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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.

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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 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:

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.

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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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