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The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:

• Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
• Fusions of the joints and bone (hand, foot, long-bone)
• Correction of bone or soft tissue deformities
• Correction of segmental or non-segmental bone, soft tissue defects or bone loss
• Neutralization of fractures stabilized with limited internal fixation
• Adult and Pediatric subgroups except newborns

The Revolution External Plating System is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components, this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.

The provided document is a 510(k) summary for the Revolution External Plating System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria in the same way a drug or novel high-risk device might.

Therefore, the document does not contain the kind of information requested regarding acceptance criteria related to device performance metrics for a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: This document reports on "Performance Testing" but does not explicitly state acceptance criteria or detailed performance results in table format.
• Sample size and data provenance for a test set: Not applicable, as this is a mechanical device undergoing performance testing, not a study involving patient data.
• Number and qualifications of experts for ground truth: Not applicable for mechanical performance testing.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a mechanical implant, not an AI or imaging diagnostic device.
• Standalone performance: While the device's mechanical performance is tested "standalone," the nature of the information isn't a human-in-the-loop setting.
• Type of ground truth used: Not applicable. Performance testing for mechanical devices involves measuring physical properties against engineering standards.
• Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
• How ground truth for the training set was established: Not applicable.

What the document does provide regarding performance testing:

The document states:
"Performance testing (ASTM F1541, and torque to failure testing) was completed to support the modifications to the system and demonstrate its substantial equivalence to the predicate device."

This indicates that:

• Type of testing: Mechanical performance testing.
• Specific tests: ASTM F1541 (Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implants) and "torque to failure testing."
• Purpose: To demonstrate that the modified device's performance is equivalent to that of the predicate device (K181630) and a reference device (K152171), ensuring that "the differences in geometry versus the predicate do not raise different questions of safety and effectiveness."

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through mechanical performance tests against recognized standards and comparison to a predicate device, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for an AI or diagnostic device.

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The TrueLok™ EVO is intended to provide bone fixation.

The TrueLok™ EVO is indicated for fractures, pseudarthrosis / non-unions, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g. bone transport) in long bones and in the foot.

The TrueLok™ EVO system is a modular circular external fixation system based on Ilizarov fixation apparatus principles. The TrueLok™ consists of external supports (rings and footplates), variable length struts and a variety of connection elements that build the external frame. The TrueLok™ external frame is secured by using the Orthofix predicates pin and wires. The Subject external support components (rings, footplates and struts), are made from AISI 316LVM, AISI 630, Aluminum alloy (EN-AW 6082 T6) and Epoxy carbon fiber. Application and removal of the TL-EVO can be performed with Orthofix general orthopedic instrumentation. TrueLokTM EVO fixator components are provided in single-use sterile configuration and they are available as single component packaged in double pouches or in multiple components packaged in double rigid blister.

The provided text describes the 510(k) premarket notification for the TrueLok™ Evo, a bone fixation device. However, it does not contain information about acceptance criteria for a device's performance, a study proving it meets such criteria, or any details related to AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to predicate devices, primarily through:

• Indications for Use: Comparing the intended use of the TrueLok™ Evo to predicate devices.
• Technological Characteristics: Highlighting similarities in materials, design, and general principles of operation.
• Performance Analysis (Non-Clinical): Detailing specific non-clinical tests conducted, such as MRI compatibility testing and mechanical testing according to ASTM standards.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria & Reported Performance: The document states that the performance data supports substantial equivalence and that the device performs "as well as or better than the predicate devices." It also lists the standards used for testing (ASTM F2052, F2213, F2182, F2119 for MRI, and ASTM F1541-17 for mechanical testing). However, it does not quantify specific acceptance criteria (e.g., "displacement must be less than X mm") nor does it report the specific measured performance values (e.g., "displacement was Y mm") that would allow for a direct comparison in a table as requested. The "Effectiveness" mentioned refers to the device's ability to achieve its intended function, not a quantifiable performance metric for an algorithm.

2. Sample Size & Data Provenance (Test Set): This document does not describe a "test set" in the context of an algorithm or AI. The performance analysis refers to physical testing of the device components.

3. Number of Experts & Qualifications / Adjudication Method (Test Set): This information is relevant for studies involving human interpretation or ground truth establishment for AI. It is not applicable to the non-clinical mechanical and MRI compatibility testing described here.

4. MRMC Comparative Effectiveness Study: There is no mention of an MRMC study or AI assistance for human readers as the device is a physical bone fixation system, not an AI diagnostic tool.

5. Standalone Performance Study: No standalone algorithm performance study is mentioned for the same reason as above.

6. Type of Ground Truth: The ground truth for the non-clinical tests described would be the physical measurements and observations during those tests, compared against the limits defined by the regulatory standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense used for AI.

