(29 days)
The MedicalCV, Inc. Atrilaze™ Surgical Ablation System is Indicated for delivery of 810nm 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 Altrilaze Malleable S-2 Disposable Probe is used with the Atrilaze™ Surgical Ablation System which consists of a generator designed for the delivery of 8 l 0nm 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, ablation, coagulation and vaporization of tissue as required by the clinician
The provided text does not describe an AI/ML powered device and therefore lacks the detailed information required to fulfill the request. The document describes a traditional medical device, the Atrilaze™ Malleable S-2 Disposable Probe, which is a surgical laser instrument.
Based on the provided text, here's what can be extracted about the device's performance and testing, but it will not fully address the detailed requirements for AI/ML acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Non-toxic, non-hemolytic, non-pyrogenic. Material change (stainless steel to nitinol) had no impact on previously gathered test results (K040744). |
| Manufacturing Specifications | Compliance to manufacturing specifications for Power Output, Tip Pull-Off, Pressure, and Flow. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests.
- Data Provenance: The document does not specify country of origin or whether the tests were retrospective or prospective. It only mentions that biocompatibility testing was conducted under Good Laboratory Practices per 21 CFR Part 58.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to a traditional device performance study as described here. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI/ML devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is a traditional device performance study, not one requiring expert adjudication of results.
5. 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:
- Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML device. The "device" itself is a probe that delivers laser light, and its performance is measured against physical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this device's testing would be based on engineering specifications and established laboratory testing protocols for biocompatibility and physical performance (Power Output, Tip Pull-Off, Pressure, Flow). It's not a diagnostic device where pathology or expert consensus would establish ground truth for a condition.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device. There is no "training set" or corresponding ground truth to establish.
In summary, the provided document details the regulatory submission for a physical surgical laser probe, not an AI/ML-powered device. Therefore, most of the requested information pertinent to AI/ML device validation is not present.
§ 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.