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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 is a medical device, and the provided text describes its 510(k) summary for FDA clearance. The "study" mentioned is a performance test to demonstrate the device's effects on tissue, rather than a clinical trial with acceptance criteria for statistical endpoints.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., "depth must be between X and Y"). Instead, the performance data seems to be presented to demonstrate the effect and healing response of the device, implying that the observed effects were deemed acceptable for its intended use and comparable to a predicate device. The conclusion of "substantial equivalence" is based on these demonstrated effects.

Reported Device Performance:

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

• Sample Size: The device was used "on a pig." The exact number of pigs or specific treatment sites on the pig is not detailed, but it indicates a very small sample, likely a single animal experimentation.
• Data Provenance: The data was generated through an experimental study on a pig. The country of origin is not specified but implicitly within the context of an FDA submission. This is a prospective study in the sense that the experiment was conducted specifically to generate this data.

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

The document does not explicitly state the number of experts or their qualifications for evaluating the histology data. It simply states the "targeted area was biopsied to evaluate the effect." It's implied that qualified personnel (e.g., pathologists or histologists) analyzed the biopsies, but no specific details are provided.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. Given the nature of the study (histology on a pig), it's highly unlikely that a formal adjudication process involving multiple human readers for a "test set" in the context of image interpretation was employed. The evaluation was likely direct analysis of tissue samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance data is derived from direct histological analysis of tissue treated by the device, not from human readers interpreting data with or without AI assistance. The concept of "human readers improve with AI vs without AI assistance" does not apply to this type of device and study.

6. Standalone Performance Study

Yes, a form of standalone performance study was done. The "Performance Data: Histology data was submitted to support clearance of the device in fractionated mode" describes the direct effect of the algorithm/device on tissue. This is a direct measurement of the device's physical output (thermal damage zones and healing response) without human-in-the-loop performance measurement.

7. Type of Ground Truth Used

The ground truth used was histology (microscopic examination of biopsied tissue). This provides direct biological evidence of the device's effects (depth and width of thermal damage zones and healing response).

8. Sample Size for the Training Set

The document does not mention a training set. This is because the Equinox CO2 Laser System is a physical laser device, not an AI/machine learning algorithm that requires a training set for model development. The performance evaluation is based on direct physical effects.

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

As there is no training set for this device type, this question is not applicable.

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The Tri-Beam Nd:YAG Laser System in indicated for: - the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):

-Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)

-Removal of Epidermal Pigmented Lesions

-Removal of Minor Vascular Lesions including but not limited to telangiectasias

-Treatment of Lentigines

-Treatment of Caff-Au-Lait

-Treatment of Seborrheic Keratoses

-Treatment of Post Inflammatory Hyper-Pigmentation

-Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength:

-Tattoo removal: dark ink (black, blue and brown)

-Removal of Nevus of Ota

-Removal or lightening of unwanted hair with or without adjuvant preparation.

-Treatment of Common Nevi

-Skin resurfacing procedures for the treatment of acne scars and wrinkle

The E-Beam Nd:YAG Laser System is a O-Switch laser with wavelengths of 1064nm and 532nm. Optional Dye attachments to the handpiece add additional wavelengths of 585nm and 650nm. This system consists of main body, color touch screen, articulated arm hand-piece and Foot switch.

The E-Beam Nd:YAG Laser System can also be used in a long pulse mode.

Here's a breakdown of the acceptance criteria and the study information for the E-Beam Nd:YAG Laser System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this 510(k) summary does not provide explicit acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for clinical outcomes. Instead, the "acceptance criteria" are implied through the direct comparison of technical specifications to a predicate device, aiming for substantial equivalence. The reported device "performance" is, therefore, the matching of these technical specs to the predicate.

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

• The document explicitly states "None" for "Performance Data: Results of Clinical Study".
• Therefore, there is no test set sample size and no data provenance (country of origin, retrospective or prospective) for a clinical study. The submission relies solely on technical comparison for substantial equivalence.

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

• Since no clinical study was performed, there was no ground truth established by experts for a test set.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical study or 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. This is a laser device, not an AI diagnostic or assistive device that would involve human "readers" or an "effect size of human improvement with AI." The document explicitly states "None" for clinical study results.

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

• Not applicable. This is a medical device (laser system), not an algorithm or AI. The concept of "standalone performance" in this context refers to the device's technical specifications and intended functionality, which were evaluated through direct comparison to the predicate.

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

• For the purpose of this 510(k) submission, the "ground truth" for the device's performance is established by its technical specifications directly matching or being functionally equivalent to the technical specifications of the legally marketed predicate device (Lutronic Spectra Laser System K113588). No clinical ground truth (e.g., pathology, outcomes data) based on human subjects was used.

8. The sample size for the training set

• Not applicable. This is not an AI or machine learning device that would require a "training set."

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

• Not applicable. As there is no training set mentioned or implied.

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