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K Number
K103797
Device Name
K2M COCR WIRE
Manufacturer
K2M, INC.
Date Cleared
2011-05-20

(144 days)

Product Code
JDQ,REG
Regulation Number
888.3010
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K031127
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

K2M CoCr Wires are intended for:
. Bone fracture fixation
. Osteotomy
Arthrodesis .
Correction of deformity .
Revision procedures when other treatments or devices have been unsuccessful, and, .
Bone reconstruction procedures .

Device Description

K2M CoCr Wires are single stranded implants, with a diameter of 1.0mm (18 gauge).
Materials: The wires are manufactured from Cobalt Chrome per ASTM standards.
Function: K2M CoCr Wires are single use devices intended for the stabilization of bony segments.

AI/ML Overview

The provided 510(k) summary for the K2M CoCr Wire is for a medical device (orthopedic wire) that is seeking clearance based on substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on new performance studies with specific acceptance criteria like those often seen for novel AI/software as a medical device (SaMD) products.

Therefore, the document does not contain the information required to populate most of the requested fields regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment. This is because the K2M CoCr Wire is a hardware device, not an AI/SaMD device, and its clearance process does not involve performance studies in the same way.

Here's an explanation of why the requested information is absent and what can be extracted from the document:

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

  • Absent. The document does not define specific performance acceptance criteria or report performance metrics in the context of a clinical or analytical study. For hardware devices like this wire, "performance" is often assessed through bench testing (e.g., mechanical strength, corrosion resistance, fatigue life) against established ASTM or ISO standards, and comparison to the predicate device's specifications. While the document states "The K2M CoCr Wires are manufactured in compliance with ASTM F1091," it doesn't list specific acceptance criteria from this standard or detailed test results.

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

  • Absent. No test set sample size or clinical data provenance is mentioned because this type of 510(k) clearance does not typically involve clinical data collection for establishing effectiveness, but rather focuses on substantial equivalence based on design, materials, function, and intended use.

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)

  • Absent. Ground truth establishment by experts is not applicable here as there is no clinical "test set" in the context of diagnostic or predictive performance.

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

  • Absent. 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

  • Absent. Not applicable, as this is not an AI/SaMD device.

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

  • Absent. Not applicable, as this is not an AI/SaMD device.

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

  • Absent. Not applicable.

8. The sample size for the training set

  • Absent. Not applicable, as this is not an AI/SaMD device.

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

  • Absent. Not applicable, as this is not an AI/SaMD device.

What can be extracted from the document regarding "acceptance criteria" and "study":

The "study" in this context is the comparison to a predicate device and demonstration of adherence to recognized standards.

Acceptance Criteria (Implied by Substantial Equivalence):

The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device(s). This is achieved by showing that the K2M CoCr Wire is as safe and effective as the predicate based on:

  • Identical Intended Use: The intended uses must be the same or highly similar.
  • Similar Technological Characteristics: The design, function, materials, and overall technological characteristics must be sufficiently similar to the predicate that any differences do not raise new questions of safety or effectiveness.
  • Compliance with Standards: Adherence to recognized consensus standards demonstrates safety and performance.

The "Study" (Demonstration of Substantial Equivalence):

The document itself is the summary of the "study" that proves the device meets the acceptance criteria of substantial equivalence.

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

    • Acceptance Criteria:
      • Intended Use Equivalence: K2M CoCr Wire's intended uses must match those of the predicate device (Howmedica Orthopedic Wire, K031127).
      • Material Equivalence: Must be made from Cobalt Chrome per ASTM standards, similar to predicate.
      • Design/Functional Equivalence: Single stranded, 1.0mm (18 gauge) diameter, intended for stabilization of bony segments, with no significant differences from predicate.
      • Compliance with Standards: Manufactured in compliance with ASTM F1091.
    • Reported Device Performance (as presented for 510(k) purposes):
      • Intended Use: Matches predicate (Bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures, bone reconstruction procedures).
      • Material: Cobalt Chrome per ASTM standards.
      • Design/Function: Single stranded, 1.0mm (18 gauge) diameter, functions for stabilization.
      • Compliance: "The K2M CoCr Wires are manufactured in compliance with ASTM F1091." "There are no significant differences between the K2M wire and other wires currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."

  2. Sample size used for the test set and the data provenance: Not applicable; no clinical test set mentioned.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

  4. Adjudication method for the test set: Not applicable.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.

  7. The type of ground truth used: For this device type, "ground truth" is established through engineering specifications, material standards (ASTM F1091), and verified manufacturing processes that ensure the device meets its design requirements and is equivalent to the predicate.

  8. The sample size for the training set: Not applicable.

  9. How the ground truth for the training set was established: Not applicable.

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.