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The 400um Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The 400um Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment of incompetent (i.e. refluxing) perforator veins (IPVs).

The 400μm Perforator and Accessory Vein Ablation Kit is used to treat patients with varicose veins. Varicose veins are large, twisted, visibly bulging veins usually located in the legs. Varicose Veins occur when either the blood flow is too slow or valves are not functioning correctly resulting in "pile-up" of blood within the lower extremity veins. AngioDynamics proposes that this include the Incompetent Perforator Veins (IPVs). The 400um Perforator and Accessory Vein Ablation Kit is provided in a procedure kit which includes a 400μm Fiber along with the following accessory components:

• 21G Entry Needle
• . 4F Introducer Sheath/Dilator
• 0.018" Guidewire ●
  The 400μm Perforator and Accessory Vein Ablation Kit is presented sterile and contains all of the accessories needed to perform the EVLT procedure, with the exception of generic disposable items routinely found in a well-equipped minor treatment room such as drapes, swabs, bandages etc.

The provided text is a 510(k) summary for the AngioDynamics 400um Perforator and Accessory Vein Ablation Kit. It details the device, its intended use, and substantial equivalence to predicate devices, including a clinical study conducted to evaluate its performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The primary acceptance criterion is acute primary ablation success for Incompetent Perforator Veins (IPVs).

2. Sample Size and Data Provenance

• Sample Size for Test Set: 125 Incompetent Perforator Veins (IPVs) were treated (ITT Population). The number of patients in the ITT set was 74 (sum of patients from all sites listed in the table under "Site").
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was "multi-center" and the sponsor is AngioDynamics, Inc. based in Marlborough, Massachusetts, USA. Given it's an FDA submission, it's highly likely to be US-based or an international study adhering to US regulatory standards.
  • Retrospective or Prospective: Prospective. The study is described as a "single-arm, prospective, multi-center, non-blinded clinical trial."

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts used to establish the ground truth for the test set, nor their qualifications. The study focused on clinical outcomes post-procedure rather than interpretation of diagnostic images by experts. The "ground truth" for acute primary ablation success seems to be determined by clinical assessment at the 10-day visit.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given that the primary endpoint is "acute primary ablation success" based on clinical assessment, it's likely that this was determined by the treating clinician or study investigator at each site, rather than a separate panel of adjudicators.

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

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This study evaluated the performance of the device itself for a therapeutic procedure (ablation), not a diagnostic algorithm that assists human readers. Therefore, there's no discussion of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This study is not evaluating an AI algorithm or diagnostic tool. It's evaluating the performance of a medical device (a laser ablation kit) used in a therapeutic procedure. The "performance data" refers to the clinical outcome of the procedure when using the device, not an algorithm's performance.

7. Type of Ground Truth Used

The type of ground truth used is clinical outcome data (acute primary ablation success at the 10-day visit). This is a direct measure of the effectiveness of the therapeutic intervention.

8. Sample Size for the Training Set

Not applicable. This study is a clinical trial evaluating a physical medical device (laser ablation kit) for a therapeutic procedure. It does not involve machine learning or AI, and therefore there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided text.

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808 nm, 940 nm, 980nm Wavelengths
The Quanta System Diode Medical Lasers Family, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The Quanta System Diode Medical Lasers Family are indicated for use in the performance of specific surgical applications in gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics. ophthalmology, pulmonology, and thoracic surgery as follows:

Gastroenterology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy.

Neurosurgery (Medical 30, 6)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex.

General Surgery (Medical 30)
Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy; cholecystectomy; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma; thyroidectomy; thoracotomy; cavernous hemangioma.

Genitourinary (Urology) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia

Thoracic Surgery (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectomy; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection: hemostasis; thoracotomy.

Gvnecology (GYN) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum.

Pulmonology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.

Ophthalmology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endo-nasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty.

Orthopedics (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: Open: Dissect and coagulate.

Otolaryngology (ENT) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy; Laryngotracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy.

