(90 days)
The Prima KTP lasers are intended for the surgical treatment (i.e., incision, excision, ablation, coagulation, vaporization, debulking or hemostasis) of soft tissue in all surgical applications. This includes:
Head and Neck (ENT), General Surgery, Plastic Surgery, Thoracic Surgery and Urology.
Dermatology: Photocoagulation of cutaneous lesions, including the following general categories of lesions: Vascular lesions; Angiomas, telangiectasia. Benign pigmented lesions: Nevi, Lentigines, chloasma, café-au-lait, Tattoos. Other Cutaneous Lesions. Verrucae, Skin Tags, Keratoses, Plaques, Cutaneous Lesion Treatment Goals Include; Hemostasis, Color Lightening, Blanching, Flattening, Reduction of Lesion Size. Gastroenterology: Ablation of esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma. Ablation and excision of obstructive colorectal carcinoma. Hemorrhoidectomy. Ablation of villous adenoma in non-operative patients. Ablation of familial polyposis of the colon. Excision of gastric cancer. Ablation of sessile polyps of the colon.
Gynecology: Vaporizing, incising or coagulating tissue associated with treatments for conditions such as; Endometriosis, Cervical, vulvar and vaginal intraepithael neoplasia. Condyloma acuminata. Interuterine septum. Intrauterine adhesions. Submucosal fibroids. Neurosurgery: Vaporizing, coagulating, incising, excising, debulking, and ablating neurological tissue in both open and endoscopic intracranial procedures such as: Third ventriculostomy, transseptal fenestration, intraventricular cysts fenestration, ventriculocystostomy, tumor biopsy and excision, removal of proximal shunts occluded by choriod plexus.
Ophthalmology: Post-vitrectomy endophotocoagulation of the retina. Spinal Surgery: Percutaneous lumbar diskectomy.
Prima KTP Laser System
The provided text describes a 510(k) premarket notification for the Nidek Prima KTP Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for device performance. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Performance Standard Compliance | The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable. | This indicates compliance with general safety standards for laser products. Specific performance criteria (e.g., power output, wavelength stability) are implied by these regulations but not detailed here. |
| Substantial Equivalence (Indications for Use) | Nidek's Prima KTP Laser System is intended for all cleared Laserscope AURA KTP applications. The Nidek KTP system is substantially equivalent to Laserscope's Aura KTP laser system. | The "acceptance criteria" here is that the indications for use align with a legally marketed predicate device (Laserscope Aura KTP), and the device performs similarly for those applications. |
| Substantial Equivalence (Risks & Benefits) | The risks and benefits of the Nidek Prima KTP are comparable to the predicate device when used for similar clinical applications. | This is a qualitative assessment of equivalence, not a quantitative performance metric. |
| Substantial Equivalence (Method of Operation & Construction) | The Nidek Prima KTP laser system is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device. | This is a structural and functional comparison rather than a performance measurement. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a 510(k) submission, relying on substantial equivalence to a predicate device, not a de novo clinical study with a "test set" in the context of AI or diagnostic performance. The data provenance would be related to the predicate device's existing market history and any internal testing conducted by Nidek to confirm compliance with general laser standards and equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No "test set" and no "ground truth" were established for diagnostic performance in this 510(k) submission. Substantial equivalence relies on comparing the device's characteristics and intended use to an existing, cleared device.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication in the context of AI or diagnostic performance was described.
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 is a laser surgical system, not an AI diagnostic tool. No MRMC study was conducted or described for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As a 510(k) submission based on substantial equivalence, there is no "ground truth" in the sense of a definitive clinical diagnosis that the device's output is being compared against. Instead, the "truth" is the established safety and effectiveness profile of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As mentioned above, this is a physical medical device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.