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The Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal. 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 Intense pulsed light therapy device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 650-1200nm. 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 Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal.

The document is a 510(k) Summary for an Intense Pulsed Light (IPL) therapy device (Model: FI-L06) seeking FDA clearance for permanent hair removal. It compares the proposed device to a predicate device (K192519) to establish substantial equivalence.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications. The key performance comparison is presented in tables 6-2 and 6-3.

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

• Sample Size: Not applicable. The submission explicitly states: "No clinical study is included in this submission." The evaluation for substantial equivalence relies on non-clinical (bench) testing and comparison to the predicate device's established performance and specifications.
• Data Provenance: Not applicable, as no clinical data was submitted. Non-clinical tests were conducted by the manufacturer, Hebei Zhemai Technology Co., Ltd., in China.

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 requiring expert ground truth was created for this submission. The submission relies solely on non-clinical testing and comparison to an existing predicate device.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication 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. This device is an Intense Pulsed Light therapy device for hair removal, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant for this device type.

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

• Not applicable. This device is a physical IPL therapy machine; it does not involve an algorithm running in a standalone mode without human interaction, nor an AI component to evaluate. Its operation is managed by a user.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No clinical ground truth was established or used as no clinical studies were performed. The "ground truth" for demonstrating substantial equivalence was based on bench testing and comparison against recognized industry standards (IEC 60601-1-2:2020, AAMI/ANSI ES 60601-1: 2012, IEC 60601-2-57: 2011, ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 14971: 2019) and the established specifications and indications for use of the predicate device.

8. The Sample Size for the Training Set

• Not applicable. No AI model or algorithm requiring a training set was part of this submission.

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

• Not applicable. No training set was used.

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The Diode laser therapy device 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.

Diode Laser Hair Removal adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.

The Diode laser therapy device utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch.

The provided documentation does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond substantial equivalence to a predicate device.

Here's an analysis of the provided information based on your request:

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

No explicit acceptance criteria with numerical targets for performance (e.g., hair reduction percentage, adverse event rate) are presented for the proposed device itself. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K210663). The "performance" reported is primarily a comparison of technical specifications to the predicate device.

Differences and their analysis for safety and effectiveness:

• Spot Size:
  • Proposed: 12mm × 35mm
  • Predicate: 10 × 30 mm
  • Analysis: "Spot size only affects the area of treatment, not affect the therapeutic effect. Therefore, this difference will not affect the safety and effectiveness."
• Pulse Duration:
  • Proposed: 5-200ms
  • Predicate: 15-400ms
  • Analysis: "The frequency of the proposed device is within the range of that of the predicate device, which can justify that the difference in the parameter of Pulse duration will not raise new safety issues of the proposed device. In addition, we also found a reference device (K181019), which has the same intended use as the reference device. The Pulse Duration of the reference device is 30-200 ms, which is similar to the proposed device's pulse duration, so this difference will not affect the effectiveness of the device."
• Dimension:
  • Proposed: 55cm × 55 cm × 123cm
  • Predicate: 65cm × 65cm × 123cm
  • Analysis: "the dimension and weight difference are just in physical specification and this difference will not raise any issues in safety and effectiveness. By complying with AAMI/ANSV/ES 60601-1, the mechanical performance of the proposed device is determined to be accepted."
• Weight:
  • Proposed: 62kg
  • Predicate: 75kg
  • Analysis: (Same as Dimension)

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no clinical test set, sample size, or specific data provenance (country of origin, retrospective/prospective) for device performance on 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)

Not applicable, as no clinical study was performed.

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

Not applicable, as no clinical study was performed.

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, as this device is a laser therapy device for hair removal, not an AI-assisted diagnostic tool involving human readers.

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

This refers to the performance of a software algorithm. This device is a hardware laser therapy device, not a standalone algorithm. Therefore, this question is not applicable.

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

Since no clinical study was conducted, there is no patient-level ground truth data (like expert consensus, pathology, or outcomes data) specifically for this proposed device. The basis for substantial equivalence relies on the technical specifications and indications for use being similar to a legally marketed predicate device, and the device complying with relevant electrical, laser, and biocompatibility standards through non-clinical testing.

8. The sample size for the training set

Not applicable, as no algorithm or machine learning model requiring a training set is mentioned for this device.

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

Not applicable, as no algorithm or machine learning model requiring a training set is mentioned for this device.

In summary: The provided FDA 510(k) clearance document for the Diode laser therapy device is based on demonstrating substantial equivalence to a predicate device (K210663) through non-clinical performance testing (compliance with standards) and a comparison of technical specifications, rather than a new clinical study. Therefore, most of the requested information regarding clinical study design, test sets, ground truth, and AI-related metrics is not available in this document.

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The Q-Switched Nd: Yag laser is indicated for the treatment of: benign cutaneous lessons, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and the removal of black or blue tattoos.

The Q-switched laser therapy device is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In laser handpiece, there is one optical cavity containing the Nd: YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.

The provided document is a 510(k) premarket notification letter from the FDA regarding a Q-Switched Nd:Yag laser device. This type of document establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical data, especially not for AI/machine learning devices where such studies would be critical.

The document explicitly states:

• "No clinical study is included in this submission." (Page 9)
• The entire evaluation for substantial equivalence is based on "Non-Clinical Test Conclusion," showing compliance with various electrical safety, biocompatibility, and laser safety standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10), and Software Validation & Verification Test.

Therefore, I cannot provide the requested information for an acceptance criteria table, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided FDA 510(k) summary for this laser device.

The questions you've posed (acceptance criteria, sample size, expert ground truth, MRMC, etc.) are highly relevant for the validation of AI/ML-based medical devices or devices with a diagnostic component whose performance is assessed against human interpretation or clinical outcomes. The device in this document is a physical laser for treatment, and its FDA clearance is based on demonstrating equivalence in its technical specifications and adherence to relevant safety standards, not on diagnostic accuracy or AI performance.

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