(54 days)
ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.
Table-mounted self-retaining endoscope holder system consisting of stainless steel tubular, articulated arms that are connected to a vertical stand and are freely adjustable within the articulating radius according to the requirements of the particular surgical procedure. Accessories include endoscope holders for 2.7mm to 10mm scopes. The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
The provided text is a 510(k) summary for the ASSISTO® Arm Systems, describing its substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study that quantitatively measures the device's performance against such criteria using a test set of data with ground truth. Instead, it focuses on demonstrating equivalence through design analysis and verification testing.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be extracted from this document, as they pertain to performance studies typically involving AI/software devices evaluated against ground truth. This document describes a mechanical device.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document for a quantitative performance study. | "Design analysis and comparison as well as verification testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness." |
Explanation: The document states that verification testing confirms "basic functional characteristics" and "substantial equivalence." It does not provide specific, measurable acceptance criteria (e.g., accuracy thresholds, sensitivity, specificity) that would be relevant for a software or AI device. The device is a mechanical arm system, and its "performance" is assessed through engineering analysis and confirmation of functional equivalence to existing devices.
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified. The verification testing mentioned likely refers to engineering tests on the physical device, not a test set of data.
- Data provenance: Not applicable, as there's no "data" in the sense of medical images or patient records being analyzed by the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
Explanation: Ground truth, in the context of AI regulatory submissions, typically refers to expert labels or confirmed diagnoses used to evaluate an algorithm's performance. This type of "ground truth" is not relevant for a mechanical device like the ASSISTO® Arm System.
4. Adjudication method for the test set
- Not applicable, as there is no "test set" or "ground truth" in the context of an AI/software performance study.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or decision-making systems, not for a mechanical endoscope holder.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a mechanical system, not an algorithm.
7. The type of ground truth used
- Not applicable. There is no ground truth in the sense of expert consensus, pathology, or outcomes data, as this is a mechanical device. The "ground truth" equivalent for such a device is likely compliance with design specifications and functional requirements through engineering tests.
8. The sample size for the training set
- Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary for the ASSISTO® Arm Systems based on the provided text:
The ASSISTO® Arm Systems is a mechanical device, an endoscope holder, and therefore the regulatory submission (510(k)) focuses on demonstrating substantial equivalence to predicate mechanical devices. This involves design analysis and verification testing to confirm its basic functional characteristics and safety, rather than performance metrics against a data-driven ground truth that would be relevant for AI or software devices. The document explicitly states: "Design analysis and comparison as well as verification testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness." This statement serves as the "proof" that the device meets the implied "acceptance criteria" of being functionally equivalent and safe.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).