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The MILAGRO® ADVANCE PEEK Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9 mm x 23 mm screws are indicated for: medial and lateral ligament repar , medial patellofemoral ligament reconstruction) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The MILAGRO® ADVANCE PEEK Interference Screw is a non-absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The Interference Screw is made from Polyetheretherkeytone (PEEK). The MILAGRO® ADVANCE PEEK Interference Screw is provided sterile and is for single patient use only.

This document is a 510(k) premarket notification for a medical device called the MILAGRO® ADVANCE PEEK Interference Screw. It establishes substantial equivalence to predicate devices and describes the device's intended use and technological characteristics.

Here's an analysis of the provided text in the context of device acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Verification activities were performed on the implant and / or its predicate. Testing assessments include pull out testing, and insertion / failure torque." and "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." It also states, "The proposed device also met requirement of bacterial endotoxin testing."

However, the specific quantitative acceptance criteria (e.g., minimum pull-out strength, maximum insertion/failure torque) and the exact reported device performance values are not explicitly stated in the provided text. The document broadly states the device "met requirement" and "demonstrated suitability."

Therefore, a table with specific numerical criteria and performance cannot be generated from this text alone.

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

The document mentions "Verification activities were performed on the implant and / or its predicate." There is no information provided regarding:

• The specific sample size used for the pull-out, insertion/failure torque, or bacterial endotoxin testing.
• The data provenance (e.g., country of origin, retrospective or prospective) of any testing data.

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

This information is not applicable to the type of device and study described. This document pertains to a medical device (an interference screw) and its mechanical and biological performance, not a diagnostic algorithm or imaging study that would require expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic performance of algorithms where human readers' performance is compared and enhanced. This document describes the mechanical and biological performance of an orthopedic implant.

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

No, a standalone study in the context of an algorithm's performance was not done. This is a medical device approval, not an AI/algorithm submission. The device itself is the "standalone" product being evaluated for its physical and biological properties.

7. The Type of Ground Truth Used:

For the tests mentioned (pull-out, insertion/failure torque, bacterial endotoxin):

• Pull-out Testing and Insertion/Failure Torque: The "ground truth" would be established by the physical properties and mechanical engineering standards relevant to such implants. This is determined through standardized laboratory testing procedures where forces and torques are measured against predefined engineering specifications for strength and durability.
• Bacterial Endotoxin Testing: The "ground truth" is established by biological safety standards and validated laboratory assays that detect and quantify endotoxins. The "met requirement" implies compliance with established safety thresholds.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an orthopedic implant, not an AI model requiring a training set.

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

This information is not applicable for the same reasons as point 8.

In summary, the provided document focuses on establishing substantial equivalence for a medical implant based on its design, materials, and mechanical/biological performance, rather than the performance of a diagnostic algorithm or AI system. Therefore, many of the requested points related to AI/algorithm studies (like expert ground truth, adjudication, MRMC studies, training sets) are not relevant to this specific FDA submission. The document broadly states that performance testing was conducted, and results indicated suitability, but the specific quantitative criteria and results are not detailed.

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