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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.

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.

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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 (Duet EDMS) is a complete system for externally draining and monitoring cerebrospinal 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 or lumbar region and a catheter is inserted into patient's ventricle or the lumbar 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.

Here's a breakdown of the acceptance criteria and study information for the Medtronic Duet External Drainage and Monitoring System (EDMS), 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 document does not explicitly state the sample sizes used for the leakage and attachment tests. It refers to "the patient line and drip chamber subassembly" and "junctions" without specifying the number of units tested.

• Data Provenance: The document does not specify the country of origin of the data. It appears to be internal verification/validation testing conducted by Medtronic. The study is retrospective in the sense that the testing was conducted on samples of the device to verify design changes.

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

This information is not applicable as the described performance tests (leakage and attachment strength) are objective engineering tests rather than subjective evaluations requiring expert interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable for these objective performance tests. The results (Pass/Fail) are determined by direct measurement against pre-defined thresholds.

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 study described focuses on technical performance of device components rather than human reader accuracy or improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this is not an AI/algorithm-based device. The device is a physical external drainage and monitoring system. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used:

The ground truth for the performance tests were engineering specifications and measurable thresholds. For example, the "5-pound load" for junction attachment and the requirement to "withstand air pressure without causing leaks" serve as the objective ground truth against which device performance was measured.

8. The Sample Size for the Training Set:

This information is not applicable as there is no mention of a "training set" for an algorithm in this submission. The device is a physical medical device, not an AI/ML product.

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

This information is not applicable as there is no "training set" for an algorithm.

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The StrataMR II Valves and shunts are designed to provide continuous Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasively adjust valve pressure/performance level pre-and post-implantation by using magnetic adjustment tools without the need of radiographic confirmation.

The StrataMR™ II adjustable valves are single-use implantable devices which provide a noninvasive method to address changing patient needs in the management of hydrocephalus. The valves and their associated catheters drain cerebrospinal fluid (CSF) from ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. StrataMR™ II valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. Flow control is achieved, and retrograde flow is prevented by combined resistance of the ball and cone and siphon control diaphragm. Pre- and postimplantation, the performance level of the valve can be modified by StrataMR™ Adjustment Tools: Locator tool, guider tool, indicator tool and adjustment tool cleared under K181622.

The provided text is a 510(k) Summary for the Medtronic StrataMR™ II Valves and Shunts, submitted to the FDA. It details performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not describe a study involving an AI/Machine Learning device or a MRMC comparative effectiveness study involving human readers.

The document primarily focuses on bench testing and biocompatibility testing to show that changes in the device (specifically, the cap material and an additional tantalum marker) do not raise new safety or effectiveness concerns compared to the predicate device.

Therefore, many of the requested criteria, such as those related to AI model performance, human reader studies, ground truth establishment for training sets, and sample sizes for AI test sets, are not applicable to this submission.

Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not applicable:

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

The document provides a table titled "Performance Data – Bench" which outlines various tests, their summaries, and results. These results implicitly define the acceptance criteria, as all tests "met acceptance criteria."

Biocompatibility Testing:

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

This information is not applicable as the provided text describes bench and biocompatibility testing of a physical medical device, not an AI/ML system tested on a data set. The sample size for each bench or biocompatibility test would refer to the number of physical device units or animal subjects used, which is not explicitly stated for individual tests but is inherent in standard device testing protocols. No provenance for "data" in the context of AI is relevant here.

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 is not applicable. Ground truth, in the context of AI, refers to expert-labeled data for model training/testing. This document describes physical device testing against engineering and biological standards, not AI-based image analysis or diagnosis.

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

This is not applicable. Adjudication methods are used to establish ground truth from multiple human experts for AI model evaluation. Not relevant to this device submission.

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, a MRMC comparative effectiveness study was not done. This submission is for a physical medical device (shunt and valve), not an AI-assisted diagnostic tool.

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

This is not applicable. This describes a physical device, not an algorithm.

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

For the bench and biocompatibility tests, the "ground truth" or standard for acceptance is based on:

• Pre-established engineering specifications: For pressure, flow, strength, and durability tests.
• International standards (e.g., BS EN ISO 7197:2009, ASTM F2052-15, F2213-06, F2182-11a, F2119-07): For performance and MRI safety.
• Biocompatibility standards (e.g., ISO 10993-1): For biological safety tests in vitro and in vivo.

There is no "expert consensus" or "pathology" in the AI sense.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable.

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Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

The Medtronic StrataMR™ valves are implantable adjustable valves for the management of hydrocephalus. The valves and their associated catheters drain Cerebrospinal Fluid (CSF) from the ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. Before and after implantation, the pressure/flow characteristics of the Medtronic StrataMRTM valve can by modified by the StrataMR adjustment tool.

