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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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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 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 catheter is used for cerebrospinal fluid (CSF) shunting.

The ventricular catheter is part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for shunting of excessive CSF.

The ventricular catheter will be offered in lengths of 18 cm or 25 cm with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. The ventricular catheter contains five stripe depth markers at 3, 5, 7, 10 and 13 cm from the catheter tip. The ventricular catheter is manufactured using barium sulfate filled silicone elastomer.

The purpose of this submission is to seek clearance for modifications to the ventricular catheter which is part of the Miethke Shunt System (K020728). This submission proposes the following modification:

• adding stripe depth markers at 4, 6, 8, 9, 11 and 12 cm and point markers at 1 cm intervals on both sides of the tubing starting at 3.5 cm to 12.5 cm from the catheter tip.

The ventricular catheter is 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, proSA Progammable Shunt System, Miethke Shunt System miniNAV valve, Miethke Shunt System Gravity Assisted Valve (GAV), and the Miethke Shunt System (DSV, ShuntAssistant, paedi-GAV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K120559/K110206/K103003/K062009/K031303/ K030698/K011030).

The provided text is a 510(k) summary for the Miethke Ventricular Catheter, which addresses a modification to an existing device rather than a new AI-powered diagnostic tool. Therefore, much of the requested information regarding AI study design, such as MRMC comparative effectiveness, standalone performance, training set details, and expert ground truth establishment, is not applicable to this document.

However, I can extract information related to the acceptance criteria and the study performed for this specific device, as it pertains to the physical catheter modification.

Here's the relevant information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated. The document mentions "All samples" in relation to meeting acceptance criteria, implying a test set was used, but the exact number is not provided.
• Data Provenance: Not explicitly stated, but it is implied to be from non-clinical laboratory performance testing.

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

• Not Applicable. This device is a physical medical device (catheter) and the testing performed relates to its physical properties (radiopacity) rather than diagnostic accuracy requiring expert interpretation for ground truth.

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

• Not Applicable. As mentioned above, this testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.

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 a physical medical device, not an AI-powered diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an AI-powered diagnostic tool.

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

• For the radiopacity testing, the "ground truth" would be established by the physical measurements and standards defined in the ASTM F 640-12 standard test methods. This is an objective measurement rather than a subjective interpretation requiring expert consensus or pathology.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI algorithm.

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

• Not Applicable. There is no training set for this type of device.

Study Details:

• Study performed: Non-clinical laboratory performance testing.
• Standard used: ASTM F 640-12 standard test methods for determining radiopacity for Medical Use.
• Purpose: To demonstrate that the modification (additional depth markers) to the ventricular catheter maintains its intended performance, particularly regarding radiopacity, and is substantially equivalent to the predicate device.

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The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is intended for use as a stereotaxic image guided surgical navigation system during cranial surgical procedures. The Cranial Application software assists in guiding surgeons during cranial surgical procedures such as biopsies, tumor resections, and Ventricular Catheters placement. The Cranial Application software works in conjunction with 7D Surgical Machine Vision Guidance System which consists of clinical software, optically tracked surgical Pointer, a reference frame instrument and platform/computer hardware which is substantially equivalent to K181041. Image guidance tracks the position of instruments in relation to the surgical anatomy and identifies this position on DICOM images or intraoperative structured light images of the patient. The Cranial software functionality is described in terms of its feature sets which are categorized as imaging, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The 7D Surgical System Cranial Application is comprised of 5 major components:

1. Cart
2. Arm
3. Head
4. Tracked 7D Surgical System Cranial Instruments
5. Software

Here's a breakdown of the acceptance criteria and study information for the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document states that device performance tests were conducted "on phantom models in a clinical simulated environment." It does not specify the exact sample size (number of phantom models or individual measurements) for the TRE and ATE testing.
   • The data provenance is from non-clinical studies conducted by 7D Surgical Inc. There is no information regarding country of origin for the data or if it was retrospective or prospective in the context of clinical data, as this was a non-clinical study.

