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The SIB Catheter is intended for the delivery of diagnostic contrast media agents into the female reproductive tract for examination of the uterus

The SIB Catheter consists of a 5 F balloon catheter with a single lumen polyurethane shaft with an end hole. The balloon inflates upon infusion of contrast media into the uterus. Increasing the infusion rate will cause the balloon to grow thereby occluding the cervical canal. Cessation of saline injection will cause the balloon to collapse.

The provided text describes a 510(k) premarket notification for a medical device called the "SIB Catheter." The submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy or performance through a traditional clinical study with detailed acceptance criteria as one might find for a novel therapeutic device or diagnostic algorithm.

Therefore, many of the requested categories for a study proving device acceptance criteria cannot be directly answered from the provided text, as this type of information is not typically included in a 510(k) for a device like a catheter demonstrating substantial equivalence. The "acceptance criteria" here refer more to meeting design and manufacturing specifications.

Here's an analysis based on the provided text, highlighting what can and cannot be answered:

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

Based on the provided text, there isn't a specific table of acceptance criteria with reported performance metrics in the way one would evaluate an AI algorithm or a diagnostic test. The acceptance criteria for a device like the SIB Catheter in a 510(k) context primarily revolve around demonstrating:

• Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
• Performance Requirements: That the device meets its design and functional specifications (e.g., balloon inflation, material integrity, sterility).

The text states:

• "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the SIB Data Catheter performs safely and effectively."

This is a general statement of compliance, not a detailed breakdown of specific performance metrics or acceptance thresholds.

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

The text mentions "Pre-clinical testing" but does not specify the sample size, type of test set (e.g., in-vitro, animal, human), or data provenance. This is typical for a 510(k) focused on a relatively simple, non-novel device demonstrating substantial equivalence.

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. The text does not describe a study involving expert-established ground truth for a diagnostic assessment. The "ground truth" for this catheter's performance would relate to its physical and functional specifications (e.g., balloon integrity, material biocompatibility, flow rates), which are typically verified through engineering and bench testing, not expert consensus on diagnostic images.

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

Not applicable. No expert-based adjudication in a diagnostic context is described.

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 is a catheter for contrast media delivery, not an AI algorithm or a diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm, but a physical medical device.

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

For a device like the SIB Catheter, the "ground truth" effectively comes from engineering specifications, material science testing, and manufacturing quality control. For instance:

• Balloon inflation capability: Verified against design specifications.
• Lumen patency: Verified against design specifications.
• Biocompatibility: Verified through standard testing (e.g., ISO 10993).
• Sterility: Verified through validation of sterilization processes.

The text does not go into this level of detail, simply stating that "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described."

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

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