(266 days)
The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.
The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide) 70:30. The product is provided as a perforated sheet comprised of multiple "rod" like elements. The sheet is nominally 24.5 x 20.0 mm with a thickness of 1.1 mm. The bridge sections are nominally 3.0 x 1.9 mm and the voids are nominally 2.4 x 1.9 mm. The implant can be trimmed and shaped to dimensions suitable for the surgical need. The device is implanted using standard surgical tools and techniques The Spirox INEX implantable sheet is a sterile, single use device.
The manufacturer, Spirox, Inc., did not conduct a study to prove the device met acceptance criteria in the traditional sense of a clinical trial or comparative effectiveness study with specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data.
Here's an analysis of the provided text in direct reference to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) or a direct comparison to acceptance thresholds. The "reported device performance" is described qualitatively as:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance | Confirmed that the Spirox INEX Device performs according to product specifications. |
| Functional Performance | Confirmed that the Spirox INEX Device performs according to product specifications. |
| Biocompatibility | Complies with ISO 10993 "Biological Evaluation of Medical Devices" and FDA's recent guidance. |
| Sterilization | Complies with the requirements prescribed in ISO 11137 for radiation sterilization. |
| Packaging and Shipping Validation | Conducted pursuant to the applicable ISO and ISTA 3A guidelines. |
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 mentions "Design verification testing," "comparative testing with the cited predicate devices," and a "GLP animal study." However, it does not specify the sample sizes for any of these tests. The provenance of the data (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 information is not applicable as the device is an absorbable implant for nasal septal cartilage support, not an AI/diagnostic device requiring expert ground truth establishment for a test set. The validation relies on physical and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #3.
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 MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or AI-powered devices where human interpretation is involved. The Spirox INEX Device is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical performance tests was based on established engineering specifications, regulatory standards (ISO 10993, ISO 11137, ISO/ISTA 3A), and the outcomes of the GLP animal study. For the biocompatibility and sterilization, the "ground truth" aligns with the requirements outlined in the respective ISO standards and FDA guidance.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" in the context of this device's evaluation. The device is not learning-based.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #8.
In summary:
The approval of the Spirox INEX Device was based on demonstrating substantial equivalence to existing predicate devices through non-clinical performance data. This included mechanical and functional testing against product specifications, biocompatibility testing according to ISO standards and FDA guidance, sterilization validation, and packaging/shipping validation. A GLP animal study was also conducted to verify device safety, biocompatibility, and use. There was no mention of specific acceptance criteria with quantitative thresholds nor a study involving human readers or AI algorithms.
§ 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.