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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 NeoLas Er: Y A G laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures:

In dentistry for:

Endodontic Surgery (Root Amputation) Indications:

· Root end preparation for retrofill amalgam or composite

· Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex.

NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation

Laser Periodontal Procedures:

• · Full thickness flap
• · Partial thickness flap
• · Split thickness flap
• · Laser soft tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket

· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

· Removal of granulation tissue from bony defects

· Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

The NeoLas 810nm Soft Tissue laser and its accessories are intended for use on adult and pediatric patients in dentistry, dermatology and other surgical areas in the following procedures:

Soft Tissue Indications including Pulpal Tissues*

Incision, excision, vaporization, ablation and coagulation or oral soft tissues, including:

• · Excisional and incisional biopsies
• · Exposure of unerupted teeth
• · Fibroma removal
• · Flap preparation-incision of soft tissue to prepare a flap and expose the bone.
• · Flap preparation-incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
• · Frenectomy and frenotomy
• · Gingival troughing for crown impressions
• · Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• · Hemostasis and coagulation

NeoLas is a portable, microprocessor controlled dual laser system with both ER: Y AG and Soft Tissue capabilities. The NeoLas provides treatment capabilities via two separate fiber jumper and handpiece assemblies; NeoLas1 (ER:YAG) and NeoLas2 (Soft Tissue).The NeoLas1 treatment delivery system emits a 2.94um infrared photon pulses that used in the treatment of various endodonic and soft tissue indications. The NeoLas2 treatment delivery system utilizes solid-state diode laser (GaAlAs) technology to emit constant wavelength and pulsed energy of 808nm to perform soft tissue treatments.

The provided document is a 510(k) summary for the NeoLas laser system. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria from scratch. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes, expert involvement, and ground truth for a new clinical study is not explicitly present in this type of submission.

However, I can extract the information that is available and explain why some of the requested details are not in this document.

Summary of Acceptance Criteria and Performance (Based on Substantial Equivalence):

The core "acceptance criteria" here are that the NeoLas device demonstrates substantial equivalence in safety and effectiveness to its predicate devices for the stated indications for use. This is proven by showing that the NeoLas has similar specifications and treatment capabilities, and that any differences do not raise new safety or efficacy concerns.

Detailed Breakdown of Requested Information:

1. A table of acceptance criteria and the reported device performance
   See table above. The acceptance criteria are largely implied by the concept of substantial equivalence to the predicate devices. Performance is described in terms of its similarity to these legally marketed devices.

2. Sample sizes 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 in the context of a 510(k) summary focused on substantial equivalence. This document does not describe a clinical study with a "test set" of patients in the way a de novo or PMA submission might. The "test set" implicitly refers to the device itself and its components undergoing non-clinical bench testing.
   • Data Provenance: Not specified as no clinical data from a patient cohort is presented. The data provenance mentioned is primarily from manufacturing and validation testing (e.g., sterilization validation).

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)

   • Number of Experts/Qualifications: Not applicable. Since this is a 510(k) submission based on substantial equivalence and primarily non-clinical testing, there is no mention of external clinical experts establishing ground truth for a patient test set. The "ground truth" for the non-clinical tests would be defined by the relevant engineering and sterilization standards.

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

   • Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this 510(k) summary.

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

   • MRMC Study: Not applicable. The NeoLas is a laser surgical instrument, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC study is not relevant to its type of submission.

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

   • Standalone Performance Study: Not applicable. The NeoLas is a surgical instrument operated by a human, not an algorithm. Its "performance" is assessed through its physical specifications, safety features, and the demonstrated capabilities of its predicate devices, rather than an algorithm's standalone performance. Non-clinical bench tests (e.g., sterilization) are done in a "standalone" manner for the components.

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

   • Type of Ground Truth: For the non-clinical tests (e.g., sterilization), the ground truth is established by validated laboratory methods and recognized consensus standards (e.g., ISO standards for sterilization, FDA guidance documents). For the device's main claim, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective, and the NeoLas is sufficiently similar. The Note section under Indications for Use emphasizes that any removed tissue must be submitted for histopathological evaluation, which would serve as a ground truth for pathology diagnosis if such tissue is removed.

8. The sample size for the training set

   • Training Set Sample Size: Not applicable. This document does not describe a machine learning algorithm that requires a training set.

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

   • Training Set Ground Truth Establishment: Not applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

In summary, this 510(k) submission for the NeoLas laser system primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices through comparison of specifications, intended use, and non-clinical bench testing (e.g., sterilization validation). It does not present a de novo clinical study with patient cohorts, expert readers, or AI algorithms, which are typically associated with many of the detailed questions posed.

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