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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.

Device Description

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

AI/ML Overview

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.

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K Number

K961710

Device Name

AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM

Manufacturer

APPLIED OPTRONICS CORP.

Date Cleared

1996-11-01

(183 days)

Product Code

GEX

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

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.

Device Description

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 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:

Fiber Model	Type
AOC DCLF-600	600um Conical tip
AOC DCLF-1000	1000um Conical tip
AOC DCLF-600B	600um Hemispherical Ball tip
AOC DCLF-1000B	1000um Hemispherical Ball tip
AOC DBLF-60S	600um Side firing
AOC DBLF-100S	1000um Side firing
AOC DBLF-60SF	600um Scatter Free Side firing
AOC DBLF-60	600um Free Beam
AOC Neos	Conical (conical shaped)
AOC Neos	Delta (wedge shaped) Handpiece, Laparoscopic
and Bare Fiber
AOC HSD	Conical shaped with electrode

AI/ML Overview

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."

Acceptance Criteria (Inferred)	Reported Device Performance
Wavelength: Nominal wavelength matching 980nm predicate devices.	980nm (centered at 980nm with a total range from approximately 970-1000nm), matching AOC 25, Cynosure Phototome, and Cytocare DioLase HP-1 lasers.
Output Power: Up to 25 watts.	Up to 25 watts of CW optical power. The document states "The output power of the AOC Phase II 25 is about the same as the power of the Diomed 25, Indigo 830, and Sharplan 6020." It acknowledges lower power compared to CytoCare and Cynosure 980nm lasers but states this is not clinically significant for contact fiber applications or can be compensated. Bench test data confirmed the device produces the rated power.
Temporal Output Modes: Ability to operate in Continuous Wave (CW) and electronically gated pulses (single, repeat, countdown, exponential).	Continuous, Single Pulse, Countdown Pulse, Repeat Pulse, and Exponential Pulse output. These modes are stated to be found on one or more of the predicate lasers, and its range of timed outputs are within the ranges of cleared products.
Safety Features: Inclusion of standard safety interlocks, aiming beam, foot/hand switch activation, Ready/Standby modes, etc.	The AOC Phase II 25 has "the same overall characteristics and features as the predicate diode laser systems," including: adjustable power output, internal monitoring of power output accuracy, prominent power output display, foot switch activation, safety interlocks, a red aiming beam, Ready and Standby Modes, an electrically safe design, visual and audible indicators of operation, and a rugged cabinet. It also includes handswitch activation (like Sharplan 6020) and a Decay (exponential) Pulse mode (like Indigo unit).
Tissue Interaction: Expected to be identical to 980nm predicate lasers.	"Its laser tissue interactions would be expected to be identical" to other 980nm predicate lasers. The document also notes that "The 980 nm wavelength, like the Nd:YAG wavelength at 1064 nm, is less dependent on variations in tissue pigment and blood content," and absorbed less in pigment/blood rich tissue than 805-830 nm lasers. The 980 nm wavelength also has slightly higher water absorption than 1064 nm. Peer-reviewed clinical articles on tissue interaction at 980 nm were included in the 510(k) submission.

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.

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.
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.
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.
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.
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.
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.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set was used.