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The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.

The Kahook Dual Blade (KDB) Glide is a single-use, ophthalmic knife for use in adults. It is intended to remove a strip of trabecular meshwork tissue to allow for fluid outflow in glaucoma patients. The device is designed for ease of use and easy access to the structures within the eye. The blades are made of surgicalgrade stainless steel. The tip of the knife is pointed and allows for easy piercing of tissue. The ramp that the tip is attached to lifts tissue and exposes it to two parallel dual blades of the instrument, effectively remove a narrow strip of tissue.

Here's a summary of the acceptance criteria and study information for the Kahook Dual Blade Glide, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly present a table of quantitative acceptance criteria with corresponding performance directly within the "Performance Data" section for each specific test in the same way a software validation might. However, it states that "Results of the non-clinical bench testing demonstrate that the Kahook Dual Blade Glide meets the defined specifications and functions as intended." It broadly indicates that "All samples met the acceptance criteria" for tests like corrosion, endotoxin, visual inspection, bubble leak, tensile test, and non-cytotoxicity, non-sensitizer, non-irritant, and non-toxic for biocompatibility.

For clinical effectiveness, the primary endpoint was used as an acceptance criterion, and device performance is reported against it.

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

• KDB Glide Procedure Performed with Cataract Surgery (Falkenberry et al.):
  • Test Set Sample Size: 82 eyes of 82 subjects (KDB-phaco cohort). 79 eyes were available for the 12-month visit.
  • Data Provenance: Prospective, randomized, active-controlled, parallel group clinical trial. Conducted at 9 study sites in the U.S.
• KDB Glide Procedure Performed Standalone (ElMallah et al.):
  • Test Set Sample Size: 42 eyes of 35 subjects. 35 eyes were available for the 12-month visit (6 required SSI, 1 lost to follow-up).
  • Data Provenance: Retrospective, multicenter case series. Collected from 8 surgeons at 8 study sites (6 in the U.S. and 2 in Mexico).

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

The clinical studies involved surgeons performing the procedures and evaluating outcomes, but the text does not detail an independent panel of experts establishing ground truth for the data points themselves outside of the study design. For a clinical trial/case series, the "ground truth" for IOP measurements and medication usage would typically be based on direct clinical assessment by the ophthalmologists at the study sites. The document does not specify the number or qualifications of these individual ophthalmologists/surgeons beyond them being "surgeons" at "study sites."

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes in either study. Clinical data collection in these types of trials typically relies on the assessments made by the treating physicians/investigators at each site.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The studies focused on the effectiveness and safety of the KDB Glide procedure itself (alone or with cataract surgery) and compared it to other procedures (e.g., iStent trabecular micro-bypass in Falkenberry et al.) or evaluated it standalone. There is no mention of human readers evaluating cases with and without AI assistance to determine an effect size of AI improvement. The device is a surgical tool, not an AI diagnostic/interpreting system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The Kahook Dual Blade Glide is a physical surgical device, not an algorithm. Therefore, an "algorithm only" or "standalone" (in the AI context) performance study is not relevant. The "KDB Glide Procedure Performed Standalone" refers to the surgical procedure without concurrent cataract surgery, not an AI algorithm.

7. Type of Ground Truth Used

• Bench Testing: Engineering specifications, industry standards (ISO, ASTM), and laboratory test results.
• Clinical Studies (Falkenberry et al. and ElMallah et al.): Clinical outcomes data, primarily:
  • Intraocular Pressure (IOP) measurements (medicated and unmedicated)
  • Number of IOP-lowering medications
  • Occurrence and type of adverse events
    These are measurements taken directly from patients in a clinical setting by medical professionals.

8. Sample Size for the Training Set

• Not applicable. This device is a physical surgical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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