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

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the non-clinical phantom model testing. It mentions that TRE and ATE evaluate "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a physical measurement standard was used as ground truth rather than expert consensus on images.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by physical measurement on phantom models, not by expert review requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is a surgical navigation system, not an AI-based diagnostic imaging tool that would typically involve human readers interpreting images. The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application."

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

   • The "Non-Clinical Accuracy" testing, specifically the TRE and ATE measurements on phantom models, represents a standalone performance evaluation of the system's accuracy in tracking and reporting positions without a human surgeon's interaction being part of the measurement of error. The system itself is designed to be used with a human surgeon.

6. The type of ground truth used:

   • For the non-clinical accuracy testing (TRE and ATE), the ground truth was established by physical measurement on phantom models. The document states it's "the ground truth position measured physically or otherwise."

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of machine learning. The 7D Surgical System uses "Machine Vision Guidance System" and structured light imaging. While these technologies involve algorithms, the submission focuses on the performance verification of the integrated system and its components. It does not detail the development or training of specific machine learning models with a distinct training dataset.

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

   • As no specific "training set" for machine learning is detailed in the document, information on how its ground truth was established is not provided. The system uses pre-calibrated geometry of instruments and structured light scanning, which inherently rely on engineering and metrological standards for accuracy rather than a labeled training dataset in the typical AI sense.

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The Alivio Ventricular Catheter and Flusher System) is for use in the treatment of patients with hydrocephalus, as components of a shunt system when draining of cerebrospinal fluid (CSF) is indicated. The Alivio Flusher may be used by a qualified clinician as a tool to facilitate a non-invasive retrograde fluid flush of the Alivio Ventricular Catheter to unblock inlet holes or open its relief membrane to restore or increase CSF flow in a non-flowing shunt. The Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions.

The Alivio System, consisting of the Alivio Flusher and Alivio Ventricular Catheter, is an implantable component of a CSF Shunt System used in the treatment of patients with Hydrocephalus. The Ventricular Catheter is implanted in the ventricle and connected distally to the Flusher, which is in turn connected to a commercially available flow regulating valve (not provided as part of the Alivio System).

Similar to manual pumping of a flow requlating valve or performing an invasive shunt tap via the flow regulating valve; the Alivio Flusher, a fluid reservoir, may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush to the Alivio Ventricular Catheter to unblock occluded, proximal inlet holes. If the inlet holes are not able to be unblocked, the retrograde fluid flush will open the relief membrane of the Alivio Ventricular Catheter, creating a new fluid pathway to restore or increase CSF flow in a non-flowing shunt with occluded inlet holes. Once the relief membrane has been used to restore flow in a non-flowing shunt, subsequent retrograde fluid flushing of the Alivio Ventricular Catheter with the Alivio Flusher may not be sufficient to reopen the relief membrane, which may become occluded similar to proximal catheter inlet holes.

After flushing the device, standard methods of care should be used to determine that the reservoir is refilled prior to flushing a second time. Similar to commercially available reservoirs used in shunt systems, refilling of the Flusher reservoir can be confirmed by palpation of the dome. Repeated flushing of the device with an empty reservoir may not be effective. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the Alivio System.

The Alivio Flusher does not requlate flow of the shunt system. A flow requlating shunt valve is not provided with the Alivio System. During passive fluid from the ventricular catheter flows freely, without restriction through the passive flow channel of the Flusher. The Alivio System is compatible and has been tested with the Integra Contour-Flex™ Valve. The Alivio System is designed to be compatible with all commercially available flow requlating valves with standard inlet connectors, similar to the integra "Contour-Flex"" Valve.

The Alivio Ventricular Catheter and Flusher System (Alivio System) is a medical device for treating hydrocephalus. The FDA document K172006 provides information on the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are generally demonstrated by compliance with recognized standards and successful completion of various tests, with results deemed suitable for the intended use and substantially equivalent to predicate devices. Specific quantitative acceptance criteria are not explicitly detailed for all tests in the provided text, but the reported performance consistently states that the criteria were met.

