(93 days)
The Edwards E360 surgical ablation device is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, and colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).
The Edwards E360 surgical ablation device is indicated for use in medicine and surgery with 980 to 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Cardiac/Thoracic Surgery, Plastic Surgery, and Dermatology.
The Edwards E360 surgical ablation device is a sterile, single-use, disposable device for delivery of 980 nm laser energy in the contact mode.
This document does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria in the typical sense of a clinical or analytical performance study with statistical endpoints.
Instead, this is a 510(k) summary for the Edwards E360 surgical ablation device. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing numerical performance metrics against predefined acceptance criteria for a novel device.
Here's an analysis based on the provided text, while acknowledging the information gap:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document is a 510(k) summary demonstrating substantial equivalence, not a detailed performance study with quantitative acceptance criteria. The "Functional/Safety Testing" mentioned generally confirms "successfully completed design verification testing," but specific acceptance criteria and performance metrics are not reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available. No specific test set, its sample size, or data provenance is detailed for a clinical or analytical performance study. The testing mentioned ("design verification testing") would typically involve engineering tests, not patient data in the context of a "test set" for performance evaluation against ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available. As there is no described test set for performance evaluation against a specific ground truth, there is no mention of experts involved in establishing such ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No adjudication method is mentioned as there is no specific test set or performance evaluation described.
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
This information is not available. An MRMC study is not mentioned. This device is a surgical ablation device, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available. No specific ground truth is mentioned. The testing described is design verification, which likely involves engineering specifications and safety standards rather than clinical ground truth establishment.
8. The sample size for the training set
This information is not available. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not available. There is no mention of a training set or its associated ground truth.
Summary of what the document does provide regarding "proof" of meeting criteria:
The primary "proof" in this 510(k) submission is the demonstration of substantial equivalence to predicate devices.
- Acceptance Criteria (Implicit): The implicit acceptance criteria for a 510(k) is demonstrating that the new device is "as safe and effective as a legally marketed device." This is achieved by showing comparable design, intended use, materials, and principle of operation to predicate devices, and successful completion of design verification testing.
- Study Proving Device Meets Criteria: The "study" is the Comparative Analysis and Functional/Safety Testing described:
- Comparative Analysis: "It is demonstrated that the Edwards E360 surgical ablation device is comparable to the predicate device in design, intended use, materials, and principal of operation." This is the core of the substantial equivalence argument.
- Functional/Safety Testing: "The Edwards E360 surgical ablation device has successfully completed design verification testing." This confirms the device meets its own engineering and safety specifications, which support the claim of being as safe and effective as the predicates.
In essence, for this type of medical device submission, the "study" is the entire submission package which argues for substantial equivalence based on comparisons to predicate devices and internal design/safety verification, rather than a clinical performance study with statistical endpoints against a "ground truth" as might be required for a novel diagnostic or AI 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.