Search Results

The indications for use for the SILKPRO-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the SILKPRO-S20S-755A 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. Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes) The indications for use for the SILKPRO-S20S-810B 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 airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

The working principle of SILKPRO Titanium Diode Laser System is selective photothermal effect. It uses its unique long pulse width laser to penetrate the epidermis to the hair follicle. The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The treatment head adopts a uniquely designed sapphire dynamic cooling device. SILKPRO Titanium Diode Laser System is a sophisticated high-tech laser equipment. The machine includes water cooling system. Water flows through the pipes in the handpiece to dissipate heat for the light source and the TEC water cooling block , which is used to cool the skin tissue during treatment.

The provided text is a 510(k) premarket notification for a medical device, specifically a laser system for hair removal. It aims to demonstrate that the new device, SILKPRO Titanium Diode Laser System, is substantially equivalent to a legally marketed predicate device, the Soprano Titanium.

However, the provided document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of an AI/ML-driven medical device. The document is a traditional 510(k) summary, which focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and safety/performance verification through non-clinical testing (e.g., electrical safety, software validation, biocompatibility).

The text does not mention:

• Any AI/ML components or algorithms in the device.
• Performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML validation.
• Test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies.

Therefore, I cannot populate the requested table or sections related to AI/ML device validation. The information in the prompt is specific to an AI/ML system's evaluation, which is not described in the provided FDA document.

To directly answer your request based on the provided text, the document does not present the type of information needed to fill out the table and study description you've requested because the device (SILKPRO Titanium Diode Laser System) is a traditional laser device, not an AI/ML device.

The document primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and intended use of the proposed device to a predicate device. The "acceptance criteria" are implied by meeting the standards and demonstrating similar safety and performance characteristics to the predicate, as verified through non-clinical tests.

If this were an AI/ML device, the requested information would be crucial. Since it is not, the concept of "acceptance criteria" and "study proving it meets acceptance criteria" for an AI/ML system, as you've defined, is not applicable here.

Ask a specific question about this device

The Powersculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

PowerSculp laser lipolysis system is a diode laser system that emits laser radiation centered at 1064nm in order to achieve non-invasive laser lipolysis. Main components of the device include the laser console with display and controls, and four cooled laser applicators that attach to frames and a belt that is attached to the person being treated. The device is powered by an alternating current electrical power source.

The provided document, a 510(k) Premarket Notification summary for the Lotuxs Medtech (Suzhou) Co., Ltd. Powersculp laser lipolysis system, explicitly states:

"No clinical tests were provided for this pre-market notification." (Page 7, Section 9. Clinical Tests)

Therefore, based on the provided text, there is no study that proves the device meets acceptance criteria, as no clinical studies were submitted. The acceptance criteria and the study details requested cannot be extracted from this document because such a study was not performed or submitted as part of this 510(k) application.

The 510(k) clearance for this device was based on non-clinical tests demonstrating substantial equivalence to a predicate device (K191068 Powersculp laser lipolysis system), not on a clinical effectiveness study.

Here's an breakdown of the information that can be extracted from the provided document, in relation to the prompt's requests:

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

• Acceptance Criteria (Implied by Non-Clinical Testing): The acceptance criteria for this 510(k) submission are based on demonstrating that the proposed device performs as intended and is as safe and effective as the predicate device through non-clinical testing. This primarily involved meeting engineering specifications and safety standards.
  • Software verification and validation: Software performs as intended.
  • Power Output: Meets specification.
  • Electromagnetic Compatibility and Electrical Safety: Complies with IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-2-22, and IEC 60825-1.
  • Biocompatibility: Patient contacting materials assessed per ISO 10993-1 and found to be biocompatible.
• Reported Device Performance (from Non-Clinical Tests): The document confirms that the device met these criteria:
  • Software verification and validation performed, demonstrated software performs as intended.
  • Testing confirmed power output meets specification.
  • EMC and electrical safety testing performed, results confirmed the device meets the standards.
  • All patient contacting materials assessed and found biocompatible.

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

• Not applicable as no clinical test set was used. Non-clinical tests would involve specific units of the device and testing materials, but these are not analogous to patient sample sizes for clinical studies.

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

• Not applicable as no clinical test set requiring expert ground truth was used.

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

• Not applicable as no clinical test set 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 as no clinical effectiveness study, specifically an MRMC study, was conducted or submitted. This device is not an AI-assisted diagnostic tool.

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

• Not applicable. This is a laser lipolysis system, not an algorithm, so standalone performance in the context of an algorithm is irrelevant.

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

• Not applicable for clinical ground truth as no clinical studies were performed. For the non-clinical tests, "ground truth" would be the engineering specifications and safety standards against which the device performance was measured.

8. The sample size for the training set:

• Not applicable as no AI/machine learning model requiring a training set was involved.

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

• Not applicable as no AI/machine learning model requiring a training set was involved.

In summary, the 510(k) clearance for the Powersculp laser lipolysis system (K211402) was based solely on non-clinical testing and a demonstration of substantial equivalence to a predicate device, not on clinical performance data or studies involving human subjects to establish effectiveness for the indicated use.

Ask a specific question about this device