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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

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.

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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

• 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.

• 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.

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