The BioSorb® SR-PDLA Endobrow Screw is intended for use in Endoscopic Browplasty surgery. The Endobrow Screw will be specifically indicated for use to reattach the subdermis to the cranial bone in endoscopic browplasty procedures. The Endobrow Screw is used as a post to tie an absorbable suture to the subdermis. In conjunction with adequate surgical technique, the Endobrow Screw holds the subdermis securely in place to allow for reattachment to the cranial bone. Use absorbable sutures that provide wound support for at least thirty (30) days.

Device Description

The BioSorb® SR-PDLA Endobrow Screw is a biodegradable threaded fixation rod intended for use in endoscopic browplasty surgery. It is used as a post to tie an absorbable suture to the subdermis to reattach it to the cranial bone. The screw is inserted into the cranial bone after a drill hole is made. It is constructed of a blended copolymer of SR-PDLA.

AI/ML Overview

This document is a 510(k) summary for the BioSorb® Biodegradable Threaded Endobrow Screw. It is a submission to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared predicate devices.

Based on the provided text, the document does not contain acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a de novo study with strict acceptance criteria and performance metrics, the manufacturer is asserting that their device is as safe and effective as devices already on the market.

Therefore, many of the requested points regarding acceptance criteria, specific performance metrics, sample sizes for testing and training, expert ground truthing, and MRMC studies are not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be extracted and what cannot:

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

Not applicable / Not provided. The document is a 510(k) submission, which relies on demonstrating substantial equivalence to predicates rather than presenting de novo performance data against specific acceptance criteria for the new device. It discusses "technical characteristics" in comparison to predicates but doesn't set specific, quantitative performance targets for the BioSorb® screw itself and then show data meeting those targets.

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

Not applicable / Not provided. No specific test set data is presented. The submission relies on the established safety and efficacy of the predicate devices.

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 / Not provided. No specific test set with ground truth established by experts is mentioned.

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

Not applicable / Not provided. No test set or 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 / Not provided. This device is a physical medical implant, not an AI or imaging device with readers. Therefore, 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 / Not provided. This is a physical implant; the concept of "standalone algorithm performance" does not apply.

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

Not applicable / Not provided. No specific ground truth establishment is described for performance testing of this device. The "ground truth" for this submission is essentially the legally marketed status and presumed safety/effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable / Not provided. No training set for a new algorithm or device development is mentioned.

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

Not applicable / Not provided. As no training set is mentioned, its ground truth establishment is also not applicable.

Summary of what the document does provide in relation to "proving" substantial equivalence:

The "study that proves the device meets acceptance criteria" in this context is the comparison to predicate devices and the argument of substantial equivalence, which is the core of a 510(k) submission.

Basis for Substantial Equivalence: The primary "proof" is the detailed comparison of the BioSorb® SR-PDLA Endobrow Screw to four predicate devices:
- Techmedica, Inc. TMP Micoplate System (K921458)
- W. Lorenz Surgical, Inc. LactoSorb® System (K955729)
- Bionx Implants, Inc. BIOFIX® SR-PLLA Threaded Rod (K952871)
- Synthes, Inc. PDLA Polypin (K961608)
Key Arguments for Equivalence (and implied "performance"):
- Intended Use: The BioSorb® screw shares the same intended use (endoscopic browplasty surgery, reattaching subdermis to cranial bone) as some predicates. Even where specific indications differ slightly (e.g., holding a bone fixation plate vs. holding sutures), the underlying surgical procedure and anatomical site are similar.
- Principles of Operation: They share similar operational principles (insertion into cranial bone for fixation).
- Technical Characteristics:
  - Diameter: All are 2.0 mm in diameter (though predicates may offer other sizes).
  - Material: It is made of SR-PDLA. The Lorenz screw is bioabsorbable (PLA-PGA copolymer with similar degradation). The Synthes Polypin uses a blended copolymer, and FDA has recognized similar physical properties and biocompatibility of PLLA, PGA, and polydioxanon (which includes PDLA).
  - Degradation: BioSorb® screw degrades by hydrolysis over 12-24 weeks in vivo, with complete reabsorption in 2-4 years. The Lorenz predicate has a similar degradation period.
  - Self-tapping: Neither BioSorb® nor Lorenz screws are self-tapping.
  - Surgical Instruments: Uses the same instruments as the previously cleared 2.0 mm BIOFIX® SR-PLLA Threaded Rod.
  - Function: While some predicates hold bone plates, the BioSorb® screw's function (holding sutures for soft tissue approximation) is argued to be "less demanding" than fixing "low load" fractures (like the Polypin).
- Safety/Effectiveness: The submission argues that "The minor differences in the technical characteristics of the devices, such as differences in the configuration, do not raise new questions of safety or effectiveness." This statement is the crux of the 510(k) "proof."

