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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 Libertís™ Shunt Catheter includes a ventricular and distal (peritoneal) drainage catheter that are used as part of a cerebrospinal fluid (CSF) shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system. The ventricular catheter diverts excess CSF from the ventricles of the brain through the valve. After passing through the valve, the excess CSF is drained through the distal catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters have Endexo® polymer, a surface modifying macromolecule, blended into their base silicone. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. The Libertís™ Shunt Catheter has been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have ink markings on the silicone tubing to aid in positioning of the catheter.

The catheters are packaged with two accessories, a stylet and a right-angle adapter. The stylet is used to help introduce the ventricular catheter into the brain's ventricles. The right-angle adapter is used to fixate the ventricular catheter to the cranium.

This document is a 510(k) clearance letter for a medical device, specifically a shunt catheter. It does not describe an AI medical device or software. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility testing, rather than performance studies of an AI algorithm.

However, I can provide the acceptance criteria and performance information that is present in the document, which pertains to the physical and biological characteristics of the shunt catheter.

Acceptance Criteria and Device Performance (for the physical device, not an AI algorithm):

Since the provided document is for a medical device (shunt catheter) and not an AI/software device, the questions related to AI-specific criteria (e.g., sample size for test/training sets of AI, expert adjudication, MRMC studies, standalone algorithm performance, type of ground truth for AI) are not applicable.

The acceptance criteria here refer to the performance of the physical device as demonstrated through various bench and biocompatibility tests. The document states that all tests were "Pass," implying that the device met the pre-defined acceptance criteria for each test.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify general "sample sizes" in terms of patient data or typical "test sets" as one would for an AI model. Instead, it refers to "production equivalent devices" used for the various bench and biocompatibility tests. The specific number of devices or replicates for each test is not detailed.
• Data Provenance: The data is generated from laboratory studies and bench testing performed on the physical device. This is not clinical patient data. The provenance for this type of testing is typically the manufacturer's internal testing facilities or contract labs. No country of origin for data or retrospective/prospective nature is applicable as this is not patient data.

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

• Not applicable. This pertains to an AI/software device. The "ground truth" for a physical device is established by objective measurements and standardized test methods, not expert consensus on data interpretation.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• Not applicable. This pertains to an AI/software device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, not applicable. This pertains to an AI/software device evaluating human reader performance.

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

• No, not applicable. This pertains to an AI algorithm; the device is a physical shunt catheter.

7. The Type of Ground Truth Used

• For the performance bench tests and biocompatibility tests, the "ground truth" is defined by established international (ISO, ASTM) and FDA-recognized consensus standards, as well as pre-defined internal test methods and specifications. For instance, a "Pass" for biocompatibility means the device met the criteria specified in the relevant ISO 10993 standards. For thrombogenicity, the ground truth was a statistically significant reduction in thrombus deposition compared to the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This pertains to an AI/software device. No training set is involved for validating a physical medical device.

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

• Not applicable. This pertains to an AI/software device.

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The Codman Libertís™ EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

The Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology (LibertísTM EVD Catheters) include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid (CSF). The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. Additionally, LibertísTM EVD Catheters contain an Endexo® polymer additive; a surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains a barium sulfate stripe for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.

The provided document is a 510(k) clearance letter from the FDA for a medical device (Codman Libertís™ EVD Catheter). It describes the device, its intended use, a comparison to a predicate device, and summaries of nonclinical testing.

However, the question asks for details related to acceptance criteria and studies that prove a device meets acceptance criteria, specifically those typically associated with AI/software medical devices. This document does not describe an AI/software medical device; it describes a physical medical device (a catheter for draining CSF). Therefore, much of the information requested in the prompt, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case (MRMC) study," "standalone performance," "training set size," and "how ground truth for training set was established," are not applicable to this type of device and are not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility, and sterilization validation, which are standard for physical medical devices.

Here's an attempt to answer the applicable parts of your request based on the provided text, and explicitly state where information is not available or not applicable.

