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The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
· Cotton (opening wedge) osteotomies of the medial cuneiform
· Evans lengthening osteotomies
The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.
The Integra Titanium Bone Wedges are not intended for use in the spine.

The Integra® Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for angular correction of small bones in the ankle and foot. The Integra Titanium Bone Wedges are constructed from commercially pure titanium formed into a cancellous-like structure, and are offered in a variety of sizes and shapes to correct various skeletal deformities in the foot. The Integra® Titanium Bone Wedges are intended to be used with ancillary plating fixation.

The provided context refers to a 510(k) Pre-market Notification for a medical device called the "Integra® Titanium Bone Wedge." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria like those used for AI/ML-driven diagnostic devices.

Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as typically applied to AI/ML diagnostic tools, is not applicable to this device.

The "study" conducted for this medical device is focused on mechanical and biocompatibility testing to demonstrate that it is safe and performs comparably to a legally marketed predicate device.

Here's an analysis based on the provided text, addressing the relevant points and explaining why others are not applicable:

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

Not Applicable in the context of an AI/ML diagnostic device with performance metrics like sensitivity/specificity.

For the Integra® Titanium Bone Wedge, the "acceptance criteria" are not reported as specific numerical thresholds like those for AI performance. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (BIOFOAM™ Bone Wedge, K093950) through:

• Similar design features, materials, and intended use.
• Successful completion of specific mechanical and biocompatibility tests.

The reported device performance is summarized as:
"The results of these verification activities demonstrate that the Integra Titanium Bone Wedges are safe for the intended use, and are substantially equivalent to the predicate device identified."

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

Not Applicable in the context of an AI/ML diagnostic device.

For this mechanical device:

• Sample Size: The document does not specify the exact number of Integra® Titanium Bone Wedges used for each mechanical or biocompatibility test. It simply states that "Mechanical testing, including expulsion, abrasion, static compression, and compressive fatigue, as well as biocompatibility testing were performed."
• Data Provenance: The data would originate from laboratory testing of the physical devices, not clinical data from patients. Therefore, country of origin or retrospective/prospective nature of data are irrelevant.

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. Ground truth, in the context of AI/ML, refers to expert-labeled data. For a mechanical bone wedge, "ground truth" is established by engineering standards and validated laboratory test methodologies. There are no "experts establishing ground truth for a test set" in the sense of medical diagnosis.

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

Not Applicable. Adjudication methods are used in scenarios where multiple experts might disagree on the "ground truth" for a diagnostic label. This is not relevant to mechanical or biocompatibility testing.

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. MRMC studies are specific to evaluating diagnostic devices, typically AI-assisted imaging tools, and their impact on human reader performance. This device is a surgically implanted bone wedge, not a diagnostic tool, and therefore, no MRMC study was performed.

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

Not Applicable. This refers to AI algorithm performance. The Integra® Titanium Bone Wedge is a physical medical device, not an algorithm.

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

Not Applicable in the AI/ML sense.

For this device, "ground truth" equates to:

• Engineering Standards: Established benchmarks for mechanical strength, fatigue, and material properties.
• Biocompatibility Standards: Regulations and tests (e.g., ISO 10993 series) to ensure the material is safe for implantation and does not elicit adverse biological responses.
  These are determined by established scientific and regulatory guidelines, not clinical expert consensus on diagnostic labels.

8. The sample size for the training set

Not Applicable. There is no "training set" for a mechanical device in the AI/ML sense. The device itself is manufactured, and then samples are taken for testing.

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

Not Applicable. (As above, no training set in this context).

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