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The SafeCross Transseptal Puncture Device and Introducer (TSP/I) System is used to introduce various cardiovascular catheters to the heart, including the left side of the heart. The system enables left heart access through a puncture of the atrial septum during a transseptal catheterization procedure. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.

The SafeCross Transseptal Puncture and Introducer (TSP/I) System is used to access the heart left atrium through a puncture of the atrial septum. The System includes three (3) components: the Steerable Introducer Sheath, the RF Puncture Member, and an Access Dilator. The Steerable Introducer Sheath has a compliant balloon at the tip for protection of the septum, and the RF Puncture member is compatible with five (5) of the most common electrosurgical generators.

The provided text describes a medical device, the SafeCross Transseptal Puncture and Introducer (TSP/I) System, and its substantial equivalence to predicate devices, as reviewed by the FDA. However, the document does not contain the specific acceptance criteria or the study data that would allow for a detailed table of acceptance criteria versus reported device performance, nor does it provide information on sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance, as these are typically part of a comprehensive V&V report rather than a 510(k) summary.

The document does list various performance tests conducted and mentions that "All testing passed the acceptance criteria." It also lists biocompatibility testing, sterilization validation, and packaging/shelf-life validation.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a summary of what information is available from the text provided:

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

The document states: "A series of bench tests was performed to demonstrate that the TSP/I System meets its performance specifications using final finished, sterilized and preconditioned product. Comprehensive verification and validation activities were successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria."

Specific acceptance criteria and reported numerical performance values are not provided in the document. The general categories of tests performed are listed under "PERFORMANCE TESTING."

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

• Sample Size for Test Set: Not specified in the provided document. The document refers to "a series of bench tests" and "comprehensive verification and validation activities," but no sample sizes are given for any of these tests.
• Data Provenance: Not specified in the provided document. The tests were conducted as part of the 510(k) submission, likely by or for East End Medical I LLC (based in Sunrise, FL, USA), but the geographical origin of the data or whether it was retrospective/prospective is not mentioned.

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 in the document. The testing described is primarily bench and biocompatibility testing, not clinical studies requiring expert ground truth for interpretation of medical images or diagnoses. Usability validation testing is mentioned, which may involve experts, but details are absent.

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

This information is not provided in the document. As mentioned above, the disclosed testing is largely bench-based, where "adjudication" in the clinical sense is not typically applicable.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a transseptal puncture and introducer system, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.
• Effect Size of AI improvement: Not applicable, as it is not an AI device.

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

• Standalone Study: No, a standalone algorithm-only performance study was not done. This is a physical medical device, not a software algorithm.

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

For the performance testing mentioned (e.g., dimensional verification, structural integrity, electrical verification), the "ground truth" would be the engineering specifications, design requirements, and established industry standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). These are objective criteria rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable.

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