(28 days)
The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.
The intended use of the Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is for the performance of specific surgical applications in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows:
Dermatology
Podiatry
Otolaryngology (ENT)
Gynecology and GYN Laparoscopy Indications
Neurosurgery Indications
Orthopedic Indication
General and Thoracic Surgery
Dental and Oral Surgery
The Lumenis AcuPulse Family of CO2 Laser Systems are advanced computer-controlled Carbon Dioxide (CO2) laser systems based on a DC-excited sealed-off CO2 laser tube, that depending on their configuration, can provide up to 30 or 40-Watts on tissue. The AcuPulse Family of CO2 Lasers includes the following system models:
- The AcuPulse (previously called AcuPulse 30/40ST) system that incorporates a Free Beam Port only.
- The AcuPulse 40WG System that incorporates a Fiber Port only.
- The AcuPulse DUO, a new member of the family, which incorporates both a Free Beam Port and a Fiber Port.
The AcuPulse DUO laser added to the AcuPulse family represents a combination of the previously cleared AcuPulse 30/40ST and AcuPulse 40WG lasers. The minor differences in technological characteristics between the AcuPulse DUO and the predicate systems exist to facilitate this integration (mechanical and software adaptations that enable having two ports in one System) and do not affect any of the device's functionalities or performance specifications. The AcuPulse DUO System, with the incorporation of both the Free Beam and the Fiber port in one console, shares the same underlying technology and fundamental functionality as the previously cleared AcuPulse Family of CO2 Laser Systems. All of these laser systems are comprised of the following main functional components:
- a Laser Console with a port: a Free Beam Port to which an articulated arm is attached (AcuPulse model), a Fiber Port to which a Fiber is attached (AcuPulse 40WG), or both the Free Beam Port and Fiber Port (AcuPulse DUO)
- a Footswitch
- Various Free Beam Delivery Device and accessories (AcuPulse and AcuPulse DUO compatible) or Fiber Delivery Devices and accessories (AcuPulse 40WG and AcuPulse DUO compatible).
The AcuPulse DUO, similarly to the previously cleared AcuPulse and AcuPulse 40WG, is operated and controlled via proprietary software embedded in the Main controller. Peripheral controller units and PC.
The Delivery Devices and accessories, in accordance with their type and compatibility (e.g., Fiber Port or Free Beam port) are shared by all AcuPulse Laser Systems. The Free Beam Deliverv Devices and accessories include: Endoscopes/Laparoscopy accessories, Handpieces/Tips, Micromanipulators, and Scanners with accessories and adaptors. The Fibers that may be used with the Fiber Port are supplied with various handpieces (through which the Fiber may be inserted for more convenient handling during surgical procedures) and additional accessories for Fiber maintenance and handling.
The provided text is a 510(k) summary for the Lumenis AcuPulse Family of CO2 Laser Systems. It describes the device, its intended use, and indicates that performance testing was conducted. However, it does not contain detailed information regarding specific acceptance criteria, reported device performance in those criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone algorithm studies) in the manner typically associated with clinical performance evaluation for AI/ML devices.
The document focuses on demonstrating substantial equivalence to a predicate device (AcuPulse 30/40ST and AcuPulse 40WG CO2 Lasers, K100415) based on:
- Intended use and indications for use: These are stated to be the same as the predicate devices.
- Principles of operation: Stated to be the same.
- Technological characteristics: Stated to be "nearly identical," with "minor differences" related to combining capabilities of previously cleared devices.
- Performance data: General statements about risk analysis, electrical and laser safety, electromagnetic compatibility testing, software verification and validation, and system testing to ensure compliance with specifications.
Given these limitations, I cannot provide a table of acceptance criteria, reported device performance, or details about clinical study specifics such as sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC/standalone study results for AI.
Here's a breakdown of what can be extracted from the document based on your request, and where information is explicitly not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Risk Analysis | Performed (ISO 14971) |
| Electrical Safety | Conforms to AAMI/ANSI/IEC ES 60601-1 |
| Laser Safety | Conforms to IEC 60825-1, IEC 60601-2-22 |
| Electromagnetic Comp. | Conforms to IEC 60601-1-2 |
| Software Verification | Performed |
| Software Validation | Performed |
| System Performance | Performs in compliance with specifications and requirements; performs as intended and comparably to predicate devices. |
Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for laser power output, pulse duration accuracy, beam quality, or safety interlock response times) are not detailed, nor are the precise numerical results of the performance tests against such criteria. The document states "performance in compliance with their specifications and requirements" but does not list those specifications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The performance testing mentions "system testing" but does not refer to a clinical "test set" in the context of diagnostic or predictive performance metrics. The evaluation focuses on device functionality and safety.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The tests appear to be engineering/technical verification and validation rather than clinical data studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not specified. Ground truth in the context of clinical interpretation, as would be relevant for AI/ML devices, is not mentioned. The testing described relates to the laser system's technical specifications and safety.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. This information is relevant for studies involving human interpretation or challenging cases, which is not the type of study described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not mention any clinical comparative effectiveness study involving human readers, with or without AI assistance. The device is a surgical laser system, not an AI diagnostic tool that would typically be evaluated with MRMC studies.
- Effect Size of Human Readers with AI vs. without AI: Not applicable, as no such study was conducted or reported.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No. This device is a physical CO2 laser system, not an AI algorithm intended for standalone performance evaluation against a diagnostic problem. Performance testing was related to the physical and software functionality of the laser itself.
7. Type of Ground Truth Used
- Type of Ground Truth: For the performance tests conducted (risk analysis, electrical/laser safety, EM compatibility, software V&V, system testing), the "ground truth" would be the engineering specifications, regulatory standards (e.g., IEC standards), and the device's design requirements. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus) as would be relevant for a diagnostic or prognostic device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. This concept is relevant for AI/ML models that learn from data. The document describes a traditional medical device (laser system) with embedded proprietary software, but not an AI/ML system with a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable/Not specified. As there's no mention of an AI training set, this information is not relevant to the provided document.
In summary: The provided 510(k) summary is for a traditional surgical laser system. The "performance data" section focuses on engineering verification and validation against regulatory standards and internal specifications to demonstrate safety and effectiveness for substantial equivalence, rather than clinical performance evaluation of an AI/ML algorithm against a diagnostic ground truth. Therefore, many of the specific details requested regarding AI/ML study design are not present in this document.
§ 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.