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ 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 - Mr. David W. Schlerf

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia 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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1 Page 1 ---র্ত

K970829 510(k) Number:

Phusis® Absorbable Interference Screw Device Name:

Intended Use:

1. Interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
  Specific Indications For Use:
1. Open Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)
1. Arthroscopic ACL Reconstruction

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

cosello

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 14970829

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.