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The CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The device emits CO2 laser at the wavelength of 10.6um, which is the spectral line in the far infrared range. The device is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

This FDA 510(k) summary describes a CO2 Laser System by Beijing Superlaser Technology Co., Ltd. and seeks to demonstrate its substantial equivalence to a predicate device (K192528).

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

The document doesn't explicitly state "acceptance criteria" as a separate section with specific thresholds. Instead, the substantial equivalence is based on a comparison to a predicate device, showing that the proposed device performs "the same" or "similarly" across various specifications and complies with relevant safety standards.

Here's a table based on the "Performance Comparison" and "Safety Comparison" sections, with "Reported Device Performance" being the specifications of the Proposed Device and "Acceptance Criteria" being implicitly met if it's "SAME" or "SIMILAR" to the Predicate Device, or complies with established standards.

The study (non-clinical testing) states that "The test results demonstrated that the proposed device complies with the following standards" for safety and that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." This implicitly means the device meets the acceptance criteria of conforming to the predicate device's performance characteristics and a set of recognized electrical, EMC, and laser safety standards.

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

• Sample size for the test set: Not applicable. The document describes non-clinical bench testing and software validation, not a study with a "test set" of patient data or images.
• Data provenance: Not applicable, as there isn't patient data/images involved in this type of submission. The tests are bench tests performed in a laboratory setting by the manufacturer. The company is based in Beijing, China.

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

Not applicable. This submission is for a CO2 Laser System that performs surgical functions, not an AI/imaging device requiring expert consensus for ground truth on diagnostic interpretations. The "ground truth" for this device would be its physical performance specifications and adherence to safety standards, verified through engineering tests.

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

Not applicable, as there is no "test set" in the context of clinical or image-based studies requiring 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:

No, an MRMC comparative effectiveness study was not done. The device is a physical CO2 laser system, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is not an AI algorithm. The device performance is assessed through its physical operation and compliance with engineering standards.

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

The "ground truth" for this device's performance and safety is established through:

• Engineering specifications and measurements: Comparing output power, wavelength, spot size, etc., against the predicate device's documented specifications.
• Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 for electrical, EMC, and laser safety.
• Bench Performance Tests: These would involve direct measurements of the device's output and function.
• Software Validation & Verification Test: Ensuring the control system software operates correctly according to its design specifications.

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

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The ND: YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and the removal of black or blue tattoos.

The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

The device is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos. It is for prescription use only.

This document is a 510(k) Pre-market Notification for a medical device called the "ND:YAG Laser" (Model SL-NY602) from Beijing Superlaser Technology Co., Ltd. It seeks to demonstrate substantial equivalence to a predicate device, the "ND YAG Q-switch Laser Therapy Machine" (K161926) from Beijing ADSS Development Co., Ltd.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, this document does not present "acceptance criteria" in the traditional sense of specific performance metrics with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it aims to demonstrate substantial equivalence (SE) based on comparative tables for general, technical, and safety aspects. The "acceptance criteria" for this type of submission are that the proposed device is as safe and effective as the predicate device. The reported performance is implicitly the device meeting the described characteristics.

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The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all 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 Diode Laser 808nm 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 has six main function modules as following:

Water cooling system:

Through refrigeration compressor to achieve heat and cold exchange of air, the internal water tank by the water and water pump for cooling water cycle, with cooling water to cool the parts of the tools, the system to achieve this function is called water cooling system.

Power system:

Through the main circuit control system, according to the control requirements to provide the size of laser energy, the system to achieve this function is called the power system.

User Interface system:

Through the display screen and touch screen, 1. Provide users with relevant information about display equipment; 2. Users operate or set relevant parameters or functions; 3. Display fault information. The system that realizes this function is called human-machine switching system.

Handpiece system:

According to the choice of different treatment methods to choose the appropriate treatment tools, the system to achieve this function is called the handpiece system.

Main circuit power supply system:

The system that realizes the power supply of equipment and the control switch or stops the power supply is called the main circuit power supply system.

Main circuit control system:

It is used to control the parts of the equipment to work in a reasonable sequence and provide fault or warning sound. The system that realizes this function is called the main circuit control system.

