(701 days)
The software only provides visual guidance for data interpretation. It is not considered in and of itself to be diagnostic without skilled interpretation.
Continuous recordings provide information in the form of amplitude versus time, but it is difficult to understand because of the visual complexity of the record due to channel separation and duration of the recorded traces and sporadic nature of the activity. The software reports arranges the information in concise, reproducible, consistent reports that are more consistent than visual analysis. The Small Bowel software adds no new information, but takes existing information and rearranges it to make it more accessible to interpretation. Source information has dimensions of amplitude and time while the software presents the same information including numerous calculated results, such as duration, mean, maximum and median, motility index, frequency and cycle values for contractions and clusters (groups of contractions).
This document (K942247) is a 1996 510(k) premarket notification for a software device. As such, it predates many of the modern requirements and best practices for clinical studies and algorithm validation that are standard in medical device submissions today. Consequently, most of the detailed information you've requested regarding acceptance criteria, study design, and performance metrics is not present in the provided text.
Here's an analysis based on the given input, highlighting what's available and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Provides information in concise, reproducible, consistent reports | "The software reports arranges the information in concise, reproducible, consistent reports that are more consistent than visual analysis." |
| Rearranges existing information to make it more accessible for interpretation. | "The Small Bowel software adds no new information, but takes existing information and rearranges it to make it more accessible to interpretation." |
| Calculates specific results (duration, mean, max, median, motility index, frequency, cycle values for contractions and clusters). | "the software presents the same information including numerous calculated results, such as duration, mean, maximum and median, motility index, frequency and cycle values for contractions and clusters (groups of contractions)." |
| Electrically safe. | "Safety is assured in that the catheter and the sensors used to transduce the pressures are connected to fully electrically isolated amplifiers as per UL544." |
| Provides visual guidance for data interpretation but is not diagnostic on its own. | "The software only provides visual guidance for data interpretation. It is not considered in and of itself to be diagnostic without skilled interpretation." |
Missing:
- Specific quantitative acceptance criteria (e.g., target accuracy, precision, sensitivity, specificity, or inter-reader agreement improvement).
- Any quantitative performance metrics demonstrating the device meets these criteria. The statements are descriptive rather than data-driven.
2. Sample Size Used for the Test Set and Data Provenance
Not Provided. The document describes the function of the software but does not mention any specific test set, sample size, or the provenance of any data used for evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Provided. There is no mention of a test set, ground truth establishment, or expert involvement for validation.
4. Adjudication Method for the Test Set
Not Provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe any MRMC study. It states the software "rearranges the information to make it more accessible to interpretation" and that reports are "more consistent than visual analysis," but it doesn't provide a comparative effectiveness study with human readers to quantify this improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not Applicable/Not Provided as a study. The device is explicitly stated to not be diagnostic on its own ("It is not considered in and of itself to be diagnostic without skilled interpretation."). Its function is to process and present data, implying it's an aid, not a standalone diagnostic. There is no mention of a standalone performance study in the context of diagnostic accuracy.
7. The Type of Ground Truth Used
Not Applicable/Not Provided. Given the nature of the device (data visualization and calculation tool for continuous recordings) and the lack of a formal clinical validation study described, there is no mention of "ground truth" in the modern sense (e.g., pathology, outcomes data) being used to validate its diagnostic capabilities. The "ground truth" for the software's calculations would inherently be the raw amplitude-over-time data from the sensors, which it processes.
8. The Sample Size for the Training Set
Not Provided. There is no mention of a training set, as the document describes a rule-based software for data manipulation and visualization, not an AI/ML model that would require training data.
9. How the Ground Truth for the Training Set was Established
Not Applicable/Not Provided. As it's not an AI/ML model, there's no concept of a training set or its associated ground truth establishment in this context. The software's "truth" is its adherence to the specified calculation methodologies (e.g., how it calculates mean, median, frequency).
Summary of Document K942247's Approach:
This submission relies on a "functional equivalence" and "safety" argument typical of older 510(k)s for software that primarily processes and presents data.
- Safety: Addressed by electrical isolation to UL544 standards.
- Effectiveness: Stated as providing information in a more accessible, consistent, and organized manner than manual visual analysis of raw continuous recordings. It's an information-processing tool, not a diagnostic algorithm in the modern sense, and therefore, extensive clinical performance studies with acceptance criteria for diagnostic accuracy were not described or likely required at the time for this type of device. The effectiveness is described in terms of its utility for interpretation by a skilled user, rather than a standalone diagnostic capability.
§ 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).