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The inflation system is recommended for use during esophageal, pyloric and colonic balloon dilatation to inflate and deflate balloon dilators and to monitor the pressure within the balloon.

The Bard" Inflation System is a disposable, two-piece, plastic 60cc syringe with a cantilevered inflation/deflation lock design and a manometer that is mounted on the distal tip of the syringe barrel.

The provided text is a 510(k) summary for the Bard® Balloon Inflation System from 1999. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a specific study with acceptance criteria.

The document states: "Safe and effective in vivo use has been demonstrated with the Bard Balloon Inflation System since its initial commercialization in 1991." and "Comparative bench testing has been evaluated and supports the use of a GI inflation device." However, no specific performance metrics, acceptance criteria, or study details are provided in this regulatory submission.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, with many points marked as "Not specified in the provided text":

Acceptance Criteria and Device Performance

Since specific acceptance criteria and detailed performance data are not explicitly stated in the provided 510(k) summary, the table below reflects the general claims and the type of assessment mentioned.

1. A table of acceptance criteria and the reported device performance:
See the table above. The document primarily relies on the device's prior commercialization history and comparative bench testing to assert safety and effectiveness and substantial equivalence. Specific quantitative acceptance criteria (e.g., pressure accuracy within X mmHg, inflation time within Y seconds) are not detailed.

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

• Sample Size: Not specified for the comparative bench testing or the "in vivo use" claim.
• Data Provenance: Not specified. It mentions prior commercialization since 1991, which implies retrospective real-world use data, but no specifics are given. The "comparative bench testing" is implied to be internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified. The document refers to "Accepted scientific methods" for bench testing and "in vivo use" but does not detail expert involvement in evaluating this for the 510(k) submission.

4. Adjudication method for the test set:
Not specified.

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 manual medical instrument (a balloon inflation system), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device requiring human operation. The "performance data" refers to the device's mechanical function, not an algorithm's.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "safe and effective in vivo use," it implies outcomes data from its commercialization history. For the "comparative bench testing," the ground truth would be based on engineering specifications and measurements of the device's mechanical performance in comparison to predicate devices, but the specifics are not provided.

8. The sample size for the training set:
Not applicable. This is a hardware device, not a machine learning model.

9. How the ground truth for the training set was established:
Not applicable.

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