(27 days)
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 subject AcuPulse W system is a new scaled-down version of the recently FDA cleared Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. It is based on the following hardware components in the AcuPulse:
- . A Laser Console with a Free Beam Port to which an articulated arm attached.
- Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser O tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel.
- . An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue.
- . 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 AcuPulse and AcuPulse W systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The differences between the two are the enabled or disabled software features, through a hardware key (HASP dongle), that reflects the capabilities of each laser system or the particular configuration of a given system. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K180597.
The AcuPulse W is offered with a subset of the previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. In addition, Lumenis is adding a Titanium (Ti-6Al-4V) 90° Side-firing Handpiece design. Like the cleared handpieces, it has multiple uses. The 90° Side-firing handpiece connects to the cleared 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
- Tip (Standard or Fine)
- . Limiter ring (Standard or Fine)
This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories:
Observation: The provided text is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific, novel acceptance criteria through a primary clinical study. It details changes from a previous version and outlines various verification and validation activities conducted. Therefore, it does not contain information about a traditional "study that proves the device meets acceptance criteria" in the sense of a standalone clinical trial with pre-defined performance endpoints. Instead, it indicates that the device was evaluated against existing standards and specifications to ensure it performs comparably to the predicate.
Given this context, I will extract relevant information to address your points, acknowledging that some fields might not be directly applicable as they pertain to clinical performance studies, which are not detailed here.
Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are primarily established by the successful demonstration of substantial equivalence to the predicate device and compliance with relevant industry standards for safety and performance. There isn't a table of specific clinical performance criteria (e.g., sensitivity, specificity for a diagnostic device) and reported device performance from a clinical trial in this document.
The document implicitly states that the device performs in accordance with its requirements and specifications similarly to its predicate device. The "reported device performance" is effectively its compliance with the listed standards and its functional equivalence to the cleared predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with Risk Analysis (ISO 14971) | Risk analysis performed and design verification processes conducted to address any new safety/effectiveness questions from modifications. |
| Electrical, laser safety, and electromagnetic compatibility (EMC) testing based on: |
- IEC 60601-1
- IEC 60601-1-2
- IEC 60825-1
- IEC 60601-2-22 | Testing performed and results indicated that the new configuration performs in accordance with its requirements and specifications similarly to its predicate device. This implies successful completion and compliance with these standards. |
| 90° Side-firing Handpiece performance (functional) | Testing demonstrated that the accessory (90° Side-firing Handpiece) together with the AcuPulse W system performs in compliance with their specifications and requirements. This includes functional equivalence to existing cleared CO2 delivery devices based on the same technology and principles. |
| 90° Side-firing Handpiece Cleaning Validation (AAMI TIR 30) | Validation activities performed. |
| 90° Side-firing Handpiece Sterilization Validation (ISO 17665-1) | Validation activities performed. |
| 90° Side-firing Handpiece Biocompatibility (ISO 10993) | Biocompatibility testing performed for materials. |
| Software Validation | The AcuPulse and AcuPulse W systems use the same proprietary software version, which was already validated, verified, and submitted under K180597. The differences are enabled or disabled features via a hardware key. This implies the software continues to meet its previously established performance criteria as the core software remains unchanged. |
| Substantial Equivalence to Predicate Device (K180597) | The device is deemed substantially equivalent. Test results indicated that the new configuration performs in accordance with its requirements and specifications, similarly to its predicate device, and does not raise new questions of safety and/or effectiveness. |
Study Details (as inferable from the 510(k) Summary):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable in the context of a clinical test set. The document describes engineering verification and validation activities (testing against standards, functional testing of accessories). For these engineering tests, sample sizes are not explicitly stated, but typically involve representative samples of the device and its components.
- Data Provenance: Not applicable for a clinical test set. The studies are engineering and regulatory compliance tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This device is not an AI/diagnostic device that requires expert-established ground truth for a test set. The "ground truth" for the engineering tests is compliance with established safety and performance standards and the functional specifications of the device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of clinical outcomes or diagnostic interpretations.
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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:
- No. This device is a laser surgical instrument, not an AI-based diagnostic or assistive system for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm but a physical medical device. Software validation was done, but it pertains to the device's operational control, not a standalone diagnostic algorithm. The software is embedded and controls the laser device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the evaluation documented here is primarily compliance with recognized electrical, laser safety, and biocompatibility standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993, ISO 17665-1, AAMI TIR 30), and the functional specifications set for the device and its accessories, evaluated through engineering tests, rather than clinical outcomes or expert consensus on patient data.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that involves a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.
§ 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.