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The Q-Swithched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows:

1064nm:

• Tattoo removal
  • dark ink: blue and black
• Treatment of Benign Pigmented Lesions
  • Nevus of ota

532nm:

• Tattoo removal
  • Light ink: red, sky blue and green.
• Treatment of benign vascular lesions
  • Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
• Treatment of benign pigmented lesions
  • Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Nd:YAG laser is a type of solid laser that is stimulated through Yttrium Aluminum Garnet (YAG Crystal) doped with a very small amount of Neodymium (Nd). Nd:YAG laser can generate pulsed or continuous laser, emitting laser with specific wavelength (usually 532nm or 1064nm). The principle of Nd:YAG laser product is that electrons in atoms can absorb energy and change from a lower energy level to higher energy level, then these electrons fall back to the lower energy level, releasing energy in the form of photons. Compared with ordinary light source, laser is monochromatic, directional and brighter.

Q-Switched Nd:YAG Laser is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel.

Machine System
Q-Switched Nd:YAG Laser (hereinafter referred to as "Machine") consists of machine main body (including Laser Device, Transmission and Target Indicating Device, Laser Power Supply and Control System, Safety Protection System, Cooling System, Power Supply System, Control System), 7-Joint Laser Arm, Vari-Focusing Handpiece, Foot Switch, Laser Protective Glasses, Power Cable, Support Bar (A Group of Support Bar and 2 Support Clamps), Casters and Attached Machine Accessories, etc. As shown by Figure 1, the machine shell is ABS shell, its accessories are aluminum alloy parts.

The provided FDA 510(k) clearance letter and summary for the Q-Switched Nd:YAG Laser (SHE-LSP101-1) does not describe acceptance criteria, nor does it detail a study that proves the device meets specific performance criteria related to clinical outcomes or diagnostic accuracy.

The summary focuses on non-clinical tests to verify that the device meets safety and performance standards for laser equipment, and that its technological characteristics are similar to predicate devices. It explicitly states, "Clinical study is not applicable." This indicates that the regulatory pathway for this device did not require a study demonstrating its effectiveness or diagnostic performance against defined acceptance criteria in a clinical setting.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or cannot be extracted from the provided text.

Here's the information that can be derived from the document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Engineering Specifications)

Since no clinical acceptance criteria or performance against such criteria are explicitly stated in the document, the "performance" presented here relates to the engineering specifications and safety standards adherence.

Study Details (Non-Clinical)

1. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical tests (engineering and safety standards adherence), not a test set of data for clinical performance or AI evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established from experts for performance evaluation.

3. Adjudication method for the test set: Not applicable. No test set for clinical performance.

4. 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.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests was adherence to established international safety and performance standards for medical electrical equipment and laser products (e.g., IEC, ISO standards) and verification of its stated engineering specifications (wavelength, energy, spot size). There is no clinical "ground truth" discussed.

7. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The "study" refers to a series of non-clinical tests conducted to verify that the Q-Switched Nd:YAG Laser (SHE-LSP101-1) met its design specifications and complied with relevant international safety and performance standards for medical devices and lasers. These tests confirmed parameters such as laser peak wavelength, spot size, laser pulse energy, and maximum fluence, finding them to be within the specified ranges. Additionally, the device demonstrated compliance with a comprehensive set of standards, including:

• Electrical Safety: IEC 60601-1 (general requirements for basic safety and essential performance).
• Electromagnetic Compatibility (EMC): IEC 60601-1-2 and IEC/TR 60601-4-2.
• Laser Specific Safety: IEC 60601-2-22 (for surgical, cosmetic, therapeutic, and diagnostic laser equipment) and IEC 60825-1 (safety of laser products).
• Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), and ISO 10993-23 (irritation).

The conclusion of these non-clinical tests was that the device is substantially equivalent to its predicate devices based on these performance and validation studies. The document explicitly states that a "Clinical study is not applicable," indicating that clinical efficacy or diagnostic accuracy studies were not required for this 510(k) clearance.

