The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair

Device Description

FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.

The implant is available in 2 different configurations:

· FIXIT®Knotless: supplied in a holder,
FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
The implant is supplied sterile, ready to use.

AI/ML Overview

The provided text describes a medical device submission (K170868) for the FIXIT® Threaded Anchor System. This device is a suture anchor, and the submission aims to demonstrate its substantial equivalence to a predicate device, the Arthrex Bio-Composite Corkscrew (K082810).

It is crucial to understand that this document describes a non-AI/ML medical device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth used," "sample size for the training set," and "how the ground truth for the training set was established" do not apply in the context of an AI/ML device validation study.

Instead, the acceptance criteria for this type of device (traditional medical device) are outlined by regulatory bodies such as the FDA. For a Class II medical device like the FIXIT® Threaded Anchor System, the primary acceptance criteria for market clearance via a 510(k) pathway revolve around demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of:

Intended Use: Must be the same or very similar to the predicate.
Technological Characteristics: Must be similar to the predicate.
Performance Data: Non-clinical testing (e.g., mechanical, biocompatibility) must show that the new device performs as safely and effectively as the predicate, and any differences in technological characteristics do not raise new questions of safety or effectiveness.

Here's a breakdown based on the provided text, adapted for the context of a traditional medical device:

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

Acceptance Criteria (for Substantial Equivalence to Predicate)	Reported Device Performance and Comparison to Predicate
Intended Use: Sameness with predicate (Fixation of suture (soft tissue) to bone in specific anatomical locations and procedures).	Same intended use as the predicate device (Arthrex Bio-Composite Corkscrew K082810). Both are for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow for specific procedures. The detailed indications for use are identical for both devices.
Technological Characteristics: Similar materials, configuration/dimensions, and packaging.	Materials: FIXIT® uses TCP/PLDLA. Predicate uses TCP/PLLA or TCP/PLDLA. (Similar) Configuration/Dimensions: FIXIT®: Ø 4.5mm x 14.5mm (2 sutures), Ø 5.5mm x 17.6mm (2 sutures), Ø 6.5mm x 17.6mm (2 sutures). Predicate: Ø 4.5mm x 15mm (2 sutures), Ø 5.5mm x 15mm (2 or 3 sutures), Ø 6.5mm x 15mm (2 or 3 sutures). (Similar, with slight variations in length and suture count for some dimensions). Packaging: FIXIT®: Anchor pre-loaded on driver, sealed in foil pouch. Predicate: Anchor pre-loaded on driver, sealed in plastic tray with Tyvek pouch, then sealed in foil pouch. (Similar, main difference being an intermediate plastic tray/Tyvek pouch for the predicate). Conclusion from submitter: "The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device. This device and its predicates use similar performance characteristics, manufacturing materials, and design."
Non-Clinical Performance: Demonstration of biocompatibility, biological, and mechanical performance equivalent to predicate.	Non-clinical testing performed, including biocompatibility, biological, and mechanical performances. Results indicated functional equivalence within intended use and equivalence to predicate devices. Bacterial endotoxin testing completed and demonstrated devices meet endotoxin limits.
Clinical Performance: Not explicitly stated as a required criterion for this 510(k), as demonstrated substantial equivalence through non-clinical means is often sufficient for Class II devices.	Clinical performance data was not included. This implies that the substantial equivalence could be established through non-clinical testing alone, as is common for many Class II devices. ("Clinical performance testing: Clinical performance data was not included.")

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 as it pertains to AI/ML validation studies. For this traditional device, non-clinical tests typically involve:

Mechanical testing: A certain number of samples (e.g., a statistically significant number of anchors) would be tested for properties like pull-out strength or fixation strength. The specific sample sizes are not detailed in this summary.
Biocompatibility testing: This is typically performed under ISO standards (e.g., ISO 10993) using standardized biological models (e.g., cell cultures, animal models) with a defined number of replicates, but the specifics are not in this summary.
Bacterial Endotoxin Testing: This involves testing samples of the final sterile device using established methods like the Limulus Amebocyte Lysate (LAL) assay, with specific sample numbers.

The data provenance is inherent to laboratory testing rather than clinical data sets. The testing would have been conducted by the manufacturer or contracted labs following established protocols.

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 concept is not applicable to this type of traditional device submission. "Ground truth" established by experts is relevant for AI/ML diagnostic or interpretative devices. For the FIXIT® Threaded Anchor System, the "ground truth" for performance is established by objective, quantifiable physical and chemical tests (e.g., measuring force, observing cell reaction, detecting endotoxins) against industry standards or predicate device performance.

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

This is not applicable for a traditional medical device like a suture anchor. Adjudication methods are typically employed in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts on ground truth.

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. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in the context of AI assistance. The FIXIT® Threaded Anchor System is a surgical implant, not a diagnostic tool, and involves no "human readers" or "AI assistance" in its intended function.

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

This is not applicable. This refers to AI/ML algorithm performance without human intervention. The FIXIT® Threaded Anchor System is a physical implant; there is no algorithm involved.

