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The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for patients 6 months and older.

The Solo+ Tympanostomy Tube Device (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation (blue) button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.

The provided text describes the 510(k) clearance for the Solo+ Tympanostomy Tube Device (TTD). While it details the device's characteristics, comparison to predicate devices, and general non-clinical testing, the clinical study information focuses on comparative effectiveness and patient safety/success, rather than specific acceptance criteria for performance metrics that would typically be seen in a study evaluating an AI device or a device with quantifiable performance outputs like accuracy, sensitivity, or specificity.

The Solo+ TTD is a surgical instrument, and its "performance" in this context is primarily related to its ability to successfully place a tympanostomy tube and maintain patient safety. Therefore, the "acceptance criteria" discussed here are related to the success rate of tube placement and the absence of serious adverse events.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance Study

The provided document describes a clinical study to support the substantial equivalence of the Solo+ TTD for an expanded patient population (pediatric patients 6 months and older) compared to its primary predicate (K232702, which was indicated for patients 6-24 months) and a secondary predicate (K221254, which already covered patients 6 months and older). The "acceptance criteria" are implicitly derived from the successful outcomes observed in the study and their comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • For the Solo+ TTD (proposed device) in patients ≥24 months: 20 pivotal cohort patients (36 ears).
  • For the primary predicate Solo+ TTD (K232702) in patients ≥6 to <24 months: 20 patients (corresponding to 40 ears, assuming 2 ears per patient).
  • For the secondary predicate Hummingbird TTS (K221254) in patients ≥2 years: The number of patients/ears is not explicitly stated, but percentages are provided.
• Data Provenance: The study was a multi-site study. The country of origin is not explicitly stated in the provided text. It is a prospective clinical study as it describes active enrollment and follow-up of patients.

3. Number of Experts and Qualifications for Ground Truth

This type of device (a surgical instrument) does not typically involve "experts establishing ground truth" in the same way an AI diagnostic device does. The "ground truth" for success or adverse events is observable clinical outcomes. The procedures were performed by medical professionals, presumably surgeons or ENTs, but their specific number or qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for classifying study outcomes or establishing ground truth, as it's not a diagnostic study where independent review for consensus is typically required. Clinical outcomes (successful placement, adverse events) are typically reported by the treating physician and/or verified by study monitors.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an interpretive diagnostic tool that involves human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

6. Standalone Performance Study

The clinical study described is a standalone performance evaluation of the Solo+ TTD (proposed device) in the specified patient population (≥24 months) to demonstrate its safety and effectiveness, and compare its outcomes to predicate devices. It is not an "algorithm-only" study as there is no AI component mentioned for this device. The non-clinical engineering tests (Table 2 and 3) also represent standalone evaluations of the device's physical and functional characteristics.

7. Type of Ground Truth Used

The ground truth used for the clinical study was observable clinical outcomes. This includes:

• Successful placement of the tympanostomy tube as planned.
• Whether additional instruments were needed during placement.
• The occurrence of device or procedure-related serious adverse events.

8. Sample Size for the Training Set

This document describes a medical device (a surgical instrument), not a software or AI device that requires a "training set" for an algorithm. Therefore, there is no training set sample size.

9. How the Ground Truth for the Training Set was Established

As there is no AI component or training set, this question is not applicable.

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The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.

The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6-24 months old.

The Solo+ Tympanostomy Tube Device TTD (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.

The provided text describes the Solo+ Tympanostomy Tube Device (TTD) and its substantial equivalence determination. However, it does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance, as typically seen in submissions for AI-powered devices. The device described, the Solo+ TTD, is a physical medical device for placing tympanostomy tubes, not an AI/software device.

Therefore, many of the requested points in your prompt are not applicable to the provided document. I can, however, extract the relevant information regarding the clinical study performed to demonstrate the device's safety and effectiveness compared to a predicate device.

Here's the closest possible answer based on the provided text, focusing on the clinical study conducted for the physical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The study conducted for the Solo+ Tympanostomy Tube Device (TTD) was a multi-site clinical study designed to demonstrate substantial equivalence to its predicate device, the Preceptis Hummingbird TTS, for in-office tympanostomy procedures in pediatric patients.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents the "acceptance criteria" (though not explicitly labeled as such, these are the primary outcomes measured for comparison of substantial equivalence) as clinical outcomes compared between the Solo+ TTD and the predicate device.

2. Sample Size and Data Provenance:

• Test Set Sample Size: A total of 20 patients (40 ears).
• Data Provenance: Conducted in a multi-site study across 2 sites. The country of origin is not explicitly stated, but the applicant company is based in Ireland. The study was a clinical study, implying a prospective design for the purpose of demonstrating substantial equivalence.

3. Number of Experts and Qualifications: Not applicable. This was a clinical study involving patients and the mechanical placement of a device, not an AI/image-based diagnosis requiring expert readers for ground truth establishment.

4. Adjudication Method: Not applicable. (See #3)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This was not a study evaluating human reader performance with or without AI assistance but rather the performance of a physical surgical device.

6. Standalone (Algorithm Only) Performance: Not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used: The "ground truth" for this study was the observed clinical outcome of the tympanostomy tube placement (i.e., whether the tube was successfully placed and if additional instruments were needed). This is essentially outcomes data directly observed during the procedure and initial follow-up.

8. Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set was Established: Not applicable. (See #8)

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