(283 days)
The HANAROSTENT LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant structures.
The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
This self-expanding tubular prosthesis is designed to maintain patency of colorectal or duodenal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAxTM Duodenum/Pylorus (NNN) are intended for single use only.
The provided text describes a 510(k) premarket notification for two devices: HANAROSTENT LowAx™ Colon/Rectum (NNN) and HANAROSTENT LowAx™ Duodenum/Pylorus (NNN). This notification aims to demonstrate substantial equivalence to previously cleared predicate devices.
However, the document does not contain information about acceptance criteria for device performance based on a clinical study or a study proving that the device meets such criteria. Instead, it focuses on demonstrating technological equivalence and presents the results of bench testing to confirm safety and effectiveness.
Therefore, I cannot provide a table of acceptance criteria and reported device performance derived from a clinical study, nor can I answer questions about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to clinical or AI performance studies which are not detailed in this document.
The document does provide information pertinent to physical and material performance, as outlined in the "Performance Summary" section.
Here's what can be extracted from the document regarding the performance validation performed:
1. A table of acceptance criteria and the reported device performance:
The document describes bench testing performed to confirm safety and effectiveness compared to predicate devices, but it does not explicitly list quantitative acceptance criteria or specific reported performance values for these tests. It only lists the types of tests conducted.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document describes bench testing, not a clinical study with human subjects.
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):
Not applicable. The document describes bench testing, not a clinical study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The document describes bench testing, not a clinical study requiring adjudication of expert interpretations.
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:
Not applicable. The document describes a medical device (stent) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The document describes a medical device (stent) and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the bench testing, the "ground truth" would be the expected physical or mechanical properties and behaviors of the stent as per engineering specifications and relevant standards. This is inherent in the design control system and the performance tests themselves.
8. The sample size for the training set:
Not applicable. The document describes a medical device (stent) and its physical and mechanical performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. The document describes a medical device (stent) and its physical and mechanical performance testing, not a machine learning model requiring a training set.
Summary of available information related to performance (bench testing):
The document states that "Appropriate bench testing was performed to confirm the safety and effectiveness of the proposed devices as compared to the identified predicate device." This testing was conducted "as per the design control system" and consulted "Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998."
Types of Bench Tests Conducted:
- Axial force
- Compression force
- Corrosion
- Deployment force
- Deployment accuracy
- Dimensions
- Expansion force
- Repositioning force
- Stent separation
- Tensile strength
- Trackability
Biocompatibility Assessment:
- Assessed in accordance with ISO 10993-1:2003, 2012.
Conclusion from Bench Testing:
The non-clinical data (bench testing) supports the safety of the proposed devices and demonstrates that they are safe and effective and will perform as intended in the specified use conditions. It also concludes that the proposed device is substantially equivalent to the predicate devices based on these tests and technological characteristics.
§ 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.”