(252 days)
The MedicalCV, Inc. Atrilaze™ Soft Tissue Ablation System is indicated for delivery of 810nm 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 Soft Tissue Ablation System consists of a generator designed for the delivery of 810nm laser light and a hand held fiber optic light delivery device (probe) fitted with a standard SMA 905 connector at the proximal rond. The system may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coaeglytion and vaporization of tissue as required by the clinician.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: | Non-toxic, non-hemolytic, non-pyrogenic |
| Materials used in the disposable probe must be biocompatible. | |
| Manufacturing Specifications Compliance: | Compliance to manufacturing specifications for: |
| - Power Output | - Power Output |
| - Tip Pull-Off | - Tip Pull-Off |
| - Pressure (for fiber optic delivery device) | - Pressure |
| - Flow (for fiber optic delivery device) | - Flow |
| Visual Evaluation of Lesions on Cardiac Tissue: | Lesions obtained using the Atrilaze System on cardiac tissue were visually evaluated. |
| Substantial Equivalence: | Demonstrated substantial equivalence to predicate devices (Biolitec/Ceramoptec Ceralas D10-25 and CardioFocus Diode Laser System) for the incision, dissection, vaporization, ablation or coagulation of soft tissue. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of an algorithm or diagnostic device. This document describes a traditional medical device (a surgical laser system), and the testing performed is related to its physical and functional characteristics, not an AI or diagnostic algorithm applied to data.
Data Provenance: Not applicable in the context of an AI/diagnostic device. The testing involved biocompatibility testing and performance testing of the physical laser system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a surgical laser system, not an AI or diagnostic algorithm that relies on expert interpretation of "ground truth" for a test set. The visual evaluation of lesions on cardiac tissue would likely involve medical professionals (e.g., surgeons, pathologists), but the number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not applicable as the device is a surgical laser system, not an AI or diagnostic algorithm that requires adjudication of expert opinions for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers interpret cases, and is not applicable to a surgical laser device described here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study as would be understood for an algorithm was not done. The device is a surgical laser system, and its performance is inherently tied to its use by a clinician.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the verifiable outcomes of the testing performed on the physical device. This includes:
- Laboratory-established standards for biocompatibility: Demonstrating non-toxicity, non-hemolysis, and non-pyrogenicity.
- Manufacturing specifications: Compliance with objective measurements of power output, tip pull-off strength, pressure, and flow.
- Visual evaluation of tissue effects: Observation of lesions on cardiac tissue, likely compared against expected outcomes for surgical lasers.
- Predicate device performance: The ability to perform equivalently to established predicate devices for soft tissue incision, dissection, vaporization, ablation, and coagulation.
8. The Sample Size for the Training Set
This information is not applicable. The device is a surgical laser system, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of medical 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.