(88 days)
The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release in indicated for use in the treatment of esophageal obstructions produced by malignant neoplasms.
The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release is self-expandable metal stent which is mounted on a delivery catheter. The stent is manufactured from a nickel titanium (Nitinol) material and is comprised of a center stenting section of adjacent coils and two flared ends which enhance fixation. The delivery catheter is manufactured from a thermoplastic material with a tapered end and flexible tip. The stent is wound in a reduced diameter configuration and held in place by a restraining means. The restraining means in connected to the "slow release" handle on the proximal end of the catheter. The slow release allows the stent to be released from the catheter in a fixed and controlled speed manner.
Here's an analysis of the provided text regarding the Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release, addressing your specific questions.
Important Note: The provided document is a 510(k) submission, which primarily focuses on demonstrating "substantial equivalence" to a predicate device, rather than detailed performance studies with acceptance criteria and statistical analysis typical of a new PMA application or extensive clinical trial. As such, many of your requested items, particularly those related to quantitative performance metrics, sample sizes for specific studies, and detailed expert ground truth processes, are not present in this document. The document states, "Testing was performed to evaluate the safety and effectiveness of the slow release mechanism. No other testing was deemed necessary for the modification of this device." This implies a focus on engineering and functional testing of the new mechanism, rather than a broad clinical efficacy study.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no explicit quantitative acceptance criteria or reported device performance metrics in the format of a table. The submission states that "Testing was performed to evaluate the safety and effectiveness of the slow release mechanism." However, the results of this testing, specific metrics like release speed, force profiles, or deployment success rates against numerical acceptance criteria, are not detailed in this document. The conclusion is a qualitative statement of substantial equivalence.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Implied) |
|---|---|
| (Likely related to controlled stent release, safety, and functional equivalence to predicate) | "Testing was performed to evaluate the safety and effectiveness of the slow release mechanism." |
| "Based on the testing performed and the nature of the change, it was concluded that the modified device is substantially equivalent to the currently marketed device." |
2. Sample sized used for the test set and the data provenance
The document does not specify a sample size for any "test set" in the context of a clinical or performance study where ground truth would be established. The testing mentioned appears to be focused on the "slow release mechanism" itself, likely engineering or bench testing. No information on data provenance (country of origin, retrospective/prospective) related to patient data is provided, as no clinical study with patient data appears to be described for this specific modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given the nature of the modification (a change in the release mechanism), any "ground truth" for the testing performed would likely relate to engineering specifications or functional performance, not clinical diagnoses requiring expert consensus.
4. Adjudication method for the test set
This information is not provided in the 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
No, an MRMC comparative effectiveness study was not conducted or described. This device is a medical stent, not an AI diagnostic tool, so this type of study is not applicable.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
No, a standalone algorithm or AI performance study was not performed. This device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the testing of the "slow release mechanism." Given the "safety and effectiveness" evaluation of a mechanical feature, the ground truth would likely be based on:
- Engineering specifications: For release speed, force, integrity of the stent upon deployment, etc.
- Bench testing results: Demonstrating consistent and controlled release compared to design intent.
- Predicate device comparison: Functional equivalence to the previously cleared device's release characteristics.
There is no mention of ground truth based on patient outcomes, pathology, or expert clinical consensus for this specific modification.
8. The sample size for the training set
This information is not applicable and not provided. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”