(27 days)
The Medical CV Atrilaze™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, dissection, vaporization, ablation, or coagulation of soft tissue.
The Altrilaze Surgical Ablation System consists of a generator designed for the delivery of 810nm or 1064nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal end. The system may be used in conjunction with surgical treatment for hemostasis, incision, coagulation and vaporization of tissue as required by the clinician.
Here's a breakdown of the acceptance criteria and study information for the Atrilaze™ Surgical Ablation System, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Power Output (Manufacturing Specs) | Not explicitly stated as a numerical acceptance criterion, but "compliance to manufacturing specifications for Power Output" was a performance test. The results generally indicate compliance as substantial equivalence to the predicate device was found. |
| Lesion Characteristics (Visual) | Not explicitly stated as a numerical acceptance criterion, but visual evaluation of lesions obtained using the 1064nm wavelength on cardiac tissue was performed. |
| Lesion Characteristics (Histology) | Not explicitly stated as a numerical acceptance criterion, but histology evaluation of lesions obtained using the 1064nm wavelength on cardiac tissue was performed. |
| Substantial Equivalence | Testing demonstrated that lesions obtained using the Nd:YAG laser at 1064nm wavelength are substantially equivalent to those obtained with the currently cleared laser at 810nm wavelength (the predicate device K040744 & K052495). This is the overarching acceptance criterion for the modification to the device (new wavelength). |
| Biocompatibility | For the fiber optic delivery systems (probes), the acceptance criteria (and results from prior submissions K040744 & K052495) were that the materials are non-toxic, non-hemolytic, and non-pyrogenic. Since there was no change to the probe design, packaging, or sterilization, additional testing was not required for the current submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "visual and histology evaluation of the lesions obtained using 1064nm wavelength on cardiac tissue" but does not specify the number of lesions or tissue samples.
- Data Provenance: Not explicitly stated, but given the nature of the device (surgical ablation system) and the testing (cardiac tissue), it is highly likely to be pre-clinical/laboratory testing on ex vivo or in vivo animal models, rather than human data. The document does not specify country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated, though it can be inferred that the visual and histology evaluations would be performed by qualified professionals such as pathologists or biomedical researchers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. Given the context of visual and histology evaluation, single or multiple expert assessments would be expected, but no specific adjudication process (e.g., 2+1, 3+1) is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed. The study focused on technical performance and substantial equivalence of the device's output (lesion characteristics) when using a new wavelength, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical surgical laser system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study would not be relevant.
7. Type of Ground Truth Used
- Direct Measurement/Observation and Expert Evaluation:
- Histology: Provides microscopic examination of tissue, considered a high-fidelity ground truth for tissue effects.
- Visual Evaluation: Direct observation of the lesions.
- Power Output Compliance: Measured against manufacturing specifications.
8. Sample Size for the Training Set
- Not applicable. This device is a physical surgical laser system and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
§ 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.