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510(k) Data Aggregation

    K Number
    K202935
    Device Name
    Syntec Femoral Nail Extended System
    Manufacturer
    Syntec Scientific Corporation
    Date Cleared
    2020-10-28

    (29 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K181296,K984543
    Why did this record match?
    Device Name :

    Syntec Femoral Nail Extended System

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

    The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondy lar and ipsilateral fractures; Delayed union fractures: Open and closed femur shaft fractures: Combined inter and subrochanteric fractures: High subtrochanteric fractures . Pseudoarthrosis and correction osteotomy: Pathological fractures, impending pathologic and tumor resections: Pertrochanteric fractures: and Nonunions and malunions.

    Device Description

    The Syntec Femoral Nail Extended System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 5° proximal bend allows the nail to be inserted through the tip of the greater trochanter for an easier surgical approach. These nails have a 135° recon screw angle for easier placement of two 6.3 mm Recon Screws into the femoral neck and ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø13 in 3, 5, 10, 15mm lengths is available for proximal closing of the nail. The Syntec Femoral Nail Extended System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

    AI/ML Overview

    This document is a 510(k) submission for the Syntec Femoral Nail Extended System, a medical device used for long bone fracture fixation. The submission declares the device substantially equivalent to previously cleared predicate devices.

    Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Based on the provided text, the acceptance criteria are generally implied rather than explicitly stated with numerical thresholds. The primary criterion is conformance to established material and mechanical property standards, and the reported performance is simply that the device meets these standards.

    Acceptance Criteria (Implied)Reported Device Performance
    Conformance to ASTM F138-13 (Surgical Stainless Steel - SUS316L)The Syntec Femoral Nail Extended System is manufactured from commercially available SUS316L (stainless steel) per ISO 5832-1:2007/ASTM F 138-13. "Those nails in the scope of this submission were in conformance with those standards and are therefore substantially equivalent to the predicate devices."
    Conformance to ASTM F136-13 (Surgical Titanium Alloy - Ti-6AL-4V)The Syntec Femoral Nail Extended System is manufactured from commercially available Ti-6AL-4V (Titanium alloy) per ISO 5832-3:1996/ASTM F136-13. "Those nails in the scope of this submission were in conformance with those standards and are therefore substantially equivalent to the predicate devices."
    Substantial Equivalence in mechanical strength"Mechanical strength comparison, analysis of results, engineering justifications, dimensional and material comparisons were conducted to determine substantial equivalence to the predicates." "Stress analysis result, risk analysis and design control activities including verification activities were conducted to demonstrate the subject device does not raise any different questions of safety or effectiveness associated with smaller diameter devices. Thus, the Syntec Femoral Nail System is substantially equivalent in design, configuration, and indications for use to the Predicate Device."
    Design, Configuration, and Indications for UseThe device has "the same intended uses and indications, technological characteristics, and principles of operation to the predicate device." Its indications for use are "patterned after the predicate devices and supported by an extensive collection of literature references for a long time."

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

    • Sample Size for Test Set: Not explicitly stated. The document refers to "those nails in the scope of this submission" and "mechanical strength comparison, analysis of results, engineering justifications, dimensional and material comparisons." This implies laboratory testing on representatives of the device variants, rather than a sample of patient data.
    • Data Provenance: Not applicable in the context of clinical data. For the non-clinical testing, the testing was conducted for the specific submission as part of the regulatory process. The manufacturing location is Taiwan.

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

    • This information is not provided in the document. The studies described are non-clinical, mechanical, and material characteristic comparisons, not studies requiring expert clinical assessment for ground truth.

    4. Adjudication method for the test set

    • This information is not provided and is not applicable given the nature of the non-clinical testing 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

    • No, an MRMC comparative effectiveness study was NOT done. This device is an intramedullary nail, which is a physical implant for fracture fixation, not an AI-powered diagnostic or assistive technology.

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

    • No, a standalone algorithm performance study was NOT done. This device is a physical medical implant.

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

    • For the non-clinical tests, the "ground truth" is established by engineering standards and specifications (e.g., ASTM F136-13, ASTM F138-13, ISO 5832-1:2007, ISO 5832-3:1996) and established mechanical testing methodologies.

    8. The sample size for the training set

    • This is not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.

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

    • This is not applicable. This device is a physical medical implant, not an AI/ML algorithm.
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