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Contact Transscleral Cyclophotocoagulation (CYC) for the reduction of intra ocular pressure (IOP) in glaucoma patients. This ocular contact probe to be used with marketed (approved) infrared lasers for this procedure. Ablation of the Ciliary Body in glaucoma patients.

The TSX Probe consists of three basic parts; handgrip, tip and focusing lens and is a presterilized (Ethylene Oxide) disposable contact probe. Its tip is a clear amber medical plastic that is angled to match the curvature of the human eye and therefore allows for the placement of the probe vertically, closest to the limbus. The angle of the contact tip (distal end) conforms to the curvature of the eye. The three-meter 600 um fiber plugs into an HGM SmartScan™ laser or other SMA connection compatible device allows the physician to perform noninvasive contact CYC with marketed (approved) infrared lasers.

The provided text is a 510(k) summary for the TSX Probe, a laser delivery device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document. The 510(k) submission primarily focuses on establishing substantial equivalence to an existing legally marketed device, not on presenting detailed performance study results against specific acceptance criteria.

The submission is essentially a declaration that the TSX Probe is similar enough to the Iris G-Probe that it doesn't require a new, full pre-market approval process. It highlights similarities in fiber size, intended use (reduction of IOP in glaucoma patients via CYC), and compatibility with existing lasers.

The information you're asking for would typically be found in a more comprehensive clinical trial report or a detailed performance validation study, which is not included in this 510(k) summary.

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532nm Wavelength:
General Surgery: Coagulation, hemostasis, vaporization, excision, and incision of tissue. Photocoagulation of Vessels/Veins up to 1.5 mm
Endoscopic & Laparoscopic: Excising, Coagulation or Vaporization of tissue during Endoscopic or Laparoscopic procedures, Cholecystectomy and Appendectomy.
Gynecology: Ablation or lysis of intra-abdominal tissues via laparotomy or laparoscope. Ablation of endometrial implants, lysis of adhesions, ablation of the uterosacral ligaments, cutting/coagulating, treatment of uterine polyps and fibroids, salpingo-ophorolysis, and transection of uterine septa.
Laryngology: Photocoagulation or Vaporization of soft or fibrous tissue such as; hereditary hemorrhagic telangiectasia (vascular lesions), pigmented structures that are highly vascular, and tonsillectomy.
Otology: For; stapedotomy, stapedectomy, tympanoplasty with fascia graft, myringotomies, control of bleeding, removal of osseous disease of the external canal, removal of acoustic neuromas, lysis of adhesions and soft tissue adhesion, in both micro- and macro- otologic procedures.
Rhinology: For; control of epistaxis, turbinate reduction (excludes bone), treatment of endonasal polyps, hereditary hemorrhagic telangiectasia, synechia, hemangiomas, telangiectasia, vaporize of maxillary sinus cysts and polyps, treatment of papillomas and granulomas, endonasal dacryocystorhinostomy, treatment of lesions within the nose and sinus, creation of nasoantral window and coagulation of vessels or veins up to 1.5 mm in diameter.
Urology: Coagulation of veins or vessels up to 1.5 mm in diameter, management of condyloma acuminata, carcinoma in situ, small papillary bladder tumors, port wine stains, hemangioma of the external genitalia or bladder and urethral recanalization.
Neurosurgery: For; dorsal root entry zone lesions, spinal intramedullary tumor, medulloblastomas, acoustic neuromas, intracranial meningiomas, ventricular ependymomas, choroid plexus, carcinomas, hemangioblastomas, ependymoma extending into the brain stem, and intra- / extra- axial spinal cord tumors.
Ophthalmology: For; posterior and anterior treatment procedures including; diabetic retinopathy, retinal detachments, ablate tissues of the iris or trabeculum, peripheral iridectomy and iridotomy, trabeculoplasty, and senile macular degeneration. Other conditions of the retina in which the laser is deemed useful involving endophotocoagulation. Extraorbital procedures such as; coagulation of vessels or veins up to 1.5 mm in diameter, extra orbital pigmented or venous lesions; port wine hemangiomas or telangiectasia. Treatment for chronic dacryocystitis.
Dermatology: For; treating vascular lesions, dermatologic lesions, and/or cutaneous lesions such as; facial or extremities telangiectasias, venous anomalies, leg veins up to 1.5 mm in diameter, and port wine stains.

