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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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The CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET is intended to connect a CO2 source (insufflator), and a sterile water source (water bottle), to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.

The Bracco Diagnostics Inc. (BDI) CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (ILTS) is intended for use with BDI CO2 Endoscopic Insufflators and OEM endoscope systems, in this specific case the Olympus® 140, 160, 180, and 190 series endoscopes. The ILTS is supplied sterilized using Gamma radiation to a Sterility Assurance Level (SAL) of 10-6. The ILTS is individually packaged At the time of this submission, accelerated aging tests confirmed a one (1) year shelf life.

The provided text describes the acceptance criteria and the studies conducted for the "Bracco Diagnostics, Inc. CO2 Endoscopic Insufflator In Line Tubing Set (ILTS)."

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

• Device compatibility
• Usability
• Environmental
• Delivery flow rate
• Delivery pressure
• Leakage
• Mechanical integrity
• Shipping and transportation
• Labeling | Test results indicate that the ILTS complies with its predetermined specification for all listed performance parameters (device compatibility, usability, environmental, delivery flow rate, delivery pressure, leakage, mechanical integrity, shipping and transportation, and labeling). |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., sterilization validation, biocompatibility, performance testing). Instead, it refers to "verification results" and "test results" indicating compliance with standards.

The data provenance is not specified regarding country of origin or whether studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device accessory, these would typically be internal laboratory tests and validations rather than clinical studies with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The "ground truth" for a medical tubing set's performance is established by objective engineering and scientific standards (e.g., sterility, biocompatibility, flow rates) rather than expert clinical consensus or interpretation of subjective data.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert interpretation, such as image reading or clinical assessments, to resolve discrepancies. This is not relevant for the objective performance testing described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The "LINE TUBING SET" is a hardware accessory, not a diagnostic AI tool.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The device is a physical tubing set, not an algorithm. The performance testing described (sterilization, shelf-life, biocompatibility, device compatibility, flow rate, etc.) constitutes its standalone performance assessment.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• International Standards: e.g., ISO 11137 for sterilization, ISO 11607 for packaging, ISO 10993-1 for biocompatibility.
• Predetermined Specifications: Internal engineering specifications for performance parameters like delivery flow rate, delivery pressure, leakage, and mechanical integrity.

8. The Sample Size for the Training Set

This is not applicable. The ILTS is a passive medical device accessory, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this device.

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The Bracco Diagnostics, Inc. (BDI) CO2MPACT ENDOSCOPIC INSUFFLATOR™ is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

The BDI CO2MPACT ENDOSCOPIC INSUFFLATOR™ allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.

The Bracco Diagnostics, Inc. (BDI), CO2MPACT ENDOSCOPIC INSUFFLATOR™ (CO2MPACT) is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2MPACT regulates CO2 flow rate and pressure during the insufflation process.

The BDI CO2MPACT allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.

Consistent with the predicate devices, the BDI CO2MPACT is used to administer CO2 to the patient for distention purposes. For this application, the actual displacement of CO2 to the patient through the endoscope is controlled by the clinician modulating an "air-water" valve on the endoscope. The BDI CO2MPACT only provides source pressure and flow to the endoscope in a similar manner to the predicates BDI CO2Efficient Endoscopic Insufflator (K053008) and Olympus UCR Endoscopic CO2 Regulation Unit (K081173), or the internal air pump included within the endoscope light source.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not specify a sample size for a test set in the context of clinical data or patient studies. The testing described is primarily bench testing, software verification/validation, and compliance with recognized standards (electrical safety, EMC, biocompatibility).

The data provenance is internal testing by Bracco Diagnostics, Inc. on the device itself and its components. There is no mention of external data or patient data, nor is there any indication of retrospective or prospective data collection from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable or not provided in the submission. The "ground truth" for the tests described relates to compliance with engineering standards and internal specifications, which would be established by the engineering and quality control teams at Bracco Diagnostics, Inc., rather than clinical experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Since the testing is primarily objective measurements against specifications and standards, a clinical adjudication method (like 2+1, 3+1 concensus) is not relevant to the studies described.

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

No, an MRMC comparative effectiveness study was not done. This device is a CO2 insufflator, a physical medical device, not an AI or imaging diagnostic tool. Therefore, questions regarding human reader improvement with or without AI assistance are not relevant to this submission.

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

No, a standalone algorithm study was not done. As mentioned, this is a physical medical device, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the device's performance was predetermined specifications and applicable engineering/medical device standards (e.g., ISO, IEC, UL, FDA guidances for software). This is not a clinical ground truth like pathology, expert consensus on images, or patient outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. There is no mention of a "training set" as this device does not involve machine learning or AI that would require such a set. Any "development" or "design" process for the device refers to engineering and software development, not model training.

9. How the Ground Truth for the Training Set was Established

This information is not applicable or not provided for the reasons stated in point 8.

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