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The Diomed Delta 15 and Diomed Delta 30 Lasers are intended for use in delivering up to 15 or up to 30 Watts, respectively, of continuous wave or pulsed radiation to a flexible optical fiber or spot handpiece for use in ablation, incision, excision, coagulation and vaporisation of soft tissues in open and endoscopic surgical procedures, including EndoVenous Laser Treatment (EVLT).

Indications For Use:

• General Surgery .
• Ophthalmology/Oculoplastic .
• Urology .
• Gastroenterology .
• Gynecology .
• Otorhinolaryngology .
• Pulmonary/Thoracic .
• Dermatology/Plastic Surgery .
• Neurosurgery (coagulation only) .
• Orthopedic .
• Treatment of varicose veins and varicosities with superficial reflux of the Greater ● Saphenous Vein.
• Treatment of incompetent refluxing veins in the superficial venous system in the lower limb

The purpose of this Special 510(k) is to notify FDA of the proposed new Diòmed Delta 15 and Diomed Delta 30 Lasers, which are equivalent replacements for the Diomed 15plus and 30plus. Like their predecessors, the Diomed Delta 15 and Diomed Delta 30 Lasers consist of a Class IV GaAlAs (Gallium Aluminium Arsenide) diode laser with a wavelength of 810 ± 20 nm and a visible light (aiming beam) 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm.

The Diomed Delta 15 and Diomed Delta 30 Lasers are made up of a treatment laser and aiming beam. The Diomed Delta 15 is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic hand piece or 15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The Diomed Delta 30 is a diode laser capable of delivering up to 400 J/cm2 of pulsed radiation via a fiber optic hand piece or 30 W of continuous wave radiation via an optical fiber coupled to the laser aperture.

The provided text is a 510(k) summary for the Diomed Delta 15 and Delta 30 Lasers. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results in the same way an AI/ML device submission would.

Therefore, many of the requested elements for an AI/ML device (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document as it describes a laser device, not an AI/ML diagnostic tool.

However, I can extract the acceptance criteria (implicitly, the claim of equivalence) and the "study" that proves it as described in the document.

Detailed Breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a laser device, not an AI/ML diagnostic system that uses test sets of data. The "test protocols" refer to engineering and functional testing of the physical laser device.

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

• Not Applicable. See point 2.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

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 surgical laser, not an AI assistance tool for human readers.

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

• Not Applicable. See point 5.

7. The type of ground truth used:

• Not Applicable. For a medical device like a laser, "ground truth" would relate to its physical specifications and safety standards, confirmed through engineering tests and compliance, rather than clinical outcomes or expert labels on data as in AI/ML. The "performance data" refers to technical validation that the device operates as specified and safely.

8. The sample size for the training set:

• Not Applicable. This document does not describe an AI/ML algorithm that requires a training set.

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

• Not Applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states:
"The Diomed Delta 15 and Diomed Delta 30 lasers have undergone a comprehensive series of test protocols in order to qualify and validate the performance of the devices. The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance. The Diomed Delta 15 and Diomed Delta 30 are therefore validated for use on this basis."

This indicates that the "study" was a technical qualification and validation process comparing the new Delta 15 and Delta 30 lasers against their predecessors (Diomed D15Plus and D30Plus Diode Lasers). The core of the acceptance criteria is substantial equivalence to these predicate devices. The "proof" is the outcome of these internal "test protocols" which demonstrated that the new devices perform equivalently to the previously cleared devices. This equivalence includes matching specifications like wavelength, power output, and intended uses. The clinical efficacy and safety are implicitly covered by the "substantial clinical and market evidence" of the predicate devices.

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The SLT Venous Fiber is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

SLT Venous FDS products include the Venous Diffusing Fiber, the Venous Conical Fiber, and the Venous Flat Fiber.

SLT Venous Diffuser Fibers are flexible fibers with an active diffusing portion that diffuses the laser energy in a uniform pattern about its active diffusing length, resulting in a cylindrical or elongated spheroidal zone of coagulation.

SLT Venous Conical Fibers splay the laser energy radially at their distally conical portion, providing a much smaller and more focused coagulation zone than the Venous Diffuser Fiber.

SLT Venous Flat Fibers direct the laser energy forward from their distally flat end, providing the highest energy density of the three SLT Venous Fibers.

SLT Venous Fibers are available with SLT proprietary connectors (to fit SLT Contact Laser Systems) and SMA-905 connectors (to fit lasers with standard SMA-905 launch interfaces).

SLT Venous Diffuser Fibers are compatible for use only with lasers having wavelengths between 980nm and 1064nm.

SLT Venous Conical and Flat Fibers are compatible for use with lasers having wavelengths between 810nm and 1064nm.

SLT Venous Fibers are flexible and therefore, when used for endovascular applications, a catheter, cannula, or similar device should be used to insert the fiber into the vein.

SLT Venous Fiber products are sold sterile, and are intended for single use only.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for "SLT Venous Fiber Delivery Systems," which focuses on establishing substantial equivalence to previously marketed devices rather than detailing specific performance acceptance criteria and a study to meet them.

Here's what the document does provide:

• Device Description and Intended Use: The SLT Venous Fiber Delivery Systems are intended for endovascular coagulation of the greater saphenous vein in patients with superficial vein reflux.
• Predicate Devices: The document lists several predicate devices (e.g., Diomed 810nm Surgical Lasers and EVLT Procedure Kit, VNUS® Closure™ System, Ceralas D Diode Laser Systems) for comparison.
• Basis for Substantial Equivalence: The submission states that the intended use, method of tissue interaction, specifications, clinical technique, and animal study results are "the same or very similar" to the predicate devices.
• Safety and Effectiveness: Animal studies were performed to demonstrate "substantially equivalent safe and effective performance" to the predicate devices. Biocompatibility testing (USP Class VI and ISO 10993-1, including hemocompatibility per ISO 10993-4) was also successfully performed.

Missing Information:

The document does not include:

1. A table of specific acceptance criteria (e.g., specific quantitative metrics for coagulation effectiveness, safety endpoints).
2. Reported device performance against such criteria.
3. Details on the sample size used for any test set in the animal studies.
4. Data provenance (country of origin, retrospective/prospective).
5. Number of experts used or their qualifications.
6. Adjudication method.
7. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with/without AI assistance.
8. Results from standalone (algorithm only) performance studies.
9. The specific type of ground truth used in the animal studies (beyond "animal studies").
10. Sample size for any training set.
11. How ground truth for a training set was established.

The document primarily focuses on asserting substantial equivalence based on general performance observations in animal studies and biocompatibility, rather than providing a detailed breakdown of acceptance criteria and a quantitative study proving adherence to them as would be expected for an AI/CADe device.

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