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

The "ground truth" for this device's performance is based on objective measurements and adherence to established standards in non-clinical testing:

Biocompatibility: Adherence to ISO 10993 series standards, using established biological models and endpoints.
Mechanical Performance: Quantifiable physical measurements (e.g., pull-out strength, torque, fatigue life) compared against engineering specifications, predicate device performance, or relevant biomechanical literature. The "ground truth" here is the physical measurement itself.
Bacterial Endotoxin: Quantitative measurement of endotoxin levels, compared against specified regulatory limits.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.

Summary

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S.B.M. SAS Science for Bio Materials Ms. Anne Cospin-Latapie Quality/Regulatory Affairs Manager ZI du Monge Lourdes, France 65100

November 30, 2017

Re: K170868

Trade/Device Name: FIXIT Threaded Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: October 19, 2017 Received: October 23, 2017

Dear Ms. Cospin-Latapie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K170868

Device Name FIXIT Threaded Anchor System

Indications for Use (Describe)

The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. SUBMITTER

S.B.M. SAS
SCIENCE FOR BIOMATERIALS
ZI du Monge
F 65100 LOURDES - FRANCE
Registration Number: 3004549189
Phone: +33 (0)5 62 42 21 01
Fax: +33 (0)5 62 42 21 00
Contact Person: Anne COSPIN-LATAPIE
e-mail : anne.cospin@sbm-fr.com
Date prepared: November 29, 2017

2. DEVICE

Name of Device	FIXIT® Threaded Anchor System
Common or Usual Name	Suture Anchor
Classification Name	Fastener, fixation, biodegradable,soft tissue
Regulatory Class	II
Product Code	MAI

3. PREDICATE DEVICE

Arthrex Bio-Composite Corkscrew manufactured by Arthrex, Inc., K082810

Referenced devices:

K070673 Force Fiber® Black Co-braid Polyethylene non-absorbable Suture

K063778 Force Fiber® Polyethylene non-absorbable Suture

4. DEVICE DESCRIPTION

FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.

The implant is available in 2 different configurations:

· FIXIT®Knotless: supplied in a holder,

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Image /page/4/Picture/1 description: The image is a logo with the letters SBM in different colors. The letter B is in blue, while the letters S and M are in gray. Underneath the letters is the text "Science & Bio Materials" in a smaller font. To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient pattern.

FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
The implant is supplied sterile, ready to use.

5. INDICATIONS FOR USE

The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction,

Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

FIXIT® Threaded Anchor System is compared to Arthrex Bio-Composite Corkscrew (K082810) manufactured by Arthrex, Inc.

The applicant device has the same intended use as the predicate device.

The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device. This device and its predicates use similar performance characteristics, manufacturing materials, and design.

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Image /page/5/Picture/1 description: The image shows the logo for Science & Bio Materials (SBM). The letters S and M are in gray, while the letter B is in blue. The words "Science & Bio Materials" are written in a smaller font size below the letters. To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue grid pattern.

	FIXIT® ThreadedAnchor System	Arthrex Bio-CompositeCorkscrew
	Present submission	K082810
Intended use(same)	Fixation of suture (soft tissue) to bone
	Shoulder: Rotator Cuff Repair, Bankart Repair; SLAPLesion Repair; Biceps Tenodesis; Acromio-clavicularSeparation Repair; Deltoid Repair; Capsule Shift orCapsulolabral Reconstruction;
	Ankle/Foot: Lateral Stabilization; Medial Stabilization;Achilles Tendon Repair; Hallux Valgus Reconstruction;Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bumonectomy;
Indications foruse (same)	Knee: Anterior Cruciate Ligament Repair; MedialCollateral Ligament Repair; Lateral Collateral LigamentRepair; Patellar Tendon Repair ; Posterior ObliqueLigament Repair; Iliotibial Band Tenodesis ;
	Wrist/Hand: Scapholunate Ligament Reconstruction;Ulnar or Radial Collateral Ligament Reconstruction,Radial Collateral Ligament Reconstruction.
	Elbow: Biceps Tendon Reattachment; Ulnar or RadialCollateral Ligament Reconstruction; Tennis Elbow Repairand Lateral Epicondylitis Repair,
Materials	TCP/PLDLA	TCP/PLLA or TCP/PLDLA
	Ø 4,5mm x14,5 mm, 2sutures	Ø 4,5mm x15 mm, 2sutures
Configuration/dimensions	Ø 5,5mm x17,6 mm, 2sutures	Ø 5,5mm x15 mm, 2 or 3sutures
	Ø 6,5mm x17,6 mm, 2sutures	Ø 6,5mm x15 mm, 2 or 3sutures
Packaging	Anchor loaded with sutureon driver sealed in foilpouch	Anchor loaded with sutureon driver sealed in plastictray with Tyvek pouch,which is then sealed in a foilpouch

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Image /page/6/Picture/1 description: The image shows a logo with the letters S, B, and M. The letter B is in blue, while the letters S and M are in gray. Below the letters is the text "Science & Bio Materials". To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient pattern.

4. PERFORMANCE DATA

Non-clinical performance testing

Non-clinical testing including biocompatibility, biological and mechanical performances was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices.

Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.

Clinical performance testing:

Clinical performance data was not included.

5. CONCLUSIONS

The FIXIT® Threaded Anchor System is substantially equivalent to its predicate device Arthrex Bio-Composite Corkscrew (K082810). Verification and validation tests demonstrate that the FIXIT® Threaded Anchor System is as safe, as effective, and performs as safely and effectively as its predicate device.

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.