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The DePuy Mitek INTRAFIX™ Advance Tibial Sheath and Screw System is indicated for fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction.

The INTRAFIX™ Advance Tibial Fastener System is an implant system used for fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction. The INTRAFIX™ Advance Sheaths are available in absorbable BR and non-absorbable Polypropylene materials. The INTRAFIX™ Advance Screws are available in absorbable BR and non-absorbable PEEK materials. The INTRAFIXTM Advance Tibial Sheaths and Screws are supplied sterile ready to use.

The provided document describes the INTRAFIX™ Advance Tibial Fastener System, a medical device used for fixation of tissue during cruciate ligament reconstruction. The information indicates that this is a 510(k) premarket notification for a Class II medical device, meaning it is substantially equivalent to legally marketed predicate devices.

The document does not describe a study in the context of an AI/ML powered device, or a diagnostic product that would typically involve acceptance criteria related to accuracy metrics (e.g., sensitivity, specificity, AUC) and ground truth establishment by experts. Instead, the "study" referred to here is non-clinical testing to ensure the physical and mechanical performance of the implant.

Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance for an algorithm, are not applicable to this type of device submission as described in the provided text.

Here's an attempt to answer the relevant questions based on the provided document:

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." However, it does not explicitly state specific acceptance criteria values (e.g., "minimum pull-out strength of X Newtons") nor specific performance values obtained from the tests. It only states that "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."

Without explicit numbers from the document, a table with specific criteria and performance cannot be created.

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

• Sample Size: Not specified in the provided document. The document refers to "the implant and / or its predicate" for testing, implying physical samples of the device were tested.
• Data Provenance: Not applicable in the context of data for an AI/ML model. The "data" here would be the physical testing results from the device itself.

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

Not applicable. "Ground truth" in the context of a physical implant's mechanical performance is usually established through standardized engineering test methods (e.g., ASTM standards) rather than expert consensus on medical images or pathology.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data, which is not relevant to mechanical testing.

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. This is a submission for a physical medical implant, not an AI/ML-powered diagnostic or assistive device. Therefore, MRMC studies are not relevant.

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

No. This is not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" for non-clinical testing would be definitions or measurements established by recognized engineering standards and biocompatibility requirements. The document states "Verification activities were performed on the implant and / or its predicate. Testing assessments include pull out testing, and insertion / failure torque." and "The proposed device also met requirement of bacterial endotoxin testing." This implies adherence to predefined physical and biological safety standards.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve a "training set."

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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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