The original StrataMR adjustment tools, including handheld locator, and adjustment tool, are designed to allow the user to determine the pressure/performance level setting of StrataMR valves and adjust the setting when needed. In this 510(k) submission, Medtronic is proposing to add an additional component, guider tool, to the StrataMR adjustment tools, to improve the method to reliably adjust the StrataMR valve, cleared in K152700.

The provided text details the acceptance criteria and the study conducted for the Medtronic StrataMR™ Valves and Shunts (Guider Tool), specifically focusing on the addition of a new "guider tool" component.

Here's a breakdown of the requested information:

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

2. Sample sizes used for the test set and the data provenance

• Non-Clinical Test Set: 29 guider tools were used in conjunction with 29 StrataMR valves.
• Human Factors Test Set: 14 clinician users performed a total of 84 adjustment cycles (6 adjustments per evaluator).
• Data Provenance: Not explicitly stated regarding country of origin. The studies are described as "verification and validation testing" and "design validation study," indicating a prospective nature for the data generation; it was specifically generated to test the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Non-Clinical: The ground truth for this testing (e.g., whether the rotor foot was correctly positioned, whether the setting inadvertently changed) appears to be established through direct observation and measurement based on engineered specifications and worst-case scenarios, rather than expert interpretation of images or clinical outcomes. No specific "experts" for ground truth establishment were mentioned beyond the design and testing engineers/personnel.
• Human Factors: 14 clinician users served as "evaluators" performing the tasks. Their qualifications were described as "neurosurgical personnel (attending neurosurgeons, residents, physician assistants, or clinical staff) with experience managing StrataMR or Strata-type valves." They were the "users" in a simulated setting, and their ability to successfully manipulate the device constituted the "ground truth" for usability.

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

• No explicit adjudication method (like 2+1 or 3+1 for discordant reads) is mentioned for either the non-clinical or human factors testing. The non-clinical testing appears to be objective pass/fail against predetermined mechanical and functional criteria. The human factors study seems to rely on the direct performance of the evaluators.

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 or comparative effectiveness study involving human readers improving with AI assistance was performed. This device is a mechanical tool (guider tool for a shunt valve adjustment) and not an AI-assisted diagnostic or therapeutic system.

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

• Not applicable as this is a mechanical medical device, not an algorithm. The "standalone" performance would be equivalent to the non-clinical testing of the tool's mechanical function, which was indeed performed without human interaction, focusing on its ability to correctly guide the adjustment given various conditions.

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

• Non-Clinical: Engineering specifications and functional requirements (e.g., rotor foot correctly positioned in a well, no inadvertent change in setting). This is a functional/physical ground truth.
• Human Factors: Successful completion of the adjustment task by qualified users in a simulated environment. This is a usability/performance ground truth.

8. The sample size for the training set

• Not applicable. This device is a mechanical tool with no AI/ML component; therefore, there is no "training set."

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

• Not applicable, as there is no training set for this mechanical device.

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Durepair is indicated as a dura substitute for the repair of the dura mater.

Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.

The document describes the Durepair Dura Regeneration Matrix, a collagen implant for repairing dura mater defects. This is a 510(k) submission, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

Key Takeaway: The entire submission focuses on demonstrating that a manufacturing process change for the Proposed Durepair Device does not alter its fundamental technological characteristics, material, indications for use, or safety and effectiveness compared to the Predicate Durepair Device. Therefore, the "acceptance criteria" discussed are largely related to ensuring the proposed device performs comparably to the predicate across various physical, mechanical, and biological properties.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides "Table 2 – Summary of Bench Top Testing" and "Table 3 – Summary of Biocompatibility Testing" which directly address acceptance criteria and the performance of the Proposed Durepair device.

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The Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

The Medtronic StrataMR™ valves are implantable adjustable valves for the management of hydrocephalus. The valves and their associated catheters drain Cerebrospinal Fluid (CSF) from the ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. The Medtronic StrataMR™ valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. Flow control is achieved and retrograde flow is prevented by combined resistance of the ball and cone and siphon control diaphragm. Before and after implantation, the pressure/flow characteristics of the Medtronic StrataMR™ valve can by modified by means of a magnetic adjustment tool.

The provided document describes the Medtronic StrataMR™ Valves and Shunts and details the testing performed to demonstrate its substantial equivalence to a predicate device (Medtronic PS Medical Strata Type Valve (K060681)). The information focuses on bench testing and biocompatibility testing, rather than a study involving AI performance or human reader studies.

