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The PROTOCO₂L Touch Colon Insufflator administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy).

The Bracco Diagnostics Inc. (BDI) PROTOCO₂L Touch Colon Insufflator (PROTOCO₂L Touch) administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy). Insufflation during CTC is used to distend the colon with uniform pressure in order to properly present the colon during the given diagnostic procedure.
The PROTOCO2L Touch consists of two (2) components:
(1) the Colon Insufflator, and
(2) the disposable, non-sterile Administration Set.

The provided text describes a 510(k) Premarket Notification for the Bracco Diagnostics Inc. PROTOCO₂L Touch Colon Insufflator. This is a submission for a medical device that administers and regulates CO₂ for colon distention during CT Colonography, aiming to demonstrate substantial equivalence to existing predicate devices.

The document does not contain information about:

• Acceptance criteria and device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Any details of a study involving a test set, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• A standalone performance study of an algorithm.
• The type of ground truth used (pathology, outcomes data, etc.) for any clinical performance evaluation.
• The sample size for a training set or how ground truth for a training set was established.

Instead, the performance testing described focuses on:

• Sterilization and Shelf-Life: Not applicable as the device is not shipped sterile and has no shelf life.
• Biocompatibility: Verification of patient contact materials within the tubing set against ISO 10993-1: 2009.
• Software Testing: Design and development based on a robust software development process, with verification and validation against internal requirements and FDA guidance documents ("The content of premarket submissions for software contained in medical devices," "General principles of software validation").
• Electrical Safety Testing: Compliance with IEC 60601-1: 2005 and UL 60601-1: 2006.
• Electromagnetic Compatibility (EMC) Testing: Compliance with IEC 60601-1-2: 2007.
• Performance Testing – Bench: Compliance with internal requirements, IEC 62366: 2007 (usability engineering), and ISTA Procedure 3A – 2008 (packaged-products for parcel delivery).

The conclusion states that these verification and validation activities demonstrate that the device is safe and effective and substantially equivalent to the predicate device.

Therefore, I cannot provide a table of acceptance criteria for diagnostic performance or details about a study evaluating such performance, as the provided text does not contain that information. The "acceptance criteria" and "device performance" in this context refer to engineering, safety, and software validation rather than diagnostic accuracy.

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