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

• Biocompatibility, Packaging, Sterilization, Pyrogenicity, Shelf Life, Pressure Leak/Flow, Durability, Break Strength, Tensile Strength, Pressure Handling, Cartridge Performance, Catheter Bond Pressure, Flusher Reliability, MR Safety, System Imaging, Occlusion Flushing Performance: These were bench and laboratory studies. Specific sample sizes for each bench test are not provided, but generally, these involve sufficient samples to establish statistical validity for the test method. The data provenance is from preclinical (laboratory/bench) testing.
• Comparative Performance Testing in Animals:
  • Pilot animal study 1: N=1 (evaluated at acute timepoint). Provenance: Preclinical animal study.
  • Pilot animal study 2: N=2 (evaluated at subacute and acute timepoints). Provenance: Preclinical animal study.
  • Pilot animal study 3: N=2 (evaluated at acute timepoints). Provenance: Preclinical animal study.
  • Animal study 4: N=11 (evaluated at subacute timepoints). Provenance: Preclinical animal study, conducted in conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.
  • Animal study 5: N=6 (evaluated at acute timepoints). Provenance: Preclinical animal study, conducted in conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.
• Usability and Human Factors Testing: The number of users (experts) involved was 24 neurosurgeons. Provenance: Simulated clinical use model, which is a form of preclinical testing.
• Alivio Flusher Clinical Study: N=4 patients. Provenance: Clinical study (registered as NCT02651337).

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

• Usability and Human Factors Testing: 24 neurosurgeons (intended users) of varying experience. Their specific years of experience are not mentioned, but their role as "neurosurgeons" implies significant medical expertise relevant to the device's application.
• Alivio Flusher Clinical Study: The "users" in the clinical study performed the primary steps and their ability to do so was assessed. While not explicitly stated as "ground truth establishment," their successful use contributed to the device's functional safety assessment and efficacy. The study involved clinicians, overseen by a physician for patient care.

4. Adjudication Method for the Test Set

This document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth from multiple experts. For the usability study, it indicates that the "24 neurosurgeons (intended users) of varying experience" evaluated the device, implying a consensus or aggregated assessment rather than a specific adjudication protocol. For the clinical study, the outcome was based on the "criteria for success outlined in the protocol."

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 mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any AI component mentioned in the context of human reader improvement. The device (Alivio System) is a physical medical device (catheter and flusher system), not an AI-based diagnostic or assistive software.

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

This question is not applicable as the Alivio System is a physical medical device, not an algorithm or AI solution. The performance tests evaluate the device's physical and functional characteristics.

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

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable in the same way to this physical medical device. Instead, the studies rely on:

• Compliance with recognized standards: For most preclinical tests (e.g., ISO, ASTM), the "ground truth" is adherence to established engineering and material performance specifications.
• Histopathology analysis: In animal studies, histological analysis of tissue provided objective data for safety comparisons.
• Comparative performance data: Comparison against predicate devices' known performance characteristics.
• Clinical outcomes data: For the small clinical study, the "criteria for success outlined in the protocol" served as the evaluation metric for the device's functional safety and ability to restore/increase CSF flow.
• User feedback/observational data: From the usability study involving neurosurgeons.

8. The sample size for the training set

This question is not applicable as the Alivio System is a physical medical device, not a software algorithm that requires a training set.

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

This question is not applicable as the Alivio System is a physical medical device, not a software algorithm that requires a training set or its associated ground truth establishment.

