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The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include:

• · Hammer toe deformity
• · Claw toe deformity
• Mallet toe deformity
• Other deformities of the feet and hands

The DigiFuse® implants are intended for single use only.

The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options.

This document is a 510(k) premarket notification for the Integra® DigiFuse® Cannulated Intramedullary Fusion System. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a separate, extensive study to define new acceptance criteria and prove performance against them.

Therefore, the requested information regarding acceptance criteria, device performance from a specific study, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not typically present or required in this type of submission.

Instead, the submission relies on demonstrating substantial equivalence to existing devices, meaning it performs as safely and effectively as a legally marketed device that does not require premarket approval (PMA).

Here's an analysis based on the provided document:

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

This document does not present a table of specific acceptance criteria (e.g., specific clinical outcomes, sensitivity/specificity thresholds) and reported device performance against those criteria. The acceptance is based on demonstrating substantial equivalence to predicate devices, not on meeting new quantitative performance metrics from a distinct study.

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

• No specific "test set" and corresponding sample size for clinical or AI performance evaluation are mentioned.
• The document states "Non-clinical evaluation and dimensional analysis was done to confirm substantial equivalence." This refers to engineering and material testing, not a clinical trial or performance study on a "test set" of patient data in the context of AI or diagnostic performance.

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

• Not applicable. There is no mention of a "test set" requiring ground truth established by experts in the context of clinical or diagnostic performance.

4. Adjudication method for the test set:

• Not applicable. No such test set or adjudication 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:

• No MRMC study or AI assistance is mentioned. This device is a physical implant (Cannulated Intramedullary Fusion System), not a software or AI-powered diagnostic tool.

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

• Not applicable. This is a medical device, not an algorithm, so standalone AI performance is irrelevant.

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

• For a traditional 510(k) submission like this, the "ground truth" for the device's equivalence isn't clinical outcomes from a new study, but rather the established safety and effectiveness of the identified predicate devices. The "proof" is in demonstrating that the new device shares fundamental technological characteristics and has similar intended use, materials, and design principles to the predicates without raising new questions of safety or effectiveness. "Non-clinical evaluation and dimensional analysis" would be used to ensure the physical properties meet engineering standards applicable to the predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of AI or machine learning for this physical implant device.

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

• Not applicable. As there is no training set mentioned, this question is not relevant.

Summary of what the document does provide regarding equivalence:

• Predicate Devices:
  • Metasurg DigiFuse Implant – K111536
  • OsteoMed Extend 2.0/2.4 Cannulated Screw System – K062863
  • NewDeal K-Wire – K022599
• Basis for Equivalence:
  • The Integra® DigiFuse® Implant is made of the same material (Titanium Alloy (Ti 6A1-4V ELI)) as the Metasurg predicate device (K111536).
  • The only difference with the Metasurg predicate is the addition of two new lengths for the Integra® DigiFuse® implant.
  • These two new lengths are already within the length range of the Osteomed predicate device (K062863).
  • The submission explicitly states: "There are no design, material, or indication differences between the proposed device and predicate devices." (This is crucial for 510(k) acceptance).
  • Substantial equivalence was confirmed through "Non-clinical evaluation and dimensional analysis." This refers to engineering tests to ensure physical and mechanical properties are comparable to the predicates, not a clinical trial on patient-specific data.

In essence, the "acceptance criteria" for this specific 510(k) clearance are derived from the characteristics and performance of the legally marketed predicate devices. The study proving this "acceptance" is the non-clinical evaluation and dimensional analysis demonstrating that the Integra® DigiFuse® device is fundamentally the same as or comparable to its predicate devices, especially regarding materials, design, and intended use, and that any minor differences (like additional lengths) do not introduce new safety or effectiveness concerns.

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