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Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

1. Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative;
2. Monitor CSF chemistry, cytology, and physiology;
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
   Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
4. Severe head injury
5. Subarachnoid hemorrhage graded III, IV. or V preoperatively
6. Reyes syndrome or similar encephalopathies
7. Hydrocephalus
8. Intracranial hemorrhage
9. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
   Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:

1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
   The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
   The main system section located on the mounting panel includes:
3. Mounting bracket for height adjustment of system
4. Optional self-adjusting cord with lock for adjustment of system height
5. Main system stopcock with optional transducer attachment location
6. Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking bracket
7. Two drainage line slide clamps for flow monitoring and sampling
8. Drainage bag connection line
9. Needleless Injection Site (Interlink or Smartsite)
10. Instructions for Use
    The system does not contain any latex components.

Here's an analysis of the acceptance criteria and supporting study for the Becker External Drainage and Monitoring System, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each specific bench test. However, the testing was conducted as part of the design verification process for a modified component (the disposable drainage bag) within the Becker EDMS. The data provenance is from bench testing, which is a controlled laboratory environment, not derived from human patients or specific geographical regions.

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

This information is not applicable as the studies were bench tests evaluating physical properties and functional performance against engineering specifications, not clinical outcomes requiring expert interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were bench tests against predetermined engineering specifications, not studies involving subjective interpretation of data that would require an adjudication method.

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 device is a physical medical device, not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.

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

This information is not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests was based on engineering specifications and design requirements for the physical properties and functional performance of the modified drainage bag.

8. The Sample Size for the Training Set

This information is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."

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

This information is not applicable. There is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device is the "Becker External Drainage and Monitoring System" (Becker EDMS), with specific modifications to its disposable drainage bag component. The study proving the device meets acceptance criteria was a series of "Performance Data - Bench" tests.

The modifications to the disposable bag primarily involved changes in its design (approximate volume capacity of 600ml with approximate volumetric markings in 50mL increments, an inlet port, an outlet port, and a hydrophobic/anti-microbial vent).

The performance testing was conducted in accordance with a risk assessment of these changes, which determined that dimensional verification and design verification testing of the bag were necessary. The specific tests performed included:

• Visual and Dimensional Inspection: To ensure the printed graduations met volumetric capacity.
• Leakage of Drainage Bag: To confirm the bag could withstand inversion without leaking.
• Flow Initiation Pressure: To record the pressure at which fluid flow begins.
• Drainage Bag Seal Weld: To ensure the bag's seals were intact and leak-free.
• Tensile Strength of Drainage Bag Inlet Port: To evaluate the durability of the connection point.

The results of all these bench tests showed that the Becker EDMS device met the specified acceptance criteria for each test. Based on these successful results, the manufacturer concluded that the changes introduced by the modified disposable bag do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence to the predicate device (Medtronic PS Medical Becker External Drainage and Monitoring System, K984053).

No animal or clinical testing was deemed necessary for these specific modifications, as the determination of substantial equivalence was based solely on the design verification bench testing.

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The DUET™ EDMS is indicated for temporary draining and monitoring of cerebrospinal fluid (CSF) flow from the lumbar subarachnoid space in:

• 1. Patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery.
• 2. Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

The Medtronic DUET™ External Drainage and Monitoring System (EDMS) that is the subject of this De Novo request is designed to drain and monitor cerebrospinal fluid (CSF) from the lumbar subarachnoid space.
The DUET™ EDMS consists of the following: a green-striped patient connection line (pressure tubing) with an inner diameter of 0.075 ± 0.005 inches, an outer diameter of 0.124 ± 0.003 inches, and a total length of 60 inches (9), a patient line stopcock (10), a main system stopcock (8) that may be attached at two locations on the main panel, a drip chamber (4) with a drip chamber stopcock (5), a rotatable pressure scale (3), three latex-free needleless injection/CSF sampling sites (Figure 1b (IS-5), (IS-10) and (IS-11)) and a removable drainage bag (7) with approximate volumetric graduations and a hydrophobic microbial barrier air vent. There is a pole mount clamp (6) and a cord (12) with a cord lock (13) to enable independent suspension of the system, or to provide additional security when using the pole clamp as identified in Figure 1 below. It should be noted that the numbers in parentheses correspond with the numbers in Figure 1.
The DUET™ EDMS are not long-term implants but are intended for limited external drainage of CSF. The drainage flow of CSF into the DUETTM EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. During use, an external lumbar catheter inserted into the lumbar subarachnoid space is connected to the DUET™ EDMS patient connection line. The CSF drains through the catheter, into the patient connection line and into the graduated drip chamber. CSF collects in the drip chamber, exits the bottom of the chamber via another connection line and is collected in a drainage bag. In the event that the patient may require administration of fluid directly into the lumbar subarachnoid space or CSF sampling is required, the DUET™ EDMS features injection/CSF sampling ports integrated into the patient connection line. The DUET™ EDMS is completely disposable. The DUET™ EDMS is recommended for use with the Clear-Site™ Laser Level (cleared under K984053) that is provided separately.

The provided document describes the Medtronic Neurosurgery DUET™ External Drainage and Monitoring System (EDMS), a device intended for temporary draining and monitoring of cerebrospinal fluid (CSF) flow. The document does not describe an AI/ML powered device, and therefore does not contain information on acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC), nor does it have a study comparing human readers with and without AI assistance (MRMC study).

