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510(k) Data Aggregation

    K Number
    K050610
    Device Name
    SALUTE FIXATION SYSTEM
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Date Cleared
    2005-05-25

    (76 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SALUTE FIXATION SYSTEM

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

    The Salute® Fixation System is indicated for use in a variety of laparoscopic/ endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

    Device Description

    The Salute Fixation System consists of a reusable handle, shaft and shaft tip, as well as a sterile, disposable implant cartridge with wire survey ube and cover. The disposable implant cartridge comes prektades from 316L stainless steel wire. The device is used to deliver permanently maginn on Q-shaped rings (Q-ring). Depending on user preference, the handle may be used with an 18cm shaft or a 38cm shaft (fits into a 5mm trocal). Implant cartridges are offered with sufficient 316L stainless steel wire to form 10, 20, 30, or 50 Q-rings and are designed to work with either a 38cm shaft or an 18cm shaft. The handle and shaft are engraved with serial numbers, which must match in order for the device to function properly. The Instructions for Use (IFU) contain information to insure the implant cartridge is used with an appropriate shaft and to confir:: serial numbers of the shaft/handle match.

    AI/ML Overview

    The provided documentation describes a premarket notification for the Salute® Fixation System (SFS). However, the document does NOT contain information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures.

    The "Performance Data" section (G.) in the K050610 document on page 2/2 primarily discusses:

    • Biocompatibility: Stating that biocompatibility testing will be completed and passed before a new PTFE material is released. This refers to material safety, not clinical performance metrics.
    • Bench Testing: Stating that "Bench testing on the Proposed demonstrated the Q-ring shape and dimensions were substantially equivalent to the Predicate." This indicates equivalency in physical characteristics, not clinical effectiveness or performance against specific criteria.

    Therefore, the requested information elements cannot be fully extracted from the provided text for a device performance study as typically understood in the context of AI/medical device performance evaluation.

    However, I can extract and present the type of "performance data" that was provided, which is focused on substantial equivalence rather than traditional performance metrics and acceptance criteria.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Biocompatibility: New PTFE material must be biocompatible."Biocompatibility will be completed and passed before the new PTFE material is released." (Implies successful completion is the acceptance).
    Q-ring Shape and Dimensions: Must be substantially equivalent to the Predicate device."Bench testing on the Proposed demonstrated the Q-ring shape and dimensions were substantially equivalent to the Predicate."
    Tissue/Prosthetic Fixation Capabilities: Must be the same as the Predicate device despite deeper initial wire penetration."Although the Proposed's shaft tip was modified to deepen the wire's initial penetration into tissue/prosthetic, the overall diameter/configuration of the Q-ring was not changed... their tissue/prosthetic fixation capabilities are the same."

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

    • Sample Size (Test Set): Not specified. The document refers to "Bench testing," which implies physical tests on the device itself, not patient data.
    • Data Provenance: Not applicable, as no human data or clinical study is described for performance evaluation.

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

    • Number of Experts: Not applicable. Performance was assessed through bench testing and comparison to a predicate device, not by expert review of clinical cases.
    • Qualifications of Experts: Not applicable.

    4. Adjudication method for the test set:

    • Adjudication Method: Not applicable. There was no test set requiring human adjudication.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

    • MRMC Study: No, an MRMC comparative effectiveness study was not done.

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

    • Standalone Performance: Not applicable. This device is a manual surgical fixation system, not an algorithm or AI.

    7. The type of ground truth used:

    • Ground Truth: The "ground truth" was the characteristics and performance of the predicate device (Salute Stapler and Staples by Onux Medical, Inc.) and the results of bench testing for physical properties (Q-ring shape, dimensions, etc.) and biocompatibility standards.

    8. The sample size for the training set:

    • Sample Size (Training Set): Not applicable. This document does not describe an AI/ML device or a training set.

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

    • Ground Truth (Training Set): Not applicable.
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