(36 days)
The SPIWay Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.
The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic sphenoid sinus or transsphenoidal surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.
The provided text is a 510(k) summary for the SPIWay Endonasal Access Guide, a Class I medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed AI algorithm study. Therefore, most of the requested information about acceptance criteria, detailed study design, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.
However, based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document mentions "design verification bench testing" and "design validation cadaver testing" were performed. It states: "Performance testing showed the device meets design specifications and performed as intended." However, specific quantitative acceptance criteria or detailed performance metrics are not provided in this summary for direct comparison in a table.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "cadaver testing," implying a set of cadavers were used, but the number is not specified.
- Data Provenance: "Cadaver testing" implies the data would be from human cadavers. The country of origin is not mentioned. It would be considered prospective for the specific tests conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a physical device like this, the "ground truth" would likely be the successful physical manipulation and visualization during the cadaveric procedures, observed by the study conductor(s), rather than an expert consensus on interpretative outputs.
4. Adjudication method for the test set:
This information is not provided. Given it's a physical device validation, formal adjudication methods like "2+1" typically used for interpretation tasks (e.g., image reading) are unlikely to apply. The assessment would likely be direct observation by the study conductor(s) or surgeon(s) performing the cadaveric tests.
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 comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretive devices. The SPIWay Endonasal Access Guide is a physical surgical guide.
- Effect Size: Not applicable as no such study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is not an AI algorithm. It's a physical guide intended for human-in-the-loop use during surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document implies the "ground truth" for the cadaveric testing was the successful physical functionality and visualization during the procedures. This would likely be assessed by the surgical team performing the testing, confirming the device "performed as intended" and "demonstrate[d] effectiveness for its intended use." It's not expert consensus on an interpretation, pathology, or outcomes data in the usual sense for diagnostic AI.
8. The sample size for the training set:
Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical device.
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.