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The AOC Phase II 25 surgical diode laser system has the same general intended use as the predicate diode lasers. This intended use includes incision, excision, coagulation and vaporization applications in the following surgical specialties:

Urology Gynecology Gastroenterology Pulmonology General and Thoracic Surgery Neurosurgery (hemostasis) Ear, Nose, and Throat; Head/Neck Surgery Dermatology/Plastic Surgery

No new intended use was sought in this Premarket Notification.

The AOC Medical Systems Model Phase II 25 Fiber-Coupled Diode Laser System delivers up to 25 watts of CW optical power from a compact, air cooled unit. It is a complete, self-contained instrument, including a high efficiency power supply, an adjustable light output with constant current operation and a visible aiming laser. The system couples the laser light into high numerical aperture delivery fibers fitted with standard SMA-905 fiber connectors.

The diode lasers in this unit were fabricated by Applied Optronics Corp. from single quantum well, strained-layer, indium gallium aluminum on gallium arsenide semiconductor material. The diode lasers are sealed in a rugged, factory-aligned, environmentally protective module. High electrical efficiency of the diode lasers eliminate the need for water cooling and assure low maintenance, reliable laser operation for this allsolid-state system. Each individual diode laser emits at a narrow wavelength; however coupling several diodes through a fiber optic bundle results in each diode wavelength contributing to a broader spectrum emitted form the final delivery fiber. The laser energy is centered at 980nm with a total range from approximately 970-1000nm.

The AOC Phase II 25 has a modular design comprised of:

Laser Diode and Cooling Module containing the laser diodes, the heat sink and fans.

Optics Module containing a beamsplitter pick-off for display of the total optical power.

Front panel for simple control of the unit.

Transformer isolated power supplies and control electronics.

Unique attributes of this system include the following:

Multiple, individually fiber-coupled, high power diode lasers mounted on a large thermal footprint to allow sustained high power CW operation without water cooling.

Optical power level continuously adjustable from the front panel, with display of optical output power.

Low power, visible aiming laser for beam targeting prior to activation of the high power lasers. The aiming laser is controlled independently of the high power lasers.

Immediate turn-on capability. No warm-up period. No system alignments or maintenance to be made by the user.

Forced air cooling (no water). Maximum inlet air temperature 30° C.

Individually replaceable, fiber pigtailed diode lasers. Repairs performed at factory.

The microprocessor controlled AOC Phase II 25 diode laser system is designed to allow easy and safe operation of the laser using controls common to other surgical laser systems. The laser system utilizes a menu driven set-up operation for user prompts and program entry. The laser can be set for continuous output or programmed for single or repeat pulses at output powers up to 25 watts. A footswitch or handswitch, activated by the user, always controls laser output. An optional remote control for use in a sterile plastic dressing (e.g., standard OR microscope drape) allows the user to change the power and activate Ready and Standby Modes.

The following pre-packaged, presterilzed disposable optical fibers are available for use with the AOC Phase II 25 laser system:

This document describes the AOC Phase II 25 Surgical Diode Laser. Based on the provided text, the device is a surgical diode laser system used for incision, excision, coagulation, and vaporization in various surgical specialties.

Here's an analysis of the acceptance criteria and the study information as requested:

Acceptance Criteria and Device Performance

The provided document does not explicitly state formal "acceptance criteria" for the AOC Phase II 25 laser in a quantitative manner. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and intended use. The "performance data" section indicates that bench test data was submitted to demonstrate the device meets its rated power and wavelength specifications.

Therefore, the table below reflects what can be inferred as the "performance criteria" based on the comparison to predicate devices and the documented "performance data."

Study Details and Ground Truth Establishment

Based on the provided text, the device's performance was evaluated through bench testing and literature review, rather than a clinical study involving human patients or a complex ground truth assessment.

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

   • Test Set Sample Size: Not applicable in the context of a clinical test set. The submission mentions "Bench test data" which would involve testing the physical device itself. The sample size for these bench tests (e.g., number of units tested, number of measurements) is not specified.
   • Data Provenance: The bench test data would be from the manufacturer (AOC Medical Systems) presumably from their manufacturing site (South Plainfield, NJ, USA). It is prospective in the sense of new device testing, but not a clinical trial.

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. No "ground truth" in the sense of expert consensus on patient data was established for the device's performance because no clinical study was conducted. The "ground truth" for the device's technical specifications (power, wavelength) would be derived from calibrated measurement equipment and engineering standards.

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

   • Not applicable. There was no clinical test set requiring adjudication of findings.

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:

   • No MRMC comparative effectiveness study was done. This is a surgical laser device; the concept of "human readers" and "AI assistance" in the context of diagnostic image interpretation is not relevant here.

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

   • Not applicable. This is a physical medical device (surgical laser), not a software algorithm. Its "standalone" performance is its technical specifications (power output, wavelength stability, etc.) as measured during bench testing.

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

   • The "ground truth" for this device's performance is its adherence to engineering specifications and established physical principles (e.g., measuring power output with a power meter, wavelength with a spectrometer). The submission relied on "Peer reviewed clinical articles on the tissue interaction at 980 nm" to support the expected clinical effects, indicating that existing scientific literature served as a form of "ground truth" for the physiological impact of the laser's wavelength.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. No training set was used.

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