(173 days)
This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.
STORC™ is a Disposable Intrauterine Pressure Monitoring System. This product is a sterile, single patient use catheter.
This document, K954952, describes a 510(k) premarket notification for a medical device called the STORC Intrauterine Pressure Catheter. The submission aims to demonstrate substantial equivalence to predicate devices already on the market.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a quantitative table of acceptance criteria with specific thresholds (e.g., "accuracy > 95%"). Instead, it
qualitatively describes areas where the STORC catheter's performance was compared to predicate devices.
| Acceptance Criteria (Qualitative) | Reported Device Performance |
|---|---|
| Safety | |
| Perforation risk | Bench testing on fresh placenta showed STORC is less likely to perforate than predicate devices. |
| Mechanical integrity | Laboratory testing and basic design assure no parts will come loose. |
| Biocompatibility and infection | Independent lab testing showed materials are safe for intended application. |
| Effectiveness | |
| Integrity of intrauterine pressure signal | Clinical trials showed STORC was as effective or more effective than predicate devices. |
| Ease of use | Clinical trials showed STORC was as effective or more effective than predicate devices. |
| Amniotic space access | Clinical trials showed STORC was as effective or more effective than predicate devices. |
| Device retention | Clinical trials showed STORC was as effective or more effective than predicate devices. |
| Zeroing and drift signal stability | Clinical trials showed STORC was as effective or more effective than predicate devices. |
| Sensor accuracy | Laboratory testing verified performance standards. |
| Overall performance | Laboratory testing verified performance standards. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "clinical studies" and "clinical trials" but does not specify the sample size for the test set (number of patients or cases).
The provenance of the data is limited to "clinical studies" and "laboratory testing." It does not specify the country of origin of the data or explicitly state whether the clinical data was retrospective or prospective. Given the context of a 510(k) for a new device, it is most likely that the clinical studies were prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document mentions "physician evaluation" as part of the safety verification in clinical studies. However, it does not specify the number of experts used to establish ground truth for the clinical effectiveness assessments, nor does it detail their specific qualifications (e.g., "obstetrician with X years of experience").
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the assessment of the clinical studies. The mention of "physician evaluation" suggests subjective assessment, but the process for resolving discrepancies or reaching consensus is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focuses on comparing the device's performance to predicate devices, but there's no indication of a structured MRMC design to measure human reader improvement with or without AI assistance, as AI is not a component of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the STORC Intrauterine Pressure Catheter is a physical medical device, not an AI algorithm. Therefore, there is no "algorithm-only" performance to assess.
7. The Type of Ground Truth Used:
For safety, the ground truth appears to be based on:
- Bench testing results (e.g., direct measurement of perforation likelihood on fresh placenta).
- Clinical physician evaluation (qualitative assessment of safety in a real-world setting).
- Biocompatibility test results from an independent lab.
For effectiveness, the ground truth appears to be based on:
- Clinical trial results and physician evaluation: Assessing attributes like signal integrity, ease of use, access, retention, and signal stability, likely through direct observation, patient outcomes, and user feedback.
- Laboratory testing: Verifying sensor accuracy and overall performance against established standards for pressure measurement.
8. The Sample Size for the Training Set:
This question is not applicable as the STORC Intrauterine Pressure Catheter is a physical medical device. It does not use machine learning or AI, and therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
§ 884.2700 Intrauterine pressure monitor and accessories.
(a)
Identification. An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).