(29 days)
The SPIWay® Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.
The SPIWay®Endonasal Access Guide is a temporary working channel sheath for use in endoscopic sphenoid sinus and transsphenoidal surgery. The device consists of a single piece of thermoplastic polymer with a low friction coating, which creates a working channel sheath in the natural orifice of the nose to facilitate visualization of the surgical site and smooth manipulation of introduced instruments during transnasal endoscopic surgery.
The shape of the SPIWay Endonasal Access Guide contains a flared portion at the proximal end of the device which remains outside the nasal passage and a conical body that sits within the nasal cavity. The flared proximal end and conical body act to anchor the device, preventing migration once inserted and allow simple removal. The device has an elliptical shape, and the major axis of the ellipse is oriented vertically with the nostril.
The device is supplied in several lengths that are selected based upon the surgeon's needs. It is provided sterile and for single use in a pack of two, one for each nostril. A pair of devices is sealed in a Tyvek pouch and 5 pouches are placed into a labeled carton.
The provided document is a 510(k) summary for the SPIWay Endonasal Access Guide, which is a Class I medical device. For devices in this class, the regulatory requirements for demonstrating safety and effectiveness are generally less stringent than for higher-risk devices and often rely on substantial equivalence to a predicate device rather than extensive clinical studies.
The document does not contain the detailed information required to fill out all aspects of your request regarding acceptance criteria and performance studies, specifically for an AI/ML-based device or a device involving human readers/ground truth experts. This is because the SPIWay device is a physical, non-AI surgical accessory, and its evaluation focuses on materials, functionality, and biocompatibility, not diagnostic performance or human-AI interaction.
However, I can extract what is available and explain why other sections cannot be completed based on this document.
Acceptance Criteria and Device Performance (Based on available information for a physical medical device)
The document primarily focuses on demonstrating substantial equivalence to a predicate device (SPIWay Endonasal Access Guide, K153686) after modifications were made (coating, material, and size range). The "acceptance criteria" for such a device are typically met through various bench testing and design validation activities to ensure physical and functional requirements are met, rather than a statistical performance study against clinical metrics.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Inferred from testing types) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Physical and Functional Requirements | "[Design verification] bench testing was performed for the SPIWay Endonasal Access Guide to demonstrate that physical and functional requirements were met." |
| Effectiveness for Intended Use | "[Design validation] cadaver testing was performed for the SPIWay Endonasal Access Guide to demonstrate effectiveness for its intended use." |
| Material Biocompatibility | "The SPIWay Endonasal Access Guide complies with the biocompatibility requirements for its intended use." (Specific tests listed: Cytotoxicity, Intracutaneous Irritation, Acute Systemic Toxicity, Sensitization, all in accordance with ISO 10993 standards) |
| Meeting Design Specifications | "Performance testing showed the device meets design specifications and performed as intended." |
Information NOT Available in the Document (and why it's not applicable/expected for this device type):
The following points pertain to AI/ML or diagnostic performance studies, which are not relevant to this physical surgical guide. Therefore, the document does not contain this information.
2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/ML diagnostic. Testing involved bench and cadaver studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device, not an AI/ML diagnostic or image reader.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a diagnostic test with subjective interpretation.
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. This device does not involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This device does not have an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Performance was likely assessed against engineering specifications and functional success in cadaver models.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Summary regarding the study proving device meets acceptance criteria:
For the SPIWay Endonasal Access Guide, acceptance was proven through:
- Design verification bench testing: To ensure physical and functional requirements were met.
- Design validation cadaver testing: To demonstrate effectiveness for its intended use.
- Biocompatibility testing (per ISO 10993): To ensure material safety.
The primary "study" proving acceptance was the successful completion of these non-clinical tests, affirming that the modified device performed equivalently to its predicate and met safety standards for a Class I intranasal splint.
§ 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.