Search Results

The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) 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, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of 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 regime. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different.

The provided FDA 510(k) clearance letter and synopsis are for a Medical Diode Laser Hair Removal Device. This document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this device submission.

The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence for a hardware device. It explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide a table of AI acceptance criteria or details about AI-specific studies as requested, because this information is not present in the provided document and is not relevant to the type of device being cleared.

However, I can extract the acceptance criteria and performance information that is relevant to this type of physical device, based on the non-clinical testing mentioned:

Acceptance Criteria and Reported Device Performance (Non-Clinical for a Physical Device)

Regarding the AI/SaMD specific questions from your prompt:

1. Sample size used for the test set and the data provenance: Not applicable. No AI/SaMD test set described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/SaMD ground truth described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Global Med Systems Milesman Compact Laser is intended for use in dermatological and general surgical procedures including hair removal and permanent hair reduction. 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. It is intended for use on all skin types (Fitzpatrick skin types 1-VI), including tanned skin.

The Global Med Systems Milesman Compact Laser delivers pulsed laser energy at 810 nm to the surface of the skin using a handpiece which contains the laser diodes. The Milesman Compact consists of the following components:

1. The main console unit
2. Handpiece
3. Umbilical (between main console and handpiece)
4. Footswitch
   The system is operated using the touch screen on top of the main console unit. Firing of the laser is controlled with either the footswitch or the trigger on the handpiece.
   During hair removal, the laser emits a wavelength of light that is absorbed by the pigment (melanin) in the hair. The light energy is converted to heat, which damages the tube-shaped sacs within the skin (hair follicles) that produce the hair. This damage inhibits or delays future hair growth.
   The face of the hand piece which comes into contact with skin is actively cooled with a circulating coolant fluid.

The Global Med Systems Milesman Compact Laser (K203804) did not provide acceptance criteria and device performance that would traditionally be found in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. The provided document is a 510(k) summary for a laser surgical instrument and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than clinical efficacy or AI model performance.

Therefore, many of the requested fields regarding acceptance criteria, study methodologies for AI, expert involvement, and ground truth are not applicable or cannot be extracted from this document because it describes a hardware device, not an AI/ML-powered one.

Here's an analysis based on the information available:

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

The document does not present a table of specific acceptance criteria for AI model performance and corresponding reported device performance, as it is not an AI/ML device. Instead, the device's performance is demonstrated through compliance with various safety and electrical standards, and through a comparison of technological characteristics with predicate devices.

2. Sample sized 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 a laser surgical instrument, and no clinical test set data for an AI/ML model is involved or reported. The performance data provided is focused on engineering and safety standards compliance.

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 this is not an AI/ML device, there is no "ground truth" to establish through expert consensus for a test set.

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

Not applicable. There is no test set for an AI/ML model to require an adjudication method.

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 is not an AI/ML device, so no MRMC study or AI-assisted human reader performance was conducted.

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

Not applicable. This is not an AI/ML device, so no standalone algorithm performance was assessed.

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

Not applicable. There is no "ground truth" in the context of an AI/ML model for this device. The assessment of the device's capabilities is based on its functional specifications and compliance with safety standards.

8. The sample size for the training set

Not applicable. This device is a laser surgical instrument and does not involve AI model training.

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

Not applicable. There is no training set or associated ground truth for an AI model.

Summary of Relevant Performance Data from the Document (Non-AI/ML):

The performance data provided for the Global Med Systems Milesman Compact Laser focuses on the following non-clinical assessments to support its safety and design verification:

• Standards Compliance:
  • IEC 60825-1 Edition 3.0 2014-05: Safety of laser products – Part 1: Equipment classification and requirements
  • IEC 60601-2-22: Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
• Biocompatibility Testing:
  • Compact Biocompatibility report for in vitro cytotoxicity
  • Compact Biocompatibility report for Dermal Irritation
  • Compact Biocompatibility report for Skin Sensitization
• Electrical Safety and Electromagnetic Compatibility (EMC):
  • IEC 60601-1:2005: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    • Note: A gap analysis was performed to demonstrate compliance with FDA-recognized standard AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012.
• Software Verification and Validation Testing:
  • Considered a "major" level of concern.
  • Testing performed at unit and integrated levels using written protocols.
  • Acceptance criteria defined by the Software Requirements Specification (SRS).
  • Verification tested actual outputs against expected outputs for pre-established inputs.
  • Validation performed at the system level using simulated use scenarios.
  • Traceability matrix used for thoroughness.
  • All software successfully passed verification and validation testing.

Conclusion stated in the document (Non-AI/ML):

The non-clinical data support the safety of the device and design verification and validation demonstrate that the Global Med Systems Milesman Compact device performs as intended in the specified use conditions. It performs comparably to the predicate device (and reference device) for the same intended use and shares similar indications, design features, and functional features, making it as safe, effective, and performant as the legally marketed predicate devices.

Ask a specific question about this device

Intended Use: The additional Soprano 1064nm Diode Laser Module is intended for use in dermatologic and general surgical procedures.

Indications for Use: The indications for use for the Soprano1064nm Diode Laser Module include:

• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended 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.
• Treatment of Pseudo folliculitis Barbae (PFB)
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The subject device, Alma Lasers Soprano 1064nm Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano 100 platform. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, footswitch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module; the footswitch and pre-existing modules are also unmodified from those cleared in K140009.

The module's operation involves emission of laser (diode) energy through the handpiece to the patient's skin. The materials that could contact the patient during device use are sapphire, aluminum, and plastic; these would all have limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

This document describes the marketing authorization for a medical device and does not include information about specific acceptance criteria or performance studies of the kind typically associated with AI/ML-driven devices.

The device in question, the "Modified Alma Lasers Soprano XL Family Of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece" (specifically, the additional 1064nm Diode Laser Module), is a laser surgical instrument. The FDA review is for a 510(k) premarket notification, which establishes substantial equivalence to existing legally marketed predicate devices.

Therefore, most of the requested information (like performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this document as it pertains to a traditional medical device approval based on technological equivalence and established safety standards rather than AI/ML performance.

However, I can extract the relevant information from the provided text:

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

This document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML device. Instead, the "acceptance criteria" for this 510(k) clearance are based on substantial equivalence to predicate devices in terms of:

• Intended Use: Dermatologic and general surgical procedures.
• Indications for Use: Permanent reduction in hair regrowth (HR and SHR modes), treatment of Pseudofolliculitis Barbae (PFB), and use on all skin types (Fitzpatrick I-VI), including tanned skin.
• Technological Characteristics: Wavelength (1064nm), laser media (Solid State), mode (HR, SHR), spot size, pulse width, pulse repetition rate, energy density, user interface, delivery device type, and compatible laser system.
• Safety and Effectiveness: Demonstrated through compliance with recognized device standards and comparison to predicate devices, without raising new questions of safety or effectiveness.

The "reported device performance" is essentially that the device functioned as intended and the results observed were as expected during performance testing against established electrical safety, electromagnetic compatibility, and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-1-6, IEC 60825-1).

Table Summarizing Equivalence:

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

No clinical studies (test sets on patients) were deemed necessary for this 510(k) submission. "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission." Therefore, this information is not applicable.

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 test set was required.

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

Not applicable, as no clinical test set was required.

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 is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

Not applicable, as no new clinical ground truth data was generated for this submission. The "ground truth" for the device's functionality is its adherence to established engineering and safety standards and its equivalence to already cleared predicate devices for the specified indications of use.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Ask a specific question about this device