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The DuraLaze™ HoLEP Laser Fiber is intended for use in laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue associated with benign prostatic hyperplasia (BPH). The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use only. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.

The DuraLaze™ HoLEP Laser Fiber is a straight fire fiber optic laser energy delivery device. The laser fiber contains a 550µm silica core jacketed with ethylene tetrafluoroethylene (ETFE) and a standard SMA-905 laser connector with a strain relief. The distal 10 cm of the ETFE jacket is pre-stripped and coated during the manufacture of the laser fiber to minimize the potential of laser fiber damage caused by jacket stripping during surgical use and for the convenience of the operating room staff. The pre-stripped distal tip comes with a printed axial line that improves the surgeon's visibility by increasing the contrast between the fiber tip and the surrounding tissue. The DuraLaze™ HoLEP Laser Fiber is contained within a 9 French, polyurethane stability sheath that holds and secures the laser fiber during surgical use. The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.

The provided text describes a medical device called the DuraLaze™ HoLEP Laser Fiber and its submission for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

However, based on the non-clinical testing section, we can infer the acceptance criteria and study type.

Here’s a breakdown of the requested information, where available and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. Instead, it lists the types of non-clinical tests performed, with an overarching statement that "The testing and assessments performed on the subject device meet all specified criteria." This implies that for each test listed, there were internal acceptance criteria (e.g., minimum energy transmission, maximum dimension deviation, acceptable bend radius, successful tensile strength, no aiming beam issues, packaging integrity, biological compatibility, successful sterilization).

Since the document confirms the device met these criteria, we can infer "Compliance" or "Met Criteria" as the reported device performance for each test.

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

The document states, "MedKey has conducted performance testing with samples aged at T=0 and T=1 year accelerated aging." It does not specify the individual sample sizes for each non-clinical test. This testing is typically performed in a laboratory setting, making the data provenance retrospective (lab-based bench testing), not human clinical data. The country of origin of the data is not specified but would presumably be the country where MedKey, LLC is based (USA, as indicated by the address: Bloomington, Indiana).

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

This information is not applicable to this submission. The tests are non-clinical, bench-top evaluations of the device's physical and functional properties, not diagnostic or interpretive tasks requiring expert consensus on a 'ground truth' in the way a clinical study would for a diagnostic AI device. The "ground truth" for these tests refers to established engineering specifications, industry standards (e.g., ISO), and material properties.

4. Adjudication Method for the Test Set

This is not applicable as the evaluations are objective measurements and validations against predetermined specifications/standards, not subjective assessments 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI systems that assist human readers, not for a physical laser fiber.

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 instrument (laser fiber), not an algorithm or AI software. The performance testing evaluates the physical and functional aspects of the fiber itself.

7. The type of ground truth used

The ground truth used for these non-clinical tests is based on engineering specifications, industry standards (e.g., ISO 11607-1:2006, ISO 10993-1:2009, ISO 11135-1:2007), and material science principles. For example, "Fiber Dimensions" would be compared against the designed dimensions, "Packaging integrity" against the requirements of ISO 11607-1, and "Biological evaluation" against the criteria of ISO 10993-1.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI or machine learning model that requires a training set. The "samples aged at T=0 and T=1 year accelerated aging" refer to test samples for validation, not a training set.

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

This is not applicable for the reasons stated above (not an AI/ML device, no training set).

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