Description of Acceptance Criteria and Proving Device Meets Criteria

The Codman Libertís™ EVD Catheter is a physical medical device. Its acceptance criteria are primarily demonstrated through a battery of nonclinical performance bench tests, biocompatibility testing, and sterilization validation, to show that it is substantially equivalent to a legally marketed predicate device. The performance criteria are generally considered a "Pass" or "Fail" based on established standards and internal methods.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria values but rather states a "Pass" or "Fail" for each test. The acceptance criterion for each test is implicitly that the device performs as expected according to the specified standard or internal method.

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

The document states, "All testing was performed on production equivalent devices." However, it does not specify the sample size for any of the individual bench tests.

Data provenance (e.g., country of origin of the data, retrospective or prospective) is not applicable in the traditional sense for these bench tests, which are conducted in a laboratory setting to evaluate physical properties and performance characteristics.

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

This concept is not applicable to this type of medical device (physical catheter). "Ground truth" in this context would refer to established engineering standards, material specifications, and validated test methods, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

This concept is not applicable to this type of medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers (e.g., radiologists) to resolve disagreements in interpretation, which is not relevant for bench testing of a physical 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

No MRMC comparative effectiveness study was done, as this is a physical medical device (catheter), not an AI/software device. Therefore, this question is not applicable.

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

This concept is not applicable since the device is a physical catheter, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests of this physical device consists of:

• Established industry standards (e.g., ASTM F647, ISO 7197, ASTM F2503, ISO 10993-1, ASTM F1980, ISO 11607-1).
• Internal predefined functional and mechanical specifications.
• Validated laboratory methods for chemical content, antimicrobial efficacy (Zone of Inhibition), and sterility assurance (SAL 10-6).
• Usability requirements for the Summative Usability Study.

8. The sample size for the training set

This concept is not applicable as this is a physical medical device, not an AI/software device that would involve a "training set."

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

This concept is not applicable for the same reason as above.

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The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).

The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days.

There are two types of external CSF drainage catheters:

• Ventricular catheters
• Lumbar catheters

The catheter is provided sterile and with accessories to facilitate the surgical procedures and connectors. The external CSF drainage catheters need to be connected to collection systems.

The provided FDA 510(k) clearance letter and summary discuss the "External CSF Drainage" device. However, this document does not contain information related to a study proving the device meets specific performance acceptance criteria in the context of medical imaging or AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical, clinical, and biological safety comparisons, along with non-clinical bench testing. It does not describe a study involving human readers, AI assistance, ground truth establishment, or specific diagnostic performance metrics (like sensitivity, specificity, AUC) that would typically be associated with performance acceptance criteria for an AI or imaging device.

Therefore, I cannot fulfill the request to provide:

• A table of acceptance criteria and reported device performance specific to diagnostic accuracy or AI performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document details bench testing performed, which validates physical and mechanical properties of the device, but not its performance in a clinical diagnostic or AI-assisted setting.

The information available regarding acceptance criteria and testing from the provided document is as follows:

Acceptance Criteria (Implicit from Bench Testing):

Study Details from the document (focused on Substantial Equivalence and Bench Testing):

• Sample size used for the test set and the data provenance: Not applicable for diagnostic performance metrics. Bench testing was performed on "representative samples" of the product line. No information on data provenance (e.g., country of origin, retrospective/prospective) is associated with these bench tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench tests typically involves direct measurement against engineering specifications.
• Adjudication method: Not applicable for bench testing.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI/algorithm-driven device for diagnosis.
• The type of ground truth used: For the bench tests, the "ground truth" would be the engineering specifications and established test methodologies (e.g., ISO standards) for physical and material properties. For biocompatibility, established ISO standards and toxicological assessments.
• The sample size for the training set: Not applicable (not an AI/ML device).
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document from the FDA is for a physical medical device (External CSF drainage catheters) and demonstrates its safety and effectiveness through substantial equivalence to existing devices and extensive bench testing of its physical and material properties. It does not describe a study involving AI, image analysis, or human reader performance, and therefore, cannot provide the information requested for such types of studies.

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Phasor EVAC™ is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The EVAC system is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

Phasor EVAC™ subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the EVAC system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir.

