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510(k) Data Aggregation
(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 (<5mW) | Red 635-650nm (<5mW) | Equivalent |
| Cooling | Air | Air | Equivalent |
| Laser Beam Delivery | Fiber | Fiber | Equivalent |
| User Interface | Color touch screen | Color touch screen | Equivalent |
| Power Source | 100-240V, 50-60Hz | 100 - 240 V, 47-63 Hz | Equivalent |
| Dimensions & Weight | 39 cm (L) x 33 cm (W) x 25 cm (H), 8 Kg. | 22 cm (L) x 22 cm (W)x 10 cm (H), 3.5 Kg. | Equivalent |
| Adherence to Standards | Implied adherence via predicate | IEC 60601-1, IEC 60825-1, EN 60601-1-2, IEC 60601-2-22, IEC 60601-1-6, IEC 62304 | Demonstrated |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a hardware device approval, not an AI/ML diagnostic. No specific "test set" of patient data is mentioned for performance evaluation in this context. The "testing" refers to verification and validation of the device's physical and electrical characteristics against engineering standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth established by experts is mentioned as this is not an AI/ML diagnostic device requiring such evaluation.
4. Adjudication Method
Not applicable. There is no mention of adjudication for a test set.
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 does not describe an AI/ML product or an MRMC study.
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 a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of AI/ML. The "ground truth" for the laser device's performance would be its adherence to established engineering specifications and safety standards, verified through physical testing.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component described that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no AI/ML component described.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):
The device (MANTA Laser Family) demonstrates that it meets "acceptance criteria" by showing substantial equivalence to a legally marketed predicate device (Quanta Diode Laser Family, K100558) and by adherence to recognized international consensus standards for medical electrical equipment and laser safety.
- Substantial Equivalence Study: The core of the submission is a comparison table (Pages 6-8) that directly compares the MANTA Diode Laser Family's specifications (e.g., maximum power, wavelength, output mode, cooling, user interface) to those of the predicate device. The document states, "The minor differences in design/operation are only a question of usability and do not play a role in safety or effectiveness as the fundamental functions and the indications for use are the same."
- Performance Testing against Standards: The document lists several international standards (e.g., IEC 60601 series for electrical safety, IEC 60825-1 for laser safety, IEC 62304 for software life cycle process) that the MANTA systems have been tested against (Page 9). Successful testing against these standards implies the device meets the safety and performance requirements codified within them. The document explicitly states "Performance testing" followed by this list of standards.
- Animal or Clinical Studies: The document explicitly states: "Animal or clinical studies: None" (Page 10), further emphasizing that the substantial equivalence and adherence to standards are the primary methods of demonstrating safety and effectiveness for this device.
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