In addition, at 808 nm and 940 nm wavelengths, the Quanta system Diode Medical Laser Family is intended for the following use:

Urology (Medical 30):
Lesions of external genitalia; Circumcision; Condyloma; Bladder tumors; Bladder neck incisions; Vaporization of the prostate

Neurosurgery (Medical 30):
Percutaneous Disc Decompression; Discectomy; Hemostasis in conjunction with meningiomas

Arthroscopy (Medical 30): Chondromalacia; Synovectomy; Menisectomy

Pulmonary Surgery (Medical 30);
Endoscopic pulmonary applications; Tracheal bronchial lesions; Benign and malignant pulmonary or stricture

Cardiac Surgery (Medical 30): Coagulation and haemostasis of cardiac tissue

Dermatology/Aesthetics (Medical 30):
Photocoagulation of vascular & dermatological lesions of the face and extremities; Photocoagulation of telangiectasia, veinulectasias of the legs and face; Treatment of reticular veins and branch varicosities; Pyogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas; Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Chery angioma, Hemangioma, Port wine stains, angiokeratoma, and benign ipidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.; Dermatology surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment; Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne treatment; Hair removal of unwanted hair from skin type I-V;

Plastic Surgery (Medical 30):
Cut, coagulation & vaporization; Blepharoplasy

Vascular Surgery (Medical 30):
Endoluminal or endovenus laser surgery for saphenous incompetent veins.

Dental applications (Medical 30, 6, 4):
Frenectomy; Frenotomy; Biopsy; Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening

808 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Quanta System Diode Medical Laser Family are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

940 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non contact open surgery (with or without a handpiece).

It (Medical 30) is also intended for use in the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.

It (Medical 30) is also indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.

The Quanta System Diode Laser Family (Medical 30, 6, 4) is also indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:Excisional and incisional biopsiesExposure of unerupted teeth; Fibroma removal; Frenectomy; Frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingivoplasty; Gingival incision and excision; Haemostasis and coagulation; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomy; Pulpotomy as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty

The Quanta System Diode Laser Family (Medical 30, 6, 4) is also indicated for Laser Periodontal procedures, including: Laser soft tissue curettage; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Model 30 is indicated for Surgical, Dermatological, Dental and Endovascular applications.

Model 6 and Model 4 are indicated for Dental and Surgical applications.

The Diode Laser Family is designed with 4 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics, which controls the power electronics, the user interface and the laser source temperature via a thermostat board; and (4) the laser system with an opto-mechanical block composed of the laser source, the Peltier cooling system with dissipater and fans, the fiber launching system, the red diode aiming beam, and the power calibration system. The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the Diode Laser Family incorporates several safety features, including a remote interlock and a key switch.

This 510(k) summary for the Quanta System Diode Medical Laser Family (Models 4, 6, and 30) does NOT contain information about specific acceptance criteria or an explicit study proving performance against such criteria in the way typically expected for an AI/ML device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means that instead of presenting novel performance data, the manufacturer asserts that their device is as safe and effective as pre-existing, legally marketed devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text because these types of studies are not typically required for a substantial equivalence claim when the technology is well-established.

However, I can extract the general acceptance criteria inferred from the substantial equivalence claim and what is stated about meeting this criterion.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided. This submission relies on substantial equivalence to predicate devices, not on a new clinical performance study with a dedicated test set.

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

• Not Applicable / Not Provided. Ground truth establishment for a test set is not detailed because a new performance study is not presented. The basis for safety and effectiveness is the established history and regulatory clearances of the predicate devices.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided. No new test set data is presented.

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 not an AI/ML device, and no MRMC study or comparative effectiveness study involving human readers is mentioned.

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

• Not Applicable. This is a laser surgical instrument, not an algorithm, so standalone performance in the context of AI is irrelevant. The performance of the laser itself would be assessed through engineering and other non-clinical testing, which are not detailed in this 510(k) summary but would have been part of the full submission.

7. The Type of Ground Truth Used:

• Substantial Equivalence to Predicate Devices: The "ground truth" for acceptance is the established safety and effectiveness of the identified predicate devices in their respective clinical applications. The submission asserts that the new device performs equivalently to these legally marketed devices.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. This is not an AI/ML device, so there is no concept of a training set in this context.

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

• Not Applicable / Not Provided. As above, no training set for an AI/ML model.

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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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