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The Reliant Technologies Laser System II is intended for:

-Dermatological procedures requiring the coagulation of soft tissue;

-Treatment of periorbital wrinkles;

-Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia.

The Reliant Laser System II consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatological procedures. The system includes scanning and focusing optics to deliver a pattern of microscopic treatment zones (MTZs) to the epidermis and upper dermis. Device attachments and pre-treatment solution are also included.

The provided document is a 510(k) summary for the Reliant Laser System II. It describes the device, its intended use, and states that clinical performance data was used to demonstrate its function and safety. However, it does not contain specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Information provided in the document:

The document states: "Results of clinical evaluations were used to demonstrate that the Reliant Technologies Laser System II functioned as intended. Sufficient data have been gathered from clinical studies to determine that the Reliant Laser System II performs as clinically intended, and no issues of safety and effectiveness are introduced."

Missing Information:

• Specific Acceptance Criteria: The document does not define any quantitative or qualitative acceptance criteria that the device was tested against (e.g., a specific percentage reduction in wrinkles, a certain lesion clearance rate, or a defined safety threshold).
• Reported Device Performance: While it states the device "functioned as intended" and "performs as clinically intended," it does not provide any specific metrics, data, or results from the clinical evaluations to substantiate this claim.

2. Sample Size for the Test Set and Data Provenance

Missing Information:

• Sample Size: The document does not mention the number of subjects or cases included in any clinical evaluation or test set.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only generically refers to "clinical evaluations" and "clinical studies."

3. Number of Experts and their Qualifications for Ground Truth

Missing Information:

• The document does not describe the establishment of a "ground truth" using experts for any test set.
• It does not mention the number or qualifications of any experts involved in reviewing the clinical outcomes or data for the studies.

4. Adjudication Method for the Test Set

Missing Information:

• Since the document doesn't detail a test set or ground truth establishment process involving experts, an adjudication method is also not mentioned.

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

Missing Information:

• The document does not mention any MRMC comparative effectiveness study, nor does it discuss human readers, AI assistance, or an effect size. Laser devices like this typically focus on direct physiological effects rather than diagnostic interpretation assisted by AI.

6. Standalone (Algorithm Only) Performance Study

Missing Information:

• This is a standalone device in the context of a laser system, meaning it functions directly on the patient, not as a diagnostic algorithm that processes data. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as it relates to AI algorithms is not applicable here and no such study is mentioned or implied.

7. Type of Ground Truth Used

Missing Information:

• The document does not specify the type of ground truth used. For a laser device, "ground truth" would typically refer to clinical outcomes validated through physician assessment, patient satisfaction, or objective measurements (e.g., imaging, biopsies for lesion clearance), but no specifics are provided.

8. Sample Size for the Training Set

Missing Information:

• The document does not refer to any "training set." This term is specific to machine learning algorithms, which is not the nature of this medical device (a laser system).

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

Missing Information:

• As there is no mention of a "training set" (due to the nature of the device), there is no information on how its ground truth was established.

In summary, the provided 510(k) summary for the Reliant Laser System II broadly states that clinical evaluations demonstrated the device performs as intended and is safe and effective. However, it lacks the detailed information required to answer most of the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment. This level of detail is typically found in the full 510(k) submission, not necessarily in the publicly available summary.

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The Reliant Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

The Reliant Laser System consists of a set of diode lasers, controlled by an embedded processor, to be used in dermatology for the coagulation of soft tissue. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis.

The provided text is a 510(k) summary for the Reliant Laser System, which is a dermatology laser. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Here's a breakdown of why this information is absent in this type of document:

• Acceptance Criteria and Device Performance Table: Not applicable for a 510(k) summary. A 510(k) demonstrates substantial equivalence, often through comparisons of technological characteristics and intended use, not by meeting predefined performance criteria in a clinical trial.
• Sample sizes for test set and data provenance: No "test set" information is provided because a formal statistical study to prove performance against acceptance criteria was not conducted for this 510(k) submission.
• Number of experts and qualifications for ground truth: No such information is present as no "ground truth" was established in the context of a performance study described here.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this document. The device is a laser system, not an AI or diagnostic imaging device that would typically involve MRMC studies.
• Standalone algorithm performance: Not applicable, as this is a laser hardware system, not an algorithm.
• Type of ground truth used: Not applicable, as no performance study requiring ground truth is detailed.
• Sample size for training set: Not applicable, as this is a physical device and not an AI/machine learning algorithm that requires a training set.
• How ground truth for training set was established: Not applicable.

The document primarily focuses on:

• Describing the device and its intended use.
• Stating its compliance with laser product regulations (21 CFR § 1010 and 21 CFR § 1040).
• Declaring substantial equivalence to a predicate device (Lumenis Ultrapulse Encore).
• Listing references (K031795 2 of 2) which are general clinical research papers about CO2 lasers and skin, not specific studies validating the Reliant Laser System's performance against predefined criteria.

In summary, this 510(k) document is not designed to provide the kind of performance study data and acceptance criteria you've asked for. It serves a different regulatory purpose. This type of information is usually found in Pre-Market Approval (PMA) applications or more extensive clinical trial reports for devices requiring higher levels of evidence.

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