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The Lagwire fixation system consists of two (2) main components, a wire and a cap. The Lagwire materials are Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136. It is available as 4.5 mm diameter device and is obtainable in various length ranges. The Lagwire is provided sterile and intended for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the Lagwire System, focusing on the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K070393) for the Fx Devices Lagwire System focuses on demonstrating substantial equivalence to a predicate device, the Triage Medical BONE-LOK® MVP Cortical-Cancellous Compression Device (K042244). As such, explicit numeric acceptance criteria and detailed device performance metrics (e.g., specific tensile strength, compression force) are not provided in this summary.

Instead, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate in key areas, and the "performance" is reported as satisfying this equivalence.

Aspect of Equivalence/Performance	Acceptance Criteria (Implicit)	Reported Device Performance
Design	"Substantially equivalent to predicate"	"Substantially equivalent in design"
Material Composition	"Substantially equivalent to predicate materiais"	"Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136. Substantially equivalent in materials"
Construction	"Substantially equivalent to predicate construction"	"Substantially equivalent in construction"
Intended Use	"Substantially equivalent to predicate intended use"	"Intended for use in the general management of fractures and reconstructive surgery. Substantially equivalent in intended use"
Performance (general)	"Comparable mechanical performance to predicate to ensure safety and efficacy"	"Bench testing was conducted to support equivalency. Does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices."

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

Sample Size: The document only mentions "Bench testing was conducted to support equivalency." It does not specify the sample size (e.g., number of devices tested) for this bench testing.
Data Provenance: The document does not specify the country of origin of the data. It is a pre-market notification to the FDA in the USA, so the testing was likely conducted in North America or by a laboratory that adheres to standards acceptable to the FDA. The testing conducted was retrospective in the sense that it's a pre-market submission, but the "bench testing" itself is a prospective experimental study on physical devices, not an analysis of existing patient 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 this type of submission. The ground truth for this device's performance is established through bench testing against engineering standards and comparison to a predicate device's known performance, rather than through expert human interpretation of data (like in imaging or diagnostic devices). There are no "experts" in the context of establishing ground truth for a test set as described for AI/diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable. Since the evaluation is based on objective bench testing and comparison to engineering specifications or predicate device characteristics, there is no need for human adjudication of test results in the way it might be done for diagnostic assessments.

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

There was no MRMC comparative effectiveness study performed. This type of study is relevant for diagnostic or AI-assisted devices where human readers (e.g., radiologists) interpret images or data. The Lagwire System is a physical orthopedic fixation device, not a diagnostic tool or AI software.

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

There was no standalone (algorithm-only) performance study done. This concept is specific to AI or software algorithms. The Lagwire System is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used for the Lagwire System is based on:

Engineering Standards: Specifically, ASTM F-136 for the Titanium 6Al-4V alloy. This implies that the material properties meet established industry standards for medical implants.
Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate device (Triage Medical BONE-LOK® MVP Cortical-Cancellous Compression Device). The bench testing would have aimed to show that the Lagwire's mechanical performance is comparable to that of the predicate, thus inferring similar safety and efficacy.

8. The Sample Size for the Training Set

This information is not applicable. Training sets are used for machine learning models. The Lagwire System is a physical medical device, not a software or AI product.

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

This information is not applicable as there is no training set for this device.

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