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The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

The modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 180), and the delivery accessories that are used with it, is comprised of the following main components:

• Laser console with fiber port and RF ID bracket
• Operating software
• Detachable footswitch
• Delivery device accessories (fiber optic, handpieces and scanner)

The provided text describes a 510(k) summary for the modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180). This document is for a medical device that has been found substantially equivalent to predicate devices, rather than a diagnostic AI/ML device that would typically have the performance criteria and studies described in your request.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth adjudication, MRMC studies, standalone performance, or training set details.

The document focuses on:

• Device Name: Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180)
• Indications for Use: Surgical applications requiring vaporization, incision, ablation, cutting, and hemostasis/coagulation of soft tissue across numerous medical specialties (Urology, Thoracic Surgery, Plastic Surgery, Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT, Radiology, Endovascular coagulation, Oral Surgery, Dental procedures, Cardiac Surgery, Vascular Surgery).
• Predicate Devices: INTERmedic Diode Laser Family (K053540) and Biolitec, Inc. 180W Ceralas D 980nm Diode Laser (Model D180) (K083682).
• Rationale for Substantial Equivalence: The modified device shares the same indications for use, device operation, technical and functional capabilities with the predicate INTERmedic device, and similar functional capabilities as the Biolitec predicate device.
• Conclusion: The device was found substantially equivalent to predicate devices.

This type of submission primarily demonstrates that the new device is as safe and effective as a legally marketed device, and does not require complex performance studies against a ground truth as would be expected for a diagnostic AI/ML algorithm.

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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 device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 150W Ceralas D980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

• Removal of benign lesions from the ear, nose and throat
• Excision and vaporization of vocal cord nodules and polyps
• Incision and excision of carcinoma in situ
• Ablation and vaporization of hyperkeratosis
• Excision of carcinoma of the larynx
• Laryngeal papillomectomy
• Excision and vaporization of herpes simplex I and II
• Neck dissection

Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

• Menisectomy
• Synovectomy
• Chondromalacia

Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

• Hemostasis of upper and lower GI bleeding
• Excision and vaporization of colorectal carcinoma
• Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

• Matrixectomy
• Excision of neuromas
• Excision of periungual and subungual warts
• Excision of plantar warts
• Excision of keloids
• Liver resection
• Excision of cutaneous lesions
• Hemorrhoidectomy
• Appendectomy
• Debridement of decubitus ulcers
• Hepatobiliary tumors
• Mastectomy
• Dermabrasion
• Vaporization and hemostasis of capillary hemangioma
• Excision, vaporization and hemostasis of abdominal tumors
• Excision, vaporization and hemostasis of rectal pathology
• Pilonidal cystectomy
• Herniorapphy
• Adhesiolysis
• Parathyroidectomy
• Laparoscopic cholecystectomy
• Thyroidectomy
• Resection of organs
• Debridement of wounds
• Photocoagulation of teleangectasia of the legs and face
• Photocoagulation of vascular lesions of the face and extremities
• Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
• Treatment of reticular veins and branch varicosities

Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:

• Vaporization of urethral tumors
• Release of urethral stricture
• Removal of bladder neck obstruction
• Excision and vaporization of condyloma
• Lesions of external genitalia
• Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

• Endometrial ablation
• Excision or vaporization of condylomata acuminata
• Vaporization of cervical intraepithelial neoplasia
• Cervical conization
• Menorrhagia

Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

• Tracheobronchial malignancy or stricture
• Benign and malignant pulmonary obstruction
• Endoscopic pulmonary applications

Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The 150W Ceralas D980 has the same technological characteristics as the cleared 100W Ceralas D980 and substantially similar technological characteristics as compared to the INTERmedic Diode Laser and the Xintec Vectra Diode Laser.

The provided text is a 510(k) summary for a medical device (Biolitec Inc.'s 150W Ceralas Diode 980nm Laser System). It discusses the device's intended use, indications for use, technological characteristics, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or specific studies proving the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence to already cleared devices, which is the regulatory pathway used for this laser system. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new safety or effectiveness concerns compared to predicate devices. It does not typically involve reporting on a study with specific acceptance criteria in the way you've outlined for performance analysis.

Therefore, I cannot populate the requested table or answer most of your questions as the information is not present in the provided text.

Here's what I can extract based on your questions, acknowledging the significant gaps due to the nature of the provided document:

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

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

Not specified in the document. The document states "Performance data demonstrate that the Ceralas D150 is as safe and effective as the predicate devices," but no details on specific studies, sample sizes, or data provenance are provided.

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

Not applicable/specified. This type of information is typically found in studies evaluating diagnostic or AI-driven devices, which is not the case here. This document pertains to a surgical laser system.

4. Adjudication method for the test set

Not applicable/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 document describes a surgical laser system, not an AI-driven or diagnostic imaging device that would typically involve a multi-reader multi-case study.

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

Not applicable. This is a surgical laser system, so the concept of an "algorithm only" performance study is not relevant.

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

Not applicable/specified. The document does not describe studies that would rely on "ground truth" as typically defined for diagnostic or AI algorithm evaluation. The "performance data" mentioned generally refers to demonstrating the device's physical operational parameters and
(presumably) safety profile in comparison to existing devices.

8. The sample size for the training set

Not applicable/specified. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable/specified. There is no mention of a "training set" or "ground truth" in this context.

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