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The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.

The Spinal Lumbar Puncture Manometer with either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7. The manometer is considered a Class II medical device as defined in 21 CFR §880.2500, product code FMJ. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to repackagers/ medical device manufacturers. Materials: PVC, Polycarbonate, HDPE. No patient contact.

Here's a breakdown of the acceptance criteria and the study information for the Spinal Manometer NRFit and Spinal Manometer LUER, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized standards and internal protocols, with the reported performance being "Pass" for all tests.

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

The document does not explicitly state the specific number of devices or test samples used for each individual performance test (e.g., liquid leakage, axial load). It mentions:

• Sterility tests: "performed using worst case devices already cleared for market and being packed in identical packaging (material and dimensions)."
• Shelf-life performance: "tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years)."

The provenance of the data is internal testing conducted by PAJUNK® GmbH Medizintechnologie, located in Geisingen, Germany, and its contract sterilizer, Sterigenics Germany GmbH, located in Wiesbaden, Germany. All testing appears to be retrospective in the sense that it's performed on manufactured devices to demonstrate compliance, rather than a prospective clinical trial.

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

This information is not provided in the document. The tests described are primarily engineering and laboratory-based performance tests against established international standards (ISO) and internal protocols. There is no mention of human expert evaluation to establish a "ground truth" in the clinical sense, as the device is for mechanical measurement and connectivity rather than diagnostic interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective, quantifiable physical and chemical performance metrics against defined standards, not subjective assessments requiring expert adjudication. The result for each test is a simple "Pass" or "Fail."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation of clinical data (e.g., AI in radiology). The Spinal Manometer is a physical device for measuring pressure, not an AI or diagnostic imaging tool.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI is not relevant. The device operates independently of human interpretation of its internal function; humans use it to observe a reading. All performance tests evaluated the device in its intended operational context without human interpretation being part of its core "performance" beyond reading the scale.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on:

• International Standards: Adherence to ISO standards (e.g., ISO 11135, ISO 10993-7, ISO 80369-6, ISO 80369-7) defines acceptable physical and chemical properties.
• Internal Protocols: For aspects not covered by specific ISO standards (e.g., Accuracy/Durability of Markings, Glue Connection Stability), internal, presumably validated, protocols establish the acceptance criteria.
• Measurement against predefined limits: For sterilization residuals and endotoxin, specific quantitative limits (e.g., 25 ppm, 0.06 EU/ml) serve as the ground truth.

8. The Sample Size for the Training Set

There is no training set as this device is not an AI/machine learning product. The term "training set" doesn't apply.

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

Since there is no training set, this question is not applicable.

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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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The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

In accordance with section 510 (k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Lumbar Puncture Kit. The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

This document is a 510(k) summary for a medical device (Lumbar Puncture Kit). It's focused on demonstrating substantial equivalence to previously cleared devices for regulatory approval, not on presenting a study with acceptance criteria for device performance as would be expected for an AI/software as a medical device (SaMD) product.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text. This type of information is typically found in clinical validation studies for AI/SaMD, which is not what this document is.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document does not describe specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance in those terms. It focuses on physical and visual testing as part of manufacturing release.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No "test set" in the context of an AI/SaMD performance study is mentioned. The testing described refers to manufacturing quality control, not a clinical performance evaluation.

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)

• Cannot be provided. No ground truth establishment by experts is described, as this is not an AI/SaMD performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No adjudication method is mentioned.

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

• Cannot be provided. No MRMC study is mentioned. This document is for a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. No standalone algorithm performance is mentioned, as this is not an AI/SaMD.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be provided. No ground truth in the context of a clinical performance study is mentioned. The "testing" refers to meeting product design specifications for material properties and manufacturing.

8. The sample size for the training set

• Cannot be provided. No "training set" is mentioned. This is a non-AI physical device.

9. How the ground truth for the training set was established

• Cannot be provided. No "training set" or its ground truth establishment is mentioned.

Summary derived from the provided text regarding "acceptance criteria" (though not in the AI/SaMD sense) and how it's met:

The document states that "All finished products are tested and must meet all required release specifications before distribution."

Acceptance Criteria (as described for manufacturing release):

• Meeting "required release specifications"
• Conformance to "product design specifications"

Reported Device Performance / How Criteria are Met:

• "The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)."
• "The physical testing is defined by Quality Control Test Procedure documents."
• "These tests are established testing procedures and parameters which conform to the product design specifications."
• "The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's."

In essence, the "acceptance criteria" are the internal quality control and design specifications, and the "study" is the routine manufacturing testing and product release procedures, ensuring the device meets its established physical and visual standards. The document emphasizes substantial equivalence to predicate devices and adherence to GMPs.

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The SIMS Lumbar Puncture (LP) Kit is indicated for sampling of Cerebrospinal Fluid (CSF) and the measurement of CSF pressure as indicated in standard textbooks.

The SIMS LP Kits are intended to be used when Lumbar Puncture is performed to obtain a CSF specimen for diagnostic study when possible CNS infection is suspected, such as sepsis and/or meningitis. The procedure can also be used to measure intracranial pressure which can result from infection, tumor, hemorthage or edema. This technique is also used to lower intracranial pressure by CSF drainage. CSF pressure is measured prior to CSF sampling using a manometer.

The SIMS Lumbar Puncture (LP) Kit is available in adult or pediatric configurations. The kit includes the preparatory and procedural components to perform Lumbar Puncture. A manometer may be included with the kit, depending upon the kit selected.

The SIMS LP Kits with a manometer are used to measure cerebrospinal fluid pressure in centimeters of water (cm of H2O). The manometer consists of two calibrated sections of tubing with a connector welded to the upper portion of the tubing.

Lumbar puncture is performed with standard prep and procedural componentry, similar to those used in spinal anesthesia kits, with the addition of a two part manometer, a 3-way stopcock and 5 inches of small bore extension tubing for the measurement of intracranial CSF pressure.

This document, a 510(k) summary for the SIMS Lumbar Puncture (LP) Kit, explicitly states:

"There were no nonclinical or clinical tests performed with these kits."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria.

Consequently, I cannot provide information for the following points as no such data is present in the document:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
2. Sample sized used for the test set and the data provenance: No test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth established from experts for a test set.
4. Adjudication method for the test set: No test set means no adjudication method.
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: No MRMC study was performed, and this device is not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study was done for an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth established.
8. The sample size for the training set: No training set was used.
9. How the ground truth for the training set was established: No training set means no ground truth establishment for it.

The document does offer a "SUMMARY OF PERFORMANCE DATA" for the manometer component stating: "Performance testing of the proposed kits show the SIMS manometer performed equal to or better than the predicate manometer from Abbott, both for the range in accuracy and for the average variance in accuracy." However, it does not detail the methodology, sample size, specific acceptance criteria, or raw performance data for this comparison. It only states a general outcome of comparison with a predicate device.

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