(87 days)
The KMedic® Internal/External Fixation Devices are non-sterile, single-use; internal/external fixation devices intended to be used for unilateral internal/external fixation in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the internal/external fixation modality.
The KMedic® Internal/External Fixation Devices consist of various fixation pins and wires for use in unilateral internal/external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. All KMedic® Internal/External Fixation Devices included in this submission are manufactured from stainless steel and will be offered non-sterile.
The provided document describes a 510(k) premarket notification for the KMedic® Internal/External Fixation Devices. This is a submission for a medical device and not for a software or AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert involvement, and multi-reader multi-case studies, which are typically relevant for AI/ML device evaluations, are not applicable here.
The document primarily focuses on establishing substantial equivalence to a predicate device based on material, design, and performance characteristics, and compliance with voluntary standards.
Here's a breakdown of the information that can be extracted or inferred from the provided text, related to the device's assessment:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ASTM F136-03 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" | The KMedic® Internal/External Fixation Devices comply with this standard. |
| ASTM F366-04 "Standard Specification for Fixation Pins and Wires" | The KMedic® Internal/External Fixation Devices comply with this standard. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing an AI/ML device's performance on a dataset. The "testing" refers to device material and mechanical testing to ensure compliance with industry standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML studies is not relevant here. The "ground truth" for this device's performance relates to its material composition and mechanical properties meeting specified standards for surgical implants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a physical medical implant, not an AI/ML software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" implicitly used for this device is the established specifications and requirements outlined in the ASTM standards (ASTM F136-03 and ASTM F366-04). Compliance with these standards indicates the device's suitability for its intended use.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Summary of Testing" in Section H. It states that "The KMedic® Internal/External Fixation Devices comply with ASTM F138-03 'Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)' and ASTM F366-04 'Standard Specification for Fixation Pins and Wires'."
This means that the manufacturer conducted tests (likely mechanical, material composition, and possibly dimensional checks) to ensure that their fixation pins and wires meet the specific requirements set forth in these two ASTM industry standards. These standards define the material properties, performance characteristics, and testing methods for such devices. By stating compliance, the manufacturer is asserting that their testing demonstrated the device adhered to all relevant criteria within these standards. The 510(k) submission relies on this compliance, along with a detailed device description, to establish substantial equivalence to predicate devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.