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Model Number 0010-2400 is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.

Model Number 0010-2400 is supplied as a single-use, sterile product and is compatible with the GreenLight™ XPS Laser System. It can access the tissue in multiple planes. Model Number 0010-2400 is a liguid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.

The provided document describes a 510(k) premarket notification for a medical device, the American Medical Systems Model Number 0010-2400 GreenLight MoXy™ Fiber Optic. This is a special 510(k) submission, indicating a modification to an already cleared device, the Fiber One (K100746). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than a de novo approval.

As such, the document does not contain information related to a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement in the way one would expect for a new or significantly modified device requiring such studies. The assessment here is based on non-clinical (bench) testing and comparison of technological characteristics to the predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial. Instead, the "acceptance criteria" for this Special 510(k) are implied by demonstrating that the modified device (Model 0010-2400) maintains substantial equivalence to the predicate device (Fiber One) through non-clinical testing and comparison of specifications.

Note: The increase in "Energy Limit" from 400kJ to 650kJ is a modification presented, but the document does not elaborate on specific testing or acceptance criteria related to this increase beyond general bench testing for substantial equivalence. The "Metal Cap" and "Labeling, IFU" changes are noted as post-510k changes that didn't trigger a new 510k.

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

The document states, "All necessary bench testing was conducted on the Model Number 0010-2400 to support a determination of substantial equivalence to the predicate device."
Regarding sterilization residue testing, a table is provided for the predicate device (Fiber One), showing 9 samples tested over 3 days (Day 1, 2, 3 with A, B, C runs each day).

• Sample Size for Sterilization Residue (Predicate): 9 units (tested over 3 days for EO and ECH)
• Data Provenance: The sterilization residue data is explicitly stated to be "extracted from the original 510k for Fiber One (MoXy) K100746, Appendix 3: Sterilization, page 12 of 15, Table 6." This indicates the data is retrospective for the predicate device. For the modified device, it states, "Model 0010-2400 is the same as Fiber One device and uses the same sterilization cycle and meets the ISO 10993-7:2008 recommendations..." implying the pre-existing data and methodology were deemed sufficient.
• Country of origin of data: Not specified, but given the submitter's address (San Jose, CA, U.S.A.) and the FDA context, it's highly likely to be US-based or to US standards.

No other specific "test set" sample sizes are provided for other non-clinical tests.

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

This section is Not Applicable to the provided document. The submission relies on non-clinical bench testing and comparison to technical specifications, not a clinical study involving experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This section is Not Applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.

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

This section is Not Applicable. The device is a surgical fiber optic (hardware), not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

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

This section is Not Applicable. The device is a surgical fiber optic, not an algorithm.

7. The Type of Ground Truth Used

For the sterilization residue testing, the "ground truth" or reference criteria used were the ISO 10993-7:2008 recommendations for limited exposure values for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH).

• EO Limit: <4 mg/device
• ECH Limit: <9 mg/device

For other characteristics, the "ground truth" is adherence to the technical specifications of the predicate device or, where modifications occurred (e.g., energy limit, metal cap design), that these changes do not raise new questions of safety or effectiveness and maintain compatibility/functionality. This is essentially a technical specification and regulatory standard adherence "ground truth."

8. The Sample Size for the Training Set

This section is Not Applicable. This is a hardware medical device submission, not an AI/machine learning model, so there is no concept of a "training set."

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

This section is Not Applicable. As there is no training set, there is no ground truth establishment for one.

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