(152 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 medical-grade thermoplastic elastomer.
The provided text describes the SPIWay Endonasal Access Guide, a medical device, and its 510(k) submission for FDA clearance. However, it does not contain specific acceptance criteria or a study with detailed performance metrics that would allow for the direct completion of the requested table.
The document mentions "Design verification bench testing" to demonstrate physical and functional requirements were met, and "Design validation cadaver testing" to demonstrate effectiveness for its intended use. However, it does not provide the acceptance criteria for these tests, nor does it report the quantitative results.
Therefore, I cannot populate the table with specific numerical acceptance criteria or reported device performance. I can only infer what kind of data the company would have gathered based on the mention of these tests.
Here's a breakdown of the information that can be extracted or inferred based on the prompt's request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from device type and general medical device testing) | Reported Device Performance (Not provided in detail in the text) |
|---|---|
| Physical/Functional Requirements: | |
| - Device integrity during use (e.g., no breakage, tearing) | Tested during design verification bench testing. Specific results or quantitative metrics not provided. |
| - Maintenance of shape/structure within nasal cavity | Tested during design verification bench testing. Specific results or quantitative metrics not provided. |
| - Compatibility with surgical instruments (e.g., smooth manipulation) | Tested during design validation cadaver testing. Specific results or quantitative metrics not provided. |
| - Ease of insertion and removal | Tested during design validation cadaver testing. Specific results or quantitative metrics not provided. |
| - Sterility (gamma radiation) | Device is supplied sterile via gamma radiation; verified as part of manufacturing and quality control. |
| - Biocompatibility (ISO 10993 compliance) | Complies with biocompatibility requirements for its intended use. Specific test results (e.g., cytotoxicity, sensitization) not provided. |
| Effectiveness for Intended Use (Cadaver Testing): | |
| - Facilitates visualization of surgical site | Demonstrated effectiveness in cadaver testing. Specific metrics (e.g., visual field improvement) not provided. |
| - Facilitates smooth manipulation of introduced instruments | Demonstrated effectiveness in cadaver testing. Specific metrics (e.g., instrument maneuverability scores) not provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "cadaver testing" but doesn't provide the number of cadavers or individual tests performed.
- Data Provenance: Not specified. Given the company (SPIWay, LLC) is in San Diego, CA, USA, and the FDA submission is in the US, it's highly likely the testing was conducted in the USA. The testing would be considered prospective as it's part of design validation, performed specifically to evaluate the device.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, but given the "cadaver testing" for endoscopic sphenoid sinus or transsphenoidal surgery, it would logically involve surgeons specializing in these procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. The document only states "Design validation cadaver testing was performed for the SPIWay Endonasal Access Guide to demonstrate effectiveness for its intended use." Details about how "effectiveness" was objectively measured or adjudicated are absent.
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 study was not done. This device is a physical surgical aid, not an AI or imaging interpretation tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No, a standalone algorithm performance study was not done. This device is a physical instrument, not an algorithm. Its function is to assist a human surgeon ("human-in-the-loop").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for the cadaver study would have been expert observation and assessment by the surgeons performing the cadaver procedures, evaluating the device's ability to facilitate visualization and instrument manipulation. It's not pathology or outcomes data in the traditional sense, but rather a direct assessment of functional performance in a simulated surgical environment.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of 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.