(333 days)
The CompuFlo® Epidural Computer Controlled Anesthesia System is intended for use with an epidural needle for the real-time verification of needle tip placement in the lumbar epidural space in patients over age of 18 who are required to have epidural needle placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider.
Once Health Care Provider verifies the epidural needle placement in the lumbar epidural space, CompuFlo® Epidural Computer Controlled Anesthesia System is disconnected and the HCP continues with the medical procedure.
The device consists of: (1) the primary unit, (2) a pneumatic foot pedal control, (3) an AC power cord and (4) single-use disposable kit, which include an external in-line fluid pressure sensor, a 20 mL plastic syringe, plastic tubing and an ID Adapter. Operation of the device is allowed when powered by the AC mains or by the internal battery source. The epidural needle and solution is not supplied in the disposable Kit.
The provided text describes the acceptance criteria and a clinical study for the CompuFlo Epidural Computer Controlled Anesthesia System.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets for clinical performance. Instead, it describes the primary objective of the clinical study as determining whether the success rate of performing lumbar epidural anesthesia with the CompuFlo Epidural is equivalent to the traditional Loss of Resistance (LOR) technique.
The reported device performance in the clinical study is:
- Primary Outcome Hypothesis: The Experimental Procedure Group (CompuFlo Epidural) is non-inferior to the Standard Care Group (LOR technique) with respect to the successful performance of a lumbar epidural procedure.
- Non-inferiority margin (delta): An absolute difference of 1 percent.
- Result: The primary outcome hypothesis was met.
While not explicitly called "acceptance criteria" in a tabulated format, the success in meeting the non-inferiority hypothesis serves as the key clinical performance acceptance criterion for this device.
2. Sample Size and Data Provenance
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Test Set (Clinical Study):
- Sample Size: A total of 400 subjects were enrolled. Of these, 388 procedures were actually performed (12 subjects did not have the procedure).
- Data Provenance: The study was conducted at 6 US clinical centers. It was a prospective, randomized, parallel group, multicenter, pivotal study.
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Training Set: The document does not provide details about a specific "training set" for an AI algorithm. This device is described as a "Computer Controlled Anesthesia System" that uses real-time pressure sensing for needle tip verification, rather than a machine learning model that would typically require a training set. The "Software" section mentions development and maintenance per IEC 62304 and FDA guidance for software contained in medical devices, but this refers to the control software and not typically an AI/ML training process for diagnostic output.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish ground truth for the clinical study. However, the study focuses on the "success rate of performance of lumbar epidural anesthesia," implying evaluation by the Health Care Provider (HCP) performing the procedure and assessing its successful completion. The "Indications for Use" explicitly states: "Once Health Care Provider verifies the epidural needle placement in the lumbar epidural space..." This suggests that the ground truth for "successful placement" was established by the medical professionals involved in performing the procedures within the study.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the primary endpoint assesses the "successful performance of lumbar epidural procedure" in a non-inferiority study comparing two techniques, the "ground truth" would likely be the treating physician's assessment of success, potentially supplemented by standard clinical measures for confirming epidural placement. There's no mention of a separate panel for independent adjudication of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study comparing human readers with and without AI assistance was not performed. This device is a real-time assistance system for a procedural task (epidural needle placement) rather than a diagnostic imaging AI designed to assist human readers in interpreting medical images. The clinical study was a comparative effectiveness trial between two techniques for epidural placement: CompuFlo Epidural (a device-assisted technique) and Loss of Resistance (LOR) (the traditional technique).
6. Standalone (Algorithm Only) Performance Study
No. A standalone performance study of an algorithm without human-in-the-loop performance was not conducted in the way typically seen for AI/ML diagnostic devices. The device is fundamentally designed to be used by a human healthcare provider as an aid in real-time needle placement. Its performance is intrinsically tied to human interaction (e.g., the HCP verifies placement and disconnects the device). The clinical study evaluated the device's performance in the hands of human users compared to the traditional method.
7. Type of Ground Truth Used
The ground truth for the clinical study appears to be clinical success/outcomes data as defined by:
- "successful performance of lumbar epidural procedure"
- Verification of needle tip placement by the Health Care Provider (as mentioned in the Indications for Use).
8. Sample Size for the Training Set
No specific "training set" or its sample size is mentioned, as the device is not described as an AI/ML model that undergoes a training phase with a distinct dataset. The "Software" section refers to software development and compliance standards, which relate to embedded control software rather than a learning algorithm.
9. How Ground Truth for the Training Set Was Established
Since no AI/ML training set is explicitly discussed, the establishment of ground truth for such a set is not applicable or detailed in this document. The device's operation is based on real-time objective measurement of pressure changes at the needle tip, which is a deterministic physical principle, not a learned pattern from a training dataset.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).