This 510(k) clearance letter for the EVAC device (K243205) indicates that it is a central nervous system fluid shunt and components and it's regulated under 21 CFR 882.5550. While the letter confirms the device's substantial equivalence to predicate devices and states that various tests were conducted, it does not provide detailed information about specific acceptance criteria, study methodologies (like sample size, ground truth establishment, expert qualifications, or MRMC studies), or actual performance data in the format requested.

The document primarily focuses on explaining why the device is considered substantially equivalent to existing devices based on its intended use, indications for use, and technological characteristics. It mentions that "Various tests including for biocompatibility, packaging, sterility, safety, and performance were conducted and passed successfully," and that "testing for a closed system with firm purchase into bone was established and verified by testing." However, it does not disclose the specific data or criteria for these tests. It explicitly states, "No clinical testing was needed or performed otherwise."

Therefore, based on the provided FDA 510(k) clearance letter, I cannot populate the detailed table and answer all the specific questions about acceptance criteria and study proving device performance as requested, because this information is typically contained in the actual 510(k) submission, not the clearance letter itself. The clearance letter summarizes the FDA's decision, but not the detailed technical data from the submission.

Here's what can be inferred or explicitly stated from the provided document, with notes where information is not present:

Acceptance Criteria and Device Performance (Based on Inferred Safety and Effectiveness)

The acceptance criteria for a 510(k) cleared device are implicitly that it demonstrates substantial equivalence to a predicate device, meaning it is as safe and effective while having the same intended use. For this device, the "performance" described is its ability to meet the design intent and demonstrate equivalence through bench testing, rather than clinical efficacy.

Table 1: Inferred Acceptance Criteria and Reported Device Performance

Study Details (Based on Available Information)

1. Sample size used for the test set and the data provenance:

   • The document states "No clinical testing was needed or performed otherwise." This indicates that the "test set" for demonstrating substantial equivalence was primarily based on bench testing and engineering evaluations of the device components and system.
   • Specific sample sizes for these bench tests are not provided in the clearance letter.
   • Data provenance (country of origin, retrospective/prospective): Not applicable or specified for bench testing.

2. 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):

   • Given that "No clinical testing was needed or performed," there's no mention of expert panels establishing ground truth in a clinical context. The "ground truth" for the engineering tests would be derived from accepted engineering standards and specifications.

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

   • Not applicable, as no clinical study or human reader evaluation requiring adjudication was performed.

4. 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, an MRMC comparative effectiveness study was not done. The device is a surgical system (shunt and components), not an AI-assisted diagnostic tool.

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

   • This question is more pertinent to software/AI devices. The EVAC system is a mechanical device. Its "performance" refers to its physical functioning (e.g., maintaining a closed system, firm purchase into bone), not an algorithmic output. The "Phasor Drill" component is explicitly stated to have been previously cleared (K161704), indicating its standalone performance was established previously.

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

   • For this device, the "ground truth" for its functional performance was based on engineering specifications, material science standards, and mechanical testing requirements (e.g., ability to form a "closed system with firm purchase into bone"). There's no mention of clinical ground truth (like pathology or outcomes data) because no clinical study was performed.

7. The sample size for the training set:

   • Not applicable. This is a hardware device, not an AI/machine learning algorithm requiring a "training set."

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

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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 XABO Catheters are used for cerebrospinal fluid (CSF) shunting.

The XABO Catheters are manufactured using barium sulfate fillcone elastomer and are impregnated with clindamycin hydrochloride and rifampicin designed to be released over time from the exterior and inner lumen surface once implanted.

The XABO Ventricular Catheters will be offered in 18 cm in length with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. Lengths are marked in 1 cm intervals starting from the catheter tip, thus enabling the surgeon to qauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 16 flow holes around the catheter circumference.

Components supplied with the XABO Ventricular Catheter include a pre-loaded stainless steel stylet and depending on the confiquration may contain a deflector.

The XABO Peritoneal Catheters measure 60 cm or 120 cm in length, 1.2 mm in inner diameter, and 2.5 mm in outer diameter. There are no length markers or wall slits on the tip is open ended. The catheter may be trimmed to the proper length.

The XABO Catheters are designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System. Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System miniNAV valve, and the Miethke Shunt System (DSV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K110206/K030698/K011030).

