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1550nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

1927nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring the coagulation of soft tissue.

The Fiber laser Treatment systems (HS-232) is the desktop type, and (HS-233) is the mobile type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system)，fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is an Erbium(1550nm) and Thulium(1927nm) fiber laser, producing a pulsed beam upon activation by a footswitch. The system is equipped with a 650nm aiming beam with less than 2mW, the beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.

The 1550nm laser and 1927nm laser works independently and cannot work together, the output laser source can be selected according to different indication for use

The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the Fiber Laser Treatment Systems (HS-232, HS-233). This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria is not present in this document. The FDA 510(k) process for this type of device (laser surgical instrument) typically relies heavily on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing (electrical safety, EMC, performance against standards) and functional comparisons, rather than requiring extensive clinical trials with specific performance endpoints.

Here's a breakdown of what can and cannot be answered from the provided text:

What can be extracted:

• Device Name: Fiber Laser Treatment Systems (HS-232, HS-233)
• Intended Use/Indications for Use:
  • 1550nm: Intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
  • 1927nm: Intended for use in dermatological procedures requiring the coagulation of soft tissue.
• Non-Clinical Testing Performed: Electrical safety and electromagnetic compatibility based on several IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
• Clinical Testing: Not applicable, as stated in the document.

What cannot be extracted (as per your request, because the document doesn't contain a specific study demonstrating performance against acceptance criteria beyond general safety and equivalence):

1. A table of acceptance criteria and the reported device performance: No specific performance acceptance criteria (e.g., minimum percentage of fractional skin resurfacing achieved, specific coagulation depth) or reported performance results (e.g., test scores, sensitivity, specificity, accuracy) are provided. The "performance testing" mentioned refers to verifying design specifications and compliance with standards, not performance against clinical or perceptual criteria.
2. Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned as clinical testing was not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test with expert-established ground truth was reported.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 surgical instrument, not an AI-powered diagnostic device with human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established for "performance" beyond compliance with engineering standards.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA document focuses on demonstrating that the Fiber Laser Treatment Systems are substantially equivalent to previously cleared predicate devices based on technological similarity, indications for use comparison, and compliance with general electrical safety and laser standards. It does not detail a study proving the device meets specific clinical performance acceptance criteria.

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The Electromagnetic Stimulation System is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks, thighs and calves.
• Improvement of muscle tone and firmness, for strengthening muscles in arms.

The HS-591 Electromagnetic Stimulation System is a non-invasive therapeutic device which comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue of adult patients. The device is equipped with a color touch-screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch-screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The provided text is a 510(k) summary for an Electromagnetic Stimulation System. It describes the device, its indications for use, and a comparison to a predicate device. However, it explicitly states that "Clinical Testing" is "not applicable" and relies on performance testing and validation studies to demonstrate substantial equivalence to the predicate device.

Therefore, the document does not contain any information regarding specific acceptance criteria for device performance related to a clinical study, nor does it provide details of a study that proves the device meets such criteria. It is a regulatory submission focused on demonstrating equivalence for marketing clearance, not a report on a clinical trial with performance metrics.

For that reason, I cannot provide the requested information, as it is not present in the provided text.

If you are looking for information about clinical acceptance criteria and performance studies for a medical device, you would typically need to consult clinical trial reports, peer-reviewed publications, or more detailed regulatory submissions (like a PMA, if applicable, which this device is not).

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The Fiber Laser Treatment System is in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

The Fiber laser Treatment system (HS-230) is the desktop type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system), fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is a Erbium fiber laser, producing a pulsed beam of near-infrared light (1550nm) upon activation by a footswitch. The beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.

The provided text describes a 510(k) premarket notification for a medical device called "Fiber Laser Treatment System" (K221770). This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a novel AI device.

Based on the provided information, I can extract the following:

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

The document describes non-clinical testing for safety and performance against recognized electrical and laser safety standards. Acceptance is implied by compliance with these standards.

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

• The document explicitly states that non-clinical testing was performed. This typically involves laboratory testing of the device itself and its components, not studies on a "test set" of patient data in the way AI/software devices are evaluated.
• Therefore, there is no patient sample size mentioned, nor is there information on data provenance (country of origin, retrospective/prospective) because such data was not applicable to this type of regulatory submission.

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

• Not applicable. As this is a physical medical device (fiber laser) and not an AI/software device requiring interpretation of medical images or data, there was no "ground truth" to be established by experts in this context. The "ground truth" for compliance testing is against the specified engineering and safety standards.

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

• Not applicable. Since there was no test set involving expert review for diagnostic accuracy or similar, no adjudication method 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:

• No, an MRMC study was not done. This device is a laser treatment 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 is a physical laser device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the non-clinical testing was compliance with recognized international standards for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993-1).

8. The sample size for the training set:

• Not applicable. The device is a physical laser system, not an AI algorithm that requires a training set.

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

• Not applicable. As there is no training set mentioned or implied, this question does not apply.

