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This product has applications for surgery in the saphenous vein, or radial artery for establishment of a port of entry for endoscopic instruments.

The Short Port Blunt Tip Trocar (BTT) is used to provide a port of access for insertion of endoscopic instruments into an incision site. The device consists of a main body with a Balloon on the distal end, a Balloon inflation port, an Endoscope seal on the proximal end, and an external port with a one-way valve for gas insufflation. It also includes a Cannula seal to allow insertion of the Harvesting Cannula. The balloon minimizes leakage and secures the port. A 30 cc syringe is provided for inflation/deflation of the Balloon.

The provided text details a 510(k) premarket notification for a medical device, the MAQUET Cardiovascular Short Port Blunt Tip Trocar (BTT), rather than an AI/ML software device. Therefore, the information requested for AI/ML device acceptance criteria and study particulars is not present in the document.

The document discusses the substantial equivalence of the Short Port BTT to predicate devices based on:

• Intended Use: Same
• Operating Principles: Same
• Sterilization: Same materials and processes
• Packaging: Same

Differences noted:

• Material change from Latex balloon (implying the new device does not use Latex, though not explicitly stated as such, it's inferred from the "Revision of Latex content statement").
• Labeling change regarding Latex content.
• Change from "converter door" to "Cannula Seal and 7mm O Seal."

The document states that these differences are "not considered a technological difference and is substantially equivalent to the predicate devices."

The "study" mentioned is the development process and testing conducted to demonstrate substantial equivalence, not an AI/ML specific study. The results of these in-vitro tests are cited as demonstrating that "the functionality and performance characteristics of the device are comparable to the currently marketed Short Port BTT."

Therefore, I cannot populate the table or answer the specific questions about AI/ML device acceptance criteria and studies, as this document pertains to a traditional medical device (trocar) and not an AI/ML product.

However, I can extract information relevant to a traditional medical device submission based on the provided text:

Acceptance Criteria and Reported Device Performance (Traditional Medical Device Context):

Missing Information (for AI/ML context, not applicable here):

1. Sample size for the test set and data provenance: Not applicable. The "test set" here refers to in-vitro performance tests of the physical device.
2. Number of experts used to establish ground truth & qualifications: Not applicable.
3. Adjudication method: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
5. Standalone (algorithm only) performance: Not applicable.
6. Type of ground truth used: Not applicable. The ground truth here is the performance of the predicate device for comparison in physical tests.
7. Sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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