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K Number
K973009
Device Name
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
Manufacturer
MITEK PRODUCTS
Date Cleared
1997-11-10

(89 days)

Product Code
MBI
Regulation Number
888.3040
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Mitek meniscal fasteners ( "H" Fix) are intended for the repair of torn meniscal tissue as well as the repair of a separation of the meniscus from the synovium.

Device Description

The "H" Fix is cylindrical in cross section and configured to have one leg of the letter "H" in a 90 degree opposed position to the other. The Mitek non absorbable "H" Fix is made from polypropylene.

AI/ML Overview

The provided text describes the "Mitek Polypropylene 'H' Device" and its comparison to a predicate device, the Acufex "T" Fix device. The study described focuses on non-clinical pull tests, rather than clinical studies with human subjects or expert readers.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

| Acceptance Criteria | Reported Device Performance |
| :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Implicit Criterion: The "H" Fix device should demonstrate mechanical strength suitable for its intended function (holding meniscal tissue in apposition during healing) and be at least equivalent to, or superior to, the predicate device. | The Mitek polypropylene non absorbable "H" Fix provided an average failure load of 16.29 pounds in bovine meniscus. |
| Implicit Criterion: The "H" Fix device should demonstrate a significantly greater failure force compared to the predicate device. | The Mitek "H" device showed a significantly greater failure force than the predicate Acufex "T" Fix device when tested in the bovine meniscus. |

Note: The document only provides the performance of the Mitek "H" Fix and states it was "significantly greater" than the predicate. It does not explicitly state the failure load of the Acufex "T" Fix or a specific numerical threshold for "significantly greater." The acceptance criteria are inferred from the comparative nature of the non-clinical test.

Study Details

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

    • Sample Size: Not explicitly stated. The text mentions "an average failure load" which implies multiple tests were conducted, but the specific number of samples (e.g., number of "H" Fix devices tested, number of bovine menisci used) is not provided.
    • Data Provenance: The tests were conducted on bovine meniscus. The country of origin is not specified, and it is a non-clinical (ex-vivo) study, not a human clinical trial.

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

    • Not Applicable. This was a non-clinical, mechanical pull test. There were no human experts establishing ground truth in the context of diagnostic or clinical outcome assessment. The "ground truth" was the objective measurement of force required for failure.

  3. Adjudication method for the test set:

    • Not Applicable. As a mechanical test, there was no subjective assessment requiring adjudication. The failure load was presumably measured by an instrument.

  4. 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 was a non-clinical mechanical test, not a study involving human readers or AI.

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

    • Not Applicable. This test did not involve an algorithm or AI.

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

    • Mechanical Failure Load Measurement: The ground truth was the objectively measured force (in pounds) at which the device failed when embedded in bovine meniscus.

  7. The sample size for the training set:

    • Not Applicable. There was no "training set" as this was a non-clinical mechanical performance study, not an AI or machine learning model development.

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

    • Not Applicable. No training set was used.

§ 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.