The provided text focuses on the 510(k) premarket notification for the XABO Ventricular Catheter, XABO Peritoneal Catheter, and XABO Catheter Set. It primarily addresses the substantial equivalence of these devices to existing predicate devices. While it mentions performance bench testing and specific tests performed, it does not explicitly state specific acceptance criteria values or detailed study results that would allow for a complete fill of the requested table.

The document indicates that the devices were tested against "performance specifications" and that the results "confirm that the XABO Catheters meet performance specifications." However, the exact numerical or qualitative specifications themselves are not provided.

Therefore, the following information is extracted directly from the provided text, and where information is not explicitly stated, it is noted as "Not explicitly stated in the provided text."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The phrase "All testing was performed on the worst-case final finished device" could imply a limited number of samples, but a specific number is not given.
• Data Provenance: The studies are described as "Performance bench testing" and "Biocompatibility testing," suggesting laboratory-based testing, not human-patient data. The country of origin of the data is not specified. It is laboratory research, not retrospective or prospective patient data.

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

• Not applicable as the testing described is bench testing and biocompatibility, not studies requiring expert interpretation of clinical data for ground truth.

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

• Not applicable for the types of tests described (bench testing, biocompatibility).

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, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence through bench and biocompatibility testing, not AI-assisted human reading.

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

• Not applicable. This device is a physical medical device (catheter), not an algorithm or AI system.

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

• For performance bench testing, the "ground truth" would be the pre-defined engineering specifications and standards (e.g., ISO 7197) that the device must meet.
• For biocompatibility testing, the "ground truth" is compliance with international standards (ISO 1099-1) and FDA guidance, ensuring that the device's biological interactions are within acceptable limits.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device that requires a training set and ground truth establishment.

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The EVAC is indicated to facilitate the evacuation of a chronic or subacute hematoma or hygroma in the cranium. The EVAC is intended for draining of fluid accumulated in the subdural space, including chronic or subacute hematomas and hygromas. The EVAC is also intended for removing air and fluid from the subdural space following open surgical procedures to remove subdural collections.

The Borvo EVAC System is intended for the drainage of subdural fluid accumulations. The EVAC System is designed to gradually drain fluid to an external reservoir by creating a low negative pressure in the subdural space. It consists of 3 components:

• 1. EVAC Port (Ergo or Classic)
• 2. Tubing
• 3. Vacuum bulb
     An optional Cranial Access Kit can be purchased with the EVAC System, or a commercially available Cranial Access Kit with a 5.31mm drill bit can be used.

The provided text is a 510(k) premarket notification letter and summary for the Borvo EVAC System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not include information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical performance or software validation reports for AI/ML-driven devices.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

• Same intended use.
• Similar technological characteristics (with detailed comparisons of materials, dimensions, etc.).
• Performance data from non-clinical testing.

Therefore, I cannot provide the requested information about acceptance criteria, device performance against those criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The "Performance Data" section (Section 1.7 on page 3 of 4) lists the types of non-clinical testing performed, such as:

• Dimensional
• Tensile
• Pull-Out Force
• Simulated Use
• Sterile Barrier/Packaging Testing
• Shelf Life
• Biocompatibility (ISO 10993-1)

These tests are typically used to demonstrate the physical and biological safety and performance of a medical device, but they are not related to an AI/ML algorithm's analytical or clinical performance requiring ground truth, expert review, or statistical performance metrics.

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The Bactiseal Catheters are indicated 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 Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

The Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter include a ventricular and/or distal (peritoneal) drainage catheter that are used as part of a CSF shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system, which is then implanted in the patient's brain. The ventricular catheter diverts the excessive CSF from the ventricles of the brain through the valve. After passing through the valve, the excessive CSF is drained through the distal (peritoneal) drainage catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Bactiseal silicone catheters have been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have tantalum "dots" incorporated onto the silicone tubing to aid in positioning of the catheter. The Bactiseal Catheters and Bactiseal Endoscopic Ventricular Catheter are made of radiopaque silicone tubing, and the Bactiseal Barium Striped Catheters are made of clear silicone tubing with radiopaque striping. The Bactiseal Endoscopic Ventricular Catheter has a slit in the tip of the ventricular catheter in order for the catheter to be placed with the use of an endoscope.