In summary: The provided document is for a traditional medical device (laser system) and focuses on demonstrating substantial equivalence through comparison of technical specifications and compliance with non-clinical performance and safety standards, rather than clinical studies involving patient data or AI performance evaluation. Therefore, many of the questions related to AI device evaluation are not applicable.

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The Platform Treatment System can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.

(1) IPL Handpiece

• Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
• Moderate inflammatory acne vulgaris;
• Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• Cutaneous lesions including scars;
• Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

(2) Q-switched Nd: Y AG laser Handpiece (1064nm wavelength):

• Benign vascular and pigmented lesions, age spots:
• Nevus spilus:
• Tattoo removal.

(3) Long pulsed Nd:YAG Handpiece:

• Benign vascular lesions
• Superficial and deep telangiectasias (venulectasias)
• Benign cutaneous lesions
• Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles
• Laser skin resurfacing procedures
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
• Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
• Removal or lightening of unwanted hair (with and without adjuvant preparation)
• Treatment of pseudofolliculitis barbae (PFB)

The proposed device, Platform Treatment System, HS-900K can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. These five handpieces are (1) Intense Pulsed Light (IPL) Handpiece, (2) Q-switched Nd:YAG laser Handpiece and (3) Long pulsed Nd:YAG Handpiece. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use.

The main unit consists of:

• (1) The Power supply module: Controls electrical supply to the entire system.
• (2) The Control module: Controls and coordinates the various components of the system for optimum performance. It also contains the following control features:
  • a) Key switch: Used to turn on and off the power supply. (Clockwise to turn on and counter clockwise to turn off)
  • b) Emerqency turn off switch: The red button found in the front panel of the machine is used to immediately shut off the machine's power supply in case of any emergency. Depressing this button will cut off the power supply to the whole system. Rotating the button in the direction of the arrow printed on its surface will disengage the button and will reengage the power supply. When this button is engaged remember to turn the key switch to the off position afterwards.
  • c) The touch Screen: True color TFT LCD (Liquid Crystal Display) shows the operational settings and adjustments as well as system status is displayed on the screen.
• (3) The display module: Displays various information of the system and accept users' instruction.
• (4) High current capacitors: Delivers adequate electrical energy to guarantee sufficient power during operation.
• (5) Cooling system: Maintains a stable thermal environment for optimum performance.
• (6) Laser generator: The unit uses 110V 50/60Hz single-phase power supply. Its capability should be less than 2900W. Use a 25A (110V 50/60Hz), single-phase three-wire outlet at an international level.

The provided text is an FDA 510(k) premarket notification for a "Platform Treatment System." It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical testing performed. However, there is no information presented in this document regarding acceptance criteria for clinical performance, or a study proving that the device meets such criteria.

The document explicitly states in Section VIII: "Clinical Testing It is not applicable." This means that the 510(k) submission did not include clinical trial data to demonstrate the device's performance. Instead, the submission relies on substantial equivalence to predicate devices and non-clinical testing (electrical safety and electromagnetic compatibility) to support its clearance.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: No clinical performance acceptance criteria or reported performance is mentioned.
2. Sample sizes used for the test set and the data provenance: No clinical test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
4. Adjudication method: Not applicable as there's no clinical test set.
5. MRMC comparative effectiveness study: Not applicable as no clinical study was performed.
6. Standalone performance (algorithm only without human-in-the-loop performance): This device is a laser/IPL system, not an AI algorithm, and no such study is mentioned.
7. Type of ground truth used: Not applicable as there's no clinical test set.
8. Sample size for the training set: Not applicable as there's no AI algorithm with a training set.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical safety/EMC testing, rather than clinical performance data.

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The Diode Laser Body Sculpture Systems is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The HS-851 Diode Laser Body Sculpture Systems is a 1060nm Diode Hyperthermic Laser Lipolysis system and utilizes the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce stubborn fat in areas such as flank, abdomen, back and thighs. The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. The proposed device consists of the main unit, control unit with dedicated software and user interface, and the treatment applicators.

The provided text is a 510(k) premarket notification for a medical device called the "Diode Laser Body Sculpture Systems." This document outlines the device's indications for use, its comparison to predicate devices, and the non-clinical testing performed. It explicitly states that clinical testing was not applicable. Therefore, the document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in a clinical setting.

The response to your request will reflect the absence of this information from the provided document.

Acceptance Criteria and Device Performance Study

As per the provided 510(k) summary (K201731), clinical testing for the Diode Laser Body Sculpture Systems was stated as "not applicable." Therefore, the document does not contain information regarding:

• A table of acceptance criteria and reported device performance based on clinical outcomes.
• Sample sizes used for a clinical test set.
• Data provenance (country of origin, retrospective/prospective) for a clinical test set.
• Number of experts and their qualifications used to establish ground truth for a clinical test set.
• Adjudication method for a clinical test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance study.
• Type of ground truth used for performance evaluation (beyond non-clinical safety and performance).
• Sample size for the training set for a clinical performance study.
• How ground truth for a training set was established for clinical performance.