Instead, the document focuses on the safety and performance of a medical device through biocompatibility, shelf-life, and performance bench testing, along with a review of existing clinical literature to support its intended use.

Here's a breakdown of the requested information based on the provided text, adapted to the nature of the device:

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

The document provides extensive tables for biocompatibility and shelf-life testing, and a list of performance testing - bench. Since there are many individual tests within these categories, I will present a summary table derived from them. Each of these tests had specific acceptance criteria and the document explicitly states that the device "passed" or "meets requirements" for all of them.

• Sensitization: Meets ISO 10993-1 requirements (Non-Sensitizer).
• Intracutaneous Reactivity: Meets ISO 10993-1 requirements (Non-Irritant).
• Acute Systemic Toxicity: Meets ISO 10993-1 requirements (No Acute Systemic Toxicity, Biocompatible Materials). | All tests passed: Non-Cytotoxic, Non-Sensitizer, Non-Irritant, No Acute Systemic Toxicity, Biocompatible Materials. |
  | Shelf-Life/Sterility| - Functional and Package Integrity Testing: Maintain secure connections (e.g., MSS assembly, clamp, drip chamber, junctions) under specified torque/load.
• Vent Integrity: Withstand 150 mm Hg fluid pressure; allow fluid withdrawal without compromising mechanical integrity; allow drainage of blood/Ringer's solution; provide CSF flow with minimal resistance.
• Leakage: Bonds to withstand 200 mmHg air with ; non-pyrogenic.
• Packaging: Secure, undamaged, and meet specifications after simulated shipping. | All shelf-life testing, including functional and package integrity, passed acceptance criteria after 3 years and one month of real-time aging and EO sterilization. Device achieved SAL of 10⁻⁶, met endotoxin limits, and was non-pyrogenic. Packaging integrity was maintained. |
  | Performance Testing | - Dimensional measurements within specifications.
• Mechanical Strength: MSS assembly, clamp, cord, drip chamber attachment, junctions, bottom cap bond to withstand specified forces/torques.
• Vent Functionality: Ensure proper fluid pressure withstand, blood solution drainage, and minimal CSF flow resistance.
• Leakage: UV-cure bonds and drainage bag to show no leakage under specified conditions.
• Flow Initiation Pressure within limits.
• Drip Chamber: Verify fluid weight and proper volume.
• Hydrophobic Microbial Barrier Vent: Demonstrate 99.9% Bacterial Filtration Efficiency (BFE). | All "Performance Testing - Bench" 항목 had specific test methods and the document states the DUET™ EDMS "was tested and passed" all of them. Specific quantitative results are not provided for each test in the summary. |

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

• Bench Testing (Biocompatibility, Shelf-Life, Performance): The sample sizes for each specific test (e.g., number of devices, number of material samples) are not explicitly stated in the provided text. The data provenance is internal testing conducted by Medtronic (the manufacturer).

• Clinical Literature:

  • "Coselli et al." (2002): 145 subjects. Prospective, randomized study.
  • "Estrera et al." (2001): 148 subjects. Retrospective study.
  • "Estrera et al." (2005): 238 subjects in adjunct group, 62 subjects in "other" groups (12 CSF drainage alone, 34 DAP alone, 16 neither). Retrospective study.
  • "Safi et al." (2003): 1004 subjects (741 in adjunct group, 263 in non-adjunct group). Retrospective study.
  • "Svensson et al." (1998): 17 subjects in treatment group, 16 subjects in control group. Randomized, prospective study.

  The countries of origin for these clinical studies are not explicitly stated, but are likely in countries with advanced surgical capabilities (e.g., USA, Europe), based on the typical publication venues for such medical research.

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)

This question is not applicable in the context of this device and study. The "ground truth" for the bench testing is established by engineering standards and measurement accuracy, not by human expert assessment. For the clinical literature review, the "ground truth" refers to patient outcomes and diagnoses reported by medical professionals in those studies, determined by standard clinical practice in those contexts. The number and qualifications of experts involved in establishing those clinical outcomes are not detailed in this document.

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

Not applicable. The bench tests are objective measurements against defined standards, not subjective assessments requiring adjudication. The clinical studies cited were clinical trials or retrospective reviews, not studies involving adjudication of a test set for this specific device.

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

Not applicable. This is not an AI/ML device, and no MRMC study was performed or is relevant to its evaluation.

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

Not applicable. This is not an AI/ML device. The device's performance is standalone in the sense that it functions mechanically and physically as designed, but it always requires a human in the loop for its operation, monitoring, and interpretation of its output (e.g., CSF pressure readings).

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

• Bench Testing (Biocompatibility, Shelf-Life, Performance): The "ground truth" is based on pre-defined engineering specifications, international/national standards (e.g., ISO, ASTM, USP), and objective measurements (e.g., torque, load, pressure, leakage volume, dimensional measurements).
• Clinical Literature: The "ground truth" for the effectiveness section is patient outcomes data (e.g., incidence of spinal cord injury, neurological deficit rates) collected in the cited clinical studies, as diagnosed and managed by the clinical teams in those studies.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for this device.

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