In conclusion, this document is a regulatory submission for premarket clearance based on substantial equivalence, not a scientific publication detailing a conventional study with quantifiable acceptance criteria for de novo device performance.

Summary

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K972919

Attachment 16

510(K) SUMMARY FOR THE BIONX IMPLANTS, INC. BIOSORB® BIODEGRADABLE THREADED ENDOBROW SCREW

Submitter's Name. Address. Telephone Number, And Contact Person

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall Suite 400 Bluebell. PA 19422

David W. Anderson. Contact: President and CEO Phone: (215) 643-5000 Facsimile: (215) 653-0984

Date Prepared

February 12, 1998

Name of the Device

BioSorb® Biodegradable Threaded Endobrow Screw

Common or Usual Name

Bioabsorbable Threaded Fixation Rod

Classification Name

Bone Fixation Screw

Predicate Devices

(1) Techmedica, Inc. TMP Micoplate System (K921458)
W. Lorenz Surgical, Inc. LactoSorb® System (K955729) (2)
Bionx Implants, Inc. BIOFIX® SR-PLLA Threaded Rod (K952871) (3)
Synthes, Inc. PDLA Polypin (K961608) (4)

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Intended Use

The BioSorb® SR-PDLA Endobrow Screw is intended for use in endoscopic browplasty surgery. The Endobrow Screw will be specifically indicated for use to reattach the subdermis to the cranial bone in endoscopic browplasty procedures. The Endobrow Screw is used as a post to tie an absorbable suture to the subdermis. In conjunction with adequate surgical technique, the Endobrow Screw holds the subdermis securely in place to allow for reattachment to the cranial bone. Use absorbable sutures that provide wound support for at least thirty (30) days. The BioSorb® SR-PDLA Endobrow Screw will maintain sufficient physical integrity and mechanical holding properties within the bone well beyond the 30 days needed for complete biological healing and reattachment of the subdermis to the cranial bone.

Principles of Operation

After preparing the area according to standard surgical procedures, several small incisions are made just behind the frontal hairline based upon the elevation and direction needed for the patient. A subperiosteal plane is obtained and a drill hole is made in the cranial bone on one side of the head. The position of the drill hole is determined based upon the individual needs of each patient. The drill hole is made with an Aesculap power drill with a 1.5 mm x 3.7 mm bit and a 3.5 mm stop on the bit to prevent further penetration and injury to the dura. Once

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endoscopic browplasty is completed. the accompanying screw-thread tap is used and the BioSorb® SR-PDLA Endobrow Screw is inserted 3.0 mm to 3.5 mm into the cranial bone. The BioSorb® SR-PDLA Endobrow Screw is used to tie an absorbable suture to the subdermis. An absorbable suture which provides wound support for at least thirty (30) days is recommended. The BioSorb® SR-PDLA Endobrow Screw provides secure fixation of the subdermis to the cranial bone to allow for reattachment of the soft tissue to the bone. The scalp is closed with a chromic suture and the procedure is repeated on the contralateral side.

