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Ablation, incision, excision, coagulation and vaporisation of soft tissues in the following open and endoscopic surgical procedures: General Surgery, Ophthalmology/Oculoplastic, Urology, Gastroenterology, Gynecology, Otorhinolaryngology, Pulmonary/Thoracic, Dermatology/Plastic Surgery, Neurosurgery (coagulation only), Orthopedic

The Diomed Delta 25 Laser consists of a Class IV InGaAs/A1GaAs laser diode with a wavelength of 1064nm ± 20 nm and a visible laser (aiming beam) of 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm. The Diomed Delta 25 is a diode laser capable of delivering up to 25 W of continuous wave or pulsed radiation via an optical fiber coupled to the laser aperture.

The provided document is a 510(k) summary for the Diomed Delta 25 Laser, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with acceptance criteria and device performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not explicitly available in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "The Diomed Delta 25 laser has undergone a comprehensive series of test protocols in order to qualify and validate the performance of the device." It then concludes, "The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance."

It does not provide specific quantitative acceptance criteria or detailed reported device performance metrics. This type of 510(k) summary typically relies on demonstrating that the new device performs as well as or similarly to existing legally marketed devices, rather than establishing new performance benchmarks.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for a test set in the context of a clinical study or a dataset for AI. This is a medical device approval based on substantial equivalence, which primarily involves comparing technical specifications and safety aspects to existing cleared devices. The "test protocols" mentioned likely refer to engineering and functional testing of the laser itself, not a clinical trial with human subjects or a dataset for AI.

Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable here as no such data is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the document describes a physical medical device (laser instrument) and its technical equivalence, not an AI device requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices to assess human reader performance with and without the device. The Diomed Delta 25 Laser is a surgical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone evaluation was not done. This concept is only relevant for AI algorithms. The Diomed Delta 25 is a physical laser device.

7. The Type of Ground Truth Used:

This information is not applicable as the clearance is for a physical laser surgical instrument, not an AI device. The "ground truth" for this device would be its ability to safely and effectively produce laser energy within specified parameters, as demonstrated through engineering and safety testing.

8. The Sample Size for the Training Set:

This information is not applicable as the Diomed Delta 25 Laser is not an AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as above.

In summary, the provided document is a 510(k) summary for a traditional medical device (a surgical laser) seeking clearance based on substantial equivalence. It does not contain the detailed information about acceptance criteria, study design, and ground truth establishment that would be present for an AI/ML-based device. The "study" mentioned refers to the "comprehensive series of test protocols" to ensure the device's performance is equivalent to predicate devices, focusing on technical specifications and safety rather than clinical endpoints established through a patient study.

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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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Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Diomed 810 nm Surgical Lasers and EVLT Procedure Kit is a semiconductor diode lasers operating at 810 ± 20 microns and associated disposables.

The provided text describes a 510(k) summary for the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit, which establishes substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria, specific study results, or the methodology used to generate performance data in the way a traditional study report would.

Here's an analysis of the information available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific quantitative performance metrics. It generally states:

"Clinical tests performed by Diomed have demonstrated the substantially equivalent performance of the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit with the predicate device used for substantially equivalent indications."

2. Sample Size Used for the Test Set and Data Provenance

The document states "Clinical tests performed by Diomed," but it does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The nature of the device (a surgical laser) suggests that "ground truth" would likely be related to clinical outcomes, rather than image interpretation requiring multiple expert readers.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the likely nature of the "clinical tests" (evaluating surgical outcomes), a formal adjudication method for a test set in the context of expert consensus may not be applicable in the same way as for diagnostic imaging.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided and is unlikely to be relevant for this type of device. MRMC studies are typically used for diagnostic devices where human readers interpret medical images. This device is a surgical laser, and its performance would be assessed through surgical outcomes.

6. Standalone Performance Study

The document states "Clinical tests performed by Diomed have demonstrated the substantially equivalent performance," implying a study was done on the device's performance. However, it does not explicitly state if this was a "standalone" study in the sense of an algorithm-only performance without human intervention, as the device is a surgical tool requiring human operation. The performance described would inherently involve human users.

7. Type of Ground Truth Used

The document implies that "clinical tests" were performed. For a surgical laser used for endovascular coagulation of veins, "ground truth" would most likely be established through clinical outcomes data, such as:

• Successful occlusion of the saphenous vein.
• Absence of reflux post-procedure.
• Adverse events (e.g., pain, bruising, nerve injury).
• Follow-up ultrasound findings.

The document does not explicitly state the type of ground truth, but clinical outcomes are the most logical.

8. Sample Size for the Training Set

This information is not provided. The concept of a "training set" is typically associated with machine learning algorithms. While clinical experience and data might inform the design and use of a medical device, the document does not suggest a formal machine learning training set was used for this laser device.

9. How Ground Truth for the Training Set Was Established

This information is not provided, as a formal "training set" in the context of machine learning is not mentioned or implied for this device.

In summary:

The 510(k) summary provided is for a surgical laser, and it focuses on establishing substantial equivalence to a legally marketed predicate device based on "clinical tests." It lacks the detailed quantitative performance metrics, study methodologies, and expert involvement descriptions that would be typical for an AI/ML-driven diagnostic device. The primary takeaway is that the device's performance was deemed "substantially equivalent" to the predicate, but the specifics of how that equivalence was determined (e.g., sample sizes, precise outcomes measured) are not included in this summary.

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