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510(k) Data Aggregation

    K Number
    K073342
    Device Name
    SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
    Manufacturer
    SALVIN DENTAL SPECIALTIES, INC.
    Date Cleared
    2008-03-26

    (119 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K023260,K970912,K050492,K040860
    Why did this record match?
    Device Name :

    SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW

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

    The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction. Single patient use only

    Device Description

    The Salvin Dental Specialties Titanium Fixation Screw System consists of 1.5mm and 2.0mm Titanium (Ti-6Al-4V) bone screws in lengths of 4, 6, 8, 10, 13 and 15mm. The 2.0mm diameter screws are “emergency” screws. The devices are provided non-sterile.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the "Salvin Dental Specialties, Inc. Titanium Fixation Screw System". The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, many of the requested categories related to acceptance criteria, ground truth, and clinical study details are not directly applicable or available in this type of submission.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    This 510(k) summary does not define specific performance acceptance criteria in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) or statistical thresholds. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.

    Acceptance Criteria (Implied by Substantial Equivalence)Reported Device Performance
    Design: Substantially equivalent to predicate devices.Engineering drawings reviewed, deemed substantially equivalent.
    Materials of Composition: Substantially equivalent to predicate devices.Titanium (Ti-6Al-4V) bone screws, deemed substantially equivalent.
    Indications for Use: Same as predicate devices."internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction." - deemed substantially equivalent.
    Mechanical Testing: Meets standards like ASTM F 543-02 for metallic bone screws.Mechanical testing performed (referenced as "mechanical testing have demonstrated"), but specific results/metrics are not detailed in this summary.
    Labeling: Consistent with predicate devices.Labeling reviewed, deemed substantially equivalent.

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

    • Test Set Sample Size: Directly applicable "test set" sample size for evaluating performance against clinical acceptance criteria is not mentioned because no clinical study with human subjects (patients) was conducted or referenced for this 510(k) submission.
    • Data Provenance: Not applicable, as this submission relies on engineering design, material specifications, and non-clinical mechanical testing, rather than patient data.

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

    • Number of Experts & Qualifications: Not applicable. No "ground truth" for a clinical test set was established in this context. The determination of substantial equivalence relies on regulatory review of technical documentation by FDA reviewers.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable, as there was no clinical test set requiring expert adjudication.

    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

    • MRMC Study: No MRMC comparative effectiveness study was conducted or referenced. This device is a mechanical fixation screw, not an AI-powered diagnostic or assistive tool.

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

    • Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm.

    7. The type of ground truth used

    • Type of Ground Truth: The "ground truth" in this context is the regulatory standard of "substantial equivalence" to legally marketed predicate devices, established through engineering specifications, material properties, intended use, and non-clinical mechanical testing (e.g., compliance with ASTM F 543-02). It is not based on expert consensus, pathology, or outcomes data from a clinical trial for this specific device.

    8. The Sample Size for the Training Set

    • Training Set Sample Size: Not applicable. This is a physical device, and the evaluation relies on established engineering principles and comparison to existing devices, not machine learning or AI models that require training data.

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

    • Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for this device.
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