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510(k) Data Aggregation

    K Number
    K020970
    Device Name
    MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
    Manufacturer
    BIOMET, INC.
    Date Cleared
    2002-04-04

    (9 days)

    Product Code
    JDI,KRO
    Regulation Number
    888.3350
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K002757
    Why did this record match?
    Device Name :

    MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)

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

    The Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

    Indications:

      1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
      1. Correction of varus, valgus, post traumatic deformity
      1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
      1. Ligament deficiencies
      1. Tumor resections
      1. Treatment of non-unions, femoral neck, and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
      1. Revision of previously failed total joint arthroplasty
      1. Trauma

    These devices are single use implants.

    These devices are for cemented use only.

    Device Description

    The Biomet® Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

    There are twelve diaphyseal segment lengths available in 3cm, 4cm, and 5cm to 23 cm in 2cm increments. The diaphyseal segments are machined from wrought Ti-6AI-4V (ASTM F-1472). All the segments have a smooth satin finish.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the Biomet® Oncology Salvage System Diaphyseal Segments (OSS-K). It is a medical device submission seeking clearance, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical trial.

    Therefore, many of the requested categories are not applicable to this type of regulatory submission. The submission aims to demonstrate "substantial equivalence" to a predicate device rather than fulfilling specific performance acceptance criteria through clinical studies.

    Here's a breakdown based on the provided text:

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

    Acceptance Criteria (for 510(k) Substantial Equivalence)Reported Device Performance
    Technological Characteristics: Similar to or identical to predicate device materials, design, sizing, and indications.The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device.
    Non-Clinical Testing: Sufficient to establish substantial equivalence.Surface finish analysis and mathematical calculations were performed to establish substantial equivalence.
    Clinical Testing: Not required if substantial equivalence can be established otherwise.None provided as a basis for substantial equivalence.

    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. This submission is for regulatory clearance based on substantial equivalence to a predicate device, not a performance study with a test set in the clinical or AI context. The non-clinical testing involved surface finish analysis and mathematical calculations, but no "test set" of patients or data, as typically defined for performance studies.

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

    • Not Applicable. No ground truth establishment by experts for a test set was described as this is a 510(k) submission based on substantial equivalence, not a clinical performance study requiring expert adjudication of data.

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

    • Not Applicable. No test set or expert adjudication method was used for this 510(k) submission.

    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 surgical implant (prosthesis components), not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

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

    • Not Applicable. This device is a physical implant, not an algorithm.

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

    • Not Applicable. The "ground truth" for this 510(k) submission is the demonstration of substantial equivalence to the legally marketed predicate device (Biomet® Oncology Salvage System (OSS)- K002757) based on technological characteristics and non-clinical testing, rather than a clinical ground truth established through expert consensus, pathology, or outcomes data for a new performance claim.

    8. The sample size for the training set

    • Not Applicable. There is no "training set" as this is not an AI/machine learning device or a clinical study for training purposes.

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

    • Not Applicable. As there is no training set, no ground truth needed to be established for one.
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