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The Scandius ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.

The ACL Reconstruction System consists of a two piece implant designed to fixation soft tissue for ACL reconstruction. The graft block secures the soft tissue graft. A fixation pin placed transversely to the femoral tunnel secures the graft block in place. The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.

This 510(k) premarket notification (K041749) for the Scandius ACL Reconstruction System focuses on substantial equivalence to a predicate device, the Depuy Linx HT, rather than establishing de novo acceptance criteria and performing a detailed study to prove the device meets these.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with explicit, quantifiable acceptance criteria. Instead, it states:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document only mentions "Bench testing."
• Data Provenance: Not specified, but generally, bench testing for medical devices is conducted in a laboratory setting. No country of origin for the data is mentioned, and it's inherently prospective in the sense that the tests are performed on the device being submitted.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not applicable. For mechanical bench testing, ground truth is established through validated testing methodologies and equipment, not typically by expert consensus in the way a clinical study's ground truth would be.
• Qualifications of Experts: Not applicable. The "experts" in this context would be the engineers or technicians performing the mechanical tests.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Since this involves mechanical bench testing and not subjective interpretation, there is no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This submission is for a medical device (an ACL reconstruction system) and not an imaging or diagnostic device that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

• Standalone Performance: Not applicable. This device is an implantable surgical system, not an algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for the "ultimate failure strength" would be the objectively measured force at which the device fails, determined by established mechanical testing standards and protocols.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training set" concept does not apply to the mechanical testing of a surgical implant.

9. How the Ground Truth for the Training Set Was Established:

• How Ground Truth Established: Not applicable, as there is no training set.

Summary of Acceptance Criteria and Study Approach in K041749:

The core of this 510(k) submission relies on demonstrating substantial equivalence to a predicate device (Depuy Linx HT). The primary "acceptance criterion" is implicitly that the Scandius ACL Reconstruction System performs at least as well as or similarly to the predicate device in terms of mechanical properties and does not raise new questions of safety or effectiveness.

The "study" conducted for this purpose was bench testing, specifically focusing on "Mechanical ultimate failure strength." The outcome of this testing likely showed that the Scandius system's mechanical strength was comparable to the predicate device, thereby fulfilling the requirement for substantial equivalence. The FDA's letter confirms substantial equivalence, indicating that they were satisfied with the provided performance data in comparison to the predicate.

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