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The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

The Stryker SonicAnchor System is intended to be used for suture or tissue fixation in open procedures in the foot, ankle, knee, hand, wrist, elbow and shoulder. The Stryker SonicAnchor is designed only to be inserted with the SonicFusion equipment.
Indications Include:
Foot/Ankle
• Achilles Tendon Repair
• Lateral Stabilization
• Medial Stabilization
• Hallux Valgus Reconstruction
• Midfoot Reconstruction
• Metatarsal Ligament Repair
• Digital Tendon Transfer
Shoulder
• Acromio-Clavicular Separation Repair
• Proximal Deltoid Repair
Elbow
• Ulnar or Radial Collateral Ligament Reconstruction
Knee
• Patellar Tendon Repair
Hand/Wrist
• Scapholunate Ligament Reconstruction
• Carpal Ligament Reconstruction
• Repair/Reconstruction of Collateral Ligaments

Stryker SonicPin System: The Stryker SonicPin System consists of a sterile bioresorbable pin implant, the SonicFusion equipment and associated accessories intended for the internal fixation of bone fractures and fragments. The pin is made of PLDLLA (Poly(L-lactide-co-D.L-lactide) which has been evaluated for magnetic resonance safety and is implanted using SonicFusion technology which is a process that employs ultrasonic energy to liquefy a polymer and facilitate a fixed interface between the implant and host bone. The associated accessories include: SonicFusion equipment, Drill, Handpiece Tip, TipTool, Direct Depth Gauge.

Stryker SonicAnchor System: The Stryker SonicAnchor System consists of a bioresorbable anchor with suture implant, the SonicFusion equipment and associated accessories intended for the fixation of suture or soft tissue to cancellous bone. The implant is comprised of the anchor, made of PLDLLA (Poly(L-lactide-co-D,L-lactide) which has been evaluated for magnetic resonance safety and a Teleflex Force Fiber suture, made of braided ultrahigh molecular weight polyethylene (UHMWPE) and polypropylene (PP) strands. The associated accessories include: SonicFusion equipment, Drill, Handpiece Tip, TipTool.

This document describes the Stryker SonicPin System and the Stryker SonicAnchor System, both of which utilize the SonicFusion equipment. The information provided outlines the regulatory clearance for these devices based on substantial equivalence to predicate devices, supported primarily by non-clinical testing.

Here's an analysis of the acceptance criteria and the supporting study information based on the provided text:

• Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are implicitly defined by the performance of the predicate devices and general safety/effectiveness standards for the device type. The "reported device performance" refers to the results of the non-clinical tests conducted to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify sample sizes for any of the mechanical, biocompatibility, electrical safety, EMC, or software verification tests.
• The data provenance is not explicitly stated as country of origin, retrospective, or prospective. However, based on the nature of the tests (mechanical, biocompatibility, electrical, software), these are typically performed in a controlled laboratory or testing facility environment, usually prospective for a regulatory submission. The submitter is Stryker Trauma GmbH, Germany.

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 information is not applicable as the studies are primarily non-clinical engineering and laboratory tests (mechanical, biocompatibility, electrical, software). There is no mention of expert-established ground truth in a clinical context for these tests.

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

• This information is not applicable. Adjudication methods are typically used in clinical trial settings, especially for establishing ground truth from multiple readers/observers. The described studies are non-clinical engineering and laboratory tests.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for medical devices (pins and anchors) and associated equipment, not an AI or imaging diagnostic device.

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

• This concept is not applicable to these medical devices. These are physical implants and associated surgical tools, not an algorithm.

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

• For the mechanical testing, the "ground truth" is defined by established engineering principles and standards for evaluating material properties and device performance (e.g., tensile strength, fatigue strength).
• For biocompatibility testing, the "ground truth" is established by recognized international standards (ISO 10993 series) and FDA guidance for biological evaluation.
• For electrical safety and EMC, the "ground truth" is compliance with international standards (IEC 60601-1, IEC 60601-1-2).
• For software verification and validation, the "ground truth" is the successful execution of planned tests according to predefined specifications as outlined in FDA guidance.
• No expert consensus, pathology, or outcomes data (clinical ground truth) were used, as clinical testing was not required.

8. The sample size for the training set

• This information is not applicable. There is no "training set" as these are not machine learning or AI models.

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

• This information is not applicable as there is no "training set."

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