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510(k) Data Aggregation

    K Number
    K013657
    Device Name
    MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
    Manufacturer
    BIOMET ORTHOPEDICS, INC.
    Date Cleared
    2001-12-03

    (27 days)

    Product Code
    HRS,JDO
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K982545
    Why did this record match?
    Reference Devices :

    K982545

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

    Fixation of a humeral fracture near the site of an intramedullary implant. Fixation of fractures where a combination of screws and cerclage cables would improve stabilization.

    Device Description

    The Biomet® Humeral Cable Plate System consists of two (2) 316LVM Stainless Steel (ASTM F138) Plates. The plates are straight and have a combination of cortical screw holes and integrated cable crimp sleeves. The first plate is 156mm in length and has six (6) cable crimps and five (5) alternating cortical screw holes. The second plate is 206mm in length with eight (8) cable crimps alternating with seven (7) cortical screw holes. Both plates will utilize 3.5mm Cortical Screws and standard 2.0mm Diameter 316LVM Stainless Steel BMPTM Cable Cerclage.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Biomet® Humeral Cable Plate, focusing on acceptance criteria and supporting studies:

    This document is a 510(k) Premarket Notification Summary for a medical device. For devices seeking 510(k) clearance, the primary method of "proving" a device meets acceptance criteria is demonstrating substantial equivalence to a previously legally marketed predicate device, rather than through extensive clinical trials or performance metrics against defined acceptance criteria for novel devices.

    Therefore, the structure of the answer below reflects this context.

    Acceptance Criteria and Study for the Biomet® Humeral Cable Plate

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria Category (for 510(k))Reported Device Performance (vs. Predicate)
    Material Equivalence: Materials of construction are equivalent to predicate.Met: The device is made of 316LVM Stainless Steel (ASTM F138). While not explicitly stated for the predicate in this document, the summary implies material similarity: "The Biomet® Humeral Cable Plate's material, design, sizing, and indications are similar or identical to the predicate devices."
    Design Equivalence: Device design (e.g., dimensions, features) is equivalent to predicate.Met: Device consists of straight plates with cortical screw holes and integrated cable crimp sleeves (156mm/6 crimps/5 screw holes, 206mm/8 crimps/7 screw holes). "The Biomet® Humeral Cable Plate's material, design, sizing, and indications are similar or identical to the predicate devices."
    Sizing Equivalence: Size ranges are equivalent to predicate.Met: Specific sizes (156mm, 206mm, 3.5mm cortical screws, 2.0mm cables) are provided. "The Biomet® Humeral Cable Plate's material, design, sizing, and indications are similar or identical to the predicate devices."
    Intended Use/Indications for Use Equivalence: Clinical use matches predicate.Met: Fixation of humeral fractures near an intramedullary implant; fixation of fractures where screws and cerclage cables improve stabilization. These are listed under "Intended Use" and later confirmed as "Indications for Use" for the new device.
    Technological Characteristics Equivalence: Fundamental technological methods are equivalent.Met: "The Biomet® Humeral Cable Plate's material, design, sizing, and indications are similar or identical to the predicate devices." This implies that the fundamental way the device functions (plate and cable cerclage for fixation) is not novel compared to the predicate.
    Safety and Effectiveness: Device presents no new questions of safety or effectiveness.Met: "Finite Analysis and literature review determined that the Biomet® Humeral Cable Plate presented no new risks and were therefore, substantially equivalent to the predicate device."

    Note: For 510(k)s, "acceptance criteria" are often implicit in the demonstration of substantial equivalence. The "study" proving it meets these criteria is the comparison to the predicate device through non-clinical (and sometimes clinical) testing or analysis.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to a predicate device, not on a traditional "test set" of patient data for performance evaluation in the way a diagnostic AI device would.
    • Data Provenance: Not applicable for a traditional test set. The data presented is primarily a comparison against a predicate device (Biomet's BMP™ Cable System - K982545). The "Finite Analysis and literature review" that supported the safety claim would be based on engineering principles and existing scientific/medical literature, not patient data from a specific "test set."

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    • Number of Experts: Not applicable. Ground truth, in the context of diagnostic or prognostic devices, is not established for this type of 510(k) submission.
    • Qualifications of Experts: Not applicable.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. There was no "test set" requiring adjudication in the context of this 510(k) submission.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

    • MRMC Study: No. The provided document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no comparative effectiveness study, including an MRMC study, was performed or submitted.
    • Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study or AI component is involved.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

    • Standalone Performance: Not applicable. This device is a mechanical bone plate system, not an algorithm or AI.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: Not applicable in the traditional sense of a diagnostic/prognostic device. For this submission, the "ground truth" is effectively:
      • The established performance and safety profile of the predicate device (Biomet's BMP™ Cable System - K982545).
      • Engineering principles and existing literature that support the safety and non-inferiority of the new device's design relative to the predicate (as determined by "Finite Analysis and literature review").

    8. The Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

    9. How the Ground Truth for the Training Set was Established

    • Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this mechanical device.
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