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The Diode Laser Therapy Device (Model: DF-DIODE LASER-S1) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Diode Laser Therapy Device adopts semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. The Diode Laser Therapy Device utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch.

This document is a 510(k) summary for a Diode Laser Therapy Device. Such summaries often focus on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than reporting on extensive clinical studies with detailed acceptance criteria and performance metrics typically seen for novel AI/ML-based devices.

Based on the provided text, the device in question is a Diode Laser Therapy Device (DF-DIODE LASER-S1), intended for hair removal and permanent hair reduction.

Here's an analysis of the requested information, specifically noting what is not present, as this is a traditional medical device submission, not an AI/ML device:

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

The document doesn't present a table of specific acceptance criteria in the way one might expect for an AI/ML device (e.g., minimum sensitivity, specificity, or AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device (K211335) through non-clinical performance and safety testing. The "acceptance criteria" are implicitly met by successful compliance with various international standards.

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

• Sample Size: Not applicable. This submission relies on performance testing (e.g., electrical, EMC, laser safety, biocompatibility) against established standards rather than a clinical test set with a "sample size" of patients/studies.
• Data Provenance: Not applicable for the type of testing described (non-clinical).

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

Not applicable. There is no "ground truth" establishment in the context of clinical images or patient data for this type of device submission. The device's performance is assessed against technical safety and performance standards.

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

Not applicable. No adjudications of clinical data were performed.

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 laser therapy device, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. The "ground truth" for this device exists in compliance with international safety and performance standards (e.g., IEC 60601 series, ISO 10993 series) and the demonstrated equivalence of its technical parameters to a legally marketed predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. No training set.

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The Diode laser therapy device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Diode Laser Hair Removal adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.

The Diode laser therapy device utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch.

The provided documentation does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond substantial equivalence to a predicate device.

Here's an analysis of the provided information based on your request:

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

No explicit acceptance criteria with numerical targets for performance (e.g., hair reduction percentage, adverse event rate) are presented for the proposed device itself. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K210663). The "performance" reported is primarily a comparison of technical specifications to the predicate device.

Differences and their analysis for safety and effectiveness:

• Spot Size:
  • Proposed: 12mm × 35mm
  • Predicate: 10 × 30 mm
  • Analysis: "Spot size only affects the area of treatment, not affect the therapeutic effect. Therefore, this difference will not affect the safety and effectiveness."
• Pulse Duration:
  • Proposed: 5-200ms
  • Predicate: 15-400ms
  • Analysis: "The frequency of the proposed device is within the range of that of the predicate device, which can justify that the difference in the parameter of Pulse duration will not raise new safety issues of the proposed device. In addition, we also found a reference device (K181019), which has the same intended use as the reference device. The Pulse Duration of the reference device is 30-200 ms, which is similar to the proposed device's pulse duration, so this difference will not affect the effectiveness of the device."
• Dimension:
  • Proposed: 55cm × 55 cm × 123cm
  • Predicate: 65cm × 65cm × 123cm
  • Analysis: "the dimension and weight difference are just in physical specification and this difference will not raise any issues in safety and effectiveness. By complying with AAMI/ANSV/ES 60601-1, the mechanical performance of the proposed device is determined to be accepted."
• Weight:
  • Proposed: 62kg
  • Predicate: 75kg
  • Analysis: (Same as Dimension)

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no clinical test set, sample size, or specific data provenance (country of origin, retrospective/prospective) for device performance on human subjects.

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, as no clinical study was performed.

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

Not applicable, as no clinical study was performed.

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, as this device is a laser therapy device for hair removal, not an AI-assisted diagnostic tool involving human readers.

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

This refers to the performance of a software algorithm. This device is a hardware laser therapy device, not a standalone algorithm. Therefore, this question is not applicable.

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

Since no clinical study was conducted, there is no patient-level ground truth data (like expert consensus, pathology, or outcomes data) specifically for this proposed device. The basis for substantial equivalence relies on the technical specifications and indications for use being similar to a legally marketed predicate device, and the device complying with relevant electrical, laser, and biocompatibility standards through non-clinical testing.

