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510(k) Data Aggregation
(29 days)
AUTOTOME RX MODEL # 4515, 4516
The Autotome™ RX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to cannulate and inject contrast medium.
The proposed Autotome™ RX is a triple lumen sphincterotome with controlled orientation and rotation features. It is compatible with the Boston Scientific Microvasive® Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .035" guidewire while allowing simultaneous injection through an adjacent lumen.
The provided document is a 510(k) summary for the Autotome™ RX device, which is a sphincterotome. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as would be found for novel AI/machine learning devices.
Therefore, much of the requested information cannot be extracted from this specific document, as it describes a traditional medical device submission based on predicate device comparison.
Here's an attempt to answer the questions based on the available information and highlighting what is not present:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Rapid Exchange™ Cannulating Sphincterotome (K970053, Ultratome RX) in terms of performance characteristics and biocompatibility. | The submission states, "The proposed device is substantially equivalent to currently marketed Rapid Exchange™ Cannulating Sphincterotome in terms of performance characteristics tested and biocompatibility." This indicates that the device's performance characteristics (though not specified in detail) were compared to the predicate and found to be similar enough to warrant substantial equivalence. Specific quantitative performance metrics or acceptance criteria beyond "substantially equivalent" are not provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The submission focuses on device comparison rather than a clinical study requiring a specific test set.
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 applicable/provided. Ground truth establishment by experts for a test set is typically relevant for studies validating diagnostic or AI devices, which is not the nature of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided.
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 applicable. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithmic/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The evaluation is based on "performance characteristics tested and biocompatibility" compared to a predicate device, not on diagnostic accuracy against a ground truth.
8. The sample size for the training set
This information is not applicable/provided. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided.
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