Technical Characteristics

The BioSorb® SR-PDLA Endobrow Screw has the same intended use and principles of operation and very similar technical characteristics as the bone screws used in the previously cleared W. Lorenz LactoSorb System (K955729) and Techmedica TMP Microplate System (K921458) fixation systems. The BioSorb SR-PDLA Endobrow Screw also is identical in technological characteristics to the previously cleared BIOFIX® Bioabsorbable Self-Reinforced Poly-L-lactide Threaded Fixation Rod for use in the ankle (K952871). Additionally, the BioSorb® SR-PDLA Endobrow Screw is constructed of the same blended copolymer used in the previously cleared Synthes Polypin (K961608).

Like the bone screws in the Lorenz and Techmedica products, the BioSorb® SR-PDLA Endobrow Screw is intended for use in endoscopic browplasty surgical procedures. All three types of screws are inserted into facial or cranial

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bone to provide fixation: the Lorenz and Techmedica screws are inserted to hold a bone fixation place. while the BioSorb® SR-PDLA Endobrow Screw is inserted as a post to hold fixation sutures that secure the subdermis so that reattachment to the cranial bone can occur during the healing process. All are 2.0 mm in diameter (the Lorenz and Techmedica products offer other sizes as well). Both the BioSorb® SR-PDLA Endobrow Screw and the Lorenz screw are bioabsorbable, although the former is made from PDLA and the latter from a PLA-PGA copolymer with a similar degradation period. Neither the BioSorb® SR-PDLA Endobrow Screw nor the Lorenz screws are self-tapping. The Techmedica screw is metallic and is self-tapping.

Finally, the BioSorb® SR-PDLA Endobrow Screw is identical in technological characteristics to the BIOFIX® Bioabsorbable Self-Reinforced Poly-Lrlactide Threaded Fixation Rod for use in the ankle, although the two do not share the same anatomical site/ intended use. The BioSorb® SR-PDLA Endobrow Screw also is constructed of the same blended copolymer used in the previously cleared Synthes Polypin (K961608). Like the Endobrow Screw, the Polypin is an implantable orthopedic fixation device. The Polypin is intended for use in fixation of small bone fragments in "low load" fractures, while the Endobrow Screw is intended for the less demanding task of soft tissue approximation. The Polypin was found substantially equivalent to predicate devices composed of PLLA, polyglycolic acid ("PGA"), and polydioxanon. Thus, FDA has previously recognized that all of these polymers have similar physical properties and biocompatibility

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characteristics. The BioSorb® SR-PDLA Threaded Endobrow Screw will degrade by hydrolosis over a period of 12 to 24 weeks in vivo, with complete reabsorption within two to four vears after implantation.

Like its predicates, the BioSorb® SR-PDLA Endobrow Screw requires good surgical technique. The surgical instruments used for implantation of the BioSorb® SR-PDLA Endobrow Screw are the same as those cleared for use in implanting the currently marketed 2.0 mm BIOFIX® SR-PLLA Threaded Rod for use in the ankle.

Summary Basis for the Finding of Substantial Equivalence

Like the previously cleared TMP Microplate System, the Lactosorb®, and the BIOFIX® SR-PLLA Threaded Rod, the BioSorb® SR-PDLA Threaded Endobrow Screw is intended for use in endoscopic browplasty surgery. The BioSorb® SR-PDLA Endobrow Screw will be specifically indicated for use to reattach the subdermis to the cranial bone in endoscopic browplasty procedures. Although the indications for use of the screws differ slightly, all of the devices possess similar principles of operation and technical characteristics. The minor differences in the technical characteristics of the devices, such as differences in the configuration, do not raise new questions of safety or effectiveness. Thus, the devices are substantially equivalent.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three human profiles forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 27 1998

Bionx Implants, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109

K972919 Re : Biosorb® Biodegradable Threaded Trade Name: Endobrow Screw Regulatory Class: II Product Codes: HWC and MAI Dated: January 5, 1998 Received: January 5, 1998

Dear Mr. Kahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above submitted on behalf of Bionx Implants, Inc. 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 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 General regulation (21 CFR Part 820) and that, Devices: 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.

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Page 2 - Mr. Jonathan S. Kahan

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.

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 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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: BioSorb® Biodegradable Threaded Endobrow Screw Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Docêêto

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.