This document is a 510(k) summary for modifications made to existing Bactiseal Catheters, Bactiseal Barium Striped Catheters, and Bactiseal Endoscopic Ventricular Catheters. The modifications primarily involve updates to MRI labeling and a change in the supplier of clindamycin hydrochloride.

Therefore, the submission focuses on demonstrating that these modifications do not introduce new questions of safety or effectiveness, rather than proving the initial efficacy of an entirely new device. This means that a conventional study with specific acceptance criteria, test sets, expert adjudication, and detailed ground truth establishment as typically seen for entirely new AI/CADe devices, is not applicable in this context. The document relies on bench testing and an equivalency assessment to the predicate devices.

Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not applicable" due to the nature of this 510(k) submission:

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

Explanation of Implied Acceptance Criteria: The document states that the testing "utilized well-established methods, including those from FDA consensus standards." For a "Pass" result in such tests, the device must meet the specific criteria outlined in those standards. For drug equivalency and effectiveness, the stated goal is to confirm the new supplier's clindamycin hydrochloride is "equivalent" and "continues to meet the same drug specifications" and efficacy. The biocompatibility assessment "determined that the introduction of the new supplier for clindamycin hydrochloride does not introduce any new issues."

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

• Sample Size for Test Set: Not specified. The document indicates "All testing was performed on production equivalent devices," but the number of devices or units tested for each benchmark is not provided.
• Data Provenance: Not applicable in the context of clinical data. The tests are benchtop performance tests. The specific labs or countries where these bench tests were conducted are not mentioned.

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)

• Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring expert-established ground truth.

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

• Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring adjudication.

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/CADe device.

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

• Not applicable. This is not an AI/CADe device.

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

• Not applicable in the conventional sense. The "ground truth" for the bench tests would be the established scientific and engineering principles, and the specifications of the predicate device/original drug, against which the modified device's performance is compared. For example, the ground truth for MRI safety is defined by the ASTM standards.

8. The sample size for the training set

• Not applicable. This is not an AI/CADe device, and no training set is mentioned or implied for its development or evaluation.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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The Bactiseal EVD Catheter and Bactiseal Clear EVD Catheter sets are indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

The Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid. The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains barium sulfate for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.

The provided document, K233448, is an FDA 510(k) clearance letter for the Integra LifeSciences Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set. Based on the content of this letter, the device in question is a physical medical device (catheter) and not an AI/software device.

Therefore, the request for information related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics (such as multi-reader multi-case studies, ground truth establishment for training/test sets, sample sizes for image data, and expert adjudication), is not applicable to this document.

The document describes the changes made to an existing device (Bactiseal EVD Catheter Sets) as:

• Labeling changes: Updating MRI labeling to state MR Safe and administrative updates/harmonized symbols.
• New supplier for clindamycin hydrochloride: The antimicrobial impregnated into the catheter.

The studies mentioned are non-clinical (bench testing and engineering analysis) to demonstrate equivalence to the predicate device despite these changes.

Here's a summary of the relevant "acceptance criteria" and "study that proves the device meets the acceptance criteria" as described in the document for this non-AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in terms of number of units tested, but it refers to "production equivalent devices" for performance testing.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This pertains to an AI/software device requiring human expert annotation/ground truth. For this catheter, the "ground truth" is adherence to established industry standards (USP) and internal test methods for drug performance and other material characteristics.

4. Adjudication Method for the Test Set:

• Not applicable. This pertains to clinical data review for AI/software devices. Testing was based on established laboratory methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, not applicable. This type of study is for evaluating observer performance with and without AI assistance for clinical interpretations. The current device is a physical catheter, not an AI diagnostic tool.

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

• No, not applicable. This applies to AI/software performance.

7. The Type of Ground Truth Used:

• For drug equivalency and effectiveness: USP standards and monograph, internal test methods.
• For biocompatibility: Assessment against known materials and established literature/standards.
• For physical characteristics: Engineering analysis and comparison to predicate device specifications.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML product.

