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SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.

The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.

The provided text describes the acceptance criteria and a summary of performance data for the SCOPE BUDDY PLUS Endoscope Flushing Aid.

Here's an analysis of the requested information:

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

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing to demonstrate substantial equivalence to the predicate has been completed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests described (Fluid Delivery Flow Rate, Tubing Durability, Software Verification) appear to be engineering/performance tests rather than tests requiring expert human interpretation or ground truth establishment based on clinical observations.

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

This information is not applicable/not provided as the tests described are technical performance verifications and do not involve human adjudication for ground truth.

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

An MRMC comparative effectiveness study was not done. The device is an electro-mechanical flushing aid for endoscopes, not an AI or diagnostic tool that assists human readers.

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

This concept is not applicable to this device. It is an electro-mechanical device with software control, not an algorithm performing a standalone diagnostic or interpretative function. The software verification confirms the software's functionality within the device.

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

The "ground truth" for the tests appears to be engineering specifications and defined performance metrics.

• For Fluid Delivery Flow Rate, the ground truth is the "manufacturers minimum requirements for individual channel flushing volumes."
• For Tubing Durability, the ground truth is the specified requirement to "withstand at least 40 full automatic cycles without leaking."
• For Software Verification, the ground truth is the "verification steps outlined in procedure."

These are objective, measurable criteria rather than clinical ground truth established by experts.

8. The sample size for the training set

The document does not mention a "training set" as this device is not a machine learning or AI model.

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

This question is not applicable as there is no mention of a training set.

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Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.

The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. These fluid volumes are defined by the endoscope manufacturer. Scope Buddy Plus is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver an endoscope manufacturer specified volume of fluid to the endoscope channels. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.

The provided text is a 510(k) Summary for the "Scope Buddy Plus Endoscope Flushing Aid" and details its equivalence to a predicate device, not its acceptance criteria or a study proving it meets such criteria in the traditional sense of a clinical trial for diagnostic performance.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Fluid Pump CP-3, K914524) rather than establishing novel safety and effectiveness through a clinical performance study with acceptance criteria like sensitivity, specificity, or accuracy. Therefore, many of the requested points below are not directly applicable or available in this type of submission.

However, I can extract information related to the device's functional performance testing which serves as a form of "acceptance criteria" for its intended mechanical function.

Here's an attempt to answer your questions based on the provided document:

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

Since this is a mechanical flushing aid, the "acceptance criteria" from the document revolve around its ability to deliver fluids according to manufacturer specifications and meet safety standards.

2. Sample size 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: The document does not specify sample sizes for any of the functional or safety tests. These types of tests typically involve a set number of devices or iterations to demonstrate performance and compliance, but the exact numbers are not provided in this summary.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given that Medivators Inc. is a US-based company and the submission is to the US FDA, the testing was likely conducted in the US and prospectively as part of the device development and validation.

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 question is not applicable to this type of device. The "ground truth" for a mechanical flushing aid is its ability to perform its specified function (e.g., deliver a certain volume of fluid, meet safety standards). This is assessed through engineering and performance testing, not via expert interpretation of diagnostic images or patient outcomes.

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing medical images). For engineering and functional tests, results are typically objective measurements against a predefined specification, not subjective interpretations requiring adjudication.

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 question is not applicable. The Scope Buddy Plus Endoscope Flushing Aid is a mechanical device, not an AI-powered diagnostic tool involving human readers or interpretation of cases. No MRMC study was conducted.

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

• This question is not applicable. The device is not an algorithm, but a mechanical flushing aid. While it has software, its "standalone" performance refers to its ability to pump fluids, which is what the functional performance testing assessed.

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

• The "ground truth" for this device's performance is objective measurement against engineering specifications and regulatory standards. For example:
  • Detergent Dosing/Fluid Delivery: Measured volumes and flow rates compared to pre-defined manufacturer requirements.
  • Electrical Safety/EMC: Compliance with specified international standards (IEC 61010-1, IEC 61326-1) based on test measurements.
  • Software Validation: Adherence to software development lifecycle processes and functional requirements.
  • Human Factors/Usability: Observation and assessment of user interaction against usability goals and safety criteria.

8. The sample size for the training set

• This question is not applicable. The Scope Buddy Plus Endoscope Flushing Aid is a hardware device with software controls, not a machine learning or AI algorithm that requires a "training set" in the context of data-driven model training.

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

• This question is not applicable, as there is no "training set" for this type of device.

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