Search Results

The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

The DIOMED 15 Plus is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The DIOMED 30 Plus is a diode laser capable of delivering up to 400 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-30 W of continuous wave radiation via an optical fiber coupled to the laser aperture. An EVLT procedure kit is available which may contains a 400 -1000 micron corc, 2.5 meter long bare tip fiber with location markers, a 25-100 cm long, 4- 5 Fr graduated introducer sheath with dilator, a 19 Gauge, 7 cm percutaneous entry needle, and a 0.035" J guide wire.

The provided text is a 510(k) summary for the Diomed, Inc. EVLT Kit and D15Plus and D30Plus Lasers from 2004. It describes the device, its indications for use, and a clinical study. However, it does not contain the specific acceptance criteria or detailed results that would allow for the construction of a comprehensive table comparing acceptance criteria to reported device performance. It also lacks information regarding sample sizes for test and training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations.

Therefore, much of the requested information cannot be extracted from this document, as it predates the widespread regulatory evaluation of AI/ML devices and the specific reporting requirements for such systems.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in the document. 510(k) summaries from this era often refer to substantial equivalence and clinical data but rarely detail pre-defined acceptance criteria for performance metrics in the way modern AI/ML device submissions do.
• Reported Device Performance: The document only states: "Clinical data was presented on 213 subjects treated with endovenous laser treatment with the Diomed D15Plus Laser System and EVLT Kit." Specific performance metrics (e.g., success rates, complication rates, recurrence rates) are not provided in this summary.

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 for Test Set: 213 subjects were treated in the clinical study. It is implied this forms the primary dataset used to support the device.
• Data Provenance: Not specified (country, retrospective/prospective). The document states "Clinical data was presented," which typically implies prospective clinical trials, but specific details are missing.

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. This device is a surgical laser system, not an AI/ML diagnostic or prognostic device that relies on human expert-established ground truth for performance evaluation in the way contemporary AI devices do for image interpretation. The "ground truth" for this type of device would be patient outcomes (e.g., vein occlusion, symptom relief), which are typically assessed by treating physicians and follow-up examinations, not by a panel of independent experts establishing a "ground truth" label in a blinded fashion.

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

• Not Applicable. See point 3. Adjudication methods are relevant for expert consensus on AI ground truth, which is not the context here. Clinical outcomes are typically assessed by treating physicians and standard clinical follow-up protocols.

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

• No. This is a surgical laser device, not an AI-assisted diagnostic tool. MRMC studies and the concept of "human readers improving with AI assistance" are not applicable to the evaluation of this device.

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

• No. This is a medical device (laser system) that requires direct human operation, not a standalone algorithm.

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

• For this type of device (a surgical laser for vein treatment), the "ground truth" for determining effectiveness would be based on clinical outcomes data. This would include measures such as successful vein occlusion, reduction in reflux, improvement in symptoms, and assessment of adverse events, typically determined through follow-up examinations (e.g., ultrasound, patient reported outcomes) and clinical evaluation by treating physicians.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set in the computational sense. The "training" for the device's development would refer to engineering and pre-clinical testing, not a dataset used to train an algorithm.

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

• Not Applicable. See point 8.

Ask a specific question about this device

EVLT kits and Diomed D15plus and D30plus Diode Lasers are indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein

Not Found

The provided document is a 510(k) substantial equivalence letter from the FDA for a medical device: "EVLT Kit and D15Plus and D30Plus Diode Lasers."

This type of document primarily confirms that a new device is "substantially equivalent" to an already legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.

Crucially, a 510(k) does not typically contain detailed acceptance criteria, device performance tables, sample sizes for studies, ground truth establishment, or information about AI/MRMC studies as would be expected for a novel device or a clinical trial submission. The focus is on demonstrating equivalence to an existing device.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

• Not Available: The document does not provide specific acceptance criteria or detailed performance data for the EVLT Kit and Diode Lasers. Substantial equivalence relies on demonstrating that the new device is as safe and effective as a predicate device, but specific performance metrics against pre-defined acceptance criteria are not typically part of this public summary.

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

• Not Available: This information would be found in detailed study reports, which are not included in this FDA 510(k) letter.

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 Available: This information pertains to the underlying data and ground truth establishment for a clinical trial or performance study, which is not detailed in this 510(k) letter.

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

• Not Available: As above, this level of detail regarding study methodology is not present.

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: The device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant in this context.

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

• Not Applicable: This device is a laser surgical instrument, not an algorithm. Standalone algorithm performance studies are not relevant.

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

• Not Available: Without detailed study reports, the type of ground truth used for any underlying data supporting the predicate comparison cannot be determined from this document. However, for a surgical device for varicose veins, ground truth would likely involve clinical outcomes, imaging confirmation of treatment success (e.g., ultrasound demonstrating vein closure), and expert clinical assessment.

8. The sample size for the training set

• Not Available: This information would be part of detailed study reports, which are not provided here. Also, for a device like this, the concept of a "training set" as understood in machine learning/AI is not applicable. The device's safety and effectiveness are established through engineering design, bench testing, and potentially clinical studies, rather than a machine learning training paradigm.

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

• Not Applicable / Not Available: As mentioned, the concept of a "training set" doesn't directly apply here in the AI/ML sense. For traditional medical devices, the "ground truth" for design validation and clinical evidence would be established through a combination of engineering principles, established medical knowledge, clinical observations, and potentially clinical trial results compared to standard-of-care. The specific methods are not detailed in this 510(k) letter.

In summary, the provided document is a regulatory clearance letter, not a detailed technical or clinical study report. It focuses on the legal determination of substantial equivalence, not the granular details of performance studies.

Ask a specific question about this device

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

Ask a specific question about this device

The DioScan Scanning Handpiece Accessory is indicated for incision, excision, vaporization, ablation, cutting, hemostasis, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.

The DioScan Scanning Handpiece is intended to allow the rapid treatment of a large area of skin by scanning a laser spot over a treatment area. The area treated allows the majority of the operator's time to be spent in treatment, with a small proportion of time spent in moving the scanner between areas. To minimize patient discomfort and reduce spent in moving the counter ous, the handpiece employs a cooled sapphire window in thermal contact with the skin during treatment.

The provided text is a 510(k) summary for the DioScan Scanning Handpiece Accessory. It explicitly states that no performance data or studies were required because the device's specifications and indications for use are "the same or very similar" to legally marketed predicate devices.

Therefore, the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this document, as such a study was not performed for this submission.

Here's a breakdown based on the information provided:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: None explicitly stated as performance data was not required. The implicit acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices.
• Reported Device Performance: Not applicable, as performance data was not required or reported.

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

• Not applicable, as no performance tests were conducted.

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

• Not applicable, as no performance tests were conducted.

4. Adjudication method for the test set:

• Not applicable, as no performance tests were conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• No, an MRMC comparative effectiveness study was not done.

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

• No, a standalone performance study was not done. This device is a physical handpiece accessory, not an algorithm.

7. The type of ground truth used:

• Not applicable, as no performance tests were conducted.

8. The sample size for the training set:

• Not applicable, as no training set was used for this type of device submission.

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

• Not applicable, as no training set was used.

Ask a specific question about this device