8. The sample size for the training set

Not applicable, as no algorithm or machine learning model requiring a training set is mentioned for this device.

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

Not applicable, as no algorithm or machine learning model requiring a training set is mentioned for this device.

In summary: The provided FDA 510(k) clearance document for the Diode laser therapy device is based on demonstrating substantial equivalence to a predicate device (K210663) through non-clinical performance testing (compliance with standards) and a comparison of technical specifications, rather than a new clinical study. Therefore, most of the requested information regarding clinical study design, test sets, ground truth, and AI-related metrics is not available in this document.

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The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact mode during surgical procedures. The device's 980mm laser is generally indicated for use in incision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The diode laser generates a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coaqulation of the target tissue. The diode laser generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Diode laser therapy device has following characteristics:

• Dual wavelengths A
• A Temperature monitoring system

This document is a 510(k) summary for the Diode laser therapy device, and it details the device's characteristics, intended use, and comparison to predicate devices, but it does not specify acceptance criteria or a study designed to prove the device meets those criteria in the typical sense of a clinical performance study. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical, performance, and safety comparisons.

Here's an analysis of the provided text based on your request, highlighting what is and isn't available:

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

The document does not explicitly state "acceptance criteria" in the form of performance thresholds that the device was required to meet for clearance. Instead, it relies on demonstrating that the proposed device is "as safe, as effective, and performs as well as or better than" the legally marketed predicate devices. The "reported device performance" is presented through technical specifications and safety comparisons to these predicate devices.

Table: Comparison of Proposed Device Performance to Predicate Devices (Implied Acceptance Based on Substantial Equivalence)

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

The document explicitly states "No clinical study implemented for the Diode laser therapy device." Therefore, there is no test set in the sense of patient data, nor data provenance information related to clinical performance. The assessment is based on non-clinical (bench) testing and comparison to predicate devices. For the 1470nm max power, it mentions "clinical survey data, and clinical literature" were collected to support efficacy, but no details on sample size or provenance are given for this supporting evidence.

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

Not applicable. No clinical test set.

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

Not applicable. No clinical test set.

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 therapy device, not an AI-assisted diagnostic or interpretive device.

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

Not applicable. This is a medical device, not an algorithm.

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

Not applicable. No clinical study with a traditional "ground truth" was performed for the device itself. For the "clinical survey data and clinical literature" mentioned regarding the 1470nm laser power, the type of "ground truth" used there would depend on the nature of those external studies/surveys, but no details are provided.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The assessment is based on non-clinical testing and comparison to predicate devices.

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

Not applicable. No training set.

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The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact mode during surgical procedures. The device's 980mm laser is generally indicated for use in incision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The diode laser generates a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coaqulation of the target tissue. The diode laser generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Diode laser therapy device has following characteristics:

• Dual wavelengths A
• A Temperature monitoring system

The provided text describes a 510(k) submission for a Diode laser therapy device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a performance study in terms of medical outcomes, nor does it detail a study proving device performance in a clinical context with human interaction.

Instead, the document focuses on non-clinical tests to establish safety and fundamental technical specifications.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document provides technical specifications and biocompatibility test results, which can be interpreted as fulfilling non-clinical acceptance criteria. These are compared against predicate devices.

The study that proves the device meets (these non-clinical) acceptance criteria:

The document refers to a "Non-Clinical Test Conclusion" (Section 7.0) and lists various tests, including:

• Performance testing: The technical specifications (Table 1) indicate measurement and verification of parameters like wavelength, max power, output mode, pulse width, cooling, size, weight, fuse, laser output power, fiber diameter, and aiming beam. The compliance with these specifications shows that the device meets its stated technical design and performance parameters.
• Biocompatibility testing: As detailed in Table 2, these tests were performed according to ISO standards:
  • Cytotoxicity (ISO 10993-5)
  • Irritation (ISO 10993-10)
  • Sensitization (ISO 10993-10)
  • Acute systemic toxicity (ISO 10993-11)
  • Pyrogen test (ISO 10993-11)
  • In vitro hemolytic test (ISO 10993-4)
• Electrical Safety & EMC testing: Compliance with IEC 60601-1_2005+A1_2012, IEC 60825-1_2014, IEC 60601-2-22_2007+A1_2012 for electrical safety and IEC 60601-1-2_2014 for EMC.

