(72 days)
The MANTA810 diode laser is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Cyneology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.
The MANTA980 diode laser is indicated for use in surgical application, incision, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.
The MANTA1064 diode laser is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics. Podiatry, Arthroscopy, Spinal Surgery, Gyneology, Pulmonary Surgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.
The MANTA1470 diode laser is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.
The MANTA1940 diode laser is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gyneology, Pulmonary Surgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.
The MANTA diode lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode, the laser system can radiate one factory set wavelength with any of the following: 810nm, 980nm, 1064nm, 1470nm or 1940nm.
The MANTA is a compact diode laser with a high-resolution color touchscreen for user control.
The provided document is a 510(k) premarket notification for the MANTA Laser Family. It focuses on establishing substantial equivalence to a predicate device (Quanta Diode Laser Family, K100558) rather than presenting a study to prove acceptance criteria for device performance in the way clinical diagnostic AI/ML products typically do.
Therefore, much of the requested information regarding a study proving acceptance criteria for AI performance (e.g., sample size for test sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or available in this document.
The document primarily addresses the safety and performance of a laser surgical instrument, which is a hardware device, through adherence to recognized international standards and comparison of technical specifications.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the context of a performance study for AI. Instead, it compares the technical specifications of the MANTA device to a predicate device to demonstrate substantial equivalence. The "performance testing" section refers to adherence to safety and electrical standards.
| Specification | Predicate Device (Quanta) Performance (K100558) | Subject Device (MANTA) Reported Performance | Substantial Equivalence |
|---|---|---|---|
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Equivalent |
| Product Code | GEX | GEX | Equivalent |
| Regulatory Class | Class II | Class II | Equivalent |
| Laser media | Diode laser | Diode laser | Equivalent |
| Use of device | RX only | RX only | Equivalent |
| Max. power (Watts) | 30 – 808nm, 30 – 980nm, 30 – 1064nm, 15 – 1470nm, 5 - 1950nm | 28 – 810nm, 28 – 980nm, 24 – 1064nm, 12 – 1470nm, 5 – 1940nm | Equivalent |
| Wavelength (nm) | 808, 980, 1064, 1470, 1950 | 810, 980, 1064, 1470, 1940 | Equivalent |
| Laser class | 4 | 4 | Equivalent |
| Output Mode | CW, pulsed, single pulse | CW, pulsed, single pulse | Equivalent |
| Pulse Duration | 3 msec – 2.5 sec adjustable | 10 msec – 30 sec adjustable | Equivalent |
| Pulse frequency | 0.016 - 250 Hz | 0.02 – 50 Hz | Equivalent |
| Aiming Beam | Red 650nm ( |
§ 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.