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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 SonicPin System consists of a sterile bioresorbable pin (implant), the SonicFusion equipment as well as associated accessories and is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization. The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.

The provided text is a 510(k) Premarket Notification from the FDA for the Stryker SonicPin System. It describes the device, its intended use, indications for use, and summaries of non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Crucially, the document explicitly states: "Clinical testing was not required for this submission."

This means that the device's acceptance criteria and performance were not evaluated through a study involving human subjects or AI-assisted diagnostic performance. Instead, the clearance was based on demonstrating substantial equivalence to a previously cleared predicate device fundamentally through non-clinical testing.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially points 1 through 7, and 9 for a clinical context) cannot be extracted from this document, as a clinical study was not performed.

Here's what can be addressed based on the provided text:

Acceptance Criteria and Device Performance

Since no clinical study was conducted for this 510(k) submission, there are no acceptance criteria related to a diagnostic device's performance (e.g., sensitivity, specificity, or human improvement with AI). The acceptance here is based on the device demonstrating equivalence to its predicate through non-clinical means.

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

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

• This information is not applicable as no clinical test set was used for patient outcomes or diagnostic performance evaluation. The "test set" would refer to the physical devices subjected to non-clinical mechanical, material, and biocompatibility tests. The provenance of the data is from the manufacturer's (Stryker Trauma GmbH) non-clinical laboratory testing.

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

• Not applicable as no clinical test set requiring expert ground truth for diagnostic or outcome assessment was used.

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

• Not applicable as no clinical test set requiring adjudication was used.

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. This device is a bioresorbable pin for bone fixation, not an AI diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is a physical medical device, not a standalone algorithm.

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

• Not applicable for a clinical context. The "ground truth" for this submission was the established performance and safety profiles of the predicate device, against which the modified device's non-clinical performance was compared to demonstrate equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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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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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, brace). The Stryker SonicPin™ is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin™ System.

The Stryker SonicPin™ System consists of a bioresorbable implant pin made of a PLDLA copolymer and an ultrasonic unit (generator and sonotrode). Pins are implanted using ultrasonic energy generated by an ultrasonic unit, allowing the pin to adapt to the previously drilled hole. Its intended use is the correction of the Hallux Valgus deformation.

The provided text is a 510(k) summary for the Stryker SonicPin™ System. This document focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, technological characteristics, design, materials, and operational principles. It does not contain information about acceptance criteria or a study that evaluates device performance against specific metrics.

Therefore, I cannot provide the requested information, as the input document does not detail:

1. Acceptance criteria and reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size for test set and data provenance: No test studies or associated data are mentioned.
3. Number of experts and their qualifications: No expert involvement in establishing ground truth is described.
4. Adjudication method: Not applicable as no ground truth establishment is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone performance study: No standalone algorithm performance study is described.
7. Type of ground truth used: Not applicable as no ground truth is established.
8. Sample size for the training set: No training sets are mentioned.
9. How ground truth for the training set was established: Not applicable as no ground truth for training is mentioned.

The document is a regulatory submission for substantial equivalence based on a comparison to existing devices, not a performance study evaluating the device against a set of acceptance criteria.

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