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The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to: Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angioma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars. Striea, and Psoriasis. Podiatry - for benign cutaneous lesions and warts. The Dual Yellow lase, operating at 511 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutancous pigmented lesions including but not limited to: Lentigines, Solar keratoses. Adenoma serabaceum, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringomas Seborrhoeic keratoses Verrucae vulgaris, and Warts.

The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.

The provided text describes a 510(k) summary for the Norseld Dual Yellow D10B laser, which is a medical device. As such, the concept of "acceptance criteria" and "device performance" in the context of this submission differs significantly from that of AI/ML-based diagnostic devices.

For a medical device like a laser, the "acceptance criteria" are related to its intended use and safety through substantial equivalence to predicate devices, rather than statistical performance metrics like sensitivity, specificity, or AUC against a ground truth. The "study" proving it meets acceptance criteria is primarily an a demonstration of safety and effectiveness based on this substantial equivalence.

Here's how to interpret the provided information in the context of the requested table, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a laser device, the terms "sample size," "test set," "training set," "ground truth," and "experts" are not directly applicable in the way they are for AI/ML performance studies. The primary "study" is the demonstration of substantial equivalence to already approved predicate devices.

Here's an attempt to address the other points based on the provided text, noting where information is not available or not applicable:

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

• Sample Size: Not explicitly stated as a "test set" in the context of AI/ML. The only mention of a specific study is for "inflammatory acne vulgaris." The number of subjects in that study is not provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only mentions "a published clinical study" for one indication.

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/not stated. The concept of "ground truth" established by experts for a test set, as in AI/ML performance, is not discussed. The evaluation relies on clinical outcomes and comparison to predicate devices, where expert judgment might have been involved in the original studies of the predicate devices or in the single clinical study mentioned.
• Qualifications of Experts: Not applicable/not stated.

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

• Adjudication Method: Not applicable/not stated.

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: Not applicable. This is not an AI-assisted diagnostic device, but a therapeutic laser.

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

• Standalone Performance: Not applicable. This is a therapeutic laser device, not an algorithm. Its performance is tied to its physical operation and clinical use by a human.

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

• Type of Ground Truth: For the "published clinical study" mentioned for inflammatory acne vulgaris, the "ground truth" would likely be clinical outcomes data (e.g., reduction in lesion count, improvement in severity scores) based on dermatologist assessment. For other indications, the "ground truth" relies on the established efficacy and safety of the predicate devices for those conditions.

8. The sample size for the training set

• Sample Size: Not applicable. This is not an AI/ML device that uses a "training set."

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

• Ground Truth Establishment: Not applicable.

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The Dual Yellow Laser is intended for the treatment of vascular and pigmented lesions.

The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.

The provided text describes a 510(k) submission for the Norseld Dual Yellow D10B Laser. However, it does not contain a study or detailed performance data to establish acceptance criteria or prove that the device meets them, beyond stating that it has the "same specifications and indications for use" as a previously cleared predicate device.

Here's an analysis based on the provided text, highlighting what is present and what is missing in relation to your request:

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

• Acceptance Criteria: Not explicitly stated in the document. For laser devices, acceptance criteria would typically include parameters like wavelength, power output, spot size, pulse duration, energy density, safety features, and clinical efficacy for specific indications (e.g., clearance rates for vascular/pigmented lesions, complication rates).
• Reported Device Performance: The document only states: "The Dual Yellow D10B Laser has the same specifications and indications for use as the YellowStar Laser (K013940) which is also manufactured by Norseld, Pty., Ltd." This implies that its performance is considered equivalent to the predicate device, but no specific performance metrics or clinical trial results are presented for the Dual Yellow D10B Laser itself.

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

• The document does not report on any specific test set or clinical study conducted for the Dual Yellow D10B Laser to demonstrate its performance. It relies on the substantial equivalence to the predicate device. Therefore, there is no information on sample size, data provenance, or study design.

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 no new test set or clinical study specific to the Dual Yellow D10B Laser is described in this document.

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

• Not applicable, as no new test set or clinical study specific to the Dual Yellow D10B Laser is described in this document.

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 surgical device, not an AI-assisted diagnostic tool.

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

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

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

• Not applicable, as no new clinical study specific to the Dual Yellow D10B Laser is described. For a laser device cleared via substantial equivalence, the "ground truth" implicitly lies within the established safety and efficacy of the predicate device for its intended uses.

8. The sample size for the training set

• Not applicable, as no training set for an algorithm is relevant here.

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

• Not applicable.

Summary of what is actually present in the document regarding "acceptance criteria" and "study":

The document is a 510(k) summary for the Norseld Dual Yellow D10B Laser. For devices submitted through the 510(k) pathway, the primary "acceptance criterion" is often substantial equivalence to a previously cleared predicate device.

• Acceptance Criteria (Implicit): That the Dual Yellow D10B Laser has the "same specifications and indications for use" as the predicate YellowStar Laser (K013940).
• Study That Proves the Device Meets Acceptance Criteria: The "study" here is the assertion, accepted by the FDA, that the Dual Yellow D10B Laser is substantially equivalent to the YellowStar Laser. The document states:
  • "The Dual Yellow D10B Laser has the same specifications and indications for use as the YellowStar Laser (K013940) which is also manufactured by Norseld, Pty., Ltd."
  • "Based on the information in the notification Norseld Pty., Ltd. believes that Dual Yellow D10B Laser is substantially equivalent to (i.e., the same as) the YellowStar Laser System."

This means the manufacturer did not conduct a new clinical trial for the Dual Yellow D10B Laser but rather demonstrated that its design, technology, and intended use are sufficiently similar to a device already on the market (the predicate device) that it does not raise new questions of safety or effectiveness. The FDA's clearance letter confirms their agreement with this assessment of substantial equivalence.

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