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The Nuvolase 532 Laser System for Ophthalmology is intended for use in the treatment of vascular lesions of the skin, including capillary hemangioma (port wine stain), strawberry hemangioma, telangiectasia, and rosacea. It is also intended for pigmented lesions including freckles, age spots, café-au-lait, and lentigo.

The Nuvolase 532 Cutaneous Laser System is a continuous-wave frequencydoubled diode-pumped Nd: Y AG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. The maximum power level to tissue is 2.5 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and handpiece.

The provided text describes a 510(k) premarket notification for the "Nuvolase 532 Cutaneous Laser System" and explicitly states it is a modification of a previously cleared device (Nuvolase 660 Laser System, K970667). The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission for substantial equivalence based on technological characteristics and intended use, not a clinical study report. Therefore, I cannot provide the requested information.

Here's why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are present. The submission focuses on demonstrating equivalence to a predicate device.
2. Sample size used for the test set and the data provenance: No test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is described.
4. Adjudication method for the test set: Not applicable as there is no test set or study.
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 device is a laser system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Conclusion from the document:

The provided document details a 510(k) submission for a laser device, emphasizing its technological equivalence to a predicate device for the treatment of vascular and pigmented skin lesions. It is a regulatory submission asserting substantial equivalence, not a report of a study proving performance against acceptance criteria.

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The NuvoLase 720 Laser System is intended for use in retinal and macular photocoagulation, trabeculoplasty, and iridotomy.

The NuvoLase Model 720 is a continuous wave argon ion laser system, emitting a maximum of 2.5 watts, primarily at 488 nm and 514.5 nm wavelengths. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 720 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected by fiber optic.

The provided text is a 510(k) summary for the NuvoLase 720 Laser System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with predefined acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found in a 510(k) summary for a device like the NuvoLase 720 Laser System.

510(k) submissions primarily compare the new device's technological characteristics and intended use to a predicate device. The "study" in this context is a comparison of specifications and intended uses, not a clinical trial proving performance against acceptance criteria in the way you've described.

Here's an explanation of why the requested information is absent and what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

• Not applicable for a 510(k) of this nature. The NuvoLase 720 Laser System is an ophthalmic laser. For such devices, substantial equivalence is typically based on comparing technical specifications (e.g., wavelength, power output, exposure times, aiming beam) and intended uses with predicate devices, rather than clinical performance metrics like sensitivity, specificity, or reader improvement.

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

• No test set or clinical study described. The 510(k) regulatory pathway does not mandate clinical trials for all devices, especially when substantial equivalence can be demonstrated through technological comparison. There is no mention of a test set, data provenance, or retrospective/prospective studies.

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)

• No ground truth establishment described. Since no clinical test set or study is detailed, there's no mention of experts or ground truth establishment.

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

• No adjudication method described. Again, without a clinical test set, adjudication methods are irrelevant to this submission type.

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 device is a laser system, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study, especially concerning AI assistance, would not be relevant.

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

• Not applicable. This is a hardware laser system, not a software algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• No ground truth discussed. As explained, the 510(k) focuses on technological equivalence, not clinical performance against a ground truth.

8. The sample size for the training set

• No training set described. This device is not an AI/ML model that requires a training set.

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

• No training set or ground truth described.

Information that can be extracted from the document relevant to a "device comparison" which serves as the "study" for this 510(k) submission:

"Acceptance Criteria" (Implied from Predicate Comparison) and "Reported Device Performance" (Specifications):

For a 510(k), the "acceptance criteria" are implicitly met if the new device's specifications and performance fall within the established safe and effective parameters of the predicate devices, or if any differences do not raise new questions of safety or effectiveness.

The "Study" (Comparison for Substantial Equivalence):

The "study" for this 510(k) is the direct comparison of the NuvoLase 720 Laser System with two predicate devices:

• AC 2200 Argon Laser Photocoagulator (Nidek, Inc.)
• Ultima 2000 Argon Laser Photocoagulator (Coherent, Inc.)

This comparison is documented under the "Technological Characteristics/Device Comparison" section. The conclusion states that the NuvoLase 720 is substantially equivalent based on matching materials, design, intended use, method of manufacture, warnings, cautions, and precautions.

Summary Conclusion from 510(k) Context:

The NuvoLase 720 Laser System met the "acceptance criteria" of being substantially equivalent to legally marketed predicate devices by demonstrating that its technological characteristics and intended uses were sufficiently similar, and any differences did not raise new questions of safety or effectiveness. This determination was made through a comparative analysis rather than a clinical study with performance metrics.

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The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty.

