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Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The AcuPulse W system (recently cleared under K201663) is a scaled-down version of the cleared Lumenis Family of AcuPulse CO2Laser System. Delivery Devices and Accessories under K180597. The modified AcuPulse W, identically to its predicate (K201663) is comprised of the following main functional components:

• A Laser Console with a Free Beam Port to which an articulated arm is attached .
• . A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
• . A variety of Free Beam Delivery Device and accessories
  The modified AcuPulse W and the cleared AcuPulse W (K201663) systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K201663. Also, no changes to the Hardware were made to the svstem.
  The AcuPulse W is offered with previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. Among them, the cleared 90° Side-firing Handpiece (K201663) connects to the AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing Handpiece is comprised of the following components:
• . Handpiece Adapter (cleared under K201663)
• . Tip:
  • Multiuse Standard Focus Tip (cleared under K201663) o
  • Multiuse Fine Focus Tip (cleared under (K201663) о
  • Disposable Standard Focus Tip (subject of this submission) o
  • Disposable Fine Focus Tip ((subject of this submission) o
• . Limiter ring (cleared under K201663)
  In this submission, Lumenis is introducing a disposable configuration of the 90° Side-firing Handpiece Tips in addition to the already cleared multiuse tips to respond to the increased market demand of disposable accessories for reducing the occurrence of treatment acquired infections. These 90° Side-firing Handpiece disposable tips are single use tips, packaged and EO sterilized, similarly to Lumenis devices previously cleared and used with the cleared AcuPulse Family of CO2Lasers (K100384 and K130164).

The provided document describes a 510(k) premarket notification for a medical device, specifically the Lumenis AcuPulse W CO2 Laser System, Delivery Devices, and Accessories. This document is a regulatory submission to the FDA, asserting substantial equivalence to a legally marketed predicate device.

It does not contain information about the performance of an AI/algorithm-driven device, nor does it provide acceptance criteria or study results for such a device. The modifications detailed in this 510(k) are related to the introduction of disposable tips for a laser system, which is a hardware change, not an AI software change.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document discusses design verification processes for the modified laser system and its disposable tips, which include:

• Risk analysis per ISO 14971.
• Electrical safety testing to IEC 60601-1.
• Performance verification and validation to evaluate that the 90° Side-firing Handpiece with the new disposable configuration of Tips performs according to its specifications.
• EO sterilization and Shelf-life validation activities (ISO 11607, ISO 11135-1, ISO 10993).
• Biocompatibility evaluation (ISO 10993).

The key takeaway from the document regarding "performance" is:

"Test results indicated that the AcuPulse W with the 90° Side-firing Handpiece equipped with the new configuration of disposable tips performs in accordance with its requirements and specifications similarly to its predicate device."

This statement confirms that the new disposable tips meet functional and safety requirements comparable to the existing multiuse tips, ensuring substantial equivalence to the predicate device. However, it does not provide specific quantitative acceptance criteria or detailed study results generally associated with AI/ML device performance.

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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

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.

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