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C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats.

The C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats.

The C-Wire Double Ended Orthopedic Wires are single-use devices that are indicated for surgical repair of small bone trauma. The C-Wires provide mechanical stability during the natural bone healing process. Each wire is 5" (127mm) long, with each end ground to either a spade or trocar shaped tip. C-Wires are available in four different diameters (0.7mm, 0.89mm, 1.14mm and 1.57mm). The wires are made of 316LVM stainless steel.

The provided document describes the CONMED Corporation's C-Wire Double Ended Orthopedic Wires and its substantial equivalence to a predicate device (SMT Schilling Kirschner/Guide Wires, K100736). As such, this document does not contain information about acceptance criteria and a study proving a new device meets those acceptance criteria in the typical sense of a performance study for, for example, an AI/ML device.

Instead, the submission argues for substantial equivalence based on:

1. Long-term market history: The device has been in continuous use for 38 years with few complaints. This serves as a form of "real-world evidence" demonstrating safety and effectiveness over a very long period.
2. Similarity to predicate devices: The C-Wire is very similar to other FDA-cleared wires in terms of intended use, engineering drawings, material, method of operation, and shape/size.
3. Conformance to FDA standards: The device conforms to FDA standards related to pins and wires and other recognized standards.
4. Completed testing: Transportation, biocompatibility, sterilization, and shelf-life testing were completed.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device demonstrating substantial equivalence rather than a diagnostic device relying on specific performance metrics established through a clinical or algorithmic study.

However, I can extract the information that is present and indicate where requested information is not available.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The C-Wire Double Ended Orthopedic Wires are demonstrated to be substantially equivalent to the predicate device, SMT Schilling Kirschner/Guide Wires (K100736). The "acceptance criteria" in this context are not quantitative performance metrics of a novel diagnostic algorithm, but rather the qualitative and quantitative similarities to the predicate device, along with a long history of safe use and compliance with relevant standards. The "study" proving the device meets these criteria is a substantial equivalence comparison and a review of post-market surveillance data.

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

• Continuous use for 38 years with few complaints regarding breakage, insertion, or pull-out (based on Post Market Surveillance Reports).
• Very similar to other FDA-cleared wires (including the predicate) in intended use, engineering drawings, material, method of operation, and shape/size.
• Conformance to FDA standards (e.g., related to pins and wires) and other FDA-recognized standards.
• Completed Transportation, Biocompatibility, Sterilization, and Shelf-life testing. |
  | Physical Characteristics | (e.g., diameter, length, tips) Similar range or scope as predicate. | Proposed Device: Diameter: 0.7mm, 0.89mm, 1.14mm, 1.57mm; Length: 5" (127mm); Tips: spade or trocar. Made of 316LVM stainless steel.
  Predicate Device: Diameter: 0.6 - 6.35mm; Length: 60 - 500mm; Tips: diamond or trocar point, round, flat, with or without 3- or 4-shank ends, with or without spherical shape. Made of 316L. |

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

• Sample Size for Test Set: Not applicable in the context of a traditional device substantial equivalence based on long market history and comparison to a predicate device. Performance is not measured on a specific test set of cases. The "test" is the comparison analysis and the review of 38 years of post-market surveillance.
• Data Provenance: The 38 years of "continuous use" and "Post Market Surveillance Reports" indicate retrospective real-world data, likely from various unspecified regions where the device was marketed.

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

• Experts and Qualifications: Not applicable. Ground truth in the context of diagnostic AI/ML evaluation is not relevant here. The evidence for substantial equivalence relies on device design, materials, manufacturing controls, and historical safety data.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. No "test set" in the traditional sense, and thus no adjudication of expert interpretations for ground truth.

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:

• MRMC Study: Not applicable. This document is for a physical medical device (orthopedic wires), not an AI/ML diagnostic system. No human readers or AI assistance are involved in its primary function.

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

• Standalone Performance Study: Not applicable. This is not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: In this context, the "ground truth" for the safety and effectiveness claim is primarily based on:
  • Historical Performance/Outcomes Data: 38 years of continuous use with few complaints from post-market surveillance.
  • Engineering and Material Standards: Conformance to established FDA and recognized standards for physical properties, device design, and biocompatibility.
  • Direct Comparison to Predicate: Demonstrating substantial equivalence in design, materials, intended use, and technology to a legally marketed device.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

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The subject orthopedic wires are single-use devices. Like the predicate devices, they are intended for:

• Bone fracture fixation,
• Osteotomy,
• Arthrodesis,
• Correction of deformity,
• Revision procedures where other treatments or devices have been unsuccessful, and;
• Bone reconstruction procedures.

The subject devices are also cobalt chromium alloy wires. They come either as 18" wires in an autoclavable tube (6 per tube), or as a 24" length, or as a 72" (6 Foot) coil. The subject devices are 0.0126", 0.0159", 0.020", 0.040" and 0.046" in diameter.

The provided document is a 510(k) Premarket Notification for a line extension to an Orthopedic Wire. It explicitly states: "No testing was performed to demonstrate the equivalence of the subject devices."

Therefore, based on the provided text, the device did not undergo any specific study to prove it meets acceptance criteria. Instead, its clearance was based on demonstrating substantial equivalence to a legally marketed predicate device, without new performance testing.

Given this, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred:

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

• Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., tensile strength, flexibility limits) for the new wire sizes. The acceptance was based on substantial equivalence to the predicate device.
• Reported Device Performance: Not performed or reported. The submission states, "No testing was performed to demonstrate the equivalence of the subject devices."

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

• Sample Size: Not applicable as no new testing was performed.
• Data Provenance: Not applicable.

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 as no new testing or ground truth establishment was performed for performance evaluation.

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

• Not applicable as no new testing or adjudication for performance was performed.

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 not an AI-assisted device. No MRMC study was mentioned.

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 concensus, pathology, outcomes data, etc)

• Not applicable, as no new performance data was generated for the subject device. The clearance relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable as this is not a machine learning/AI device.

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

• Not applicable as this is not a machine learning/AI device.

Summary of the document's approach:

The manufacturer pursued a "Special 510(k) Premarket Notification" for a line extension. This pathway is typically used when the modification to a legally marketed device does not raise new questions of safety and effectiveness. In this instance, the "line extension" involved new diameters of existing cobalt chromium alloy orthopedic wires. The core argument for substantial equivalence was likely based on:

• The identical material (cobalt chromium alloy).
• The identical intended use.
• Presumably, the new wire sizes falling within a range that would not significantly alter the established mechanical properties or biological compatibility compared to the predicate devices, despite the lack of new testing. The FDA concurrence letter confirms that they found the device "substantially equivalent" for the stated indications.

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