(103 days)
The Duet EDMS is indicated for draining of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to:
- · Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative.
- · Monitor CSF chemistry, cytology, and physiology.
- · Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
- · Severe head injury
- · Subarachnoid hemorrhage graded III, IV, or V preoperatively
- · Reyes syndrome or similar encephalopathies
- · Hydrocephalus
- · Intracranial hemorrhage
- · 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 Medtronic Duet™ External Drainage and Monitoring System (Duet™ EDMS) is a complete draining and monitoring cerebrospinal system for externally fluid (CSF) and monitoring intracranial pressure (ICP). It can be used for both external ventricular and lumbar drainage.
The Duet™ EDMS is an external drainage and monitoring system that uses gravity to drain cerebrospinal fluid (CSF) from the patient's ventricles or lumbar space to an external drainage receptacle. The drainage flow of CSF into the Duet™ EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. The Duet's catheter is surgically attached to the patient before it is attached to the drainage system. An opening is made in the patient's skull lumbar region and a catheter is inserted into patient's ventricle or the lumbar or subarachnoid space. The catheter is then attached to the drainage system. The CSF or blood is drained and monitored until the patient is stabilized, the infection successfully treated, or a long-term drainage method is implemented.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Duet External Drainage and Monitoring System (EDMS)". It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information about an AI/ML-based device or a study involving human readers or ground truth established by experts/pathology.
The performance testing summarized in the document focuses on the physical and functional characteristics of the Duet EDMS (e.g., dimensional accuracy, torque strength, leak integrity, flow initiation pressure, and attachment strength) rather than diagnostic or prognostic accuracy of an AI model.
Therefore, many of the requested points, such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable and cannot be extracted from this document.
If you are looking for an example of an AI/ML-based medical device submission, this document is not suitable.
Despite the irrelevance of the document to AI/ML, I will attempt to frame the acceptance criteria and study as presented for this non-AI device:
Acceptance Criteria and Device Performance for Duet External Drainage and Monitoring System (EDMS)
The Duet External Drainage and Monitoring System (EDMS) is a non-AI/ML medical device. Its performance testing focused on demonstrating its physical and functional suitability for its intended use, rather than diagnostic accuracy or AI model performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the "Pass" results for each test. The study demonstrated that the device "passed" all these checks, indicating it met the pre-defined performance requirements for each test.
| Test Name | Acceptance Criteria (Implicit from "Pass" Result) | Reported Device Performance |
|---|---|---|
| Dimensional | Vertical/horizontal alignment of scale label, pressure scale lengths, patient line tubing ID/length, cord length, drainage path ID, and stopcock flow path diameter must meet specified dimensions. | Pass |
| Drip Chamber Graduations | Drip chamber graduations must show correct readings. | Pass |
| Main System Stopcock (MSS) Assembly Torque Applied to Arm of Stopcock | MSS assembly must withstand a specified peak torque without failure or detachment. | Pass |
| MSS Assembly Load Applied to Core of Stopcock Arm | MSS assembly must withstand a specified peak load without failure. | Pass |
| Clamp to I.V. Pole Attachment Strength | Clamp must securely attach to the I.V. pole. | Pass |
| Cord to I.V. Pole Attachment Strength | Cord and cord lock must maintain secure hanging of the system. | Pass |
| Drip Chamber to Back Panel Attachment Strength | Drip chamber/bag subassembly must securely attach to the panel. | Pass |
| Strength of Attached Junctions (Tubing to Luer) | Junctions of tubes to luer must be securely attached. | Pass |
| Bottom Cap to Stopcock Junction Torque | Stopcock/bottom cap bond must be secure. | Pass |
| Drip Assembly and Drainage Bag Vent Integrity | Drip assembly and drainage bag vent must withstand appropriate fluid pressures. | Pass |
| Tensile Strength of Drainage Bag Inlet Port | Drainage bag inlet port must exhibit sufficient tensile strength to failure. | Pass |
| Drainage Bag Seal Weld | Drainage bag must have no leaks. | Pass |
| Flow Initiation Pressure | Flow must initiate at a specified pressure for each drainage bag. | Pass |
| Drip Assembly Vent Test (Exposure of Vent to Blood Solution) | Drip assembly vent must allow drainage of blood and CSF flow with minimal resistance. | Pass |
| Drip Assembly Vent Integrity | Drip assembly vent must allow fluid withdrawal without compromising mechanical integrity. | Pass |
| Leakage of UV-Cure Bonds | No leakage from UV-cure bonds between patient line and drip chamber subassembly. | Pass |
| Leakage of Drainage Bag | Drainage bag must withstand inversion without leaking. | Pass |
| Drip Chamber Volume | Drip chamber fluid weight must be verifiable. | Pass |
| Attachment of I.V. Pole and Position of Adjustable Drip Chamber | Clamping thumbscrews and cord locks must not slip from initial positions. | Pass |
| Leakage of UV Cure Bonds (Air Pressure) | UV-cure bonds must withstand air pressure without leaks. | Pass |
| Attachment of Junctions (Axial Load) | Junctions must withstand a minimum 5-pound axial load. | Pass |
| Bottom Cap to Stopcock Junction Torque | Stopcock/bottom cap bond must withstand specified torque. | Pass |
| Hydrophobic Microbial Barrier Vent on the Drainage Bag | Material must demonstrate 99.9% Bacterial Filtration Efficiency (BFE). | Pass |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not specify the quantitative sample size for each individual performance test (e.g., number of devices tested for each parameter). It only states that "Testing demonstrated the performance of the device."
- Data Provenance: The document does not provide details about the country of origin of the data or whether the testing was retrospective or prospective in the context of patient data. The tests described are laboratory-based engineering performance tests conducted on the physical device.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The "ground truth" for these tests relates to engineering specifications and physical measurements, rather than clinical interpretation requiring expert consensus.
- Qualifications of Experts: Not applicable. Testing was likely conducted by engineers or technicians involved in product development and quality assurance, following established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests involve objective measurements and physical properties, which typically have clear pass/fail criteria based on engineering specifications, not subjective interpretation requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the clinical performance of diagnostic or AI-assisted interpretation systems, which is not the function of the Duet EDMS.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: No, a standalone performance study was not done. The Duet EDMS is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the performance tests was based on engineering specifications, design requirements, and established physical measurement standards. For example, a dimension must be within a certain tolerance, a torque value must exceed a minimum, or a seal must not leak.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning; therefore, there is no "training set."
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this non-AI device.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).