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The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

The ACE™ Stapler is a single use, disposable, surgical stapler used in hospitals or surgery centers to create a plication of the wall of the stomach or lower esophagus. The stapler is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. In use, the stapler is introduced into the patient through the mouth using a disposable endogastric tube. A flexible endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication of the GI tract, which is then held in place by means of a double, circular row of titanium staples delivered by the stapler (along with a non- absorbable ring to help reinforce the staple placement in the tissue). The endogastric tube, flexible endoscope and vacuum pump used with the stapler are all standard medical devices and are not supplied with the stapler.

The provided document is a 510(k) Summary for the BaroSense ACE™ Stapler and Cartridge. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for proving device performance cannot be extracted from this document.

Here's an analysis of the available information:

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

The document does not provide a table of acceptance criteria with corresponding device performance metrics. It generally states that "All testing yielded acceptable results" without detailing the specific criteria or the quantitative results.

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

The document mentions "a series of bench and animal tests" but does not specify the sample sizes used for these tests, their provenance (country of origin), or whether they were retrospective or prospective.

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)

This information is not provided as the submission focuses on substantial equivalence based on bench and animal testing, not human expert evaluations for ground truth.

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

This information is not applicable and is not provided.

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

This type of study is not mentioned or discussed in the document.

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

This information is not applicable as the device is a surgical stapler, not an algorithm.

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

The document indicates that the safety and effectiveness were established through "bench and animal tests." This implies that the "ground truth" or evaluative standards would be based on engineering specifications, physiological measurements, and observations from animal models, rather than expert consensus, pathology, or human outcomes data in the context of clinical trials.

8. The sample size for the training set

The document does not discuss a "training set" as it is not an AI/algorithm-based device.

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

This information is not applicable as the device is not an AI/algorithm-based device.

Summary of available relevant information from the document:

• Study Type: Bench and Animal Testing
• Purpose of Study: To establish safety and effectiveness, and known biocompatibility of patient-contacting components.
• Key Findings: "All testing yielded acceptable results."
• Biocompatibility Testing: Patient-contacting components tested to requirements of ISO 10993.
• Indications for Use: The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

The document emphasizes substantial equivalence to legally marketed predicate devices (K062875, K011016, K073671) rather than detailing specific performance data against pre-defined acceptance criteria for a novel functionality.

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