(77 days)
The ATRILAZE™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.
The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.
The ATRILAZE™ Surgical Ablation System consists of a Laser Energy Generator, system cart, fluid delivery pump, fluid delivery tubing set and a fixed or flexible surgical ablation wand of various lengths. The wand is an intraoperative, sterile, single-use device designed to apply laser energy to cardiac tissue. The fluid delivery tubing set is a single-use device having a sterile fluid path designed for the delivery of sterile saline solution to the wand tip. The fluid delivery tubing may be provided together with the wand or as an accessory device. The fluid delivery pump and laser energy generator are sold separately. The wand includes a ridged metallic shaft or a flexible shaft of various lengths, and is equipped with a 905 SMA connector cable which attaches to the laser energy generator output connector. The emitted laser energy is directed toward the target tissue from the end of the optical fiber which rides within the flexible track.
The provided text describes a 510(k) submission for the ATRILAZE™ Surgical Ablation System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or the device's ability to "meet acceptance criteria" in terms of clinical outcomes with specific numerical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/ML devices.
Therefore, the requested information elements related to clinical performance metrics, sample sizes for test and training sets, ground truth establishment by experts, and MRMC studies are not applicable to this type of device and submission. The "acceptance criteria" here refer to demonstrating that the new device performs similarly and safely to the predicate device under specified laboratory conditions.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for an ablation system, the "acceptance criteria" are implied to be that the device adheres to its specifications and produces similar lesion characteristics to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Adherence to specifications (functional and safety) | "Testing demonstrated that adherence to specifications was demonstrated." This indicates that the device met its design and functional requirements. |
| Lesion characteristics (substantially equivalent to predicate) | "the lesions obtained using the ATRILAZE™ wand with 1083nm laser light are substantially equivalent to those obtained with the currently cleared ATRILAZE™ Surgical Ablation System wavelengths." This is the key equivalence finding for the new 1083nm wavelength. |
| Sterility and fluid path integrity | Both the new device and the predicate are "provided sterile with a sterile fluid path for saline delivery at the laser tip." (This is a design feature, not a performance metric from the "Testing" section, but implies an underlying acceptance criterion). |
| Compatibility with existing laser energy generator and connectors | Both devices "utilize the same laser energy generator and are connected via an SMA 905 connector." (Implies compatibility was accepted). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only states "Testing demonstrated that adherence to specifications was demonstrated." and that "lesions obtained using the ATRILAZE™ wand... are substantially equivalent." This implies a series of laboratory or bench tests were conducted, likely including tests on tissue phantoms or ex vivo tissue, but the specific number of tests or samples is not detailed.
- Data Provenance: Not specified. Given the nature of the device, it's highly probable that the testing was conducted in a laboratory or bench setting rather than using patient data from a specific country, and would be considered prospective for the specific tests performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For a device like a surgical ablation system, "ground truth" typically refers to physical measurements of ablation lesions (e.g., depth, width, morphology) rather than an expert's interpretation of images or clinical findings.
- Qualifications of Experts: Not applicable. The "ground truth" in this context would be derived from direct physical measurements and potentially histopathological analysis, which would be performed by qualified laboratory personnel or pathologists, but "experts" in the sense of clinical decision-makers are not involved in establishing this type of ground truth for substantial equivalence.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving disagreements among multiple human readers for diagnostic tasks. This device demonstrates physical performance and substantial equivalence to a predicate, not diagnostic accuracy.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is a surgical tool.
- Effect Size of Human Readers with vs. without AI: Not applicable, as no MRMC study was conducted and the device is not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a surgical tool, not an algorithm. Its performance is always predicated on human operation. The "testing" mentioned would be analogous to a standalone performance test for a mechanical or electrical device, verifying its functional specifications.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for evaluating the "lesions obtained" would likely be based on physical measurements (e.g., macroscopic and/or microscopic assessment of lesion depth, width, volume) in tissue samples, potentially supported by histopathology to confirm cellular changes. For "adherence to specifications," the ground truth would be the specified engineering tolerances and performance parameters of the device itself.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.
§ 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.