Therefore, many of the requested criteria regarding AI performance, human reader studies, and large-scale data sets (like training or test sets for AI) are not applicable to this device's submission and the testing described. The device is a physical medical device (a shunt valve), not a software or AI-driven diagnostic tool.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent/not applicable:

Analysis of Acceptance Criteria and Proving Device Performance

The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device. This means the acceptance criteria are largely tied to meeting performance benchmarks that are comparable to or better than the predicate, as well as showing the new design changes (primarily for improved MR resistance) do not introduce new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a summary of bench tests with their methods and results. The "acceptance criteria" are implied by the "Results" column stating "All valves met acceptance criteria," or by explicitly stating values (e.g., for biocompatibility).

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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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The Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus and may be used in the treatment of idiopathic intracranial hypertension (pseudotumor cerebri) when shunting is an option.

The Strata NSC Lumboperitoneal Valve and Shunt Systems are comprised of lumbar and peritoneal catheters, valves and accessories. The lumboperitoneal valve allows the physician to noninvasively adjust the pressure/flow performance level pre- and post-implantation using magnetic adjustment tools in order to address changing patient needs. The lumbar catheters are available in closed-tip and open-tip configurations and have length markers located at 5 cm intervals. A strain relief provides support to and lessens the potential of catheter kinking at the junction of the lumbar catheter to the valve and fixation tabs are provided to anchor catheters at the incisions.

Section {0} indicates that this 510(k) submission is for an expanded indication for the Medtronic Strata NSC Lumboperitoneal Valve and Shunt System to include the treatment of idiopathic intracranial hypertension (pseudotumor cerebri). The acceptance criteria and performance data described below relate to demonstrating that the device maintains its safety and effectiveness for this new indication.

1. Acceptance Criteria and Reported Device Performance

The provided text {1} states that "retrospective clinical review of data which includes prospective follow-ups is provided to demonstrate that physicians are able to palpate the valve, determine the direction of flow and to accurately read the pressure level setting using the StrataVarius device consistently with radiographic imaging verification when these shunt systems are used for lumboperitoneal applications."

Based on this, the implicit acceptance criteria relate to the consistency and accuracy of clinical assessment (palpation, flow direction, pressure level reading) of the device when compared to radiographic imaging verification. While specific metrics (e.g., percentage agreement, sensitivity/specificity) are not explicitly stated, the FDA's acceptance of the submission implies that the reported performance met their requirements for demonstrating substantial equivalence for the expanded indication.

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

The text mentions "a retrospective clinical review of data which includes prospective follow ups." However, the exact sample size used for this clinical review (test set) is not specified in the provided document.

Regarding data provenance, the study is a "retrospective clinical review... which includes prospective follow ups." This suggests a combination of retrospective data (likely patient records from previous implantations) and prospective data (follow-up observations on a subset of these or newly enrolled patients). The country of origin of the data is not specified.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth itself is stated as "radiographic imaging verification." This implies that the standard for comparison was consensus or interpretation of these images by presumably qualified medical professionals.

4. Adjudication Method for the Test Set

The document does not specify any explicit adjudication method (e.g., 2+1, 3+1). The ground truth is described as "radiographic imaging verification," suggesting that the radiographic findings served as the definitive reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section describes a medical device (a shunt system and valve for CSF management), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance was not performed and is not applicable in this context. The study focuses on the physicians' ability to clinically assess the device against radiographic verification, not on improvement with AI.

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

This is a medical device, not an algorithm. Therefore, a standalone algorithm performance study was not done and is not applicable. The performance data relates to the device's functionality (readability, adjustability, non-migration) and the ability of physicians to interact with it.

7. The Type of Ground Truth Used

The ground truth used for the clinical review was radiographic imaging verification. This implies that imaging studies (e.g., X-rays, CT scans) were used to objectively confirm the valve's setting, flow direction, or position, against which the physicians' clinical assessments were compared.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. The clinical review described is a performance evaluation, not a machine learning model development, so the concept of a training set as typically understood in AI is not directly applicable. The "retrospective clinical review" itself served as the evidence base.

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

Since there is no explicit "training set" as understood in machine learning contexts, the question of how its ground truth was established is not applicable. The evidence provided is for the device's clinical performance, with radiographic imaging serving as the objective standard for validation.

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The Medtronic ARES™ Antibiotic-Impregnated Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Medtronic ARES™ Antibiotic-Impregnated Catheters are manufactured using barium sulfate-filled silicone elastomer and are impregnated with clindamycin hydrochloride and rifampicin.

