(29 days)
The SPIWay Endonasal Access Guide is indicated for use in endoscopic transnasal sphenoid sinus and skull base surgery.
The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic transnasal sphenoid sinus and skull base surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.
This document describes a 510(k) premarket notification for a medical device called the "SPIWay Endonasal Access Guide." The core of the submission revolves around demonstrating substantial equivalence to a legally marketed predicate device.
Based on the provided text, the device itself (SPIWay Endonasal Access Guide) is a physical, sterile, single-patient-use device, not an AI or software-based medical device. Therefore, the concepts of "acceptance criteria for an AI device," "test set," "number of experts for ground truth," "adjudication methods," "MRMC studies," "standalone performance," "training set," and "ground truth for training set" are not applicable to this physical device submission.
The document explicitly states:
- "Since the subject device is unchanged from the predicate device, repeat design verification and validation testing were not required." (Section 7. Performance Data)
- "Since the subject device is unchanged from the predicate device, repeat biocompatibility testing was not required." (Section 8. Biocompatibility)
- "The subject device is identical to the predicate device." (Section 9. Conclusion)
- "There are no differences in technological characteristics between the subject device and the predicate device." (Section 6. Technological Characteristics)
The only stated change compared to the predicate device is a modification to the "Indications for Use" statement "to more accurately describe use of the SPIWay Endonasal Access Guide in current endoscopic transnasal skull base surgical practice."
Therefore, it is not possible to provide the requested information regarding acceptance criteria and performance studies for an AI/software device, as this submission pertains to a physical, unchanged medical device being cleared based on substantial equivalence to an existing predicate with a minor label change.
To answer the prompt directly, but acknowledging the device type:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Substantial equivalence to the predicate device (SPIWay Endonasal Access Guide K180141) in terms of:
- Intended use (modified to allow for skull base surgery)
- Technological characteristics (identical)
- Design (identical)
- Function (identical)
- Basic materials (identical)
- Biocompatibility (identical, no repeat testing required)
- Packaging (identical)
- Sterilization (identical)
- Reported Device Performance: The device performs identically to the predicate because it is the identical device. No new performance data was required or provided as part of this 510(k) submission due to the device being unchanged from its predicate. The change was solely in the Indications for Use statement for clarity regarding current surgical practice.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device requiring a test set for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 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.