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Sharpsite™ AC Rigid Endoscope: The Sharpsite™ AC Rigid Endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures. including thinology and endoscopic plastic and reconstructive surgery.

Sharpsite™ AC Sterilization Tray: Sharpsite™ AC Endoscope Sterilization Tray is intended to provide a specific configuration to hold, organize and protect Sharpsite™ AC Rigid Endoscope during their transport, storage and sterilization prior to use in surgical procedures.

The Sharpsite™ AC endoscopes are rigid rod lens endoscopes for imaging and are available in diameters from 2.7 mm to 4.0 mm and in angles of view of 0, 30, 45 and 70 degrees. These endoscopes are reusable, autoclavable instruments and are provided non-sterile.

The Sharpsite™ Rigid Ear, Nose and Throat (ENT) endoscopes provide access and allow observation during otolaryngology and head and neck procedures. The device consists of rigid rod inserted into body orifice. The endoscope includes an optical system to visualize the image by direct view or with use of a camera. The endoscopes are provided non-sterile and can be reused by multiple methods as mentioned in the IFU. Each Sharpsite™ endoscope is fitted with a commercially available removable light port adapter for use with different manufacturers light cables.

Sharpsite™ AC Endoscopic sterilization tray is a container which is a reusable device that includes a base and lid. It is a single level thermoplastic instrument case designed to hold Sharpsite™ AC Rigid Endoscopes. The Sharpsite™ tray is specifically configured to organize, store, protect, transport and sterilize Sharpsite™ AC Rigid Endoscopes for use in surgical procedures.

The provided text is a 510(k) summary for the Medtronic Sharpsite™ AC Rigid Endoscope and Sharpsite™ AC Endoscope Sterilization Tray. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for device performance in the context of an AI/ML-driven medical device.

The information requested in the prompt, specifically regarding acceptance criteria for device performance and the study proving it, is typically associated with AI/ML-based diagnostic or prognostic devices, or devices with complex functional output that requires rigorous validation against ground truth.

The device described here, the Sharpsite™ AC Rigid Endoscope, is a rigid rod lens endoscope used for surgical imaging. Its primary function is to provide visualization. The "testing" section (page 7) refers to cleaning and sterilization validations, biocompatibility assessment, and states that "Additional bench, animal or clinical testing was not required to establish substantial equivalence." This indicates that the substantial equivalence argument relies on the similarity of the device's technological characteristics and intended use to a previously cleared predicate device (K965233).

Therefore, I cannot extract the requested information from the provided text because it does not describe an AI/ML-driven device's performance validation. The document is about establishing substantial equivalence for a non-AI/ML optical imaging tool and its sterilization tray.

If this were an AI/ML device, the acceptance criteria and study details would be presented very differently, focusing on metrics like sensitivity, specificity, AUC, human reader agreement, and the methodology for establishing ground truth for AI model training and testing.

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The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction.

The ALAR™ Nasal Valve Stent supports and immobilizes intranasal tissues and cartilage during the post-operative healing period following intranasal and nasal valve surgery.

The elliptically shaped fluoroplastic stent is approximately 20 mm long and 16 mm wide. Slits symmetrically spaced along the stent's lateral edges allow for left and right nostril usage. The suture and needle attached to the stent provide stent anchoring and hold cartilage plates stable during post-operative healing.

The provided document is a 510(k) premarket notification for the ALAR™ Nasal Valve Stent. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

The "Discussion of the Performance Testing" section (page 4) states: "Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products. Test samples were subjected to simulated real-life use conditions during functional testing. All function testing passed the test specifications and acceptance criteria for the bench top engineering studies. A biocompatibility assessment, sterility adoption, transportation and shelf life/aging testing was also conducted Additional bench, animal or clinical testing was not required to establish substantial equivalence."

This indicates that engineering studies were performed to confirm functionality and compatibility, and these studies had "test specifications and acceptance criteria." However, these specific criteria and the detailed results are not provided in this document. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and existing predicate testing, rather than presenting a performance study with detailed clinical or diagnostic metrics.

Therefore, I cannot populate the requested table and answer many of the questions because the necessary information is not present in the provided text. The device is a physical medical device (stent), not an AI/algorithm-based diagnostic device, so many of the questions pertinent to AI performance metrics (like MRMC studies, standalone algorithm performance, training/test set details, ground truth for AI) are not applicable or detailed in this context.

Here's what can be inferred or stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Missing Information: The document does not provide the specific numerical or qualitative "acceptance criteria" for functionality, biocompatibility, sterility, etc., nor does it provide the detailed "reported device performance" metrics against those criteria. It only states that testing passed the internal specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document refers to "test samples" for "bench top engineering studies," but the number of samples is not mentioned.
• Data Provenance: Not applicable in the context of clinical/patient data, as these were bench-top engineering studies. The studies were likely conducted internally by Medtronic Xomed Inc.

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)

• Not applicable. This device is a physical stent, and the evaluation mentioned consists of engineering studies (biocompatibility, functional testing, etc.), not a diagnostic test with a "ground truth" established by medical experts in the typical sense of evaluating diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple readers. The described tests are bench-top engineering studies.

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

• No. This is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable in the context of clinical "ground truth" for diagnostic performance. Ground truth in the engineering studies would refer to established physical, chemical, or mechanical standards and specifications.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable.

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