(147 days)
The EndoFLIP system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.
The EndoFLIP® system and catheter are identical to the predicate K092850, except the addition of the new software which permits a programmed series of inflations of the balloon in steps of volume. This feature is equivalent to a modality offered by the predicate Barostat (K991288).
The device is not intended to perform a diagnostic test.
The provided text is a 510(k) summary for the EndoFLIP® Barostat Mode device. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, nor any performance data resulting from such a study.
The document states:
- "No comparative bench testing was required as the change is a software change only."
- "The proposed software modification does not change the performance specification of the EndoFLIP®, which remains identical to the predicate K092850."
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, environment of use, patient population, technology/design, and materials, asserting that the software change does not alter performance specifications.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).