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The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus and Ultimate) 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 Diode Laser Hair Removal Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch and a laser handpiece. There are five models included, EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate, the five models have same mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 J/cm^2), M-I-X MEDICAL (1-70 J/cm^2), GENESIS (1-74 J/cm^2), Lotus(1-67 J/cm^2), and Ultimate(1-65 J/ cm^2).

Changes to the device include the addition of a remote link to the device to obtain and back up the device's usage data, a remote upgrade function, and the ability to provide a URL for users to download the device's usage data, as compared to previously listed devices.

The provided text describes a 510(k) premarket notification for a Diode Laser Hair Removal Device. This document focuses on establishing substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a new device's performance.

Therefore, the sections below requiring information about acceptance criteria and a study proving the device meets them cannot be fully populated as they would for a de novo or PMA submission. The document primarily discusses non-clinical tests to verify design specifications and compliance with standards.

Here's the information that can be extracted or inferred from the provided text, with clarifications where details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of explicit acceptance criteria with corresponding device performance metrics for efficacy (e.g., specific hair reduction percentages) as would be found in a clinical study report for a new device.

Instead, the document focuses on demonstrating that the device meets safety and performance standards and is technologically equivalent to its predicate. The "performance" discussed primarily relates to meeting design specifications and regulatory standards.

2. Sample Size Used for the Test Set and Data Provenance

The document primarily refers to non-clinical tests for compliance with standards and design specifications. It does not describe a clinical test set with human subjects.

• Test Set Sample Size: Not applicable as a clinical test set is not described. The tests are for device components and system performance.
• Data Provenance: The tests are non-clinical, related to device manufacturing and engineering compliance. No country of origin for clinical data is applicable. The tests are prospective in the sense that they are conducted on the new device to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes non-clinical engineering and compliance testing, not a clinical study requiring expert ground truth assessment.

4. Adjudication Method for the Test Set

Not applicable, as this refers to a clinical study with human observers or interpreters, 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

Not applicable. This device is a laser hair removal system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in a diagnostic context.

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

Not applicable. This device is a physical laser system, not an algorithm, and the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the requirements outlined in the cited international and national standards (e.g., IEC 60601-1, ISO 10993) and the device's design specifications. These standards provide benchmarks and methodologies against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. As this document details hardware medical devices, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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Dental, oral, and soft tissue surgery including:

Sulcular debridement of diseased or fibrous tissue

Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation

Laser Periodontal procedures, including:

Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Removal of inflamed edematous tissue.

The Odyssey Navigator Diode Laser is a portable device for delivering laser energy to surfaces within the oral cavity. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to the surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 650mm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery option.

The working end of the delivery fiber is a disposable single-use tip which is attached to a metal autoclavable handpiece. This handpiece system is provided with the device. The fiber tip attachment assembly is delivered sterilized in individual mylar blister packages. Sterlization is accomplished by Irradiation.

The activation of the working beam diodes is completed by use of a foot-actuated switch.

The provided text is a 510(k) Summary for the Odyssey Navigator Diode Laser, seeking substantial equivalence to existing predicate devices. It describes the device's technical specifications, intended uses, and compliance with performance standards. However, it does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance data in the way requested by the prompt (i.e., sensitivity, specificity, accuracy, etc., from a clinical trial).

Instead, the document details the technical characteristics of the new device and compares them to legally marketed predicate devices to establish substantial equivalence. This is a common approach for 510(k) clearances for devices like this, where clinical performance is often inferred from the known performance of substantially equivalent predicate devices with similar technological characteristics and intended uses.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, accuracy). Instead, it relies on demonstrating that the new device's technical specifications (performance characteristics) are similar to those of legally marketed predicate devices.

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 / Information not provided. This document does not describe a clinical trial or performance study with a test set of data. The submission relies on technical characteristics for substantial equivalence.

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 / Information not provided. No ground truth establishment is described as there is no performance study where expert assessment would be needed for a test set.

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

• Not applicable / Information not provided. No adjudication method is necessary because no clinical test set is 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

• No. This document is for a laser device, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device submission.

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

• Not applicable. This is a hardware device (diode laser), not an algorithm.

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

• Not applicable / Information not provided for a clinical performance study. The "ground truth" here is effectively the accepted performance and safety of the predicate devices.

8. The sample size for the training set

• Not applicable / Information not provided. This is not a machine learning device, so there is no "training set."

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

• Not applicable / Information not provided. As there is no training set, this information is not relevant.

Summary of the Study (as presented in the 510(k) Summary):

The "study" presented here is a technical and regulatory comparison rather than a clinical performance study. The manufacturer, Ivoclar Vivadent, Inc., performed a detailed comparison of their new device, the Odyssey Navigator Diode Laser, against two legally marketed predicate devices: the Odyssey 2.4G Diode Laser (also by Ivoclar Vivadent, Inc.) and the SiroLaser (by Sirona Dental Systems, Gmbh).

The purpose of this comparison was to demonstrate substantial equivalence to the predicate devices. This demonstration is achieved by showing that the Odyssey Navigator shares:

• Similar indications for use in the oral environment.
• Similar design features (wavelength, operating controls, laser delivery method).
• Similar methods of control systems, safety features, and performance monitoring.
• Similar performance specifications (power output, energy type).
• Compliance with recognized performance standards (21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, and IEC 60825-1).

The "study" concludes that "The Odyssey Navigator Diode Laser is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards."

In essence, the "proof" that the device meets acceptance criteria is its demonstration of substantial equivalence in technical and functional characteristics to devices already cleared for market, along with compliance to relevant safety standards for laser products.

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