ARES Antibiotic-Impregnated Ventricular Catheter
The ARES ventricular catheter measures 23 cm in length, 0.13 cm in inner diameter, and 0.25 cm in outer diameter. Lengths are marked in 1 cm intervals starting from 3 cm to 15 cm from the catheter tip, thus enabling the surgeon to gauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 32 flow holes—four lines of eight holes spaced at 90° intervals around the catheter circumference. Components supplied with the ARES Ventricular Catheter include a pre-loaded stainless steel stylet and a Right Angle Clip, which is included to facilitate placement and use of the ventricular catheter.

ARES Antibiotic-Impregnated Peritoneal Catheter
The ARES peritoneal catheter measures 120 cm in length, 0.13 cm in inner diameter, and 0.25 cm in outer diameter. There are no length markers or wall slits on the catheter, and the tip is open ended. The catheter may be trimmed to the proper length.

This 510(k) summary describes the Medtronic ARES™ Antibiotic-Impregnated Catheters and their substantial equivalence to the BACTISEAL® Catheter. The submission primarily relies on non-clinical performance and biocompatibility data, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested elements pertaining to clinical studies, AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document primarily details non-clinical (bench and in-vitro/in-vivo animal) tests. Therefore, the concept of a "test set" in the context of clinical data or AI performance (which would typically involve patient cases) is not directly applicable.

• Bench tests: No specific sample sizes are provided within the summary for tests like performance testing or sterilization testing, although these would involve multiple units for validation.
• Biocompatibility tests: Sample sizes are implicit in the descriptions of animal studies (e.g., "All animals increased in weight" implies multiple animals were used, but specific numbers are not given for each test). The studies used Salmonella typhimurium and Escherichia coli tester strains, mice, and New Zealand White rabbits.
• Data Provenance: The data originates from internal testing conducted by Medtronic as part of their 510(k) submission. It's prospective in the sense that these tests were conducted specifically to support this submission. The origin is implied to be within controlled laboratory settings, likely in the US, given the submission is to the FDA.

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

Not Applicable. This submission relies on objective, measurable physical, chemical, and biological endpoints from non-clinical tests (bench, in-vitro, and in-vivo animal studies) rather than human expert interpretation of clinical data or images. Therefore, no experts were used to establish "ground truth" in the clinical AI sense.

4. Adjudication Method for the Test Set

Not Applicable. Since no human expert evaluation or clinical data interpretation was involved for establishing a "ground truth" or test set, no adjudication method was used.

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 submission is for a physical medical device (antibiotic-impregnated catheter) and does not involve AI algorithms or human reading of medical cases.

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

Not Applicable. This submission is for a physical medical device and does not involve an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" or reference standards used are established scientific and regulatory standards and validated test methodologies. These include:

• Engineering Standards: ISO 7197, ASTM 647-94 for performance.
• Sterilization Standards: ISO 17665.
• Pyrogen Standards: ANSI/AAMI/ST72.
• Biocompatibility Standards: ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and FDA Blue Book Memo, G95-1.
• Quantitative Measurements: Drug release kinetics (mg/day), Zone of Inhibition (mm), Drug content (weight %), mechanical strength (crush resistance).
• Biological Endpoints: Cytotoxicity (cellular response), Sensitization (immune response), Irritation (tissue reaction), Systemic Toxicity (organism-wide effects), Genotoxicity (DNA damage), Implantation responses (local tissue reaction in vivo).

Comparisons were also made directly against the predicate device (BACTISEAL® Catheter) for key performance characteristics to demonstrate "sameness."

8. The Sample Size for the Training Set

Not Applicable. This submission is for a physical medical device and does not involve AI algorithms that require a "training set."

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

Not Applicable. As there is no AI algorithm, there is no training set or ground truth for one.

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The Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus.

PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System are designed for diversion of cerebrospinal fluid (CSF) from the lumbar subarachnoid space into the peritoneal cavity.

The shunt's implantable components include:

• Strata NSC Lumboperitoneal Valve ●
• Lumbar Catheter, Closed Tip, Barium Impregnated .
• Lumbar Catheter, Open Tip, Barium Impregnated .
• Peritoneal Catheter, Small Lumen, Open End, Barium Impregnated .
• Strain Relief .
• Fixation Tabs .

The provided text is a 510(k) summary for the PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed information requested regarding acceptance criteria, specific device performance, study designs (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance), or training set details relevant to AI/ML device studies.

The text states: "Testing performed on the Strata NSC LP Valve and Shunt System verified that the system met the required specifications and acceptance criteria." but does not provide details about these specifications or the reported performance relative to them.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. This document is a regulatory submission for a traditional medical device, not an AI/ML powered device, and thus the requested information (e.g., number of experts, adjudication methods, training sets, MRMC studies, standalone performance) is not applicable or present in this type of submission.

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