These non-clinical tests collectively form the "study" that proves the device meets the listed acceptance criteria for safety and basic functionality in a laboratory setting.

Regarding the other specific questions, the document states very clearly:

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 for clinical performance. The document explicitly states: "No clinical study implemented for the Diode laser therapy device." (Section 8.0).
• For the non-clinical tests (technical specs, biocompatibility, electrical safety, EMC), device units or material samples would have been used, but specific sample sizes and provenance for these types of engineering/laboratory tests are not provided in this summary.

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 ground truth was established as no clinical study was conducted.

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

• Not applicable. No clinical test set requiring adjudication 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 device is not an AI-assisted diagnostic or imaging device. No MRMC comparative effectiveness study was done.

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

• Not applicable. This device is a laser therapy device, not an algorithm or AI system. Its performance is evaluated through direct technical and safety tests, not standalone algorithm performance.

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

• Not applicable for clinical performance. The "ground truth" for the non-clinical tests are international standards and predefined technical specifications (e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety, stated power outputs, etc.).

8. The sample size for the training set

• Not applicable. This device is not an AI system that requires a "training set."

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

• Not applicable. As above, no training set was used.

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The Diode Laser Therapy Device is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.

The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 810nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system, laser system. The 755nm, 810nm, 1064nm handpieces with different treatment size are available for different models.

The provided text describes a 510(k) premarket notification for a Diode Laser Therapy Device. However, it explicitly states "VIII Clinical Testing: It is not applicable." Therefore, the document does not contain information about clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone performance for an AI/CADe device.

The information you are requesting typically applies to the clinical evaluation of AI/CADe devices, often involving extensive human reader studies and ground truthing. This document is for a laser therapy device, and its clearance process does not involve such studies for proving device performance in the same way an AI/CADe device would.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on non-clinical testing (electrical safety, electromagnetic compatibility, biocompatibility) to demonstrate substantial equivalence to a predicate device.

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HS-890A 980mm Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization , incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as vascular lesions and dental procedure.

The Diode Laser Therapy Device is a desktop device which utilizes a semiconductor diode with invisible infrared radiation as a laser source (980nm). The laser power is delivered to the treatment via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system and laser system.

The provided document is a 510(k) summary for a medical device called the "980nm Diode Laser Therapy Device." This document details the device's characteristics, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence. It is important to note that the document does not describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/machine learning-based device. Instead, it outlines the regulatory approval process for a traditional medical laser device.

Therefore, many of the requested items (e.g., sample size for test set, expert qualifications for ground truth, MRMC study, training set information) are not applicable to the content of this document.

However, I can extract the information that is available:

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

The document does not present acceptance criteria in a table format with reported device performance in the way one would for an AI/ML device evaluating statistical metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly the adherence to established performance standards for medical laser devices, and the reported device performance is its successful compliance with these standards.

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

This information is not applicable. The device is a physical laser therapy device, not an AI/ML algorithm that processes data. Testing involved engineering and safety compliance rather than data analysis.

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

This information is not applicable. Ground truth, in the context of this device, would refer to the physical and electrical safety standards outlined, which are established by recognized regulatory and standardization bodies.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical review of imaging or complex diagnoses for AI/ML performance evaluation. The testing here is for compliance with technical standards.

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:

This information is not applicable. This is not an AI-assisted device, and no human reader studies are mentioned.

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

This information is not applicable. The device is a standalone physical laser system, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's acceptance is its compliance with established international and national standards for medical electrical equipment and laser safety. These include:

• IEC 60601-1 (General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Electromagnetic disturbances)
• IEC 60825-1 (Safety of Laser products - Equipment classification and requirements)
• IEC 60601-2-22 (Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)

The document explicitly states that "The test result demonstrated that the proposed device complies with the following standards."

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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