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The Smith & Nephew PLLA/HA Screw is indicated for fixation of bone-tendonbone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The Smith & Nephew PLLA/HA Screw is an tapcred interference screw for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery. The PLLA/HA Screw is a cannulated, sterile, single use bone screw, made of polylactic acid, a resorbable polymer, and hydroxylapatite, an inorganic ceramic.

The provided document is a 510(k) premarket notification for a medical device called the "PILLA/HA Screw". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the way a new drug or high-risk device might.

Therefore, the requested information regarding acceptance criteria, study details, and data provenance related to AI/software performance metrics (like sensitivity, specificity, MRMC studies, standalone performance) is not applicable to this document. The device is a bone fixation screw, not an AI or imaging diagnostic tool.

Instead, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this submission are focused on demonstrating substantial equivalence to predicate devices through product validation testing as described in Section H of the 510(k) summary.

Here's the breakdown of the information that is available in the provided text, reinterpreted in the context of a 510(k) submission for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the acceptance criterion for a 510(k) submission is typically demonstrating substantial equivalence to a predicate device. The performance aspect focuses on physical and functional characteristics.

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

• Sample Size: Not specified in the provided text. For mechanical devices, testing typically involves a sufficient number of devices to demonstrate statistical significance for properties like strength, degradation, etc. This is not a clinical study involving human patients for "test sets" in the AI sense.
• Data Provenance: Not specified, but generally, validation testing for such devices would be conducted in a laboratory setting by the manufacturer, rather than being clinical data from a specific country. This is primarily in-vitro or ex-vivo mechanical testing.
• Retrospective/Prospective: Not applicable in the context of device validation testing summarized here.

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

• Number of Experts: Not applicable. For a bone screw, "ground truth" is established through engineering and material science standards (e.g., tensile strength, screw-out torque, degradation rates), not expert consensus on image interpretation or clinical outcomes in the same way an AI diagnostic tool would.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept is relevant for clinical studies or expert reviews of data, not for direct device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not done. This type of study is specific to diagnostic imaging devices where multiple readers evaluate cases. The PILLA/HA Screw is a surgical implant.
• Effect Size of AI Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This concept applies to AI algorithms. The PILLA/HA screw is a physical orthopedic implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated as "ground truth" in the AI sense. However, for device validation, the "ground truth" would be established by engineering specifications, material standards, and biomechanical testing protocols (e.g., ISO standards for implants, ASTM standards for materials) against which the device's performance (e.g., mechanical strength, degradation properties, fixation stability) is compared to demonstrate equivalence to predicate devices. This is typically done through in vitro and ex vivo testing.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The PILLA/HA Screw is a physical medical device, not a software algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable.

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