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The Diode Laser Therapy Systems are intended for 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 Therapy System, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.

The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, such as arm, chest, leg, underarm etc.

The provided text is a 510(k) summary for a medical device called "Diode Laser Therapy Systems," which is intended for hair reduction. It details the device, its indications for use, and a comparison to predicate and reference devices.

However, the document does not contain information about acceptance criteria, the study design, ground truth establishment, or performance metrics typically associated with proving a device meets acceptance criteria through clinical or standalone studies for an AI/algorithm-based medical device.

Specifically, the document states: "No clinical study is included in this submission." This means there is no clinical performance data for this specific device in this submission to draw from to describe acceptance criteria or study results as requested in the prompt. The "study" mentioned in the prompt refers to a performance evaluation (often a clinical trial or a robust standalone study for AI devices).

The comparison table (Table 1: Comparison of Technology Characteristics) on page 6 primarily focuses on technical specifications (e.g., laser wavelength, spot size, fluence, electrical safety) and regulatory compliance with standards like ISO and IEC, rather than clinical performance metrics or AI algorithm performance.

Therefore, I cannot fulfill most of the request based on the provided text, as the information regarding clinical performance studies, acceptance criteria for such studies, and all related details (sample size, experts, ground truth, MRMC, standalone performance, training set details) is not present.

The document concludes that the device is "Substantially Equivalent (SE)" based on non-clinical tests and technological comparisons to predicate devices, not on the basis of a clinical performance study with defined acceptance criteria and tested results.

To answer your request based on the provided text, I must state that the information is absent.

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The device 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 Benign Pigmented Lesions
-Removal of Minor Benign 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 proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce 1064nm and 532nm two different laser wavelengths to treat the different color skin. It consists of power supply module, microprocessor control module, laser treatment handpiece module, operation display module and cooling system module. The physician is able to select the desired wavelength and the related output energy via control panel.

The provided text is a 510(k) Summary for a medical device (Nd:YAG Laser Therapy Systems). It states explicitly in section 11 "Clinical Testing" that "No clinical study is included in this submission."

Therefore, I cannot provide information on acceptance criteria and the study that proves the device meets those criteria, a table of acceptance criteria and reported device performance, sample sizes, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details, as no clinical studies were conducted or provided in this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (CuRAS Nd: YAG Laser, K173038) based on non-clinical testing, including electrical safety, EMC, biocompatibility, and software validation. It compares device specifications and indications for use, showing they are identical or very similar to the predicate.

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The Intense Pulsed Light (IPL) Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions.

The Intense Pulsed Light (IPL) Systems are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 430nm-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.

The provided text describes a 510(k) submission for the Intense Pulsed Light (IPL) Systems (K122995), which seeks to demonstrate substantial equivalence to a predicate device (IPULSELIGHT IPL SYSTEM, K093627). However, it does not contain information about a clinical study demonstrating the device's performance against specific acceptance criteria.

The document focuses on non-clinical bench tests to verify that the proposed device met design specifications and standard compliance, and a detailed comparison with the predicate device to establish substantial equivalence.

Therefore, many of the requested sections regarding acceptance criteria, study details, human reader performance, and ground truth establishment cannot be fulfilled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

Based on the provided text, there are no specific performance acceptance criteria reported for clinical efficacy. The "acceptance criteria" discussed are primarily related to safety and technical specifications, which are implicitly met by complying with the listed standards and demonstrating similarity to the predicate device.

Safety and Technical Performance Criteria (Inferred from compliance and 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/Not provided. The document states "Bench tests were conducted to verify that the proposed device met all design specifications," and these appear to be primarily engineering and safety compliance tests, not clinical performance studies involving a "test set" of patients or data in the typical sense of AI/diagnostic device evaluation. No information on data provenance or study type (retrospective/prospective) is available.

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/Not provided. No clinical ground truth establishment is mentioned, as there is no clinical performance study described.

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

Not applicable/Not provided. This is relevant for studies involving human assessment of data, 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

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an IPL system for various cosmetic and therapeutic applications, not an AI-assisted diagnostic or interpretation tool. The submission is for a medical device that directly performs a treatment.

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

Not applicable. The device is a physical IPL system, not an algorithm, and its performance is inherently human-in-the-loop (operated by a practitioner).

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

Not applicable/Not provided. For a treatment device, "ground truth" would typically refer to clinical outcomes measured against a recognized standard of care or objective physiological changes. No such clinical performance data or ground truth validation is detailed in this 510(k) summary, as the submission relies on substantial equivalence to the predicate device and compliance with safety standards rather than a de novo clinical efficacy study.

8. The sample size for the training set

Not applicable/Not provided. As there is no AI algorithm being developed or evaluated, there is no "training set" in this context.

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

Not applicable/Not provided. See point 8.

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