The non-clinical testing primarily focused on electrical safety, electromagnetic compatibility, and biocompatibility to demonstrate substantial equivalence to predicate devices, rather than establishing clinical efficacy or specific acceptance criteria related to fat reduction outcomes through a clinical study.

Summary of Non-Clinical Testing (as provided):

Note: The FDA 510(k) clearance is based on substantial equivalence to predicate devices, which may or may not require new clinical studies if the technological characteristics and indications for use are sufficiently similar and safety/effectiveness can be demonstrated through non-clinical data and comparison to existing devices. In this case, the statement "It is not applicable" for clinical testing indicates that the manufacturer relied on other means (likely benchmarking against predicate devices with established clinical profiles and robust non-clinical data) to demonstrate substantial equivalence.

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The CO2 Laser Therapy System is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.

The CO2 Laser Therapy Systems generate a 10,600nm wavelength, which is absorbed by water in the tissue. The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).

I'm sorry, but the provided text describes a medical device called "CO2 Laser Therapy System" and its FDA 510(k) clearance application. It details the device's indications for use, technological characteristics, and comparison to predicate devices, along with non-clinical testing performed to meet electrical safety and electromagnetic compatibility standards.

However, the document explicitly states in section "VIII Clinical Testing" that "It is not applicable." This means that no clinical studies, which would typically involve testing the device's performance against defined acceptance criteria on a test set with ground truth, were conducted or included in this submission for the purpose of demonstrating substantial equivalence.

Therefore, I cannot provide the information requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment, as this type of information is not present in the provided text. The FDA clearance was based on substantial equivalence to predicate devices and non-clinical performance testing.

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The PicoSecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
  532nm wavelength:
• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The PicoSecond Nd: YAG Laser System is a Nd: YAG solid state laser, which can deliver the energy at picosecond pulse bursts to the skin. The system is composed of laser generator, articulated arm, handpence, laser power supply, cooling system, display and control system.
The PicoSecond Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system.

The provided text is a 510(k) summary for the PicoSecond Nd: YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. Crucially, it explicitly states "Clinical Testing: It is not applicable." This means that there was no clinical study conducted to prove the device's performance against specific acceptance criteria.

Therefore, I cannot provide the information requested in the prompt, as the provided document indicates that no such study was performed or needed for this 510(k) clearance.

Specifically, the following information cannot be extracted because no clinical study was conducted:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample sized used for the test set and the data provenance: No test set due to the absence of a clinical study.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: "It is not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical laser system, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this refers to training data for AI/ML models, which is not relevant here.
9. How the ground truth for the training set was established: Not applicable.

The document focuses solely on non-clinical testing to demonstrate substantial equivalence, specifically mentioning:

• Electrical safety and electromagnetic compatibility: Tested against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
• Performance characteristics: Implied through comparison of technical specifications with predicate devices (e.g., wavelengths, pulse energy, pulse duration, repetition rate, spot size). The conclusion states that the maximum pulse energy of the proposed device, while higher than one predicate and lower than another, "can be considered that the propose device can achieve its intended use and is safety." This is a declarative statement based on engineering comparison and non-clinical safety/performance tests, not clinical trial data.

In summary, for this particular 510(k) submission, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" were based on a comparison to legally marketed predicate devices and a battery of non-clinical, bench and lab-based engineering tests to ensure safety and performance equivalence, rather than a clinical trial.

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The IPL treatment system is intended for medical use in the treatment of the following dermatologic conditions:

• Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;

• Moderate inflammatory acne vulgaris;

• Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);

• Cutaneous lesions including scars;

• Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

The IPL Treatment Systems utilizes an intense, visible, broad-spectrum pulse of light that when used with interchangeable filters, allowing it to selectively heat the target for different indications. The optical component is intended to drive the IPL energy to concentrate where the optical energy has selectively heated the target.

The Intense pulsed light (IPL) is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. The light-based component delivers optical energy that is absorbed by specific chromophores in the skin, which is converted to heat, according to the principle of selective photothermolysis.

The proposed device consists of the main unit, control panel and the treatment handpiece(s).

This document is a 510(k) premarket notification for an IPL Treatment System (K200746). It describes the device and claims substantial equivalence to a predicate device (iPulseLight IPL System, K093627). However, the document explicitly states:

VIII Clinical Testing: It is not applicable.

Therefore, there is no study conducted to prove the device meets acceptance criteria through clinical testing. The submission relies solely on non-clinical testing and comparison to the predicate device to establish substantial equivalence.

Given this, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study was performed or documented in the provided text.

Here is what can be inferred about acceptance criteria and device performance based on the non-clinical information provided:

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

Since no clinical study was performed for performance, the acceptance criteria are implicitly met by the device demonstrating similar specifications and safety profiles to the predicate device through non-clinical testing.

Regarding the other points, as no clinical study was performed:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
N/A - No clinical test set.

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):
N/A - No clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A - 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:
N/A - This device is not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A - This is a physical IPL treatment system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
N/A - No clinical ground truth was established for performance claims.

8. The sample size for the training set:
N/A - This is a physical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established:
N/A - Not applicable.

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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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