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The InnoCare Specialty Foley Catheter is intended for urethral catheterization for urological bladder drainage. The device is indicated for adult use only with a maximum indwell time of no more than 30 days.

The InnoCare Specialty Foley Catheter is a 16 French, two-way silicone Foley catheter for urethral catheterization to drain urine from the bladder. The catheter is retained in the bladder by use of a retention balloon attached to the distal end of the catheter. The device is offered in a straight tip configuration and a Coude tip configuration. The inflation lumen of the catheter contains a secondary balloon deflation mechanism. This mechanism is designed to provide a fluid escape pathway to allow for balloon deflation in the event of a forced withdrawal or catheter pullout. The device is provided sterile and for single use.

The provided text describes a 510(k) premarket notification for a medical device, the InnoCare Specialty Foley Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. It does not contain information about a clinical study involving human patients, nor does it detail acceptance criteria and a study proving device performance in a clinical setting as you've requested.

Specifically, the document states:

• "Performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate do not raise different questions of safety or effectiveness."
• "Bench testing of the subject device included dimensional verification, functional and performance testing per ASTM F623:2019 requirements, simulated use testing of the secondary balloon deflation mechanism and Magnetic Resonance Compatibility testing per FDA Guidance (2023)..."
• "All pre-determined acceptance criteria were met."

Therefore, I cannot provide the detailed information requested regarding a clinical study and its various components (sample size, ground truth, expert qualifications, MRMC study, etc.) because the provided document does not contain this information. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing, not a human-in-the-loop clinical trial or an AI algorithm study.

However, I can extract information about the non-clinical acceptance criteria implied by the tests performed.

Here's what can be inferred from the provided text regarding the non-clinical acceptance criteria and "study":

1. Table of Acceptance Criteria and Reported Device Performance:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Subacute Systemic Toxicity
• Genotoxicity
• Implantation | All tests demonstrated the subject device is biocompatible for its intended use. |
  | Dimensional Verification | Met pre-determined acceptance criteria. |
  | Functional and Performance (per ASTM F623:2019) | Met pre-determined acceptance criteria. |
  | Simulated Use Testing of Secondary Balloon Deflation Mechanism | Met pre-determined acceptance criteria. |
  | Magnetic Resonance (MR) Compatibility (per FDA Guidance 2023) | Met pre-determined acceptance criteria. |
  | Sterilization Validation (per ISO 11135:2014) | Validated to be sterilized using ethylene oxide. |
  | Shelf Life (including performance testing, package integrity after environmental conditioning, simulated distribution, and accelerated aging) | Data supports the claimed shelf life. |

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the non-clinical tests. Medical device bench testing typically uses a small, statistically justified sample size, but the exact number isn't provided here.
• Data Provenance: The tests are laboratory-based ("bench testing," "biocompatibility testing," "sterilization validation"), implying they were conducted by the manufacturer or a contract research organization. There is no mention of country of origin of data in terms of patient data, as this is not a clinical study. The tests are prospective in nature as they are conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. For non-clinical bench testing, "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM, FDA guidance) and validated test methods, not by human expert consensus or adjudication in the way it would be for a clinical AI study.

4. Adjudication method for the test set:

• Not Applicable. No adjudication method is mentioned as this pertains to human interpretation/reading, which is not part of this type of non-clinical device testing.

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 a non-clinical evaluation of a physical medical device (Foley catheter), not an AI-assisted diagnostic device, so an MRMC study is not relevant or performed.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• Established Industry Standards and Specifications. For each test, the "ground truth" is defined by the requirements of the specified standards (e.g., ISO 10993-1:2018 for biocompatibility, ASTM F623:2019 for functional performance, ISO 11135:2014 for sterilization) and the device's own design specifications.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning model, so there is no training set.

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

• Not Applicable. This is not a machine learning model.

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