LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990900
    Device Name
    MICROKERATOME, MODEL MK-2000
    Manufacturer
    NIDEK, INC.
    Date Cleared
    1999-09-24

    (190 days)

    Product Code
    HNO,REG
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    K912697,K972808,K973294,K981141,K981155,K974004
    Why did this record match?
    Reference Devices :

    K912697,K972808,K973294,K981141,K981155,K974004

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

    The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a pre-selected thickness and diameter.

    Device Description

    This DEVICE is an AC powered device consisting of three main parts: CONTROL BOX, HAND PIECE, and FOOT PEDAL. The CONTROL BOX has LED indicators, a pressure gauge, self test button, and connectors. The HAND PIECE contains the blade running and reversing mechanism, oscillation mechanism, attachment slot for the Suction Ring, Blade Holder, and a connector for the Control Box. It includes a Blade Holder, Applanation Plate (determining flap thickness), a disposable Blade, and a Single Suction Ring (fixing to the eyeball under suction). The FOOT PEDAL has switches for controlling suction, forward motion and oscillation of the blade, and reverse motion of the blade, and a cable for connection to the Control Box.

    AI/ML Overview

    The provided text describes the Nidek Keratome, MK-2000, a Class I medical device, and its 510(k) submission for market clearance. However, it explicitly states that no clinical performance data or non-clinical performance data was provided to demonstrate the device's effectiveness.

    Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

    Here's why and what information can be extracted:

    • No Acceptance Criteria or Reported Device Performance: The document does not define specific acceptance criteria (e.g., precision of flap thickness, success rate of flap creation) nor does it provide any reported device performance metrics against such criteria.
    • No Study Data: The document explicitly states: "No clinical performance data has been provided" and "None provide" for non-clinical performance data.

    Information that can be extracted from the provided text, related to your prompt, but indicating a lack of the requested data:

    1. A table of acceptance criteria and the reported device performance:

      • Acceptance Criteria: Not specified in the document.
      • Reported Device Performance: Not provided in the document.

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

      • Sample Size: Not applicable, as no test set data was provided.
      • Data Provenance: Not applicable, as no data was provided.

    3. 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):

      • Number of Experts/Qualifications: Not applicable, as no ground truth for a test set was established (no test data provided).

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

      • Adjudication Method: Not applicable, as no test set data requiring adjudication was provided.

    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, the device is a Keratome (surgical instrument), not an AI diagnostic tool involving human readers.

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

      • Standalone Performance: Not applicable. The device is a surgical instrument operated by a human, not an algorithm.

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

      • Type of Ground Truth: Not applicable, as no performance data with associated ground truth was provided.

    8. The sample size for the training set:

      • Sample Size for Training Set: Not applicable, as no training data for an algorithm was used or described.

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

      • Ground Truth for Training Set: Not applicable, as no training data was used or described.

    Summary of the document's approach to effectiveness:

    The document states that the effectiveness of the device "was confirmed by use of QWF050B, Nidek MK-2000 Keratome Validation Test Procedure." However, the details or results of this procedure are not provided in the 510(k) summary. The basis for substantial equivalence is primarily stated as:

    • Intended Uses and Operating & Cutting Principles are the same as six predicate devices.
    • Operational Features are the same or similar to predicate devices.
    • Safety Features are the same or very similar to predicate devices.
    • Compliance with electrical standards (UL2601-1, IEC601-1-1, IEC601-1-2) and inclusion of operational safety features (Vacuum Level Gauge, low suction LED and tone, automatic cutting stop, foot pedal controls).

    Therefore, the claim for effectiveness and safety is largely based on equivalence to already marketed devices and compliance with safety standards, rather than new performance data presented within this 510(k) summary.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1