(215 days)
The AuroLase System is intended for use in delivering up to 9 Watts of continuous wave radiation to a flexible optical fiber for use in ablation, incision, excision, coagulation and vaporization of soft tissues in open and endoscopic surgical procedures including in general surgery, ophthalmology/oculoplastic, urology, gastroenterology, gynecology, otorhinolaryngology, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedic.
The AuroLase® System (AS) is a portable, cart-based integrated liquid cooled laser system for use in professional healthcare facilities. The AuroLase System is used to generate photothermal ablation of selected soft tissues using 1-9W of near infrared optical power via 1 or 2 optical fibers either individually or simultaneously while providing liquid coolant to moderate the temperature at the fiber surface. The laser is delivered to the tissue of interest via an optical fiber system, the Nanospectra Laser Delivery Device (LDD), cleared via K202953. It is for prescription use only.
Central to the AuroLase System is the AuroLase Laser Device (ALD), a dual channel, continuous-wave, class IV GaAs diode laser (Figure 1 - red section) that provides the optical energy used to excite to soft tissues to ablative temperatures. The ALD incorporates an integrating sphere power meter (optometer) which is used to adjust the laser output that is delivered to the patient to the power shown on the display.
Enabling the ALD's functionality is the AuroLase Control Unit (Figure 1 - green section) which incorporates: a) a peristaltic pump for providing sterile coolant to the Laser Delivery Devices, b) dual ultrasonic sensors to assure that coolant flows through the LDDs, c) a footswitch to control laser activation, d) temperature monitors for up to two optional external thermocouples, and e) a software application that controls, integrates, and monitors these functions. A medical-grade power supply is near the base of the unit to provide electrical service to the rest of the system as well as mechanical stability.
The AS is designed and tested for operation in a professional healthcare facility.
AuroLase System Incorporates:
AuroLase Laser Device (ALD)
- The ALD is a dual-channel 810nm laser system capable of 1-9W of output power per channel, adjustable in 0.25W increments.
- The optical outputs of the ALD are configured to insert their optical energy into mated SMA-905 terminated optical fibers with diameters of >=600µm and numerical apertures of
The provided FDA 510(k) clearance letter for the AuroLase® System explicitly states: "No clinical study is included in this submission."
Therefore, based solely on the provided text, it's not possible to describe acceptance criteria, a study proving the device meets those criteria, or any of the detailed information regarding sample sizes, expert involvement, ground truth, or MRMC studies.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Diomed Delta 15) through non-clinical testing (electrical safety, EMC, software validation, bench testing) and comparison of technical specifications.
However, to answer your request as if such information were present in a typical submission that included a clinical study, I will outline what such a response would look like by making reasonable assumptions about a hypothetical clinical study for a medical device cleared via the 510(k) pathway. Please note, this is entirely hypothetical and not derived from the provided document.
Hypothetical Description of Acceptance Criteria and Study Proving Device Performance for a Medical Device (Not explicitly found in provided AuroLase® System 510(k) documentation)
Introduction:
For the purpose of fulfilling your request, and acknowledging that the provided 510(k) clearance letter for the AuroLase® System explicitly states no clinical study was included, the following information is purely hypothetical. It describes the typical elements one would find in a 510(k) submission where a clinical study was performed to demonstrate a device meets its acceptance criteria. This example is designed to illustrate the structure and content of such a section.
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)
As the AuroLase® System is a laser surgical instrument for soft tissue ablation, the acceptance criteria would likely revolve around its ability to achieve desired tissue effects (ablation, incision, coagulation, vaporization) safely and effectively. For this hypothetical scenario, we will assume the primary performance metric of interest is the achieved ablation zone size and adverse event rate compared to a standard of care or the predicate.
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) | Pass/Fail |
|---|---|---|---|
| Primary Endpoints: | |||
| Ablation Zone Consistency | Mean ablation zone diameter within ±15% of pre-treatment planning (for specific tissue type, e.g., prostate) | Mean ablation zone diameter: -5% to +10% of planning (across studied subjects) | Pass |
| Complete Ablation Rate | ≥85% of target lesions achieving complete ablation (based on post-procedure imaging/histology) | 92% (95% CI: 88-95%) | Pass |
| Secondary Endpoints: | |||
| Adverse Event Rate (Grade ≥2) | ≤5% (procedure-related adverse events, e.g., significant bleeding, adjacent tissue damage, infection) | 3.5% (95% CI: 2-5%) | Pass |
| Procedure Time | Not significantly longer than predicate device (e.g., within 20% of predicate's typical time for similar procedures) | On average 10% faster than predicate device | Pass |
| Device Malfunction Rate | ≤1% during clinical use | 0.2% | Pass |
Note: Specific acceptance criteria would be highly dependent on the device's indications for use and the nature of the clinical study. For a 510(k), often the acceptance criteria demonstrate equivalence or non-inferiority to a predicate device or accepted standard of care.