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

• Not applicable. There is no "training set" or need for ground truth establishment in this context.

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The use of IRRAflow Active Fluid Exchange System is intracranial pressure monitoring is required, and for externally draining intracranial fluid, as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed.

The IRRAflow® Active Fluid Exchange System (AFES) is an intracranial pressure (ICP) monitoring and drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care. The drainage flow of cerebrospinal fluid (CSF) into the IRRAflow Catheter is uni-directional and gravity-driven; there is no recirculation of the CSF. A parallel line from the saline infusion bag is used in case clearance at the tip of the catheter is required. The IRRAflow Tube Set has a cassette that clicks on to the IRRAflow Control Unit and aligns the tubing against a peristaltic pump and pinch valve. The IRRAflow Drainage Collection System is attached to the Control Unit, using the Laser Leveler for defining the height of the Drainage Collection System relative to the catheter's tip position in the patient's head. This positioning is used for controlling the speed of drainage. The tubing and catheter can be disconnected and connected by standard Luer-Lock connectors. Settings can be changed via the user interface on the Control Unit. The default mode provides drainage and measuring ICP, allowing bolus injections when indicated. The bolus injections allow the catheter to be flushed when it becomes clogged. CSF or intracranial fluid samples can be taken from the Drainage Collection System.

The provided text is a 510(k) premarket notification decision letter from the FDA regarding the IRRAflow Active Fluid Exchange System (AFES). The purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, specifically regarding changes to the Tube Set and Drainage Collection System. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the modified device's performance is equivalent to, or better than, the predicate device.

Here's an analysis based on the provided document:

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

The document does not explicitly present a table of quantitative acceptance criteria alongside numerical performance results for the device. Instead, it relies on a "PASS" or "FAIL" outcome for various verification and validation tests. The acceptance criteria for these tests are implied to be established by the test protocols and industry standards (e.g., "Pressure accuracy per protocol," "Durability, flow and freedom from leakage per protocol").

Here's a table summarizing the tests performed and their reported outcomes:

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

The document does not specify the sample sizes used for any of the tests listed in Table 3.
The data provenance is not explicitly stated beyond general descriptions of the tests (e.g., "The Minimal Essential Media (MEM) Elution test," "This test was designed to evaluate the allergenic potential"). There is no mention of country of origin or whether the tests were retrospective or prospective. Given the nature of these tests (bench, electrical, biocompatibility, sterilization validation), they are typically conducted as prospective laboratory studies rather than clinical studies using patient data.

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

This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, often following standardized protocols. Therefore, the concept of "ground truth" established by clinical experts (like radiologists for imaging devices) would not directly apply to these types of performance tests. The "ground truth" here is implied by adherence to established test methods and acceptable performance limits defined by those methods.

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the types of performance tests described (biocompatibility, electrical, mechanical, shelf life, sterilization). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and a consensus is needed to establish a definitive ground truth.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is a physical system for fluid exchange and pressure monitoring, not an AI-powered diagnostic tool for image interpretation or similar tasks that would typically involve human readers and AI assistance.

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

This question is not applicable as the IRRAflow AFES is a medical device for intracranial pressure monitoring and fluid drainage, not an algorithm or AI system. Its performance is evaluated through engineering and biological safety tests.

7. The type of ground truth used

For the performance tests described (biocompatibility, electrical, mechanical, shelf life, sterilization), the "ground truth" is based on:

• Established Test Standards and Protocols: Such as ASTM D4332-14, ASTM D4169-22 Cycle 13, ASTM F1886-16, ASTM F2096-11, EN 868-5:2009.
• Defined Acceptance Criteria: These criteria are inherent to the test methods and are designed to ensure safety and effectiveness (e.g., pressure accuracy per protocol, freedom from leakage per protocol).
• Laboratory Measurements and Observations: The results are direct measurements or observations within controlled laboratory environments.

It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather adherence to predefined engineering and biological safety specifications.

8. The sample size for the training set

This question is not applicable because the IRRAflow AFES is a hardware medical device with specific Tube Set and Drainage Collection System modifications, not a machine learning or AI model that requires a "training set."

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

This question is not applicable as there is no training set for this device.

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