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The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. The neoLaser Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact mode and are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

The neoLaser Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibilty of the target tissue.

The provided text is a 510(k) summary for the neoLaser Laser Surgery Fibers. It describes a medical device and its substantial equivalence to a predicate device, BeaMed Laser Surgery Fibers (K232769). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch.

Therefore, the document does not outline acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device performance study. Instead, it focuses on demonstrating equivalence through comparison of technical characteristics and performance bench testing.

Here's why the requested information cannot be extracted from this document:

• The device is a physical medical instrument (laser surgery fibers), not an AI/algorithm-based device. The questions about MRMC studies, human reader improvement with AI, standalone algorithm performance, and ground truth establishment for training/test sets are relevant to AI/ML medical devices, not simple surgical tools.
• The 510(k) pathway for this device is based on "substantial equivalence" to a predicate device. This means the manufacturer proves the new device is as safe and effective as an already cleared device through comparison of specifications, materials, and bench testing, not through new clinical performance studies against defined acceptance criteria for a novel technology.
• The document explicitly states: "Animal or clinical studies: None." This confirms that performance studies in the way you've outlined for AI/ML models (with test sets, ground truth, expert readers, etc.) were not conducted or required for this 510(k) submission.

However, I can extract information regarding the device's characteristics and the types of "performance" assessments that were deemed sufficient for this 510(k) clearance, even though they don't align with the typical AI/ML study framework you've described.

Based on the provided document, here's an attempt to address the prompt's points, reinterpreting them for a physical medical device clearance based on substantial equivalence:

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

The "acceptance criteria" for a 510(k) submission for a physical device like this are primarily demonstrated through substantially equivalent technical specifications and material properties to a predicate device, along with successful bench testing to ensure safety and functionality. The document presents a comparative table rather than an acceptance criteria table.

Performance Bench Testing included in the submission (serving as "proof"):

• Packaging seal strength
• Dye penetration test
• Packaging microbial barrier
• Shelf-life validation summary
• Sterilization process validation plan
• Sterilization process validation protocol
• Sterilization process validation report
• Sterility Assurance Level (SAL)
• EO-ECH residuals report
• LAL Endotoxin test
• Bioburden bare fibers test / Bioburden capped fibers tests
• Biocompatibility tests protocols & reports
• Thermal safety validation

The success of these tests (implicitly, meeting pre-defined thresholds for each) serves as the "reported device performance" that proves the device's safety and functionality for a 510(k) submission based on substantial equivalence.

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

Not applicable. This is for a physical device, and the submission explicitly states "Animal or clinical studies: None." The "tests" mentioned are bench tests on the device itself or its packaging/materials, not performance studies with human data. Therefore, concepts like sample size for a test set of patient data or data provenance (country, retrospective/prospective) are not relevant here.

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 "ground truth" was established in the context of an AI/ML algorithm's performance against human expert interpretations or pathology. The evaluation is based on engineering and material specifications, and physical bench testing results.

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

Not applicable. There was no test set requiring expert adjudication.

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 not an AI/ML algorithm that assists human readers.

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

Not applicable. This device is not an AI/ML algorithm.

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

Not applicable. The "ground truth" for this device's clearance is its conformity to engineering specifications, material standards, and successful completion of bench tests (e.g., sterilization efficacy, biocompatibility).

8. The sample size for the training set

Not applicable. There is no AI/ML training set for this physical device.

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

Not applicable. There is no AI/ML training set or associated ground truth.

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The neoV810 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The neoV980 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The neoV1064 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The neoV1470 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The neo V Diode Laser Family are medical grade, solid-state, infrared diode lasers. They include 5 models - neoV810, neoV980, neoV1064 (LSV1064-10 and LSV1064-20), and neoV1470, and are designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 810nm, 980nm, 1064nm, and 1470mm respectively, at power levels ranging from 8Watts up to 20Watts. The lasers are controlled via a high-resolution color touch screen. The touch screen display includes a user interface allowing selection of continuous, repeat pulse, or single pulse modes of operation as well as repetition rates, aiming beam settings, password key protection, and standby/ready mode selection. The units have an emergency shut off button on the front of the unit.

The Laser System: The laser system consists of an optical block which contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and electronics which include the color touch screen control panel. The unit utilizes an external low voltage power supply, as well as an external wired foot switch for laser activation.

The Delivery System: The delivery system consists of fiber optics and a hand piece. Safety goggles and a safety sign are also provided with the unit.

The provided text is a 510(k) Summary for the neoV Diode Laser Family. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on technical specifications and comparisons, not on a clinical study demonstrating the device's performance against specific acceptance criteria for an AI algorithm.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, are not applicable and not present in this document.

The "acceptance criteria" discussed in this document relate to compliance with regulatory standards and demonstrating substantial equivalence to predicate devices, rather than performance metrics of an AI model against a specific medical task.

Here's a breakdown of what can be extracted from the provided text based on your request, with the understanding that it pertains to the device as a laser surgical instrument, not an AI system:

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

The document does not present "acceptance criteria" in the typical sense of numerical thresholds for an AI's performance (e.g., sensitivity, specificity). Instead, it demonstrates compliance with international standards and substantial equivalence to predicate devices as its basis for acceptance. The "reported device performance" is essentially that it meets these standards and is comparable to existing devices.

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

• Not Applicable. This document describes a medical device (a laser), not an AI algorithm evaluated on a data set. The "testing" refers to compliance with safety and performance standards for the hardware, not an evaluation of an AI model's performance on a dataset of patient information. No patient data or test sets, in the context of AI, are mentioned.

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. There is no "ground truth" in the AI sense established for this device, as it is not an AI system.

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

• Not Applicable. No test set for an AI algorithm is present.

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. No MRMC study was done, as this is not an AI device.

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

• Not Applicable. This is a standalone medical device (a laser), not a standalone AI algorithm. It operates independently of an AI, though it is used by a human operator.

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

• Not Applicable. No ground truth in the context of AI evaluation is used. The "ground truth" for this device's acceptance is its adherence to established electrical and laser safety standards, and its technical specifications matching those of already-cleared predicate devices.

8. The sample size for the training set

• Not Applicable. This device does not involve a training set for an AI algorithm.

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

• Not Applicable. This device does not involve a training set for an AI algorithm.

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