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The Reepot laser system is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

• Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Treatment of Lentigines
• Treatment of Cafe-Au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyper-Pigmentation
• Treatment of Becker's Nevi, Freckles and Nevi Spilus

The reepot Nd;Y AG laser system is comprised of the following major components:

• 1. Laser system console
• 2. LCD control panel
• 3. VSLS handpieces (included camera and LCD display)
• 4. Footswitch.
• 5. Accessories

This document is a 510(k) premarket notification for a laser surgical instrument, the reepot Nd:YAG laser system. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data for acceptance criteria against a specific medical condition. Therefore, the detailed information requested regarding clinical effectiveness studies, such as the use of test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not available in this document.

The document primarily addresses safety and technical equivalence, rather than clinical performance acceptance criteria.

However, I can extract the relevant information that is available:

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

The document doesn't provide specific quantitative "acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. Instead, it demonstrates technical performance and safety compliance by comparing its specifications to a predicate device and adhering to recognized standards.

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

• Not Applicable. No clinical test set data is presented in this 510(k) submission. The submission states, "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission."

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 and thus no ground truth established by experts is mentioned.

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

• Not Applicable. No clinical test set 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:

• Not Applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this submission.

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

• Not Applicable. This device is a laser surgical instrument, not an algorithm.

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

• Not Applicable. As no clinical studies were performed for this submission, no ground truth data from such studies is provided. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and intended use are substantially equivalent to a legally marketed predicate device, and that it adheres to relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).

8. The sample size for the training set:

• Not Applicable. This submission is for a physical medical device (laser system), not a machine learning or AI model that requires a training set.

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

• Not Applicable. No training set for an AI/ML model is involved.

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Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse micro-needle type electrodes, footswitch and an LCD touch screen control panel.

The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.

The Secret RF is consists of ;

• 1. Secret RF main unit (FDA cleared K170325)
• 2. Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325)
• 3. Secret RF Smartcure applicator

The Secret RF Smartcure Applicator consists of :

• Smartcure handpiece
• Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)

The provided text describes a 510(k) premarket notification for the "Secret RF Smartcure Applicator" and details its substantial equivalence to predicate devices, but it does not contain information on acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or effectiveness data (e.g., sensitivity, specificity, accuracy).

The document focuses on:

• Regulatory Clearance: Affirming that the device is substantially equivalent to legally marketed predicate devices for dermatologic and general surgical procedures for electro-coagulation and hemostasis.
• Technical Specifications: Comparing the proposed device's technical characteristics (e.g., frequency, max power, RF duration, electrode type) with a predicate device (SecretRF K170325) and two reference devices (AGNES K160469, EVRF K112334).
• Performance Data (Non-Clinical/Pre-Clinical): Listing performed tests, which are primarily related to safety, electrical compatibility, and basic functionality:
  • Biocompatibility testing (ISO10993-1;2009)
  • Electrical safety and essential performance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009)
  • Animal testing (micropig models for histological data on ablation and thermal damage depth and zone at various post-treatment intervals and intensities).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy, as this information is not present. The "performance data" listed refers to design verification and validation testing for safety and basic function, not clinical efficacy or diagnostic performance metrics.
2. Sample size used for the test set and data provenance: Not mentioned, as no clinical effectiveness study is described.
3. Number of experts and their qualifications for ground truth: Not applicable, as no ground truth for labeling or diagnosing clinical conditions is discussed.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported. The document explicitly states the device's substantial equivalence is based on similarities to predicate devices and performance testing related to safety and functionality.
6. Standalone performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable in the context of clinical performance data. The animal study used histological data as an endpoint for depth and zone of ablation/thermal damage.
8. Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How ground truth for the training set was established: Not applicable.

However, based on the provided text, I can infer a type of "acceptance criteria" related to regulatory compliance and safety, and report the "performance" in terms of meeting these standards.

Inferred Acceptance Criteria and Reported Performance (based on regulatory and safety compliance):

Study Description (as reported in the document):

The document references several types of studies performed as part of the 510(k) submission, primarily for demonstrating safety and substantial equivalence, rather than clinical efficacy or diagnostic performance.

1. Biocompatibility Testing:

   • Description: Testing of patient contact components and materials.
   • Standard: ISO 10993-1:2009.
   • Data Provenance: Not specified, but generally performed in a lab setting.
   • Sample Size: Not specified (refers to materials, not patients).
   • Ground Truth: Adherence to the ISO standard.

2. Non-Clinical (Engineering/Safety) Testing:

   • Description: Evaluation of the device's electrical safety, essential performance, and electromagnetic compatibility.
   • Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009.
   • Data Provenance: Not specified, but generally performed in a lab setting.
   • Sample Size: Not specified (typically tests on a device unit).
   • Ground Truth: Compliance with the respective IEC standards.

3. Animal Testing:

   • Description: In vivo study to obtain histological data on depth and zone of ablation and thermal damage.
   • Species: Micropig models.
   • Purpose: To assess immediate, 7-day, and 14-day post-treatment effects.
   • Data Provenance: Animal study. Country of origin not specified.
   • Sample Size: Not specified (number of micropigs or treatment sites).
   • Ground Truth: Histological analysis of tissue samples.
   • Experts: Not specified, but typically includes pathologists.
   • Adjudication: Not specified.

Missing Information:

Crucially, the document explicitly states this is a substantial equivalence determination for a medical device. For such submissions, extensive clinical efficacy studies with predefined acceptance criteria for patient outcomes (like those you’d expect for an AI diagnostic device's sensitivity/specificity or a pharmaceutical drug's effectiveness) are often NOT required if the device is sufficiently similar to legally marketed predicate devices. The focus is on ensuring basic safety and functional equivalence.