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

CO2 Laser Therapy Systems is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue.iradiates biological tissue, the instantane causes photo induced solidification and photo induced vaporization to irradiaed tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After chosing laser Power, despite the frequency of laser emission, the laser is continuously output at a fixed Interval Time of 1 ms. Changes in frect interval time.

This document is a 510(k) premarket notification for a CO2 Laser Therapy System (SHE-LSP003-1). It does not describe an AI/ML powered medical device, therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies for an AI device is not available in the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices (K161925 and K241670) based on technological characteristics and performance standards for laser therapy systems, not AI performance. It explicitly states, "No clinical study is included in this submission."

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Cryojet Plus is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Cryojet Plus is composed of main body (including power supply system, cooling system), power cable, supporting arm rod (a group of supporting rod, two support clips), wind tube, adapters, casters and other accessories. Control system consists of LCD screen display and control board, etc; Cooling system includes compressor, evaporator, radiator, fan, water tank; Power supply system is composed of power cable, filter and ON/OFF switch power.

The provided text describes a medical device called "Cryojet Plus" and its substantial equivalence to a predicate device "Cryo 7". However, it does not contain a study comparing the device's performance against specific acceptance criteria in a comparative effectiveness study involving human readers or standalone AI performance.

Therefore, many of the requested sections cannot be filled from the provided document.

Here's a breakdown of what information is available and what is not:

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

The document provides a comparison of technical specifications between the proposed device (Cryojet Plus) and the predicate device (Cryo 7). While these are performance characteristics, they are not explicitly presented as "acceptance criteria" met by a study designed to prove them. Instead, they are presented as part of a substantial equivalence comparison.

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. This device is not an AI/ML diagnostic or image analysis device, and no clinical testing was performed or reported. The submission focuses on substantial equivalence based on technical characteristics and non-clinical testing.

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 test set with ground truth established by experts was used.

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

Not applicable. No clinical test set 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. No MRMC comparative effectiveness study was done. The device is a non-AI therapeutic cooling device.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. No clinical ground truth was established or used for the purpose of this 510(k) submission. The "ground truth" for the device's technical performance would be engineering measurements as per the standards listed.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm and therefore does not have a training set.

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

Not applicable. This is not an AI/ML algorithm and therefore does not have a training set.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states that the Cryojet Plus has been considered to comply with several voluntary standards through investigation and test. These standards cover aspects like electrical safety, electromagnetic compatibility, usability, software lifecycle processes, risk management, biocompatibility assessment (lack of direct patient contact negates further testing), and quality management systems.

Specifically mentioned are:

• IEC 60601-1:2005;A1:2012;A2:2020 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (Medical electrical equipment – Electromagnetic disturbances - Requirements and tests)
• IEC 60601-1-6:2013 (Medical electrical equipment – Usability)
• IEC 62366-1:2015 (Medical devices – Application of usability engineering to medical devices)
• IEC 62304:2015 (Medical devices software – software life cycle processes) - Software verification and validation tests were performed successfully and met acceptance criteria.
• ISO 14971:2019-12 (Medical devices – Application of risk management to medical devices)
• ISO 15223-1:2016 (Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements)
• ISO 13485:2016 (Medical devices – Quality management systems--Requirements for regulatory purposes)
• ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) - Biocompatibility was assessed, and no additional testing was deemed necessary due to no direct patient contact.

Non-clinical testing for Cryojet Plus included:

• Electrical safety testing according to IEC 60601-1.
• Electromagnetic compatibility testing according to IEC 60601-1-2.
• Software verification and validation.

The conclusion is that the Cryojet Plus is substantially equivalent to the predicate device (Cryo 7) in intended use, device characteristics, and application parameters, based on these technical comparisons and non-clinical testing. No clinical testing was included in this 510(k).

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• 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 proposed device is a type of the most advanced electromagnetic noninvasive treatment machine (with attachments). It is used for muscle tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc. Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications.

