(13 days)
Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.
Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.
The proposed Ultraflex Esophageal NG Stent System allows for the placement of a selfexpanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered either bare or covered and with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device also incorporates two adhesive material changes and the addition of a visual marker on two models.
The provided text describes a 510(k) premarket notification for a medical device called the Ultraflex™ Esophageal NG Stent System. This submission is a "Special 510(k)," which typically means minor changes have been made to a previously cleared device. As such, the emphasis is on demonstrating substantial equivalence to the predicate device rather than presenting new clinical performance data for acceptance criteria and a detailed study proving performance.
Here's an analysis based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative acceptance criteria for clinical performance. The submission focuses on substantial equivalence to the predicate device, implying that the new device should perform at least as well as the predicate. | * "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." (Section 7) |
Rationale: The 510(k) summary (Section 7) states that "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This confirms that the device meets its internal design specifications and performance requirements for in-vitro tests, which are used to demonstrate substantial equivalence, especially for a Special 510(k). However, specific acceptance criteria for clinical outcomes (e.g., success rates, complication rates) are not provided, as this type of submission usually relies on the predicate device's established clinical profile. The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate in all relevant aspects, supported by in-vitro testing for the changes made.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not provided.
- Data Provenance: The performance data described is "In-vitro testing." This suggests laboratory-based testing rather than patient-derived data (e.g., retrospective or prospective clinical studies). Therefore, there is no country of origin for patient data.
Rationale: The submission explicitly states "In-vitro testing." This means the testing was likely conducted in a lab environment using physical devices or models, not on a patient population. Consequently, there's no patient data, sample size for test sets (in a clinical sense), or data provenance from a geographical perspective.
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.
Rationale: Since the performance data is derived from "in-vitro testing" and not clinical studies involving diagnostic accuracy or treatment efficacy evaluated by experts, there is no need for experts to establish ground truth in the context of this submission. The "ground truth" for in-vitro tests is typically defined by engineering specifications and objective measurements.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
Rationale: As there are no human-interpreted results or clinical outcomes requiring independent review or consensus, an adjudication method is not relevant to "in-vitro testing."
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
- MRMC Study: No, an MRMC study was not done.
- Effect Size: Not applicable.
Rationale: This device is an esophageal stent system, which is a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable.
Rationale: This device is a physical stent system and does not involve an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used
- Type of Ground Truth: Engineering specifications and objective measurements for in-vitro performance.
Rationale: For "in-vitro testing," the ground truth is typically established by predetermined performance specifications, material properties, and objective measurements (e.g., mechanical strength, deployment characteristics, fatigue resistance) that the device must meet.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable.
Rationale: There is no mention of "training" in the context of an algorithm or statistical model. The testing described is performance testing of a physical device.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
Rationale: As there is no "training set" in the context of an algorithm, the concept of establishing ground truth for it does not apply.
In summary:
This 510(k) submission for the Ultraflex™ Esophageal NG Stent System is a "Special 510(k)," indicating minor changes to a previously cleared device. The primary method of demonstrating performance and substantial equivalence relies on in-vitro testing to show that the modified device's components and full systems meet all required specifications. The submission does not present clinical performance data (e.g., patient-based studies, expert evaluation, or AI algorithm performance) to establish acceptance criteria or prove effectiveness in the way one might expect for a novel device or an AI/diagnostic software product. The "acceptance criteria" are implicitly met by showing the new device performs identically to or within acceptable limits of the predicate device through laboratory testing.
§ 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.”