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510(k) Data Aggregation

    K Number
    K022094
    Manufacturer
    Date Cleared
    2002-07-25

    (28 days)

    Product Code
    Regulation Number
    888.3350
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K000254

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indications for the PAR 5 Acetabular component are as follows:

    1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
    2. Rheumatoid arthritis
    3. Correction of functional deformity
    4. Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
    5. Revision procedures where other treatment or devices have failed
    Device Description

    The PAR 5 Acetabular Component is a hemispherical metallic acetabular cup, which can accept a modular hook, ilium flange, and/or a modular ischial blade. The shell accepts a standard Ringloc® liner. The outer surface of the shells has porous coating. The shells are also available with or without hydroxyapatite (HA) coating.

    AI/ML Overview

    The provided documentation is a 510(k) premarket notification for a medical device, the PAR 5 Acetabular Component, and focuses on demonstrating substantial equivalence to a predicate device. It explicitly states:

    "Clinical Testing: None provided as a basis for substantial equivalence."
    "Non-Clinical Testing: Substrate testing with an Engineering Justification determined that the modified PAR 5 Acetabular Components presented no new risks and were, therefore, substantially equivalent to the predicated device."

    Therefore, the information typically required to describe acceptance criteria and a study proving a device meets those criteria (especially related to AI/software performance) is not present in this document. This submission relies on an engineering justification and comparison to a predicate device rather than extensive clinical or statistical performance studies in humans.

    Here's a breakdown of why each requested point cannot be answered:

    1. A table of acceptance criteria and the reported device performance: Not applicable. There are no performance metrics or acceptance criteria for a clinical or AI study described. The "performance" being evaluated is substantial equivalence based on material properties and design similarity to a predicate device.
    2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for performance comparison is described.
    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. There is no test set requiring ground truth establishment by experts.
    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set is described.
    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 a medical device (hip implant component), not an AI diagnostic tool.
    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established for device performance in this context. The "ground truth" for this 510(k) is the existing predicate device and its established safety and effectiveness.
    8. The sample size for the training set: Not applicable. No machine learning model or training set is involved.
    9. How the ground truth for the training set was established: Not applicable. No machine learning model or training set is involved.

    In summary, this 510(k) submission for the PAR 5 Acetabular Component does not contain information about clinical performance studies or AI/software validation. The basis for its substantial equivalence is an engineering justification and comparison to a previously approved predicate device.

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