Search Results

The Diomed 15plus and Diomed 30plus Lasers are intended for use in delivering 15 or The Diomed reports wave radiation to a flexible optical fiber or spot hand piece for use in ablation, incision, excision, coagulation, and vaporization of soft tissues in open and endoscopic surgical procedures.

The Diomed 15plus and Diomed 30plus lasers are indicated for contact and non-contact use for the following soft tissue applications:

• General Surgery .
• Ophthamology/Oculoplastic .
• Urology
• Gastroenterology
• Gynecology
• Otorhinolaryngology
• Pulmonary/Thoracic
• Dermatology/Plastic Surgery
• Neurosurgery (coagulation only)
• Orthopedic

The Diomed 15plus and Diomed 30plus Lasers are modified versions of the Diomed 15 and Diomed 30 lasers. A shorter pulse duration (50 ms) has been added to both the 15plus and 30plus lasers. The modified devices include a spot handpiece/software delivery system in addition to a fiber delivery system.

A Fluence Display has been added to enhance the efficiency of existing clinical indications when using the spot hand piece. A power meter (currently used in the Diomed 30 laser) has been added to the Diomed 15plus laser to improve the accuracy of delivered powcr/fluence to the treatment site.

This 510(k) summary for the Diomed 15plus and Diomed 30plus Lasers does not contain the specific acceptance criteria or a detailed study report that quantitatively proves the device meets specific performance criteria.

The submission primarily focuses on demonstrating substantial equivalence to predicate devices (Diomed 15 and Diomed 30 Lasers) and describes the modifications made to the new devices.

However, based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Verification and validation testing was successfully performed to confirm that the modified Diomed 15plus and Diomed 30plus Lasers function as intended." This is a general statement and does not provide specific numerical acceptance criteria or the reported performance values. The primary "performance" mentioned is the addition of a shorter pulse duration (50 ms), a spot handpiece/software delivery system, and a Fluence Display with a power meter for accuracy. These are functional additions, not quantitative performance metrics with acceptance ranges.

Missing information: The document does not specify quantitative acceptance criteria for parameters like:

• Accuracy of delivered power/fluence (e.g., ±X% of set value)
• Stability of laser output
• Beam quality parameters
• Safety parameters (e.g., maximum temperature, electrical safety)
• Specific performance metrics for the new pulse duration or spot handpiece.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. This type of submission would typically involve internal laboratory testing rather than clinical data from a specific country or retrospective/prospective studies for these types of modifications.

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

• Not applicable/Not specified. This submission is for laser device modifications, not a diagnostic device requiring expert consensus on clinical data for ground truth. The "ground truth" would be engineering specifications and functional performance.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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/diagnostic device.

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

• Not applicable. This is not an algorithmic or diagnostic device. Performance testing would be for the laser's physical and functional output.

7. The type of ground truth used:

• Ground Truth: Engineering specifications, functional requirements, and safety standards for medical laser devices. The "verification and validation testing" would have assessed compliance against these predefined technical specifications.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device that requires a training set.

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

• Not applicable.

Ask a specific question about this device