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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.

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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

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.

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