(183 days)
The AOC Phase II 50 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 50 Fiber-Coupled Diode Laser System delivers up to fifty (50) or sixty (60) 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 970-1000 nm. For the 60 watt version, premium, high-efficient diode laser components are selected in constructing the laser module and the output display is adjusted accordingly.
The AOC Phase II 50 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 50 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 50 or 60 watts depending on the unit specified. 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
This document is a 510(k) Summary of Safety and Effectiveness for a medical device submitted to the FDA, not a study report. Therefore, it does not contain the typical information you would expect from a study proving a device meets acceptance criteria.
Specifically, the document states:
"No clinical test data was submitted in support of this submission. Peer reviewed clinical articles on the tissue interaction at 980 nm were included in the 510 (k). Bench test data was submitted demonstrating that the design is able to produce the rated power and wavelength."
This means there is no study described in this document that explicitly proves the device meets specific acceptance criteria related to clinical performance.
However, I can extract information related to the device's technical specifications and how they compare to predicate devices, which implicitly serve as a form of "acceptance criteria" for substantial equivalence.
Here's an attempt to answer your questions based on the provided text, while making it clear where information is not available or not applicable to a clinical study:
1. A table of acceptance criteria and the reported device performance
Since no specific "acceptance criteria" for clinical performance are listed or reported against in this document, I can only infer the performance parameters derived from the comparison to predicate devices and the bench test data mentioned.
| Acceptance Criteria (Inferred from Predicate Devices & Bench Tests) | Reported Device Performance (AOC Phase II 50) |
|---|---|
| Laser Type | Diode Laser |
| Wavelength (Nominal) | 980 nm |
| Wavelength Range | Approximately 970-1000 nm |
| Output Power (CW) | Up to 50 or 60 watts (depending on the unit specified) |
| Operating Modes | Continuous Wave (CW), Single Pulse, Countdown Pulse, Repeat Pulse, Exponetial Pulse |
| Aiming Beam | Visible (red) aiming laser, controlled independently |
| Cooling Method | Forced air cooling (no water cooling), Max inlet air temperature 30° C |
| Power Output Adjustment | Continuously adjustable from front panel, internal monitoring of power output accuracy, prominent display |
| Activation Methods | Footswitch or handswitch activated |
| Safety Features | Safety interlocks, electrically safe design, visual and audible indicators, Ready and Standby Modes |
| Tissue Interaction | Less dependent on variations in tissue pigment or vascularity than 805 nm, slightly higher water absorption than 1064 nm (similar to predicate 980 nm lasers) |
| Bench Test Outcome | Demonstrated ability to produce the rated power and wavelength. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. No clinical test set data was submitted in this document.
- Data provenance: Not applicable. The "bench test data" is assumed to be internal testing by the manufacturer. No country of origin is specified for this, nor is it clinical data.
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)
- Not applicable. No clinical test set was used, and thus no ground truth was established by experts for such a set within this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set was used.
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
- Not applicable. This is a submission for a surgical diode laser system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical device, not an algorithm. Bench testing for the device's technical specifications was performed in a "standalone" fashion by measuring its output (power, wavelength), but this is not comparable to the "standalone performance" of a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench tests: The ground truth was based on instrumentation measurements for physical parameters like power output and wavelength.
- For the comparative assessment: The "ground truth" for demonstrating substantial equivalence relied on previously cleared predicate devices and their established safe and effective use, primarily based on their technological characteristics and intended use.
- No clinical ground truth (expert consensus, pathology, outcomes data) was used or provided in this submission to evaluate the performance of this specific device.
8. The sample size for the training set
- Not applicable. This is a surgical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a surgical device, not a machine learning algorithm.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.