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CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852)

Indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

CereLink ICP Sensor Ventricular Catheter Kit (82-6854)

Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications

The CereLink ICP Sensor Kits are used to monitor intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an External Ventricular Drainage (EVD) catheter. The probe, also known as the CereLink ICP Sensor is intended to be used in conjunction with all of Codman's neuromonitoring devices: the Codman ICP Express Monitor (product code 82-6634) and the DirectLink ICP Module (product code 82-6828). The ICP Express and DirectLink are intended for use in ICUs. The CereLink ICP Sensor converts the pressure sensor to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed Codman ICP Express or DirectLink as a result of the probe modifications described in this submission.

The CereLink ICP Sensor contains a small, thin pressure sensor used to measure the intracranial pressure. The sensing element uses a strain gauge located at the tip of the probe. The sensing element is protected by a titanium housing and is exposed to the environment via a silicone membrane. The sensor is connected via wires to a plastic connector housing, and the wires are snaked through a nylon catheter. The connector housing includes a compensation/calibration passive circuit on a Printed Circuit Board (PCB). Additionally, the CereLink ICP Sensor's connector housing includes a new memory PCB board. When the CereLink ICP Sensor is used with either the ICP Express or DirectLink, it functions identically to the cleared predicate Codman Microsensors. Additionally, the connector housing has an electrical connector to attach to any of the monitoring devices.

The CereLink ICP Sensor Kits include components needed to facilitate the surgical implantation of the Cerelink ICP sensor. The components that will be included with the proposed CereLink ICP Sensor Kits are currently cleared devices, and are identical to the components currently packaged within the predicate Codman Microsensor Kits (i.e. there are no changes being made to the kit components, only the ICP sensor is being modified). Each component and their function are described in the Description section of the Instructions for Use for each kit.

The provided text is a 510(k) Summary for the CereLink ICP Sensor Kits, describing the device and its substantial equivalence to a predicate device. It is not an AI/ML device, and therefore does not contain information on acceptance criteria for algorithm performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating that the modified device (CereLink ICP Sensor Kits) is substantially equivalent to a previously cleared device (Codman Microsensor Kits) by showing that it has:

• The same indications for use and intended use.
• The same fundamental scientific technology and basic design.
• Incorporates the same materials for the implantable portion.
• Uses the same packaging and sterilization methods.

The changes primarily involve minor differences in the plastic connector housing (e.g., shape, addition of PCB and memory PCB, pad printing replacing a paper label) and updated labeling.

Instead, the document details performance testing for a medical device (intracranial pressure sensor) related to its physical and functional attributes, not AI/ML algorithm performance.

Here's a breakdown of the information that is present in the document, which primarily focuses on traditional medical device testing and comparisons for regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a "Summary of Testing" table (page 8) that lists various performance tests, relevant standards, and the general "Result" for the subject device. However, it does not provide specific numerical acceptance criteria or reported performance values in a typical table format that would be expected for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity with numerical thresholds).

Instead, the results are qualitative and confirm that the device "met the established acceptance criteria and is therefore substantially equivalent to the predicate" or "Pass".

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

This information is not applicable to this document as it describes a physical medical device, not an AI/ML algorithm. The "test set" here refers to the actual physical devices subjected to bench testing, sterilization validations, and biocompatibility assessments, rather than a dataset of images or patient records. No information on data provenance (country, retrospective/prospective) is relevant or provided beyond the general understanding that testing was conducted by or for the manufacturer (Codman & Shurtleff, Inc. in Raynham, Massachusetts).

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

This is not applicable to a physical device submission like this. Ground truth in this context would be physical measurements, chemical analyses, and adherence to engineering and biological safety standards, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for human interpretation of data, typically in studies involving subjective assessments or labeling of complex medical images, which is not what this document addresses.

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

No MRMC study was done, as this is not an AI/ML device that assists human readers.

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

Not applicable. This device is an intracranial pressure sensor, whose performance is measured physically (e.g., pressure readings, electrical characteristics, material safety), not as an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established through:

• Adherence to recognized international and national standards (e.g., ISO, ASTM, IEC) for medical devices.
• Bench testing to verify physical and functional characteristics (e.g., MRI compatibility, electrical safety, pressure range).
• Sterilization validation confirming a specific sterility assurance level.
• Biocompatibility testing to ensure no adverse biological reactions.
• Comparison to the predicate device's established performance and characteristics, demonstrating "substantial equivalence."

