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The Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esoplagus, in patients from five years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The subject Endoflip™ 300 System is equivalent to the predicate Endoflip™ 300 System (K223705) except for an update to the Endoflip™ 300 System software to remove the analysis episode feature of the predicate device. Other software updates include minor feature enhancements and bug fixes. Changes to device labeling rrom the software updates and other minor changes for clarification purposes were also addressed.

The Endoflip™ 300 System software is supplied pre-installed in the Endoflip™ 300 Display System. It is also the software used for the Endoflip™ 300 Reader in reader mode only. There is no change to the display system hardware or to how the reader is supplied (USB stick).

No changes were made to any of the other components that comprise the Endoflip™ 300 System when compared to the predicate.

The provided text describes a 510(k) premarket notification for the Endoflip™ 300 System, which involves software updates to an existing device. This entire document is a 510(k) submission meant to demonstrate substantial equivalence to a predicate device, not a study specifically designed to establish acceptance criteria for a new device.

Therefore, many of the requested details regarding a standalone study, multi-reader multi-case study, and detailed ground truth methodologies for a specific study proving acceptance criteria are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted:

Acceptance Criteria and Device Performance:

The document's primary objective is to demonstrate substantial equivalence to the predicate device (Endoflip™ 300 System K223705) after software updates. Therefore, the "acceptance criteria" are implicitly that the updated device performs equivalently to the predicate device and does not introduce new safety or effectiveness concerns.

Specific numerical acceptance criteria and reported device performance from a clinical trial or performance study are not explicitly provided in terms of metrics like sensitivity, specificity, or error rates. Instead, the performance is evaluated through software verification.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria for a new device's performance are not given (as this is a 510(k) for an updated software version of an existing device), we can infer the acceptance criteria for the software updates.

Study Details:

The document describes software verification testing as the primary study type to establish substantial equivalence for the software updates.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. Software verification typically involves testing against a range of inputs and scenarios, but a "sample size" in the context of clinical data for performance metrics is not applicable here as no clinical performance data is presented.
   • Data Provenance: Not specified, as it's software verification, not a clinical data study.

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

   • Not applicable. This was software verification, not a study requiring expert-established ground truth on clinical data. The "ground truth" for software testing would be the expected behavior of the software according to its design specifications.

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

   • Not applicable. This was software verification.

4. 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, a multi-reader multi-case comparative effectiveness study was not done. The device (Endoflip™ 300 System) is a "Gastrointestinal Motility Monitoring System" that measures pressure and dimensions; it's not described as an AI-powered diagnostic tool for interpretation, but rather a direct measurement device with software for processing and displaying those measurements. The updates were minor software enhancements and bug fixes.

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

   • Yes, in a sense. The "study" was software verification, which inherently evaluates the algorithm's performance on its own against specifications, without human interpretation in the loop for diagnostic accuracy. The device itself is standalone in its measurement function, providing data to clinicians for their interpretation.

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

   • For software verification, the "ground truth" would be the software's design specifications and requirements. Each test case has an expected output or behavior based on these specifications, and the software's actual output is compared against this expected behavior. This is not clinical ground truth like pathology or expert consensus.

7. The sample size for the training set:

   • Not applicable. This was software verification testing for an updated version of an existing medical device, not a machine learning model involving a training set.

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

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The Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from 5 years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The Endoflip™ 300 System is the next generation of the predicate Endoflip™ System consisting of design changes to the device hardware and software components. The design changes improve device usability when compared to the predicate. Changes were made to the platform components only; no design changes were made to the system catheters (Endoflip™ or Esoflip™) except for labeling changes (not related to indications for use). The system is comprised of a pump, display, cart and accessories, including pre-use tube and balloon catheters.

The provided text is an FDA 510(k) clearance letter and summary for the Endoflip™ 300 System. It describes the device, its intended use, and the types of testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not contain information on acceptance criteria for a performance study evaluating the device's diagnostic accuracy or effectiveness against a ground truth, nor does it describe a study specifically designed to prove the device meets such criteria in terms of clinical performance.

The performance data summarized in section VII focuses on engineering, safety, and usability aspects of the device's hardware and software components, rather than its clinical diagnostic or treatment efficacy. Specifically, the document states:

• "Clinical studies were not required to demonstrate the safety and performance of the Endoflip TM 300 System."

Therefore, I cannot provide the requested information about acceptance criteria for clinical performance and a study proving those criteria are met. The document indicates that for this particular 510(k) submission, clinical studies to demonstrate safety and performance (in the sense of diagnostic or treatment efficacy) were not deemed necessary, likely due to the device being a "next generation" of an already cleared predicate with no change to the indications for use and improvements primarily in usability and platform components.

To answer your specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes engineering, safety, and usability testing, not clinical performance against specific diagnostic or treatment acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable for clinical performance. For engineering, safety, and usability tests, the sample sizes and data provenance are not specified in this summary, but would be part of the underlying test reports.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established for the performance studies presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not 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: Not applicable. This device is a gastrointestinal motility monitoring system, not an AI-assisted diagnostic tool for image interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of diagnostic performance. The device itself is a measurement system; its "standalone" performance relates to its ability to accurately measure pressure and dimensions, which would be verified through mechanical and software testing.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical performance evaluation. The "ground truth" for the tested engineering aspects would be established against calibrated standards or specifications.
8. The sample size for the training set: Not applicable. The document does not describe a machine learning or AI algorithm that would require a training set for diagnostic purposes.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on the engineering and design controls demonstrating the safety and effectiveness for a device that is essentially an updated version of a previously cleared system, rather than a novel diagnostic or therapeutic device requiring extensive clinical performance studies to establish efficacy against a clinical ground truth.

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