The provided document is a 510(k) summary for the HI-EMT MAGSHAPE device. It outlines the device details, intended use, comparison to a predicate device, and conclusions regarding substantial equivalence. However, it explicitly states:

"No clinical study is included in this submission." (Page 7)

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective. The acceptance criteria discussed are related to non-clinical tests (e.g., electrical safety, EMC) and performance specifications compared to the predicate device.

Here's an analysis of the information that is available, and what is missing based on your request:

Information Available from the Document:

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

The document provides "Performance Comparison" (Tables 2 and 3) which effectively serves as a comparison of the proposed device's specifications against those of the predicate device. While not explicitly labeled "acceptance criteria," the predicate device's specifications represent the benchmark for equivalence.

Missing Information (as per your request, due to no clinical study):

2. Sample sized used for the test set and the data provenance: Not applicable, no clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical ground truth established from experts.
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 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 not an algorithm-only product.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth used as no clinical study was performed for this submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
8. The sample size for the training set: Not applicable, no training set as no machine learning or AI models are mentioned.
9. How the ground truth for the training set was established: Not applicable.

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The Diode Laser Hair Removal System 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.

The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The main components of proposed device are Handpiece, Touch screen, Emergency stop switch, Key switch, LED screen, and Foot switch.

The provided document is a 510(k) summary for a medical device (Diode Laser Hair Removal System). It describes the device, its intended use, and compares it to a legally marketed predicate device to demonstrate substantial equivalence.

However, the document does not contain information regarding detailed acceptance criteria for device performance, nor does it present the results of a study designed to prove the device meets specific acceptance criteria in terms of efficacy or performance on hair removal.

Here’s a breakdown of why the requested information cannot be fully provided from the given text:

1. Table of acceptance criteria and reported device performance: The document lists technical specifications for the proposed device and compares them to the predicate device (e.g., laser type, wavelength, spot size, fluence, frequency). However, it does not define specific acceptance criteria related to efficacy (e.g., "X% hair reduction in Y% of patients") nor does it present study data against such acceptance criteria. The "Remarks" column in Table 4 simply states "SE" (Substantially Equivalent) or "Discussion 1" if there's a difference in a parameter. "Discussion 1" clarifies that the proposed device's fluence range is within the predicate's, which doesn't equate to performance acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study data is presented. The document explicitly states: "No clinical study is included in this submission."

3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical performance study requiring ground truth establishment is presented.

4. Adjudication method for the test set: Not applicable, as no clinical performance study requiring adjudication is presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. The device is a laser hair removal system, not a diagnostic device requiring human reader interpretation or AI assistance in the same way.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.

7. The type of ground truth used: Not applicable, as no clinical performance study requiring ground truth is presented.

8. The sample size for the training set: Not applicable, as this device does not involve machine learning or AI algorithms requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as this device does not involve machine learning or AI algorithms.

Summary of what the document does provide regarding acceptance and testing:

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for approval. This typically involves showing that the new device has the same intended use, technological characteristics, and safety profile as a legally marketed device.

The non-clinical testing detailed in section 7 confirms that the device complies with relevant safety and electrical standards:

• IEC 60601-1: General Requirements For Basic Safety And Essential Performance
• IEC 60601-2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
• IEC 60825-1: Safety of laser products Part 1: Equipment classification and requirements
• IEC 60601-1-2: Electromagnetic compatibility
• ISO 10993-5: Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
• ISO 10993-10: Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
• AMENDMENT 1: Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

The "acceptance criteria" here are implicitly the adherence to these standards and the demonstration of equivalent technical specifications (Table 4) and safety characteristics (Table 5) to the predicate device. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests that confirmed compliance with these standards and the comparison tables showing technical equivalence.

The document explicitly states "No clinical study is included in this submission." This means that the 510(k) clearance was based on demonstrating equivalence, not on providing new clinical performance data to meet specific efficacy acceptance criteria.

In conclusion, the document's purpose is to establish substantial equivalence based on technical specifications and safety standards, rather than proving performance against specific efficacy acceptance criteria via clinical trials.

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