7. Sample Size for Training Set: Not applicable as there is no AI/algorithm being trained.

8. How Ground Truth for Training Set was Established: Not applicable as there is no AI/algorithm being trained.

In summary, the provided document details a 510(k) submission for a physical medical device (bone fixation system) and its non-clinical testing to demonstrate substantial equivalence, not the performance of an AI or algorithm. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from this text.

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The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as components of the Smith & Nephew Taylor Spatial Frame external fixation system that is indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

The Deformity Analysis and Correction Software (DACS) and Instrumentation is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon. The instrumentation includes Radiopaque Fiducial Markers which are attached to the Smith & Nephew Taylor Spatial Frame external fixator.

The provided text is a 510(k) summary for the Deformity Analysis and Correction Software (DACS) and Instrumentation. It details the device, its intended use, and a comparison to predicate devices, but it does not contain a specific section outlining detailed acceptance criteria and a study that explicitly proves the device meets those criteria in a quantitative manner.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through qualitative comparisons and general statements about performance and accuracy testing.

However, based on the information provided, we can infer some aspects and construct a table and description as requested, noting where specific details are absent.

Here's an analysis of the document to answer your questions:

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

The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics. It generally states that "Performance and accuracy testing were performed to test the ability of the Deformity Analysis and Correction Software (DACS) and Instrumentation to produce correct results under different variations of bone deformities, anatomical orientations, and device combinations." It also states that testing "demonstrated that the Deformity Analysis and Correction Software (DACS) and Instrumentation is capable of successfully correcting the variety of deformities it may encounter in the clinical setting."

Without explicit pass/fail criteria or quantitative results such as mean error, standard deviation, or accuracy ranges, it's impossible to create a strict "acceptance criteria" table from this document. However, based on the description of the testing, the implied acceptance criteria were that the software would "produce correct results" and "successfully correct deformities."

Here's a table based on the implied performance and accuracy from the document:

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

• Sample Size for Test Set: The document mentions that testing was "executed against a variety of CAD-generated image sets and a Smith & Nephew Taylor Spatial Frame x-ray image set." The exact number (sample size) of these image sets is not specified.
• Data Provenance:
  • Source: "CAD-generated image sets" (simulated data) and "a Smith & Nephew Taylor Spatial Frame x-ray image set" (likely real patient data, but source country is not specified).
  • Retrospective or Prospective: The use of "CAD-generated image sets" implies simulated, non-patient-specific, or laboratory data. The "Smith & Nephew Taylor Spatial Frame x-ray image set" could be retrospective, either from pre-existing clinical cases or data specifically acquired for testing, but the document does not clarify.

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)

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. Given the use of "CAD-generated image sets" where "known inputs" were available, the ground truth for these would be inherent in the CAD model parameters rather than established by human experts. For the "Smith & Nephew Taylor Spatial Frame x-ray image set," it's unclear how ground truth was established or if experts were involved.

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

The document does not describe any adjudication method for the test set. The validation approach appears to be a direct comparison of software-calculated results against "known inputs" for simulated data and (presumably) against accepted clinical measurements or calculations for real image data, rather than an expert consensus process.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. The DACS is described as software that "assists the physician in calculating the lengths of the struts" and allows "the physician to visualize the moving bone position." It computes strut lengths based on physician inputs. There is no mention of an AI component that would assist human readers in interpretation or diagnosis, nor any study comparing human performance with and without such assistance. The software is a calculation and visualization tool, not an AI-based diagnostic aid that would typically be evaluated in an MRMC study.

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

The performance testing mentioned ("Performance and accuracy testing were performed to test the ability of the Deformity Analysis and Correction Software (DACS) and Instrumentation to produce correct results...") appears to be a form of standalone testing where the software's output was compared to known or expected values. The document states: "The known inputs for each image (device types and strut settings) was compared to the results calculated by the Deformity Analysis and Correction Software (DACS) and Instrumentation." This suggests testing the algorithm's direct output against a reference.

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

The ground truth used appears to be:

• "Known inputs" from CAD-generated images: For simulated data, the ground truth is the inherent parameters or "true" values defined within the CAD models. This is a form of engineered or definitional ground truth.
• For the "Smith & Nephew Taylor Spatial Frame x-ray image set," the ground truth is presumably established clinical measurements or calculations associated with those images, although this is not explicitly detailed. It does not mention expert consensus, pathology, or outcomes data specifically.

8. The sample size for the training set

The document does not mention a training set or its sample size. This is a 510(k) summary for software that appears to be deterministic (performing calculations based on input parameters) rather than a machine learning/AI model that would typically require a training set. The phrase "Deformity Analysis and Correction Software (DACS)" itself suggests a rule-based or algorithmic system, not necessarily one that learns from data.

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

As no training set is mentioned (see point 8), there is no information provided on how ground truth for a training set was established.

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