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The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions:

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

Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.

The provided FDA 510(k) summary (K240482) for the Smedtrum Medical Technology Co., Ltd. Intense Pulsed Light System (ST-690) indicates that the device's acceptance criteria are based on bench testing for optical energy output and electrical safety, and its performance is demonstrated by compliance with relevant IEC standards.

Here's an analysis of the requested information:

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

• IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2020 (Electromagnetic disturbances)
• IEC 62471 First edition 2006-07 (Photobiological safety)
• IEC 60601-2-57 Edition 1.0 2011-01 (Particular requirements for non-laser light source equipment) |
  | Bench Testing (Optical Energy Output): Spatial variation of the LS equipment output over the treatment area shall not deviate from the average irradiance or radiant exposure by more than ±20%. | The product fulfills the requirements of IEC 60601-2-57 (which includes parameters for optical energy output and spatial variation). Specifically, the document states "The Intense Pulsed Light system... has been determined through engineering testing to verify optical energy output... The product fulfills the requirements of IEC 60601-2-57." |
  | Intended Use and Indications for Use: Equivalence to the predicate device. | The device has the same intended use and indications for use as the predicate device (K231394). |
  | Technological Characteristics and Operating Principles: Equivalence to the predicate device. | The device has the same technological characteristics, energy used, and operating principles as the predicate device (K231394), with minor differences in form factor (tabletop vs. standing, single handpiece vs. potentially more on predicate). |

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 does not specify a patient-based test set sample size or data provenance (country, retrospective/prospective). The performance data cited is based on engineering and bench testing to verify hardware and software functionality and safety, not clinical trial data with 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)

This information is not applicable to this submission. The ground truth relies on engineering and safety standards compliance, not expert consensus on clinical data.

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

This information is not applicable. There was no clinical test set requiring human 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

This is not applicable. The device is an Intense Pulsed Light System, a physical medical device for treatment, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical therapeutic system, not an algorithm. Performance assessment is based on physical and electrical output specifications.

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

The ground truth used for this submission is compliance with established international engineering and electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 62471, IEC 60601-2-57) and verification of optical energy output specifications.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an algorithm or AI model for this type of medical device submission. The device is evaluated based on its physical and electrical performance against predefined engineering standards.

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

This is not applicable as there is no training set. The "ground truth" for the device's performance relies on engineering measurements and adherence to specified performance ranges outlined in the electrical and optical standards.

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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: such as tattoos removal and benign pigmented lesions.

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green 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.

Picosecond Nd: YAG Laser Systems, pulse width:

This document describes the Smedtrum Medical Technology Co., Ltd. Picosecond Nd:YAG Laser System (K240118) and compares it to a predicate device (K200116).

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The "testing" primarily refers to bench testing and electrical/software verification. Therefore, no information is available regarding sample size or data provenance (country of origin, retrospective/prospective) for a test set of patient data, as this kind of study was not conducted or reported.

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

Not applicable. No ground truth based on expert consensus for clinical data was established or reported.

4. Adjudication method for the test set

Not applicable. No adjudication method for clinical data was reported.

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 system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant and was not conducted.

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

Not applicable. This device is a standalone hardware medical device (laser system) and does not involve an algorithm with human-in-the-loop performance. The "software verification and validation testing" refers to the control software of the laser system, not an AI algorithm.

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

For the technical performance of the device, the "ground truth" was based on engineering specifications and established international standards (IEC). These standards define acceptable ranges and behaviors for laser energy output, electrical safety, electromagnetic compatibility, and specific laser device performance parameters. The measurements obtained through bench testing were compared against these established standards and specifications.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is a laser system and does not utilize machine learning or AI models that require data training.

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

Not applicable. There is no mention of a "training set" for which ground truth would need to be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria primarily consists of engineering and bench testing.

• Electrical safety and electromagnetic compatibility: The device was tested for compliance with recognized international standards: IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-22 (particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment).
• Laser Safety: Compliance with IEC 60825-1 (safety of laser products, equipment classification and requirements) was verified.
• Software Verification and Validation: Testing was conducted in accordance with FDA's guidance for software in medical devices, considering the software a "moderate" level of concern.
• Bench Testing: This involved instrumental measurements of key laser parameters:
  • Laser energy output: Verified within ±20% using a laser energy meter that meets IEC 60825 standards.
  • Wavelength: Checked with a Spectrum Analyzer to confirm 532 nm and 1064 nm.
  • Frequency and Pulse Width: Measured with an Oscilloscope to ensure consistency with specifications.
  • Spot Size: Determined by emitting a laser onto photo paper and measuring the spot size with a ruler.

The conclusion states that "The non-clinical data and performance testing reports in this submission demonstrate that Picosecond Nd:YAG Laser System meets the expected performance requirements." This indicates that the device's performance characteristics, as measured during these tests, fell within the acceptable ranges and standards established for safety and effectiveness.

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The Intense Pulsed Light System is intended for medical use in the following conditions:

1. Moderate inflammatory acne vulgaris;

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

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

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

Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.

The provided document is a 510(k) premarket notification for an Intense Pulsed Light System. It details the device's indications for use, technological characteristics, and comparison to a predicate device. However, the document does not contain information on acceptance criteria for a study demonstrating device performance against specific metrics, nor does it describe a study involving human subjects or AI performance.

The "Performance Data" section of the document primarily addresses:

• Electrical safety and electromagnetic compatibility: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 62471, and IEC 60601-2-57.
• Software Verification and Validation Testing: Stating that V&V testing was conducted, and the software was considered "moderate" level of concern.
• Sterilization and Shelf-Life: Asserting the device is not sterile, is reusable, and has no restricted shelf-life.
• Biocompatibility: Reporting results of cytotoxicity, sensitization, and irritation tests on the handpiece sapphire tip, concluding compliance with ISO 10993-1.
• Bench testing: Verifying that the spatial variation of the light source equipment output over the treatment area does not deviate by more than ±20%, and fulfilling IEC 60601-2-57 requirements.

Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance (in the context of clinical or AI performance), sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone AI performance, type of ground truth, training set sample size, or how training ground truth was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and compliance with safety and bench testing standards, rather than proving efficacy or performance through clinical endpoint studies or AI-driven assessments.

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The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size:

Single-Wavelength Handpiece

810nm wavelength

The 810nm wavelength handpiece is intended 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. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and FHR Modes)

Trio-Wavelength Handpiece

The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 mm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).

Diode Laser System is a photothermal effect surgical laser device intended for prescription use and is comprised mainly of three components: console, handpieces and water-loop cooling system. There is plenty of melanin in hair follicles and hair shafts. Melanin scatters among hair bulbs and shaft structures (like medullary substance, cortex, and cuticula pili). The laser wavelengths that ST-803 Diode Laser System uses can be well absorbed by melanin, which causes a rapid increase in temperature, destroying surrounding hair follicles, and finally removing hair. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The system can automatically identify different handpieces. The product includes 2 types of handpieces that are in the same spot size and 2 combinations of wavelengths.

The diode is exited to emit a high-power therapeutic laser beam intended to reduce unwanted body hair (e.g., armpit, leg, arm, back, chest and bikini line). It is intended to be used by a trained professional to emit a laser of wavelength around 810 nm or 755+810+1064 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat.

This is a premarket notification (510(k)) for a medical device, which seeks to demonstrate substantial equivalence to a predicate device. Therefore, the information provided does not typically include clinical study data in the same way an approval for a novel device would. The "performance data" section focuses on non-clinical testing.

Here's the breakdown based on the provided document:

There is no information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the document focuses on establishing substantial equivalence for a Class II medical device based on non-clinical performance data and comparison to a predicate device.

The document details the device's technical specifications and compares them to a predicate device, along with outlining various non-clinical tests (electrical safety, EMC, software verification, sterilization, biocompatibility, and bench testing) to demonstrate its safety and performance.

Here's what can be extracted:

• No specific acceptance criteria related to a performance study (e.g., accuracy metrics for an AI device) are mentioned. The “acceptance criteria” for a 510(k) submission primarily revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through engineering testing and substantial equivalence arguments rather than a direct clinical performance study with acceptance criteria.

• No study proving the device meets acceptance criteria in the sense of a clinical performance trial is described. The "performance data" section (Section VII) details non-clinical tests.

However, I can extract the information relevant to a 510(k) submission, even if it doesn't directly map to the clinical performance study questions:

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

Since this is a 510(k) submission for a laser device, "acceptance criteria" and "reported device performance" are primarily focused on safety, electrical characteristics, software functionality, and biocompatibility, rather than clinical efficacy metrics typically seen in AI/diagnostic device performance studies. The comparison tables are generally for technical characteristics against the predicate.

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

• No clinical test set is described. The tests are non-clinical (laboratory/bench testing).
• For Biocompatibility:
  • Cytotoxicity: L-929 cell cultures were used (cell lines, not human or animal subjects in the clinical sense).
  • Skin Sensitization: Guinea Pigs were used.
  • Skin Irritation: Rabbits were used.
• Data Provenance: The tests are conducted internally or by a contracted lab and reported by Smedtrum Medical Technology Co., Ltd. (Taiwan).

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. This information is for clinical performance studies, which were not described. The non-clinical tests rely on established scientific methods and laboratory standards.

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

• Not applicable. This applies to clinical performance studies, particularly for diagnostic devices where subjective interpretation might require 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 a laser system for hair reduction, 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 system, not an algorithm.

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

• Not applicable for clinical ground truth. For non-clinical tests, "ground truth" is defined by adherence to international standards and validated laboratory methodologies. For example, in biocompatibility, the ground truth for "no cytotoxicity" is a certain cell viability percentage.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not an AI/machine learning algorithm that requires a training set.

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

• Not applicable. This is a hardware medical device.

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

CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch. CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 mm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application.

This document is a 510(k) premarket notification for a CO2 Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

The "performance data" section primarily discusses non-clinical testing related to electrical safety, electromagnetic compatibility, laser safety standards, and software verification and validation. It does not provide clinical performance data or acceptance criteria in terms of accuracy, sensitivity, specificity, or similar metrics typically associated with AI/diagnostic device studies.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission describes non-clinical engineering and software testing of a physical laser device, not a study involving human subjects or data sets for performance evaluation of an AI or diagnostic algorithm.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth based on expert review of clinical data is mentioned. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudicated test set in the context of clinical or AI performance. The device's compliance is based on direct measurement and verification against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not describe any MRMC comparative effectiveness study, as it's for a surgical laser device and not an AI or diagnostic tool where reader performance is typically evaluated.

6. If a Standalone Performance Study was done

Yes, in a sense, a standalone engineering performance assessment was done. The device's electrical safety, laser safety, electromagnetic compatibility, and software were independently tested against specified standards. However, this is not a "standalone (i.e., algorithm only without human-in-the-loop performance)" in the context of AI or diagnostic algorithms.

7. The Type of Ground Truth Used

The "ground truth" in this context is adherence to established international and national engineering standards for medical electrical equipment, laser safety, and electromagnetic compatibility. For software, the ground truth is adherence to FDA's guidance for software verification and validation. There is no clinical "ground truth" (e.g., pathology, outcomes data) mentioned in this regulatory submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable.

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