The provided document is a 510(k) Premarket Notification from the U.S. FDA for a Diode Laser 808nm, Model: SL-HR10. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through detailed acceptance criteria and human studies for AI/software devices.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and studies for an AI/software device. Specifically, it does not include:

• A table of acceptance criteria and reported device performance for an AI/software system.
• Sample sizes for test sets, data provenance, or details on ground truth establishment for AI/software.
• Information on experts used to establish ground truth or adjudication methods for AI/software.
• Details about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample sizes or ground truth establishment methods for training sets of an AI/software.

Instead, the document details:

• Device Name: Diode Laser 808nm, Model: SL-HR10
• Intended Use: Hair removal, permanent hair reduction on all skin types (I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment.
• Basis for SE: Non-clinical tests verifying compliance with relevant medical device safety and performance standards (e.g., AAMI/ANSI/ES 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10).
• Comparison to Predicates: The device is compared to two predicate devices (K180353 and K181019) on product code, regulation number, intended use, configuration, principle of operation, laser type, classification, wavelength, spot size, fluence, frequency, pulse duration, power supply, dimension, weight, patient contact materials, and biocompatibility.
• No Clinical Study: The document explicitly states: "No clinical study is included in this submission."

In summary, this FDA submission is for a laser device, and its approval is based on demonstrating substantial equivalence to existing devices through non-clinical testing against established safety and performance standards, not through clinical trials or AI/software specific performance metrics.

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The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.

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 regimen.

The Multi-modality workstation is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 520mm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

Based on this, the Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.

This document is a 510(k) Premarket Notification summary for the "Multi-modality workstation, Model: AAD Dual Light." It demonstrates Substantial Equivalence (SE) to a predicate device, rather than providing a study that meets specific acceptance criteria for a new clinical claim.

Therefore, many of the requested details regarding acceptance criteria and performance studies in the context of clinical claims (e.g., sample size, expert ground truth, MRMC studies) are not applicable (N/A) to this type of submission. This 510(k) primarily relies on non-clinical testing and comparative analysis to establish substantial equivalence.

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

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

The concept of "acceptance criteria" in this 510(k) is framed around demonstrating substantial equivalence to a predicate device, specifically by meeting certain non-clinical performance and safety standards, and having comparable technological characteristics and intended use. There isn't a table of specific clinical performance acceptance criteria and reported clinical device performance because no clinical study was performed.

Instead, the document presents a comparison table with the predicate device (Table 9-2 Performance Comparison and Table 9-3 Setting Comparison of Specified Indication for Use), where "acceptance" means the proposed device's characteristics are either the same or have differences that are argued to have no negative effect on effectiveness and safety, supported by non-clinical bench tests.

Here's a summary of the comparative performance aspects:

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

• Sample Size for Test Set: N/A. No clinical test set data was used because no clinical study was included in the submission. The "test set" was comprised of the physical device itself undergoing non-clinical bench testing.
• Data Provenance: N/A. The data for this submission primarily comes from the manufacturer's internal non-clinical bench testing and adherence to international electrical and biocompatibility standards.

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)

• Number of Experts: N/A. Since no clinical study was performed, there was no need for experts to establish ground truth for clinical cases.
• Qualifications of Experts: N/A.

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

• Adjudication Method: N/A. No clinical study, thus no adjudication of clinical outcomes. The "adjudication" for non-clinical tests would be the pass/fail criteria of the specified international standards (e.g., IEC, ISO).

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

• MRMC Study: N/A. No clinical study. The device is a light-based system for aesthetic and surgical applications, not an AI-assisted diagnostic device.

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

• Standalone Performance: N/A. This device is an intense pulsed light system, not an algorithm. Its performance is inherent in its physical parameters and how it operates, validated by non-clinical bench tests. It requires human operation.

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

• Ground Truth: For non-clinical testing, the "ground truth" refers to the established requirements and specifications of the referenced international standards (e.g., IEC, ISO). For example, for biocompatibility, "no toxicity" or "no irritation" based on ISO 10993 series are the established ground truths/acceptance criteria for the material. For electrical safety, compliance with IEC 60601-1 is the ground truth. There is no clinical ground truth relevant to this 510(k).

8. The sample size for the training set

• Training Set Sample Size: N/A. No clinical training data was used because this is a physical device submission demonstrating substantial equivalence through non-clinical means, not a machine learning/AI device.

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

• Ground Truth for Training Set: N/A. See point 8.

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