(57 days)
The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
The Spirox Latera Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the Latera Absorbable Nasal Implant) and Accessory Delivery Device (Delivery Device). The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and overall length of 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. The Latera Absorbable Nasal Implant and Accessory Delivery Device are provided sterile and are intended for single-use only.
This document, K161191, describes the Spirox Latera Absorbable Nasal Implant, a medical device intended to support nasal upper and lower lateral cartilage. It is a Special 510(k) submission, meaning it describes modifications to an already cleared predicate device (INEX Absorbable Nasal Implant K152958), and therefore focuses on demonstrating that the modified device remains substantially equivalent to the predicate.
Given this context, the document does not describe a study to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against quantitative metrics for efficacy or diagnostic accuracy. Instead, the acceptance criteria are related to validating the changes made to the device and demonstrating that these changes do not alter the safety and effectiveness profile such that it is no longer substantially equivalent to the predicate.
Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, ground truth establishment for training set) are not applicable as this is not an AI/ML device or a device requiring a new clinical efficacy study under this 510(k) pathway.
Here's the breakdown of the information that is available in the document related to acceptance criteria and validation:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria and reported device performance in the way one would see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the verification and validation tests undertaken to confirm that the modifications do not negatively impact the device's safety or functionality and that it remains substantially equivalent to the predicate.
I will formulate a table based on the described design control activities and their implied "acceptance criteria" (i.e., successful completion of the tests).
| Acceptance Criteria Category | Reported Device Performance (as implied by successful testing) |
|---|---|
| Verification Testing | Performed successfully, details not provided. |
| Sterilization Validation | Device shown to be sterile via gamma (Implant) and e-beam (Delivery Device) irradiation, conforming to ISO standards as previously described for the predicate device. |
| Packaging and Shelf-Life Testing | Packaging and shelf-life maintained, accommodating modifications and protecting the implant during shipping. |
| Transit Testing | Packaging and device integrity maintained during transit. |
| Biocompatibility Testing | Device materials (PLLA-PDLA copolymer, stainless steel for cannula) confirmed to be biocompatible, as previously established for the predicate. |
| Human Factors/Usability Testing | Usability aspects of the system (e.g., positioning guide, prominent orientation features) validated. |
| Risk Analysis (FMEA) | Performed; no new or increased risks identified (implied by the conclusion of substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the verification and validation tests. It states that the "methods used for the verification and validation tests for the modified device are the same as those submitted in the original 510(k) application for the predicate device," but does not provide details on those methods or sample sizes in this submission. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.
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 is not applicable as this is a physical implant and delivery system, not an interpretive diagnostic device requiring expert-established ground truth on a test set of medical images or patient data. The "ground truth" for this device relates to engineering specifications, material properties, sterility, and usability, which are validated through laboratory and simulated use testing, not expert adjudication of clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as #3. There is no clinical imaging or diagnostic test set requiring human adjudication.
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 is not applicable. This device is not an AI-assisted diagnostic tool, so no MRMC study or AI assistance effect size is relevant or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like this, "ground truth" refers to established engineering standards, material specifications, biocompatibility requirements, and performance characteristics (e.g., mechanical strength, ease of delivery, sterility). The validation tests (e.g., sterilization validation, packaging tests, biocompatibility tests) establish that the device meets these pre-defined engineering and material "truths" or standards. There is no biological or diagnostic "ground truth" as might be found in clinical studies of diagnostic tools.
8. The sample size for the training set
This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.