8. The Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for this type of physical medical device in the context of this submission. The "training" here would be the design, engineering, and manufacturing processes.

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

Not applicable. No training set as described for AI/ML algorithms.

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The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.

The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.

The provided text describes a 510(k) premarket notification for a medical device called the "Cleveland Multiport Ventricular Catheter Set." This submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document refers to various tests performed to support this claim, but it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance in the context of AI/ML, nor does it include information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML models.

The information provided relates to the physical and functional aspects of a traditional medical device (a catheter) and its comparison to existing catheters. Therefore, most of the requested fields are not applicable to the given text.

Here's an attempt to answer the applicable parts of your request based on the provided text, while explicitly stating when information is not available or not applicable:

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

The document lists various performance tests and their results, indicating that the device "passed" and "results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices." The specific quantitative acceptance criteria are generally implied rather than explicitly stated as numerical thresholds in this summary, but the results confirm compliance.

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Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications.

Use of the Ventricular Catheter Kit is indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications.

The Microsensor monitors intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an EVD catheter, and is intended to be used in conjunction with the Codman ICP Express (product code 82-6635) neuromonitoring platform products. The ICP Express and Codman Microsensor are intended for use in Intensive Care Units (ICUs). The Microsensor converts the pressure signal to a voltage signal. The monitor provides power to the Microsensor, interprets the voltage signal from the Microsensor, and displays the corresponding pressure measurements taken by the Codman Microsensor during a patient's treatment and during patient transport. There is no change to the Codman ICP Express monitor as a result of the probe modifications described in this submission.

The Codman Microsensor probe contains a small, thin and delicate pressure sensor used to measure the intracranial pressure. The sensing element uses a strain gauge located at the tip of the probe. The sensing element is protected by a titanium housing and is exposed to the environment via a silicone membrane. The sensor is connected via wires to a plastic connector housing, and the wires are snaked through a nylon catheter. The connector housing includes a compensation/calibration passive circuit on a Printed Circuit Board and has an electrical connector to attach the ICP Express monitoring box.

The Codman Microsensor Kits include components needed to facilitate the surgical implantation of the ICP Microsensor. The components that will be included with the proposed Codman Microsensor are currently cleared devices, and are identical to the components currently packaged within the current Codman Microsensor kits (i.e. via this 510k, there are no changes being made to the kit components, only the Microsensor is being updated). Each component and their function are described in the Description section of the Instructions for Use for each kit.

The provided text describes the Codman Microsensor Kits, an intracranial pressure monitoring device, and the studies conducted to demonstrate its substantial equivalence to a predicate device. The information is presented in the context of a 510(k) premarket notification.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document outlines acceptance criteria and performance through a series of bench tests. The relevant information is summarized in "Table 4. Verification and Validation Bench Tests" and implicitly stated through "PASS" results for each test.

Study Details:

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

   • The document does not specify the exact sample sizes (number of devices or measurements) used for each individual bench test listed in Table 4.
   • Data Provenance: The studies are described as "Bench Testing" and "Biocompatibility Testing," implying laboratory-controlled experiments rather than human or animal subject data, except for some biocompatibility tests which use animal models. No country of origin for the data is explicitly mentioned, but the submission is to the U.S. FDA, and relevant standards like ASTM and ISO are cited. The studies are prospective in nature, conducted specifically for this submission.

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

   • This question is not applicable as the evaluation relies on physical and chemical measurements against engineering specifications and industry standards, not on expert interpretation of complex clinical data to establish a ground truth. The "ground truth" here is defined by established scientific principles and performance metrics.