Therefore, the requested details related to clinical performance metrics, ground truth establishment for a diagnostic output, training sets, or human-AI comparative effectiveness studies are not present in this regulatory summary because they were likely not part of the 510(k) submission for this type of device.

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RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.

RetiCapture is a hand-held digital ophthalmic camera that together with the optics modules used to capture digital images and video of fundus and surrounding area of the human eye. RetiCapture has an LED light source visible white light and infrared light. Light target LED's are used to eye position fixation during imaging. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.

The provided text is a 510(k) Summary for the RetiCapture ophthalmic camera. It outlines the device's technical characteristics and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop performance study.

The document focuses on:

• Device Description: A hand-held digital ophthalmic camera.
• Intended Use: To record digital photographs and video of the fundus of the human eye and surrounding area.
• Technical Characteristics: Comparison of specifications (FOV, Resolution, etc.) with a predicate device (MiiS Horus Scope DEC 100).
• Non-clinical tests: Performance according to various IEC and ISO standards related to safety, electromagnetic compatibility, photobiological safety, risk management, software validation, and ophthalmic instruments.

Therefore, I cannot provide the detailed information requested in the prompt based solely on the provided text. The requested information regarding acceptance criteria, study performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for AI models is not present in the given document.

The document only states that "Extensive software testing and validation have been conducted to ensure that RetiCapture performs to acceptable level, repeatedly and reliably referring to consensus standard IEC 62304:2006 and ISO 14971:2012." This refers to software engineering practices and risk management, not a clinical performance study with defined acceptance criteria for image quality or diagnostic accuracy.

To fulfill your request, I would need a different document that details the clinical or performance validation studies, including specific acceptance criteria and the results of those studies.

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The CuRAS Nd; Y AG laser system in indicated for : the incision, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

• Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Treatment of Lentigines
• Treatment of Cafe-Au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyper-Pigmentation
• Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength:

• Tattoo removal: dark ink (black, blue and brown)
• Removal of Nevus of Ota
• Removal or lightening of unwanted hair with or without adjuvant preparation.
• Treatment of Common Nevi
• Skin resurfacing procedures for the treatment of acne scars and wrinkle

The CuRAS Nd;YAG laser system is comprised of the following major components:

• 1. The main console unit
• 2. Delivery handpieces
• 3. Footswitch.
• 4. Accessories

The provided text is related to a 510(k) premarket notification for a medical device (CuRAS Nd:YAG Laser) and primarily focuses on its substantial equivalence to a predicate device. It details product specifications, intended use, and technical comparisons.

However, the document does not contain information regarding acceptance criteria, specific device performance metrics in the context of a study, sample sizes for test/training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a training set.

The document explicitly states under "VIII. Clinical Data [21 CFR 807.92(b) (2)]":
"Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission."

Therefore, I cannot provide the requested information as it is not present in the given text. The document refers to compliance with safety standards (IEC 60601-series and IEC 60825-1) and software verification/validation, but these are general compliance requirements rather than specific performance studies with acceptance criteria as typically understood in the context of diagnostic or AI-driven device performance.

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SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

Secret RF's High Frequency(=Radio Frequency) includes the system main body, a bipolar handpiece(Two type) with disposable micro-needle type electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.

The provided text describes a 510(k) summary for a medical device called "Secret RF". This document focuses on demonstrating substantial equivalence to a predicate device, "FRAXIS DUO_RF PART" (K160312), rather than providing detailed acceptance criteria and studies for independent device performance.

Therefore, many of the requested categories cannot be directly addressed from this document because it's a submission for substantial equivalence based on similar technology and intended use, not a clinical trial evaluating specific performance metrics against pre-defined acceptance criteria.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness for a 510(k) submission.

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

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

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "performance" demonstrated is that the device's technological characteristics and non-clinical test results are comparable or compliant with established standards, supporting its substantial equivalence to the predicate device.

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

• Non-Clinical Testing (IEC Standards): Not applicable for "sample size" in the conventional sense of a clinical test set. These are engineering and electrical safety tests typically performed on a device unit.
• Animal Testing: Micropig models were used. The document does not specify the number of animals (sample size).
• Data Provenance: The document implies these tests were conducted by the manufacturer or accredited labs for the purpose of the 510(k) submission. No country of origin for the "test set" data is explicitly stated beyond the manufacturer being in Korea. The animal study results are not presented in a way that would indicate retrospective or prospective, but animal studies for regulatory submissions are typically prospective.

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

This is not applicable to the non-clinical and animal testing described. Ground truth in a clinical context (e.g., expert consensus on image interpretation) is not part of this 510(k) summary, which focuses on device safety and technical equivalence. The animal study generated histological data, which would typically be analyzed by veterinary pathologists, but this detail and the number of experts are not provided.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple human readers, which is not described here.

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 510(k) submission for a non-AI electrosurgical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is an electrosurgical tool, not an algorithm. Its performance is directly tied to its physical and electrical characteristics and how it interacts with tissue.

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

• For Non-Clinical Testing (IEC standards): "Ground truth" is compliance with the defined parameters and limits of the specific international standards (e.g., electrical safety, EMC).
• For Animal Testing: The ground truth for evaluating tissue effects was histological data obtained from micropig models, presumably interpreted by pathologists.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. There is no training set for this device.

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