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The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair

The Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.

The provided text pertains to the 510(k) premarket notification for the "Parcus Titanium Interference Screws." This is a medical device for orthopedic fixation, specifically for ligaments and tendons. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a study evaluating the performance of a diagnostic AI device against acceptance criteria. Therefore, most of the requested information regarding AI device-specific acceptance criteria and studies (such as MRMC studies, human-in-the-loop performance, expert qualifications for ground truth, sample sizes for training/test sets concerning AI, etc.) is not applicable to this document.

However, I can extract information related to the device's performance testing where described, as it serves a similar purpose to acceptance criteria demonstration for physical medical devices.

Here's an analysis based on the closest applicable information in the provided text:

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

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

• Sample Size: The document mentions that pull-out strength and insertion torque were measured for the smallest (7mm), largest (12mm), and an intermediate size of the Parcus Titanium Interference Screws. The exact number of samples for each size is not specified in this document.
• Data Provenance: The performance data for pull-out strength and insertion torque is referenced as being included with the submission of K083619 (the predicate device). This suggests the performance data was likely generated through in-vitro mechanical testing. The country of origin for this data is not specified.

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

N/A - This medical device is a physical fixation screw, not an AI diagnostic device. Ground truth as typically understood for AI studies (e.g., expert consensus on image interpretation) is not applicable here. The "ground truth" for this device's performance would be the direct measurements of mechanical properties.

4. Adjudication method for the test set

N/A - As above, adjudication methods for expert disagreement on ground truth are not applicable to the mechanical testing of a physical medical device.

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

N/A - This is not an AI-assisted diagnostic device.

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

N/A - This is not an AI algorithm.

7. The type of ground truth used

For the mechanical performance testing (pull-out strength, insertion torque), the ground truth is the direct physical measurement of these properties, likely using laboratory equipment. For pyrogenicity, the ground truth is established through LAL testing laboratory results. For substantial equivalence, the "ground truth" is the physical and functional characteristics of the device itself compared to a legally marketed predicate device.

8. The sample size for the training set

N/A - This is not an AI device, so there is no "training set."

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

N/A - As above, no training set for an AI model.

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Titanium Interference Screws are intended for use in fixation of patellar bone grafts in ACL reconstruction.

Titanium Interference Screws are metallic bone screws used to provide fixation of patellar bone-tendon-bone grafts during anterior cruciate ligament (ACL) repair.

This document is a marketing clearance (510(k)) for a medical device called "Titanium Interference Screws." It establishes substantial equivalence to a predicate device, meaning it's considered as safe and effective as a device already on the market, and therefore does not include detailed studies demonstrating performance against specific acceptance criteria in the way a clinical trial for a novel device would.

The provided document does not contain a study focused on proving the device meets acceptance criteria in a clinical or AI-related context, nor does it provide a table of acceptance criteria and reported device performance relevant to AI/diagnostic efficacy.

Instead, the document focuses on demonstrating substantial equivalence for the Titanium Interference Screws by comparing their characteristics and non-clinical performance to an already legally marketed predicate device. The "acceptance criteria" here refer to the regulatory safety and performance standards for a substantially equivalent device, rather than specific diagnostic metrics.

However, based on the non-clinical tests described, we can infer some "acceptance criteria" as they relate to the mechanical performance of the device.

Here's an analysis based on the information provided, inferring what could be considered "acceptance criteria" for this type of device and what was done to support its clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (Titanium Interference Screws) and not an AI or diagnostic device, the "acceptance criteria" are related to its mechanical and biological safety, not diagnostic performance. The document states that the test results "indicate the device and the modifications do not introduce any new risks to the device performance" and "the testing indicates that the device performs within the intended use and did not raise any new safety and efficacy issues."

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

• Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Cyclic loading testing of Titanium Interference Screws," "Failure torque testing of Titanium Interference Screws," etc., which implies a sample of devices were tested. Typical mechanical testing involves a statistically significant number of samples, but the exact count is not disclosed here.
• Data Provenance: The tests are non-clinical, likely performed in an engineering lab environment. The country of origin of the data is not specified beyond being part of the submission from "Biomet Inc." in "Warsaw, Indiana" to the FDA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate performance, but they are in vitro (bench testing) rather than in vivo data.

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

This question is not applicable to this type of device clearance. "Ground truth" in the context of expert consensus is typically relevant for diagnostic or AI-driven devices where human interpretation provides a reference standard. For a mechanical implant device, the "ground truth" is defined by established engineering and biological safety standards (e.g., ASTM standards for mechanical properties, USP standards for endotoxins) and the expert interpretation is embedded within the test methodologies and regulatory review process.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic decisions. For mechanical testing, results are quantitative and either meet or do not meet pre-defined criteria; expert adjudication of test results is not typically part of the process, though expert interpretation of the implications of the results is part of the regulatory review.

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 clearance for a physical orthopedic implant (Titanium Interference Screws), not an AI or imaging device that would involve human readers or diagnostic interpretation.

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

Not applicable. This device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described, the "ground truth" is derived from:

• Established engineering standards: For cyclic loading, failure torque, insertion torque, and pull-out strength, these likely refer to industry-accepted mechanical testing standards (e.g., ISO, ASTM standards for orthopedic implants). The "ground truth" is the established performance benchmarks or thresholds for these mechanical properties that ensure safety and effectiveness for the intended use.
• Biological safety standards: For Bacterial Endotoxins, the "ground truth" is the regulatory limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter .

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense.

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

Not applicable, as there is no training set for this device.

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The Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The Smith & Nephew Titanium Interference Screws are available in various geometric configurations. The Smith & Nephew Titanium Interference Screws arc made with titanium alloy material. The range in diameters and lengths, combined with the variations in geometric configurations, provide the surgeon with a wide variety of sizes/configurations to choose from. Screws are available in both cannulated and non-cannulated styles. The screws may be purchased either sterile or non-sterile, to be sterilized by the end user.

The provided text describes a 510(k) summary for Smith & Nephew Titanium Interference Screws. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data for acceptance criteria directly.

Here's an analysis of the provided text in relation to your requested information:

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

The document does not explicitly state formal "acceptance criteria" with numerical thresholds as one might expect from a rigorously designed clinical or performance study for a novel device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The primary performance assertion is for mechanical properties.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "insertion torque testing and pullout force" but does not specify the sample size used for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective nature). These tests appear to be bench or pre-clinical engineering tests rather than clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the provided document pertains to mechanical performance testing of an orthopedic implant rather than diagnostic accuracy or clinical interpretation studies involving expert human readers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reason as above. There is no mention of adjudication as it's not a diagnostic or clinical interpretation study.

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

This is not applicable. This document describes an orthopedic implant (screws) and its mechanical performance compared to predicate devices. It does not involve AI or human reader performance.

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

This is not applicable, as the device is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical performance data (insertion torque and pullout force), the "ground truth" would be the measured values obtained from the specific testing methodologies (e.g., force gauges, torque meters) performed in a lab setting. The comparison is made against the performance of predicate devices, implying those predicate devices' performance serves as a benchmark for acceptable mechanical characteristics.

8. The sample size for the training set

This is not applicable. This is a 510(k) for an orthopedic implant, not a machine learning model, so there is no concept of a "training set" in this context.

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

This is not applicable for the same reason as above.

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