Indications For Use:

1. Retinal and Macular photocoagulation
2. Trabeculoplasty

The NuvoLase Model 660 is a continuous wave frequency-doubled diode-pumped Nd: YAG laser system. Treatment beam power output for the NuvoLase 660 laser is adjustable to a maximum of 2.0 Watts continuous wave at 532 nm. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected to the laser by fiber optic.

Here's a breakdown of the acceptance criteria and the study information for the Nuvo-Lase 660 Laser System, based on the provided text.

Note: The provided document is a 510(k) summary for a medical device submitted in 1997. It describes a substantial equivalence determination rather than a novel clinical effectiveness study with strict acceptance criteria and performance metrics as might be seen for newer AI/machine learning devices. Therefore, many of the requested categories related to AI performance, sample sizes for training/test sets, expert consensus, and comparative effectiveness studies are not applicable or cannot be extracted from this type of document. The study's "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices, rather than meeting specific performance thresholds for diagnostic accuracy, for example.

Nuvo-Lase 660 Laser System Acceptance Criteria and Study Information

The Nuvo-Lase 660 Laser System gained market clearance through the 510(k) pathway, demonstrating substantial equivalence to legally marketed predicate devices. This means that the "acceptance criteria" were primarily focused on showing that the device has the same intended use and similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable and not provided in the 510(k) summary. A 510(k) submission for this type of laser device in 1997 relies on technical specifications and comparison to predicate devices, not on a clinical "test set" in the context of diagnostic performance or AI validation.

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

This information is not applicable and not provided. Ground truth establishment in the context of expert review for AI algorithms is not relevant to this type of device and submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are used in studies involving human interpretation or performance evaluation, which is not the primary focus of this 510(k) submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable and not provided. An MRMC study is not relevant for a laser photocoagulator device seeking substantial equivalence based on technical specifications.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable and not provided. This is a hardware laser system, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices (Nidek Prima 532 and IRIS Oculight GL) allowed by their prior marketing. The manufacturer asserted that the NuvoLase 660 shared the same fundamental characteristics and intended use, thus making it "substantially equivalent."

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" in the context of an AI algorithm, as this is a physical medical device.

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

This information is not applicable and not provided. There is no "training set" or corresponding ground truth establishment in the context of an AI algorithm for this device.

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The Nuvo-Lase 660 Laser System is intended for use in the treatment of selected vascular and pigmented lesions of the skin. Laser light is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue. The Nuvo-Lase 660 Laser System is intended for in use the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are: For vascular lesions: (Green - 532 nm) 1. Capillary Hemangioma (port wine hemangioma) 2 . Strawberry hemangioma 3. Telangiectasia 4 . Rosacea For pigmented lesions: (Green - 532 nm). 1. Freckles 2. Age Spots 3. Cafe-au-lait 4 . Lentigo

The Nuvo-Lase 660 Laser System submission covers all of the internal parts, subassemblies and components as well as the completed device. The Nuvo-Lase Model 660 is a continuous wave frequency-doubled Nd:YAG laser system with output at 532 nm. Treatment beam output for the Nuvo-Lase 660 laser 3 Watts continuous wave at 532 nm. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Nuvo-Lase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Laser activation occurs by footswitch. Overall weight of the dimensions of 10 X 14 X 5 inches (25 X 36 X 13 Cm). The electrical power requirement is 115 VAC 15 amp single phase. The system is air-cooled by fans. Accessories available for use with the Nuvo-Lase 660 Laser include a focusing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Nuvo-Lase 660 Laser System is not a computer controlled device.

The provided text is a medical device summary for the Nuvo-Lase 660 Laser System. It focuses on regulatory information, device description, and intended use, particularly for vascular and pigmented lesions.

It does not contain information about acceptance criteria, device performance metrics, or any study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set information).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about a study that proves the device meets acceptance criteria, as this information is not present in the provided text.

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The Flaxelase 600 Series Ion Laser is intended for use in the treatment of selected yascular and pigmented lesions of the skin. Laser light of a selected wavelength is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.

Flex-Lase 600 Ion Laser is intended for use in the the a treatment of salected pigmented and vascularized lesions of the skin. Representative indications for use are:

Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm)

1. Capillary Hemangioma (port wine hemangioma)
2. Strawberry hemangioma
3. Telangectasia
4. Rosacea

For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm).