2. Sample Size Used for the Test Set and Data Provenance (Hypothetical)
- Sample Size (Test Set/Clinical Study Cohort): 150 unique patient procedures.
- Data Provenance:
- Country of Origin: Multi-center study conducted across 10 sites in the United States and Canada.
- Retrospective or Prospective: Primarily prospective, single-arm clinical study. A subset of historical control data from the predicate device was used for comparative analysis where appropriate, but the primary performance data for the AuroLase® System itself was collected prospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (Hypothetical)
- Number of Experts: 3 independent expert reviewers.
- Qualifications of Experts: All experts were board-certified interventional radiologists or surgeons with a minimum of 8-15 years of experience in performing and interpreting minimally invasive ablation procedures, specifically utilizing thermal ablation technologies. They were blinded to the device used where possible (e.g., when reviewing post-ablation imaging).
4. Adjudication Method for the Test Set (Hypothetical)
- Adjudication Method: 2+1 Consensus.
- All cases were initially independently reviewed by two primary experts.
- If the two primary experts agreed on the ground truth (e.g., complete ablation vs. incomplete ablation, presence/absence of an adverse event), their consensus was adopted.
- If there was a disagreement between the two primary experts, a third, senior expert (the "+1") independently reviewed the case, and their decision served as the tie-breaker and final ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done (Hypothetical)
For a device like a laser surgical instrument where the direct "human-in-the-loop performance" isn't typically assessed as an AI diagnostic algorithm, an MRMC study comparing human readers with AI vs. without AI assistance would not be applicable.
- Explanation: The AuroLase® System, as described, is a therapeutic device that a clinician operates, not a diagnostic AI tool that assists in image interpretation. Therefore, an MRMC study measuring AI assistance for human readers is not relevant to this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done (Hypothetical)
Again, for a therapeutic laser system, the concept of "standalone algorithm performance" (e.g., diagnostic accuracy of an AI) is not applicable. The device's performance is intrinsically linked to its operation by a human user within a clinical procedure.
- Explanation: There isn't an "algorithm" separable from the device's physical operation that would perform a task independently. The device's performance is measured by its physical output and the clinical outcomes achieved when operated by a trained professional.
7. The Type of Ground Truth Used (Hypothetical)
- Ground Truth Type:
- Expert Consensus (as described in point 4): For primary endpoints like "complete ablation," this was established by expert review of post-procedure imaging (e.g., MRI, CT, or ultrasound findings).
- Pathology: For a subset of cases where tissue resection or biopsy was performed after ablation, histopathological analysis provided confirmatory ground truth regarding the extent of tissue necrosis/ablation. This was considered the gold standard where available.
- Outcomes Data: Clinical follow-up data (e.g., recurrence rates, symptom resolution, patient quality of life) contributed to the overall assessment of effectiveness and safety outcomes.
8. The Sample Size for the Training Set (Hypothetical)
Given the nature of the AuroLase® System as a physical medical device (not an AI algorithm with a training phase), the concept of a "training set" for an algorithm's development is not directly applicable in the same way as it would be for an AI/ML diagnostic system.
- Alternative Interpretation (Pre-Clinical Testing/Engineering Design): If we interpret "training set" as data used during the engineering design and optimization of the laser parameters and system controls:
- Hundreds of in vitro (benchtop tissue models) and ex vivo (excised tissue samples) experiments were conducted.
- Tens of in vivo animal model experiments were performed to fine-tune power settings, fiber types, and coolant flow rates to achieve desired tissue effects.
9. How the Ground Truth for the Training Set Was Established (Hypothetical)
Continuing the interpretation from point 8 (focusing on engineering/pre-clinical data):
- For in vitro and ex vivo studies: Ground truth for ablation was established via precise measurements of lesion size and morphology using gross examination, histology (e.g., H&E staining), and thermal mapping (e.g., infrared thermography).
- For in vivo animal model studies: Ground truth was established through a combination of:
- Histopathology: Microscopic examination of ablated tissue sections from necropsy.
- Imaging Correlation: Pre- and post-ablation imaging (e.g., MRI) correlated with post-mortem histological findings to establish imaging characteristics of successful ablation.
- Physiological Response: Monitoring of tissue temperature and immediate physiological changes during the ablation procedure.
§ 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.