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The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of dark, unwanted body hair.

The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation.

The provided text is a 510(k) summary for the Sharplan Model 5000 Alexandrite Laser System, indicating its clearance for marketing based on substantial equivalence to predicate devices for the removal of dark, unwanted body hair. While it mentions clinical data, it does not provide detailed acceptance criteria or a comprehensive study report in the format requested.

Therefore, much of the requested information cannot be definitively extracted from the provided text. However, I will answer what is available and indicate when information is not present.

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

The document does not explicitly state quantitative acceptance criteria for device performance. It focuses on the device's substantial equivalence to predicate devices and its intended use for hair removal rather than specific metrics like success rate, adverse event rate thresholds, or hair reduction percentages.

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

• Sample Size: 40 subjects
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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)

This information is not provided in the document. The nature of "clinical data on 40 subjects" for hair removal would typically involve physician assessment, but no details about the number or qualifications of these experts are given.

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

This information is not provided in the 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

An MRMC study is not relevant to this device, which is an Alexandrite Laser System for hair removal, not an AI-assisted diagnostic tool involving human readers. Therefore, no such study was done, and no effect size for human readers with/without AI assistance is applicable or reported.

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

This question is not applicable. The device is a laser system, not an algorithm. Its performance is inherent to the device's operation.

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

For a hair removal device, the "ground truth" would likely be the observed outcome of hair reduction or removal, assessed visually or through other objective measures (e.g., hair count in a defined area). The document only states "Clinical data on 40 subjects was presented," implying that patient outcomes after treatment were evaluated.

8. The sample size for the training set

This information is not provided. The term "training set" is generally used for machine learning models, which is not applicable here. The "clinical data on 40 subjects" likely refers to the pivotal clinical evidence presented for the device, not a training set in the AI sense.

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

As the concept of a "training set" in the context of AI/machine learning is not applicable here, this information is not provided. If referring to how the "clinical data on 40 subjects" established efficacy, it would be through direct observation of hair removal/reduction results post-treatment, likely by a clinician, but the methodology is not detailed.

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The Sharplan Model 5000 Alexandrite Surgical Laser System is intended for use in dermatology for the treatment of vascular lesions.

The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation

This looks like a 510(k) summary for a medical device that was cleared based on substantial equivalence to a predicate device, rather than through a study demonstrating direct device performance against acceptance criteria. Therefore, most of the requested information (like specific acceptance criteria, sample sizes, expert involvement, and ground truth methodologies) is not present in the provided document.

Here's an attempt to answer based only on the provided text:

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

The document does not provide a table of acceptance criteria or reported device performance for the Sharplan Model 5000 Alexandrite Laser System in a study against specific benchmarks. The clearance is based on substantial equivalence to a predicate device.

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. No test set or clinical data proving direct device performance was presented. The clearance states: "No new indications were sought in this premarket notification and no clinical data was presented."

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. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No test set or adjudication process is mentioned.

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 not an AI-assisted device, and no MRMC study was conducted or referenced.

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

Not applicable. This is a laser system, not an algorithm, and no such standalone performance evaluation is mentioned.

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

Not applicable. No specific ground truth was established for the Sharplan Model 5000 Alexandrite Laser System's performance, as its clearance was based on substantial equivalence.

8. The sample size for the training set

Not applicable. This document describes a medical device cleared through substantial equivalence, not an algorithm developed with a training set.

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

Not applicable. No training set or ground truth establishment for a training set is mentioned.

Summary based on the Provided 510(k) Document:

The Sharplan Model 5000 Alexandrite Laser System was cleared based on its substantial equivalence to a predicate device, the Cynosure PhotoGenica LP Dermatological Vascular Lesion Laser (K963094).

• Basis for Clearance: The manufacturer "believes that no significant differences exist" between their device and the predicate device "From both a design and clinical perspective, the predicate and candidate laser devices, are of the same technology and have the same intended use."
• Performance Data: "No new indications were sought in this premarket notification and no clinical data was presented."
• Intended Use: The device is "intended for use in dermatology for the treatment of vascular lesions."

Therefore, the study proving the device meets acceptance criteria in the traditional sense of a performance study against specific metrics is not provided in this document. Instead, the "proof" is the argument of substantial equivalence based on technological and intended use similarities to an already legally marketed device.

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