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The Resofix® Bioabsorbable Expansion Bolt is a single-use, sterile implant that is intended for use in the interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.

The Resofix product is a two-shell bioabsorbable expansion bolt, consisting of two shell halves, forming an expanding dowel system, and a central expansion wedge. Insertion of the expansion wedge between the dowel halves results in expansion over the full length of the implant. When expanded, 2/3 of the implant cross-section is round and 1/3 is flat. The surface of the implant is designed to maximize contact and maintain implant position, both immediately after being inserted, as well as during the absorption period. The Resofix® Bioabsorbable Expansion Bolt shell halves and expansion wedge are injection molded poly-D,L-lactide (PDLLA, Resomer 208), which is substantially equivalent to the material used by Sulzer Orthopedics Ltd. in its Sysorb interference screws, previously approved by the U.S. FDA (K983592). Included in the system are associated preparation and implantation instruments, which are exempt Class I instruments, per 21 CFR 888.4540, "Orthopaedic Manual Surgical Instruments". The Resofix PDLLA implants are available in two sizes (8mm x 28mm and 10mm x 35mm) and the 10mm units are available in two expansion options (2.2mm for bone-tendon-bone grafts and 2.9mm for semitendinosus gracilis grafts).

The provided text is a compilation of FDA documents related to the Resofix® Bioabsorbable Expansion Bolt. It is important to note that these documents primarily discuss the device's intended use, description, potential risks, and the FDA's determination of substantial equivalence to a predicate device. They do not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as one would find in a clinical trial report or a performance validation study.

The FDA's 510(k) clearance process, under which this device was approved, focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving independent performance against predefined acceptance criteria through a standalone study in the same way a PMA (Premarket Approval) would require.

Therefore, the requested information elements cannot be fully addressed from the provided text in the typical format of a device performance study. However, I can extract information related to the demonstration of substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available or indicating where it is not:

Acceptance Criteria and Device Performance Study (Based on Substantial Equivalence)

The FDA clearance for the Resofix® Bioabsorbable Expansion Bolt (K043411) was based on demonstrating "substantial equivalence" to a legally marketed predicate device, the Arthrex "Bio-interference screw" (likely a misspelling of "Bio-interference Screw"). This means that the Resofix device was deemed to be as safe and effective as the predicate device for its intended use, without raising new issues of safety or effectiveness.

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

The provided text does not explicitly state specific quantitative acceptance criteria for performance (e.g., specific pull-out strength values, degradation rates, or clinical success rates). Instead, the "performance" is implicitly demonstrated through the claim of substantial equivalence to the predicate device.

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

• Test Set Sample Size: The provided text does not specify a sample size for a "test set" related to clinical performance or a specific in-vivo study used to prove effectiveness. The statement "biomechanical testing confirms that differences... do not raise any new issues of safety or effectiveness" implies in-vitro testing. No details on the number of samples or specific tests performed are provided.
• Data Provenance: The nature of the "biomechanical testing" (e.g., in-vitro, ex-vivo, animal model) and its origin (e.g., specific lab, country) are not detailed. It is likely a combination of bench testing and potentially literature review based on the predicate device's performance. The FDA approval document is from the U.S.

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

• Not Applicable. The 510(k) pathway for this medical device does not typically involve human expert adjudication of a "test set" in the context of diagnostic or AI performance, as it is based on physical and mechanical equivalence to an existing implant. Therefore, information regarding "number of experts" or their qualifications for establishing ground truth for a test set is not available or relevant for this type of device submission.

4. Adjudication method for the test set:

• Not Applicable. As no "test set" requiring expert ground truth or adjudication is described in the provided documents, there is no adjudication method mentioned.

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 is a bioabsorbable fixation bolt, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant and was not performed.

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

• Not Applicable. This device is a physical implant, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant and was not evaluated.

7. The type of ground truth used:

• The "ground truth" for this device's equivalence relies on:
  • Predicate Device History: The known safety and effectiveness profile of the legally marketed predicate device (Arthrex Bio-interference Screw and Sulzer Orthopedics' Sysorb interference screws).
  • Engineering/Biomechanical Principles: The understanding that if the Resofix device has similar materials, design principles, and biomechanical performance to the predicate, it will also be safe and effective.
  • Biomechanical Testing Data (undisclosed details): The submission claims "biomechanical testing confirms that differences... do not raise any new issues of safety or effectiveness." This implies laboratory-based, in-vitro testing where the "ground truth" would be the measured physical properties (e.g., tensile strength, shear strength, degradation rate) compared against established engineering standards or the predicate device's performance.

8. The sample size for the training set:

• Not Applicable. This device is a physical implant, not an AI or machine learning model. Therefore, the concept of a "training set" is not relevant.

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

• Not Applicable. As there is no "training set" for an AI/ML model, this question is not applicable.

Summary of what's provided for K043411:

The provided documents detail an FDA 510(k) clearance for a medical device:

• Device Name: Resofix® Bioabsorbable Expansion Bolt
• Classification: Class II, 21 CFR 888.3030 (Fastener, Fixation, Biodegradable, Soft Tissue)
• Intended Use: Interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.
• Mechanism of Clearance: Substantial Equivalence to predicate devices (Arthrex Bio-interference Screw, Sulzer Orthopedics Ltd. Sysorb interference screws).
• Key Evidence for Equivalence:
  • Material composition (PDLLA) similar to an already approved material.
  • Similar intended use to predicate.
  • "Biomechanical testing confirms that differences... do not raise any new issues of safety or effectiveness." (Specifics of this testing are not included in the provided excerpts).
• No detailed performance study with specific acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC studies are included in these 510(k) summary documents. Such details would typically be found in the actual submission package, which is generally not publicly released in its entirety.

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