(122 days)
The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction.
The ALAR™ Nasal Valve Stent supports and immobilizes intranasal tissues and cartilage during the post-operative healing period following intranasal and nasal valve surgery.
The elliptically shaped fluoroplastic stent is approximately 20 mm long and 16 mm wide. Slits symmetrically spaced along the stent's lateral edges allow for left and right nostril usage. The suture and needle attached to the stent provide stent anchoring and hold cartilage plates stable during post-operative healing.
The provided document is a 510(k) premarket notification for the ALAR™ Nasal Valve Stent. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
The "Discussion of the Performance Testing" section (page 4) states: "Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products. Test samples were subjected to simulated real-life use conditions during functional testing. All function testing passed the test specifications and acceptance criteria for the bench top engineering studies. A biocompatibility assessment, sterility adoption, transportation and shelf life/aging testing was also conducted Additional bench, animal or clinical testing was not required to establish substantial equivalence."
This indicates that engineering studies were performed to confirm functionality and compatibility, and these studies had "test specifications and acceptance criteria." However, these specific criteria and the detailed results are not provided in this document. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and existing predicate testing, rather than presenting a performance study with detailed clinical or diagnostic metrics.
Therefore, I cannot populate the requested table and answer many of the questions because the necessary information is not present in the provided text. The device is a physical medical device (stent), not an AI/algorithm-based diagnostic device, so many of the questions pertinent to AI performance metrics (like MRMC studies, standalone algorithm performance, training/test set details, ground truth for AI) are not applicable or detailed in this context.
Here's what can be inferred or stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "All function testing passed the test specifications and acceptance criteria for the bench top engineering studies." |
| Biocompatibility | "A biocompatibility assessment... was conducted." (Assumed passed) |
| Sterility | "sterility adoption... was conducted." (Assumed passed) |
| Transportation | "transportation... testing was also conducted." (Assumed passed) |
| Shelf life/aging | "shelf life/aging testing was also conducted." (Assumed passed) |
| Functionality | "Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products." (Assumed passed) |
Missing Information: The document does not provide the specific numerical or qualitative "acceptance criteria" for functionality, biocompatibility, sterility, etc., nor does it provide the detailed "reported device performance" metrics against those criteria. It only states that testing passed the internal specifications.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers to "test samples" for "bench top engineering studies," but the number of samples is not mentioned.
- Data Provenance: Not applicable in the context of clinical/patient data, as these were bench-top engineering studies. The studies were likely conducted internally by Medtronic Xomed Inc.
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. This device is a physical stent, and the evaluation mentioned consists of engineering studies (biocompatibility, functional testing, etc.), not a diagnostic test with a "ground truth" established by medical experts in the typical sense of evaluating diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple readers. The described tests are bench-top engineering studies.
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. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of clinical "ground truth" for diagnostic performance. Ground truth in the engineering studies would refer to established physical, chemical, or mechanical standards and specifications.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.