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The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.

The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.

The Equinox CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color touch screen, Arm, hand-piece and Foot switch.

The Equinox CO2 Laser System's performance for the fractionated mode was shown by histology data. The study involved using the device on a human arm with varying energy levels (10mJ, 40mJ, 70mJ per microbeam). The target area was then biopsied to evaluate the effect, specifically looking at the depth and width of thermal damage zones and the healing response over time.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the device must meet to be deemed acceptable. Instead, it presents the histology data from the study and then concludes that based on this data (and similar technology characteristics), the device is substantially equivalent to the predicate device. The performance data itself serves as the support for this claim of substantial equivalence for ablative skin resurfacing.

Therefore, the "acceptance criteria" can be inferred to be the demonstration of typical thermal damage and healing patterns consistent with fractional CO2 laser resurfacing, which the provided data aims to illustrate. The reported device performance is the histology data.

(Note: Data for 10mJ and 40mJ at Day 14 were "X", indicating they were not provided or not relevant for the conclusion at those specific energy levels and time points in this summary.)

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

• Sample Size: The document states the device was "used on a human arm." It does not specify the number of subjects or the number of sites on the arm. It implies a single human subject ("a human arm").
• Data Provenance: The document does not explicitly state the country of origin. It is a retrospective report of a study that was conducted.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the histology (e.g., who interpreted the biopsies). It simply states the target area "was biopsied to evaluate the effect."

4. Adjudication Method for the Test Set

The document does not describe any 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

No MRMC study was done, as this is a laser device, not an AI diagnostic tool involving human readers.

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

This refers to a standalone performance of the laser device itself, directly evaluating its physical effects on tissue, which is precisely what the histology study represents. The device's performance was assessed based on the direct results (thermal damage depth and width) in the biological tissue.

7. The Type of Ground Truth Used

The ground truth used was histology from biopsied tissue. This is considered objective biological evidence of the device's effects on human skin.

8. The Sample Size for the Training Set

The document does not mention a training set. This is a medical device performance study, not an AI model requiring separate training data.

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

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

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The 500 – 1200nm intense pulsed light wavelengths are indicated for:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles)
• The treatment of cutaneous lesions, including warts, scars and striae
  The 560 – 1200nm intense pulsed light wavelengths are indicated for:
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
  The 600 - 1200nm intense pulsed light wavelengths are indicated for:
• The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
  The 400 - 1200nm intense pulsed light wavelengths are indicated for:
• The treatment of moderate inflammatory acne vulgaris.

The Fusion System consists of:
The main console unit that incorporates the touch-screen control panel, power supply module, cooling system, switching module and isolation transformer
Variety of handpieces
Footswitch

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fusion System, extracting the requested information:

Assessment: The provided document is a 510(k) summary for a medical device (Fusion System), which is primarily focused on demonstrating substantial equivalence to a predicate device. While it lists intended uses, it explicitly states "None" for "Performance Data: Results of Clinical Study:", and "None" for "Conclusion:" regarding performance data specific to the Fusion System itself. Therefore, many of the requested details about acceptance criteria, device performance, and study specifics cannot be found in this document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "None" under "Results of Clinical Study".
• Data Provenance: Not specified. No clinical study data is reported.

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

• Number of Experts: Not applicable, as no external test set or ground truth establishment is reported for performance evaluation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Not applicable, as no external test set or adjudication process is reported.

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

• MRMC Study: No. The document states "None" for "Results of Clinical Study".
• Effect Size: Not applicable.

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

• No, a standalone study was not done or reported. The device is a physical IPL system, not an algorithm. The document explicitly states "None" for "Results of Clinical Study".

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

• Not applicable, as no ground truth was established or used for performance evaluation within this document.

8. The sample size for the training set

• Not applicable, as this device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable, as this device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, there is no "training set" or ground truth establishment in this context.

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