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The DARCO™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, joint fusion, and reconstruction of small bones of the feet, and toes. The system can be used in both adult and pediatric patients.

The DARCO ™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediatric patients.

The DARCO™ Locking Bone Plate system is comprised of a variety of titanium plates and screws designed for internal fixation of bone fragments. The plates are designed with rhombus (parallelogram) plates with an assortment of width, lengths, and configurations to address varying patient anatomy. The system includes locking and non-locking 2.7 mm and 3.5 mm diameter screws of various lengths.

This document is a 510(k) Summary of Safety and Effectiveness for the DARCO™ Locking Bone Plate System, essentially a premarket notification for a medical device. As such, it does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study with defined performance metrics and acceptance thresholds like those seen for AI/ML devices.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K061808 DARCO™ Locking Bone Plate System) through non-clinical testing and comparison of characteristics. The "acceptance criteria" here is met by demonstrating that the modified device performs at least as well as the predicate device in relevant non-clinical tests.

Here's an analysis based on the provided text, addressing your points where applicable:

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

Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are implied by successful completion of mechanical and performance tests, demonstrating equivalence to the predicate. Specific numerical acceptance criteria are not explicitly stated in the summary, but rather the conclusion that the testing supports substantial equivalence.

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: Not specified in the provided summary. The summary refers to "testing" but does not give specific numbers of components tested.
• Data Provenance: The testing is "non-clinical" and likely conducted in a controlled lab environment by Wright Medical Technology, Inc. The country of origin and whether it's retrospective or prospective are not relevant for this type of non-clinical mechanical testing.

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)

Not applicable. This is a submission for a physical medical device (bone plate system), not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is mechanical performance as measured in lab tests.

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

Not applicable. This is not an AI/ML device undergoing a clinical study with human readers/interpreters. The "adjudication" is based on comparing test results against established engineering standards or the predicate device's performance.

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 physical medical device, not an AI system. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device, in the context of demonstrating substantial equivalence, is primarily mechanical and material properties as measured through standardized engineering tests (e.g., measuring pullout strength, torque, yield strength). The comparison is made against the performance of the legally marketed predicate device (K061808 DARCO™ Locking Bone Plate System) to demonstrate "at least as good as" performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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The DARCO® Locking Bone Plate System is intended for use in stabilization of fresh fractures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediativ patients.

The DARCO® Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, number of plate holes and through different grades or bridge widths.

This document is a 510(k) premarket notification for the DARCO® Locking Bone Plate System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for device performance. Therefore, many of the requested details, particularly those related to a clinical study (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the device. Instead, it relies on demonstrating substantial equivalence in technological characteristics and performance to a predicate device.

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

Not applicable. This document describes a submission for a medical device that relies on substantial equivalence to a predicate device based on mechanical testing and design comparison, not a clinical study with a "test set" of patient data.

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

Not applicable. No ground truth based on expert review of a test set is mentioned.

4. Adjudication method for the test set

Not applicable. No adjudication method is described as there is no test set of clinical data.

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 document describes a physical medical device (bone plate system), not an AI-assisted diagnostic tool.

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

Not applicable. This document describes a physical medical device, not an algorithm.

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

The document does not describe the use of a "ground truth" derived from clinical data in the context of a performance study. For the mechanical testing, the "ground truth" would implicitly be engineering standards and established mechanical properties, benchmarked against the predicate device.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. No training set is mentioned.

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The DARCO Locking Bone Plate System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.

The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, lengths, number of plate holes and through different grades or bridge widths.

The provided text is related to a 510(k) submission for the DARCO Locking Bone Plate System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through performance studies.

Therefore, the document explicitly states:

"Performance Data: No clinical or non-clinical tests were used in the claim of substantial equivalence."

Based on this statement, the device's acceptance criteria and studies demonstrating its performance as requested in the prompt are not applicable to this 510(k) submission.

To directly answer your questions based only on the provided information:

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

   • No acceptance criteria or reported device performance from studies are provided, as no performance tests were conducted for substantial equivalence.

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

   • Not applicable; no test set or performance data was used.

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):

   • Not applicable; no ground truth for a test set was established.

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

   • Not applicable; no test set was used.

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 MRMC comparative effectiveness study was done. This device is a bone plate system, not an AI-assisted diagnostic tool.

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

   • Not applicable; this is a medical device (bone plate system), not an algorithm.

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

   • Not applicable; no ground truth was established for performance testing.

8. The sample size for the training set:

   • Not applicable; no training set was used.

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

   • Not applicable; no training set was used.

The focus of this 510(k) summary is to demonstrate that the DARCO Locking Bone Plate System is substantially equivalent to a legally marketed predicate device (Normed Titanium Osteotomy Plating System K022325) based on its technological characteristics and intended use, without requiring new performance data.

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