(102 days)
The Endoflip System is indicated for use in a clinical setting to measure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions 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 System comprises a measuring system and a single use catheter to provide programmed balloon distensions.
The provided text describes a 510(k) premarket notification for the Endoflip System, focusing on adding a specific age range (pediatrics) to its indications for use. The document does not contain information about the acceptance criteria or a study designed to prove the device meets specific performance criteria linked to those acceptance criteria.
The submission asserts that "There is no change between the Predicate device (K160725) and Endoflip System" and "There is no change in the technological characteristics of Endoflip System from the cleared predicate device (K160725)." Therefore, the performance data presented primarily focuses on the safety and clinical utility in the pediatric population, rather than proving specific performance metrics of the device itself.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, precision, sensitivity, specificity) for the Endoflip System itself. The "Clinical Evaluation" section mentions using the Endoflip in pediatric patients to assess myotomy adequacy and esophageal distensibility, but it does not present specific performance metrics from a study against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Partially available, but not for a formal test set with defined performance metrics. The "Clinical Evaluation" mentions a "literature review" of existing studies using Endoflip in pediatric populations. It states, "Specifically, Endoflip was used in pediatric achalasia patients during myotomy surgeries..." and "Other application described in the literature review involves the use of Endoflip in children with Eosinophilic esophagitis (EoE)..."
- Sample size: Not explicitly stated as a single number. It is implied that multiple studies were reviewed, involving an unspecified number of pediatric patients for achalasia and EoE.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective for the individual studies reviewed). The studies were part of a "literature review."
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)
- Cannot be provided. The document does not describe a formal process of establishing ground truth by a panel of experts for a specific performance study. The "Clinical Evaluation" refers to the device being used in clinical settings where surgeons and clinicians would interpret the device output in the context of patient care and surgical outcomes (e.g., "real time assessment of the adequacy of the myotomy"), but this is not a structured ground truth establishment for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No formal adjudication method is mentioned as there isn't a described performance study with a test set requiring such a process.
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. The Endoflip System is a gastrointestinal motility monitoring system, not an AI or imaging interpretation device that would typically involve "human readers" or "AI assistance" in the sense of a diagnostic interpretation product. The document makes no mention of AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot be provided. The Endoflip System measures physiological parameters (pressure and dimensions) which are then interpreted by clinicians. It is not an "algorithm only" device in a standalone performance context like an AI-based diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied clinical outcomes, but not formally defined for a performance study. For the pediatric use described, ground truth might relate to surgical success (adequacy of myotomy), patient symptoms, or other clinical assessments (e.g., diagnosis of EoE or achalasia, and response to treatment). However, this is inferred from the clinical applications mentioned, not from a specific "ground truth" definition within a performance study section.
8. The sample size for the training set
- Not applicable / Cannot be provided. The Endoflip System is a measurement device and not an AI/machine learning algorithm that would have a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. As it's not an AI/ML device with a training set, this question is not relevant.
In summary, the provided document is a 510(k) summary for a change to the indications for use of an existing device (Endoflip System) to include a pediatric age range. It relies on the substantial equivalence to a predicate device (K160725) and a "clinical evaluation" via literature review to support the safety and potential benefit of the device in the pediatric population, rather than presenting a de novo performance study against new acceptance criteria.
§ 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).