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(1) IPL: The Therapy IPL is intended for medical use in the following dermatologic conditions: Permanent hair reduction- long-terms table reduction in number of hairs re-growing after a treatment - Moderate inflammatory acne vulgaris; - Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); - Cutaneous lesions including scars; - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

(2) Diode laser: Diode laser treatment handset is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin type I-VI), including tanned skin. 3) Triple Diode laser: The device is intended for use in dermatologic and general surgical procedures.

The Triple diode laser Module is intended for use in dermatology procedures requiring coagulation. The Triple diode laser Module is indicated for: - Benign vascular and vascular dependent lesions removal.

(4) Picosecond Nd: Y AG Laser: The Picosecond Nd: Y AG Laser is intended for use in surgical and aestheir applications in the medical specialties of dermatology and general and plastic surgery. - The 1064nm wavelength of the Picosecond Nd:YAG Laser is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). - The 532mm wavelength of the Picosecond Nd: Y AG Laser is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types 1-III.

(5) 1064nm Long pulse Nd: YAG: The 1064nm Long pulse Nd: YAG is indicated for - Benign vascular lesions. - Superficial and deep telangiectasias). - Benign cutaneous lesions. - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles. - Laser skin resurfacing procedures. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. - Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. - Removal or lightening of unwanted hair (with and without adjuvant preparation). - Treatment of pseudofolliculitis barbae (PFB).

(6) Q-switch Nd:YAG laser: The Q-switch Nd:YAG Laseris Module indicated for: -Benign vascular and pigmented lesions, age spots. - Nevus spilus. - Tattoo removal.

The BL-M10 is a new platform treatment system with 12.1" display screen which combines IPL/ Diode Laser/Triple Diode Laser/ Picosecond Nd:YAG Laser/ 1064nm Long pulse Nd:YAG laser and Q-switch Nd:YAG Laser functions. This is 6 in 1 platform machine, that provides different function with attaching different hand pieces. The system is designed with a mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities in combination or in isolative and non-ablative treatment of skin surface. The system includes various energy sources and dedicated hand-pieces intended to apply the different energies to the skin for respective indications for use.

This device is a Multi-function Platform System (BL-M10) which includes IPL, Diode laser, Triple Diode laser, Picosecond Nd:YAG Laser, 1064nm Long pulse Nd:YAG, and Q-switch Nd:YAG laser functions. The acceptance criteria and supporting studies are presented through a substantial equivalence discussion with multiple predicate devices for each function.

A general acceptance criterion for all functions is that the differences between the subject device and the predicate device should not raise new concerns regarding intended use or safety.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by showing substantial equivalence to existing predicate devices. The reported device performance is demonstrated by comparing its features with those of the predicate devices. Since there are multiple functions and predicates, a combined table is challenging without further clarification of "acceptance criteria" beyond substantial equivalence. However, the document outlines feature-by-feature comparisons for each function, highlighting similarities and differences.

Let's extract a representative sample for the IPL function from "Tabel 1 Substantial equivalence discussion - IPL":

Similar tables are provided for Diode Laser, Triple Diode laser, Picosecond Nd:YAG Laser, 1064nm Long pulse Nd:YAG, and Q-switch Nd:YAG Laser functions.
The overall acceptance criterion is that any identified differences do not raise concerns regarding the intended use or safety of the subject device, which is concluded to be met for all functions.

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

The document states "VII.1. Non-Clinical Testing: A battery of tests was performed to verify that the proposed device met all design specification." and "VII.2. Performance Testing: Each handpiece underwent rigorous performance testing to verify adherence to specified energy output, wavelength accuracy, pulse duration, and spot size."
No specific sample size for a "test set" (e.g., number of devices or units tested) is provided. The testing is non-clinical.
Data provenance: The tests were conducted internally by Shanghai Bele Medical Technology Co., Ltd. for verification and compliance with standards. It is non-clinical testing.

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

Not applicable. The document describes non-clinical testing for safety and performance characteristics, comparing technical specifications to predicate devices and recognized standards. It does not involve a "test set" requiring expert-established ground truth for diagnostic accuracy, for example.

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

Not applicable. This section is for clinical studies involving human observers and diagnostic ground truth adjudication, which is not described.

