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The device is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.

The Spinal Manometer is used as part of a lumbar puncture procedure in which cerebrospinal fluid is extracted for examination, and pressure of the spinal fluid is measured. The cerebrospinal fluid is generally used to diagnose if there are problems with the central nervous system or spinal cord. The procedure requires insertion of a spinal needle into the lumbar section of the spinal manometer is attached to the hub of the needle with a three-way stopcock. An extension tube may be used to reduce movement of the spinal needle and patient discomfort. The extension tube attaches to the spinal needle hub and the stopcock. The Cerebrospinal Fluid (CSF) pressure is measured while the needle is connected to the Spinal Manometer directly or through an extension tube. The normal range for CSF pressure is 80mm-180mm (8cm) H2O. CSF pressure over 200mm (20cm) H2O is considered high and pressure less than 80mm (8cm) H2O is low. The Spinal Manometer does not directly contact the patient nor does it contact body fluids intended to be re-introduced into the human body. The Spinal Manometer is composed of polyethylene and the luer lock and connector is composed of polycarbonate. The Spinal Manometer is a two-piece Spinal Manometer. The additional Spinal Manometer length is available if required. The two-pieces are connected using a polycarbonate connector. The Spinal Manometer is packaged as part of a convenience kit for lumbar puncture. The Spinal Manometer is placed in a rigid tray composed of high impact plastic (poly styrene). The tray is wrapped and packaged in a soft pouch with Tyvek lid. The pouch is heat-sealed. The convenience kit includes a variety of devices used in the lumbar puncture procedure including 20 gauge spinal needle with stylet, syringe with needle, 22 gauge needle, spinal manometer, 5" extension tube, three-way stopcock, three sponge sticks, three gauze pads, four vials with screw caps, fenestrated drape, towel, Lidocaine Hydrochloride, CSR wrap, and bandage.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state a specific sample size for a test set. It mentions that "A qualified third party calibration laboratory tested the accuracy of the device."

• Test Set Sample Size: Not explicitly stated.
• Data Provenance: The testing was performed by "MCS Calibration Inc. of Hollbrook, NY," a third-party calibration laboratory. The nature of the data (retrospective or prospective) is not specified, but given it's a calibration test, it would inherently be a prospective test of the manufactured device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable or provided. The ground truth for the device's accuracy was established by direct physical measurement against a calibrated standard, not through expert opinions or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The accuracy test involved direct measurement against a standard, not a scenario requiring adjudication between multiple interpretations.

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 done. The document describes a technical performance test (accuracy calibration) of the device itself, not a study evaluating human reader performance with or without the device.

• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, a standalone performance test was done, in essence. The test was focused on the device's intrinsic accuracy in measuring cerebrospinal fluid pressure. This is an "algorithm-only" performance in the sense that it's evaluating the device's mechanical/sensing capabilities directly, independent of a human operator's interpretation beyond reading the measurement.

7. The Type of Ground Truth Used

The ground truth used was established through measurement against a calibrated standard. MCS Calibration Inc. is certified to ISO 17025 and ISO 9002, indicating they use established and traceable calibration procedures to determine true values.

8. The Sample Size for the Training Set

This information is not applicable or provided. The device in question (a spinal manometer) is a physical measurement tool, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's design and manufacturing rely on engineering specifications and quality control, not data-driven training.

9. How the Ground Truth for the Training Set was Established

This information is not applicable or provided for the reasons stated in point 8.

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