(29 days)
EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs, such as but not limited to the following examples:
- · endovascular aortic aneurysm repair (AAA and TAA),
- · angioplasty,
- · stenting.
- · embolization in iliac arteries and corresponding veins.
EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs.
EndoNaut system is an imaging solution for intraoperative navigation and guidance tool for endovascular procedures (aorto-iliac and peripheral).
EndoNaut provides localization assistance by combining 3D preoperative scans and 2D intra-operative fluoroscopy imagery to help position guides, catheters and other vascular devices.
EndoNaut Software is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection before endovascular procedure.
The provided document is a 510(k) summary for a modified medical device, EndoNaut, and focuses on demonstrating substantial equivalence to a predicate device (also named EndoNaut, K171829). It does not contain detailed acceptance criteria, device performance metrics, or study design information typically found in a clinical study report for proving device effectiveness.
The document primarily outlines minor changes in hardware components and software naming conventions, and reaffirms compliance with relevant standards. It explicitly states that "No new risks or possible errors were detected or identified. New clinical data were not necessary."
Therefore, I cannot provide detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you requested. The document does not describe such a study.
However, I can extract the information related to the device's validation and verification activities, which are general statements of compliance rather than specific performance metrics against pre-defined acceptance criteria.
Based on the provided document, here's what can be extracted regarding acceptance criteria and "study" (referring to verification and validation activities):
The document does not detail specific, quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the modified device (EndoNaut, subject device) is substantially equivalent to the predicate device (EndoNaut, K171829) and continues to meet general safety and effectiveness requirements. The "study" in this context refers to the design verification and validation activities conducted as part of the quality assurance system.
1. A table of acceptance criteria and the reported device performance
No specific, quantitative acceptance criteria are provided in the document, nor are specific performance metrics reported against such criteria. The document states "These tests showed that the EndoNaut Workstation TS1CA2DS1-2 meets the design specification and performed as intended." The "acceptance criteria" are implied to be conformance with "design specification" and "performed as intended," as well as compliance with various standards.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Conforms to Design Specifications | Meets design specifications and performs as intended. |
| Safe and Effective | Deemed safe and effective (based on substantial equivalence). |
| ISO 14971 compliance | Applied |
| IEC 62304 compliance | Applied |
| IEC 62366 compliance | Applied |
| IEC 60601-1 compliance (Workstation) | Yes (for CENELEC countries) |
| ANSI AAMI ES60601-1 (Workstation) | Yes (for US deviations to IEC 60601-1) |
| IEC 60601-2 compliance (Workstation) | Yes |
| IEC 60601-1-6 compliance (Workstation) | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" and thus no sample size for such a set. The validation and verification activities are generally performed internally without a distinct "test set" from real patient data in the context of a 510(k) for minor modifications. The document does not provide a sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe a clinical study involving experts establishing ground truth. Therefore, this information is not available.
4. Adjudication method for the test set
Not applicable, as no external test set or adjudication process is described in the provided document.
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
The document does not describe an MRMC study or any study evaluating human reader improvement with AI assistance. The device is described as an "imaging solution for intraoperative navigation and guidance tool," and the AI module mentioned pertains to 2D-3D fusion and semi-automatic registration, not diagnostic interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly state an "algorithm only" standalone performance study. The device is intended for "intraoperative navigation and guidance," implying human-in-the-loop use. The "Performance testing (Verification)" and "Simulated use testing (Validation)" would cover the device's functional integrity, but no details on standalone performance metrics are provided.
7. The type of ground truth used
The document does not mention specific "ground truth" data used for performance evaluation in the context of clinical accuracy (e.g., pathology, outcomes data). The verification and validation activities likely used internal reference standards and simulated use cases to confirm the device's functional performance and safety.
8. The sample size for the training set
Not applicable. The document is for a 510(k) submission for a modified device, primarily addressing hardware and software updates, and reaffirming substantial equivalence. It does not describe the development or training of an AI model, only mentions an "AI module" in the context of 2D-3D fusion and registration. Therefore, no training set size is provided.
9. How the ground truth for the training set was established
Not applicable, as no training set is described.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.