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The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

The Biomet Microfixation Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from Commercially Pure Titanium; the band is manufactured from Commercially Pure Titanium and coated with Parylene-C; the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6A1-4V); and the needle (not implantable) is manufactured from Stainless Steel.

The provided document is a 510(k) premarket notification for the Biomet Microfixation Sternalock® 360 Sternal Closure System. It is a submission to the FDA for a medical device and not a study proving a device meets acceptance criteria. Rather, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (K151019, also the Biomet Microfixation SternaLock® 360 Sternal Closure System) rather than performing new studies against specific performance acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable in the context of this 510(k) submission.

Here's why and what information can be extracted:

• No new performance studies were conducted or required to demonstrate substantial equivalence. The document explicitly states:
  • "Non-Clinical Performance Data: Non-clinical testing was not necessary for the determination of substantial equivalence."
  • "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence."

This means there's no data available in this document to populate most of your requested fields directly, as the device's performance was not re-evaluated against new acceptance criteria. The FDA's substantial equivalence determination implies that the predicate device already met established safety and effectiveness criteria, and the new device is sufficiently similar.

However, to address your request based on the spirit of the question and the available information:

1. Table of acceptance criteria and the reported device performance:

Since no new performance studies were conducted, there are no specific new acceptance criteria and reported device performance from this submission. The acceptance criteria would conceptually align with the predicate device's demonstrated safety and effectiveness.

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. No new test set was used as no new non-clinical or clinical studies were performed.

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. No new ground truth for a test set was established.

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

• Not applicable.

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 mechanical sternal closure system, not an AI or imaging device.

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

• Not applicable. This device is a mechanical sternal closure system, not an algorithm.

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

• Not applicable. The submission relies on the established safety and effectiveness of the predicate device as a "ground truth" for substantial equivalence rather than generating new ground truth data for this specific submission.

8. The sample size for the training set

• Not applicable. No new training set was used.

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

• Not applicable.

Summary of what the submission does state:

The changes proposed in this 510(k) were primarily to update the Package Insert to provide additional information to users. The claim for substantial equivalence rests on the following similarities to the predicate device (K151019, also the Biomet Microfixation SternaLock® 360 Sternal Closure System):

• Identical indications for use and contraindications.
• Equivalent device design.
• Equivalent sterilization method (steam sterilization).
• Equivalent materials.

The FDA concluded that "any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed devices are at least as safe and effective as the predicates."

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