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

   • This is not applicable as the studies are bench tests and biocompatibility evaluations, which involve objective measurements and adherence to predetermined standards rather than subjective human interpretation requiring adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intracranial pressure monitoring transducer, not an AI-assisted diagnostic imaging device that would typically involve human readers or AI algorithms for interpretation.

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

   • This is not applicable. The device is a physical medical device (a pressure transducer), not a software algorithm or AI model.

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

   • The "ground truth" for the performance evaluation is based on engineering specifications, established physical measurement methods, and compliance with recognized industry standards (e.g., ASTM, ISO). For biocompatibility, it's based on biological responses in animal models and in vitro tests (cytotoxicity, sensitization, irritation, pyrogenicity, mutagenicity, implantation, hemolysis) against accepted safety thresholds.

7. The sample size for the training set:

   • This is not applicable as the device is a physical medical device and does not involve AI or machine learning algorithms that require training sets.

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

   • This is not applicable for the same reason as point 7.

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The Rivulet™ Ventricular Catheter is designed for use as the proximal component of CSF Flow Control Shunts used in shunting cerebrospinal fluid from the ventricles of the brain to the peritoneal cavity or the right atrium of the heart.

The Rivulet™ Ventricular Catheter is a proximal catheter used in the shunting of cerebrospinal fluid (CSF), allowing for the drainage of CSF from the ventricles of the brain. The Rivulet Catheter has varying sized, evenly spaced inlet flow holes located within 1.15 cm (0.45") of the tip of the catheter. The Rivulet Catheter is designed to equalize the distribution of inflowing CSF across all of the inlets holes as well as allow for intraventricular positioning of the inlet flow holes further away from the choroid plexus.

The Rivulet Catheter is available in two (2) shunt system connector styles: standard and snap shunt. The Rivulet Catheter with a standard connector measures 15 cm (5.9") in length, 0.15 cm (.06") in inner diameter, 0.25 cm (0.10") in outer diameter. The Rivulet Snap Shunt Catheters are available in lengths ranging from 4 cm (1.6") to 14 cm (5.5"). The Rivulet Catheters contain length markers to aid in determining depth of placement. To facilitate the placement and use of the Rivulet Catheters, procedural accessories supplied with the Rivulet Catheter include a stainless steel stylet, and a Right Angle Clip or Snap Base.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Rivulet™ Ventricular Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a numerical sample size for a test set in the context of a clinical study or performance evaluation with human subjects. The evaluation relies primarily on comparison to predicate devices and adherence to an international standard.

The data provenance is not directly applicable in the sense of clinical study data from a specific country, as the argument is based on design equivalency and conformance to standards.

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

This information is not provided in the document. The device approval appears to be based on engineering design, comparison to predicate devices, and adherence to an international standard, rather than a clinical trial requiring ground truth establishment by a panel of experts.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant to the type of device evaluation described.

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

No MRMC comparative effectiveness study was done as described in the document. The device is a medical implant (ventricular catheter), not a diagnostic or AI-assisted interpretation tool. The comparison is between the new device's design and existing predicate devices, along with conformance to an ISO standard.

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

Not Applicable. This device is a physical medical component, not an algorithm, and therefore does not have a "standalone" algorithmic performance in the context of AI or diagnostic imaging.

7. Type of Ground Truth Used

The "ground truth" for this submission appears to be established through:

• Predicate Device Performance: The known and accepted performance characteristics of the Medtronic PS Medical® Ventricular Catheter (K792007) and Medtronic Ventriculostomy Reservoir (K874498).
• International Standard Conformance: Adherence to ISO 7197 Neurosurgical implants - Sterile single-use hydrocephalus shunts and components.
• Engineering Design and Testing (Implicit): While not detailed, the claims of "similar technological characteristics" and "equalized flow" imply underlying engineering design, testing, and validation demonstrating these features.

8. Sample Size for the Training Set

Not Applicable. This document describes the submission for a medical device (catheter), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply.

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