(257 days)
The CompuFlo® Epidural Computer Control Anesthesia System is intended for use with an epidural needle for the real-time verification of needle placement in the lumbar or thoracic epidural space, inclusive of cervicothoracic junction (CTJ). It is intended for patients over age of 18 who are required to have epidural needle or catheter placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider (HCP).
The CathCheck is an additional feature for clinicians to use to assess proper catheter placement inside the epidural space by evaluating a pulsatile waveform. The CathCheck function utilizes the same technology as the CompuFlo® Epidural Computer Control Anesthesia System and should only be used in conjunction with standard clinical assessment practice.
Once the Health Care Provider verifies the epidural needle or catheter placement in the epidural space, 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 can 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
Because the provided text is a 510(k) summary for a medical device and not a detailed study report, comprehensive information for each question is not available. However, based on the summary provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Study Goals) | Reported Device Performance (CompuFlo Group) |
|---|---|
| Successful performance of thoracic epidural placement (Primary Endpoint) | 96.7% success rate |
| Safety profile comparable to traditional LOR technique | 2 accidental dural punctures; mild hypotension (not related to device); no other adverse events reported. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: A total of 133 subjects were enrolled in the clinical study. The text doesn't specify an exact breakdown for the "test set" as it's a clinical trial comparing two groups. Each group would constitute part of this 133.
- Data Provenance:
- Country of Origin: US
- Retrospective or Prospective: Prospective, controlled, parallel-group randomized trial.
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)
The text does not specify the number of experts or their qualifications used to establish ground truth. The primary investigator "judged the causal relationship" of an adverse event, indicating at least one clinical expert was involved in the study's oversight and assessment. The "Health Care Provider (HCP)" is mentioned as verifying needle/catheter placement and establishing medical necessity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The text does not specify an adjudication method for the test set.
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
- MRMC Study: No, this was not an MRMC study. It was a clinical trial comparing the CompuFlo device (which assists in real-time verification of needle placement) against the traditional Loss of Resistance (LOR) technique for thoracic epidural placement. This is a comparison of a device-assisted procedure versus a standard manual procedure, not specifically an AI-assisted human reader interpretation study.
- Effect Size: The study found that the CompuFlo group had a 96.7% success rate compared to a 91.2% success rate for the traditional LOR technique. The difference in success rate is 5.5%. However, the text explicitly states, "The results of the primary efficacy endpoint demonstrated a success rate that was not statistically superior to the control. No significant difference on primary success rate was detected between the two study groups." This indicates that while there was a numerical difference, it was not statistically significant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The CompuFlo Epidural Computer Controlled Anesthesia System is a device used by a Health Care Provider (HCP) for real-time verification of needle placement. It is explicitly "intended for use with an epidural needle" and the "HCP continues with the medical procedure" after verification. Thus, it is designed for human-in-the-loop performance, and a standalone algorithm-only performance assessment would not be applicable or relevant to its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for "successful performance of thoracic epidural placement" in the clinical study would have been established by clinical assessment during the procedure, likely including confirmation by the performing physician and potentially other clinical indicators of correct placement (e.g., ability to administer medication, patient response, lack of adverse events indicative of misplacement). The text doesn't specify if additional diagnostic tests were used to confirm placement after the fact.
8. The sample size for the training set
The text does not mention a "training set" in the context of device development or algorithm training. The clinical study described is an investigation study to demonstrate safety and efficacy, not a study for training a machine learning model.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of machine learning, this question is not applicable based on the provided text. The device's underlying technology relies on "real-time verification of needle placement" using pressure waveforms, which would have been developed based on scientific principles and engineering, not necessarily a machine learning 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).