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/light treatment system, not an AI-powered diagnostic imaging device that assists human readers. No MRMC study was performed.

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

Not applicable. This device is a medical instrument used by practitioners, not a standalone algorithm.

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

For non-clinical testing, the "ground truth" for performance is based on engineering specifications, compliance with recognized international standards (e.g., IEC 60601 series, IEC 60825-1, IEC 62471), and direct measurement of physical parameters like energy output, wavelength, pulse duration, and spot size. For safety, the ground truth is compliance with the relevant safety standards.

8. The sample size for the training set

Not applicable. This submission describes a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As stated above, this is not a machine learning device.

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The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The BL-C10 Picosecond ND:YAG Laser Systems is designed with a mains electricity (AC-powered) light amplification by stimulated emission of radiation (LASER) device assembly based on neodymium-doped yttrium-aluminium-garnet (Nd:YAG) and frequency-doubled Nd:YAG laser technology. The laser system generates ultra-short pulses in the picosecond range (1 picosecond = 10^-12 seconds). The pulses are then amplified within the Nd:YAG crystal. The system operates at two wavelengths: 1064nm and 532mm. These wavelengths are chosen to target different colors of pigments in tattoos and pigmented lesions.

• 1064nm Wavelength: Used for treating tattoos with colors like black, brown, green, blue, and purple, as well as for treating benign pigmented lesions.

• 532nm Wavelength: Used for removing tattoos with colors such as red, yellow, and for treating benign pigmented lesions. The ultra-short pulses have very high peak power, allowing them to interact with target (tattoos or pigmented lesions) in a precise and controlled manner. The short duration of the pulses helps minimize heat buildup in surrounding tissues.

I am sorry, but the provided text from the FDA 510(k) K240386 submission for the "Picosecond Nd: YAG Laser Systems (BL-C10)" does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document primarily focuses on:

• Regulatory correspondence: FDA's substantial equivalence determination letter.
• Device description: Information about the Picosecond Nd:YAG Laser System (BL-C10), its wavelengths, and intended uses.
• Comparison to predicate devices: Discussion of technological similarities and minor differences between the BL-C10 and its predicates.
• Non-clinical testing: A list of international standards (IEC 60601-1, IEC 60601-1-2, etc.) that the device complies with, related to electrical safety and electromagnetic compatibility.
• Conclusion: Statement that the device is substantially equivalent to the predicate based on performance testing and validation studies which are not detailed in this public summary.

Specifically, the section "Non-Clinical and/or Clinical Tests Summary & Conclusions" states:

• "Non-Clinical Testing: A battery of tests was performed to verify that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards: [lists electrical safety and EMC standards]."
• "Clinical Testing: It is not applicable."

This clearly indicates that no clinical studies were performed or reported for this device in this submission, which means there would be no data on human-in-the-loop performance, standalone AI performance, or ground truth for such studies.

Therefore, I cannot fulfill your request for the information outlined in your prompt because the provided text does not contain it. The device in question is a laser system, not an AI/ML-driven diagnostic or therapeutic device for which such detailed performance study information would be typically found in a public 510(k) summary.

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This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The BL-A10 is a 1060nm Diode Hyperthermic Laser Lipolysis system and is the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce fat in areas such as flank and abdomen. The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. It is designed to meet international safety and performance standards.

The provided text is a 510(k) summary for the "Diode Laser Body Sculpture Systems," a medical device intended for non-invasive lipolysis. While it details the device and its equivalence to a predicate device, it explicitly states, "Clinical Testing: It is not applicable."

Therefore, I cannot provide information on acceptance criteria or a study that proves the device meets those criteria from this document. The manufacturer has determined that clinical testing is not necessary to demonstrate substantial equivalence to the predicate device for this submission.

The document discusses non-clinical testing, including electrical safety, electromagnetic compatibility, and biocompatibility, but these do not involve proving the device meets specific performance criteria for its intended clinical effect through human trials.

To summarize, for your specific request:

1. A table of acceptance criteria and the reported device performance: Not provided in the document as clinical testing was deemed "not applicable."
2. Sample sized used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 physical laser system, not an AI diagnostic tool).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (SculpSure K182741) based on similar indications for use, technological characteristics (laser type, wavelength, lipolysis method), and compliance with electrical safety and biocompatibility standards.

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