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510(k) Data Aggregation

    K Number
    K133520
    Device Name
    HAMMERLOCK 2
    Manufacturer
    BIOMEDICAL ENTERPRISES, INC
    Date Cleared
    2014-01-09

    (55 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K070598,K131640
    Why did this record match?
    Device Name :

    HAMMERLOCK 2

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

    The HammerLock® 2 is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

    Device Description

    The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force. The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called HammerLock® 2. This document focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing, rather than clinical study data involving AI or human interpretation. Therefore, many of the requested elements for AI/imaging studies are not applicable.

    Here's an analysis based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance Criteria (Implied)Reported Device Performance
    Material CompositionNitinol, per ASTM F2063-05Conforms to "Nitinol, per ASTM F2063-05"
    Mechanical BendingMeet or exceed stiffness and strength of predicate (K131640 HammerLock®)"The results showed that all of the new HammerLock® 2 designs exceed the stiffness and strength of the predicate." (Tested using ASTM F382-99)
    Corrosion ResistanceAdequate according to technical literature and substantially equivalent to predicate SmartToe devices (K070598)."Test results demonstrate that the HammerLock® corrosion resistance is adequate according to technical literature and substantially equivalent to that of the SmartToe." (Tested using ASTM F2129-08)
    Intended UseSmall bone reconstruction and fusionNo direct test result provided for this in the context of acceptance criteria, but substantial equivalence to the predicate (which has the same intended use) implies this criterion is met. The FDA's letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
    Design CharacteristicsMaintain similar design principles (intramedullary fixation, shape-memory)"The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force." (This confirms similar mechanism to nitinol shape-memory implants). The primary change is an extended proximal length for "better fixation."
    Dimensions (Ranges)New sizes introduced (17, 20, 22, 25 mm)The device comes in sizes 17, 20, 22, and 25 mm, which are a different set of sizes compared to the predicate (12, 14, 16, 19, 22 mm). The design justification is that the new HammerLock® 2 is longer than the predicate, specifically on the proximal side, to allow for better fixation. The mechanical testing implicitly covers the performance of these new dimensions. This isn't an acceptance criterion in the sense of a pass/fail range, but rather a design specification that was tested.

    For the remaining points, please note that this is a 510(k) summary for a mechanical medical device (implant) and not an AI or imaging diagnostic device. Therefore, many of the questions are not applicable to this document.

    1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

      • Sample Size: Not explicitly stated as a numerical sample size of "devices" in the same way a clinical trial would report patients. For mechanical testing, samples of the device (HammerLock® 2) and the predicate (K131640 HammerLock®) were used for each test. The ASTM standards (F382-99 for bending, F2129-08 for corrosion) would specify the minimum number of samples required for robust testing, but these numbers are not detailed in the summary.
      • Data Provenance: The data is generated from laboratory bench testing conducted in accordance with ASTM standards. The summary does not specify the country of origin of the lab or if it was prospective/retrospective; however, bench testing is inherently prospective in its execution (i.e., new tests are run for the new device).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

      • Not Applicable. This document describes mechanical testing of an orthopedic implant, not an diagnostic imaging device that requires interpretation by medical experts to establish ground truth.

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

      • Not Applicable. As above, this pertains to expert review of diagnostic results, which is not relevant to this device's testing. Mechanical testing results are objective measurements (e.g., stiffness values, corrosion rates), not subject to expert adjudication in this context.

    4. 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. No MRMC study was performed as this is a device for surgical implantation, not an AI or imaging diagnostic tool that assists human readers.

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

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

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

      • For Mechanical Testing: The "ground truth" is defined by the objective performance parameters (stiffness, strength, corrosion resistance) as measured against established ASTM standards and compared to a legally marketed predicate device. The "ground truth" for the predicate's performance is its previously characterized mechanical properties.
      • For Substantial Equivalence: The ultimate "ground truth" being demonstrated is that the HammerLock® 2 is as safe and effective as its predicate.

    7. The sample size for the training set

      • Not Applicable. There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.

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

      • Not Applicable. See point 8.
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