1. Freckles
2. Age Spots
3. Cafe-au-lait
4. Lentigo

Flex-Lase Model 620 Laser System For Wascular Sesions: (Blue/Green - 488 nm and 514.5 nm)

1. Capillary Hemangioma (port wine hemangioma)
2. Strawberry Hemangioma
3. Telangectasia
4. Rosagea .

For pigmented lesions: (Green - p14.5 mm)

1. Freckles
2. Age Spots
3. Cafe-Au-Lait
4. Lentigo

The Flex-Lase 600 Series Ion Laser submission covers all of the internal parts, subassemblies and components as well as the completed device. The Flex-Lase Model 640 is a coninuous wave krypton laser system emitting light at the 568 nm (yellow) and 520/530 nm (green) wavelengths. The Flex-Lase Model 620 is a continuous wave argon laser system emitting light at the 488 nm (blue) and the 514 nm (green) wavelengths.

Treatment beam output for the Flex-Lase Model 640 (krypton) is 1.0 Watt (yellow) and 3.0 Watts (yellow-green simultaneous). The power output for the Flex-Lase Model 620 (argon) is 5.5 watts blue-green or 2.0 watts green. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Flex-Lase 600 Series Ion Laser (in seconds) are 0.02, 0.05, 0.1. 0.25, 0.5, 1.0, and continuous.

Laser activation occurs by footswitch. Overall weight of the system is 112 lbs. (51 kg). The Flex-Lase 600 Series Ion Laser has a footprint of 16 X 24 inches (38 X 60 cm) and is 36 inches (90 cm) high.

The electrical power requirement is 208 VAC 40 amb single phase. Cooling is provided by external filtered flow-through tap water at a minimum rate of 2.5 gallons (9,5 liters) per minute.

Accessories available for use with the Flex-lase 600 Ton Laser include a fooysing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Flex-laser 600 series is not a computer controlled device.

The provided text describes a medical device, the Flex-Lase 600 Series Ion Laser, and asserts its substantial equivalence to other commercially available lasers for treating vascular and pigmented lesions. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed predicate device, rather than undergoing a de novo clinical trial with specific performance endpoints.

Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be extracted from the provided text.

Here's a breakdown of what can be inferred from the document regarding its regulatory submission and what cannot be answered:

1. A table of acceptance criteria and the reported device performance:

• Cannot be extracted. The document does not describe specific acceptance criteria (e.g., a target accuracy rate, sensitivity, specificity, or precision) for the Flex-Lase 600 Series Ion Laser itself, nor does it report performance metrics against such criteria. The "performance" described is in comparison to predicate devices, focusing on technical specifications rather than clinical outcomes with quantified performance.

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

• Cannot be extracted. Since there is no described study with acceptance criteria, there is no mention of a test set, sample size, or data provenance from a performance study. The "data" provided is a comparison of technical features between the Flex-Lase and predicate devices.

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):

• Cannot be extracted. Ground truth establishment is irrelevant in this context, as there is no performance study against a ground truth.

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

• Cannot be extracted. Adjudication methods are relevant for clinical performance studies, which are not detailed in this document.

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:

• Cannot be extracted. The device is a laser system, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study and AI performance improvement are not applicable to the information provided.

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

• Cannot be extracted. This question is also not applicable as the device is a medical laser, not an algorithm. The document describes the specifications and intended use of a physical laser device.

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

• Cannot be extracted. As there is no described performance study, there's no mention of ground truth. The "proof" of safety and effectiveness relies on comparison to predicate devices.

8. The sample size for the training set:

• Cannot be extracted. There is no training set mentioned because this is not an AI/machine learning device requiring training data.

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

• Cannot be extracted. Not applicable, as there is no training set for this type of device.

What the document does describe (relevant to regulatory submission):

The document effectively fulfills the requirements for a 510(k) Pre-market Notification by demonstrating substantial equivalence to predicate devices. Key aspects of this demonstration include:

• Comparison of Device Characteristics: Extensive tables (pages 4-7) compare various technical specifications of the Flex-Lase models (620 and 640) with several predicate devices (HGM K1, Metalaser Vasculase, Coherent Artisan). These characteristics include:
  • Type of laser (Continuous wave argon/krypton, Copper Vapor)
  • Wavelength
  • Exposure Time
  • Output Mode
  • Beam Delivery
  • Stability of Output Energy
  • Spot Size
  • Energy density
  • Aiming beam
  • Cooling
  • Electrical Requirements
  • Indications for Vascular Lesions
  • Indications for Pigmented Lesions
• Statement of Substantial Equivalence: The document explicitly states that the Flex-Lase 600 Series Ion Laser "is substantially equivalent" to the named predicate devices for both vascular and pigmented lesions based on "materials, intended use, method of manufacture, design, precautions, cautions, and treatment parameters" being "substantially the same."
• Predicate Device K Numbers: K-numbers for some predicate devices (HGM K1: K913428, K913569; Metalaser Vasculase: K903883) are provided, which is typical for substantial equivalence claims.

In conclusion, the document provides information for a regulatory clearance based on substantial equivalence, not a performance study against specific acceptance criteria.

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