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The i-lipo™ Low Level Laser System is indicated for Non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.

The i-lipo™ System consists of a main unit, and applied parts consisting of various laser diode cluster probes and pads. The Main Unit contains the mains input, fuses, power supply, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The cluster probes and pads, which are placed against the patients skin, contain the Laser diodes. Laser energy promotes disruption of adipocyte cells within the fat layer for release of fat and lipids from these cells for non-invasive aesthetic use.

The provided text describes the i-lipo™ device and its 510(k) summary, which includes information about its intended use, comparison to predicate devices, and clinical testing. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case study information, standalone algorithm performance, or ground truth details in the format requested.

The document primarily focuses on establishing substantial equivalence to predicate devices and states that "Randomised, blinded, placebo controlled circumferential reduction studies of the selected treatment area have been performed, which demonstrates the efficacy of the device..." without providing the numerical results or the specific criteria for demonstrating efficacy.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's what can be gathered, with significant gaps based on the absence of the requested data:

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

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

• Sample Size (Test Set): Not specified.
• Data Provenance: The study was "Randomised, blinded, placebo controlled circumferential reduction studies." The submitter is from the UK, so it's plausible the study was conducted there, but this is not explicitly stated. It was a prospective study.

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 the ground truth appears to be objective measurements (circumferential reduction) rather than expert interpretation of images or other data.

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

• Not applicable/not specified for the measurement of circumferential reduction.

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 low-level laser system for aesthetic treatment, not an AI diagnostic or interpretive device involving human readers.

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

• Not applicable as this is a medical device, not an algorithm. The device performance (efficacy in reducing waist circumference) was evaluated directly.

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

• The ground truth type was outcomes data, specifically the "circumferential reduction of the waist." This is a direct physical measurement.

8. The sample size for the training set

• Not applicable. This is a medical device approval, not an AI algorithm development where a "training set" would be used in the same context. The study population for the clinical testing would be equivalent to the dataset used to demonstrate efficacy. The sample size for this dataset is not specified.

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

• Not applicable (see point 8). For the clinical study demonstrating efficacy, the ground truth (circumferential reduction) was established through direct measurement on study participants.

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Indications for use for Fitzpatrick skin types (I to V).

The Chromolite™ EP System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostatis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:-

Indications for use for Fitzpatrick skin types (I to V).

• . The treatment of moderate inflammatory acne vulgaris
• The treatment of benign pigmented epidermal lesions including dyschromia, hyper-. pigmentation, melasma, ephelides (freckles)
• . The treatment of cutaneous lesions including warts,scars, and striae.
• . The treatment of benign cutaneous vascular lesioins, including port wine stains, hemamangiomas, facial, truncal, and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
• . The removal of unwanted hair and to effect stable long-term or permanent hair reduction.

1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

The Chromolite™ EP System is an Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate, to offer light based therapies as listed in the indications for use. The Chromolite" " EP System emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of up to 0.5Hz.

The provided text is a 510(k) summary for the Chromolite™ EP System, an Intense Pulsed Light (IPL) device. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert involvement, ground truth establishment, or specific performance metrics.

The document states that the Chromolite™ EP System is a hardware and software modification of a previously cleared device (Chomolite™ System) and that both have the same intended use and operating principle. The FDA's letter confirms substantial equivalence to a legally marketed predicate device. This implies that the device's safety and effectiveness are established by demonstrating it is as safe and effective as a device already on the market, rather than through a new, independent performance study meeting specific acceptance criteria that would typically be described for a novel device or a device claiming a new indication.

Therefore, I cannot fulfill your request for:

1. Table of acceptance criteria and reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to a predicate device.
2. Sample sizes, data provenance: Not mentioned.
3. Number of experts and qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned and likely not applicable for a substantial equivalence claim based on modifications to an existing IPL device.
6. Standalone performance: Not mentioned. The device's performance is implicitly linked to the predicate device it is substantially equivalent to.
7. Type of ground truth: Not mentioned.
8. Training set sample size: Not mentioned.
9. How ground truth for training set was established: Not mentioned.

The 510(k) summary provided is focused on regulatory clearance through substantial equivalence, not on detailing a performance study with specific acceptance criteria and results.

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