1064nm Wavelength:
General Surgery: For; incision or excision of all soft body tissues including; skin, subcutaneous and breast tissue, striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymphatic tissue, internal organs and glands of the gastrointestinal, genitourinary, pulmonary, endocrine and exocrine systems, as well as cancers of theses systems. Treatment of larger and deeper vessels/veins up to 3.0 mm in diameter, 4.0 to 7.0 mm in depth.
ENT, Head & Neck: For; incision or excision of all soft body tissues including; skin, subcutaneous tissue, striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymphatic tissue, organs and glands of the ENT system and access via endoscope, microscope or direct visualization.
Gastroenterology: For; esophageal neoplastic obstructions such as; squamous cell carcinoma, and adenocarcinoma, upper and lower GI bleeding such as; varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, stomach ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions and hereditary hemorrhagic telangiectasia. Papilliation of unresectable mucosal-based cancers, coagulation of arteriovenous malformations, ablation of; adenomatous polyps, benign and malignant neoplasm, angiodysplasia, polyps, ulcers, colitis and hemorrhoids. Recanalization of obstructing lesions throughout the gastrointestinal tract, and endoscopic treatment of early oesophageal or gastric cancer.
Gynecology: For; endometrial ablation, treatment of menorrhagia, treatment of endometrotic implants, lysis of adhesions, treatment of cervical, vaginal, or vulvar dysplasia, and treatment of cervical, vaginal, or vulvar condyloma.
Neurology: For; treatment of arterio-venous malformations, and vascular intracranial tumors like meningiomas and metastatic spinal tumors.
Pulmonary: For; treatment of benign and malignant tracheobronchial lesions in the pulmonary airway including; squamous cell carcinoma, papillomas, adenocarcinoma, granulomas, and tracheal stenosis.
Urology: Treatment of superficial and invasive bladder carcinoma, urethral and ureteral strictures, benign or malignant lesions of the external genitalia, urethra and anus (condyloma acuminata), bladder neck contracture, and diverticulum.
Dermatology: Photocoagulation of vascular lesions for the reduction of lesion size. Treatment of vascular lesions such as; port wine stains (PWS), hemangiomas, angiomas, and venous anomilies. Incision/Excision of soft body tissues.
Otolaryngology: Bronchoscopy procedures such as; photocoagulation of endobronchial tumors.

The Combination Nd:YAG and Solid State, (Frequency Doubled Nd:YAG) Surgical Laser System is an instrument used in the application of photocoagulation of soft tissue using a 532nm wavelength. The system has the ability to use a 1064nm wavelength for applications including; Coagulation, Vaporization, and Cutting. The system can run both wavelengths in "Captured Pulse" which delivers high energy at very short pulse durations. The laser light is "pumped" by flashlamp technology.

The provided text is a 510(k) summary for a medical device called the "Combination Neodymium (Nd:)YAG and Solid State Green, Trade Name: Frequency Doubled Nd: Y AG Surgical Laser System" (Spectrum Veinlase).

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a Class II medical device seeking substantial equivalence to legally marketed predicate devices. For such submissions, the FDA typically assesses equivalence based on technological characteristics and intended use rather than specific quantitative performance acceptance criteria from a clinical trial.

The document states that no nonclinical or clinical performance data was provided or required for this 510(k) submission. Therefore, there are no reported acceptance criteria or device performance metrics in the format of a table as typically seen for devices requiring clinical validation. The "reported device performance" is implicitly that it meets the "similar" characteristics to the predicates.

Instead, the submission argues substantial equivalence by comparing the Spectrum Veinlase's technological characteristics to several predicate devices. The "performance" is implicitly deemed equivalent if these characteristics are similar.

Technological Characteristics and Substantial Equivalence Comparison (Implicit "Performance"):

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

• Sample Size for Test Set: Not applicable. No nonclinical or clinical performance data (test set data) was required or submitted for this 510(k). This was a substantial equivalence pathway based on technological characteristics.
• Data Provenance: Not applicable. No test data was used.

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

• Not applicable. No ground truth establishment was needed for a test set, as no performance data was required/submitted.

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

• Not applicable. No test set was evaluated.

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 laser surgical system, not an AI/imaging diagnostic device. No MRMC study was conducted or relevant.

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

• Not applicable. This device is a laser surgical system, not an algorithm.

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

• Not applicable. No ground truth was established as no performance studies were conducted. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices based on their prior marketing clearance.

8. The sample size for the training set

• Not applicable. This device is a laser surgical system, not a machine learning algorithm that requires a training set.

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

• Not applicable. No training set was used.

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