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The PenLase is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications:

• Excision and Incision Biopsies
• Hemostatic assistance
• Treatment of Apthous Ulcers
• Frenectomy
• Frenotomy
• Gingival Incision and Excision
• Gingivectomy
• Gingivoplasty
• Incising and Draining of Abscesses
• Operculectomy
• Oral Papillectomy
• Removal of Fibromas
• Soft Tissue Crown Lengthening
• Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
• Tissue retraction for Impression
• Vestibuloplasty

PenLase is a surgical equipment, simple tool, portable, and easy to use. It is a tool that can be used for the treatment of oral soft tissue surgery, plastic surgery.

The PenLase utilizes a semiconductor diode which consists of semiconductor "chips" made from Aluminum, Gallium and Arsenide, together commonly referred to as AlGaAs , with invisible infrared radiation as a laser source. The laser power is delivered to the treatment area via a fiber tip. The disposable fiber tips are bendable in a variety of angle for maximum access to all areas of the mouth.

PenLase delivers 0.7 Watts and 1.7 Watts with wavelength 810±10 nm of continue laser power without cords, outlets or foot switches, which makes its battery life last longer.

The PenLase charging station recharges up to two PenLase batteries simultaneously, a fully charged battery can last for several patients or procedures.

The provided text describes a 510(k) premarket notification for a medical device called "PenLase Dental Laser Therapy System." This submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, device performance numbers, clinical study details, and ground truth establishment is not available in the provided document.

Here's a breakdown of what can and cannot be answered based on the input:

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

• Not Available. The document does not specify quantitative acceptance criteria for device performance or report specific performance metrics for the PenLase system in a clinical context. The submission focuses on substantial equivalence through non-clinical bench tests and comparison of specifications to predicate 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 / Not Available. The "Non-Clinical Test Conclusion" section (Section 7) states that "Bench tests were conducted to verify that the proposed device met all design specifications." These are technical, non-clinical tests (e.g., electrical safety, electromagnetic compatibility, biocompatibility), not clinical studies with patient test sets. Therefore, there's no sample size of patients or data provenance information of this type.

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 / Not Available. As no clinical "test set" in the sense of patient data is described, there is no information about experts establishing ground truth for such a set.

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

• Not Applicable / Not Available. There is no clinical test set described, so no adjudication method is mentioned.

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

• No. No MRMC comparative effectiveness study was done or mentioned. This device is a laser therapy system, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a physical laser therapy tool, not an algorithm. Standalone performance as an algorithm is not relevant.

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

• Not Applicable / Not Available. For the non-clinical tests conducted, the "ground truth" would be established by relevant engineering and safety standards (e.g., IEC and ISO standards mentioned), which ensure the device adheres to safety and functional specifications. There is no biological "ground truth" in the context of clinical outcomes or pathology mentioned in this submission.

8. The sample size for the training set

• Not Applicable / Not Available. There is no "training set" in the context of machine learning or AI mentioned for this device. The development process relies on design specifications and adherence to predicate device characteristics.

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

• Not Applicable / Not Available. As there is no training set described, the method for establishing its ground truth is not applicable.

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The Diode Laser Therapy System (DenLase-810/7 & DenLase-980/7) is indicated for intraoral use for the following soft tissue applications:

• Incision
• · Excision
• · Vaporization
• · Ablation
• · Coagulation.

The DenLase is a surgical device designed with compactness, portability, reliability and user-friendliness. It provides the operator with a tool for surgical and cosmetic procedures on oral soft tissue. The Denlase utilizes a semiconductor diode with invisible infrared radiation as a laser source (810nm or 980nm). The laser power is delivered to the treatment area via a flexible fiber, which has a handpiece. The emission laser is activated by a footswitch. The Denlase adopts advanced semiconductor lasers (AIGAAs) and semiconductor refrigeration technology. By laser sent out by optical fiber, it can fast and accurately dispose tissue and lesion. The device includes three operation modes as continuous. single pulse and continuous pulse, and each operation mode is adjustable respectively by three parameter of emitting power, pulse width and pulse interval. The user can save total five groups of operation mode parameter combination under different mode.

The provided text describes a 510(k) summary for a Diode Laser Therapy System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria through the kind of study described in the original request.

Therefore, many of the requested elements (like acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not applicable or not explicitly detailed in this type of regulatory document for this specific device.

The document primarily addresses non-clinical testing for safety and performance against established standards, and a comparison to predicate devices to establish substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not Applicable/Not Provided. The document states that "Laboratory testing was conducted to validate and verify that the proposed device... met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required." This indicates that the regulatory pathway did not necessitate a clinical study with a "test set" in the context of typical AI/diagnostic device validation. The testing focused on non-clinical performance against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable/Not Provided. As no clinical study or specific "test set" requiring ground truth establishment by experts is mentioned, this information is not available.

4. Adjudication method for the test set:

• Not Applicable/Not Provided. See point 3.

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 diode laser therapy system, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not Applicable. The device is a physical laser therapy system, not an algorithm. Its performance is inherent to its physical operation and energy delivery for therapeutic procedures, not an algorithmic output that could be tested "standalone."

7. The type of ground truth used:

• Not Applicable. For this device, the "ground truth" for non-clinical testing refers to compliance with engineering specifications and safety standards (e.g., laser emission parameters, biocompatibility, electrical safety), rather than a clinical ground truth like pathology or outcome data.

8. The sample size for the training set:

• Not Applicable/Not Provided. This is a hardware medical device, not an AI model requiring a "training set."

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

• Not Applicable/Not Provided. See point 8.

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