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The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA are candidates for treatment.

The CERENOVUS® Aspiration Tubing Set is intended to connect the CERENOVUS Large Bore Catheter to the canister of the NOUVAG Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.

The CERENOVUS Large Bore Catheter can be connected to the NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump) using the CERENOVUS® Aspiration Tubing Set.

The provided text describes a 510(k) premarket notification for a medical device (CERENOVUS Large Bore Catheter and Tubing Set), which focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance, animal, sterilization, shelf-life, and biocompatibility testing. It does not include information about AI/ML device performance, human reader studies, or the establishment of ground truth by expert consensus. Therefore, I cannot generate a response that fulfills the requirements of the prompt regarding acceptance criteria for an AI/ML device or studies proving its performance.

The document is purely about a physical medical device and its mechanical/physical/biological properties, not an AI/ML diagnostic or assistive technology.

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The CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices.

The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopague marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing and insertion of catheters. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.

Here's the information about the acceptance criteria and the study proving the device meets them, based on the provided text:

Note: The provided document is a 510(k) summary for a medical device (CERENOVUS Large Bore Catheter). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy in the same way a new drug or high-risk device might. Therefore, the "study" described is primarily a series of bench tests and biocompatibility assessments, not clinical trials comparing device performance with and without AI, or studies involving human experts for ground truth establishment. Many of the specific points requested (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study effect size, standalone performance, training set details) are generally not applicable or not reported in this type of document for a Class II percutaneous catheter.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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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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Use of the CODMAN EDS 3 CSF External Drainage System (EDS 3) is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

Use the External Drainage System Collection Bag with the CODMAN EDS 3 External Drainage System to measure and collect cerebrospinal fluid (CSF).

The Codman EDS 3 CSF External Drainage System (Codman EDS 3 System) is designed to drain cerebral spinal fluid (CSF) at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma. The EDS 3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame drip chamber assembly, and a collection bag. Note: The collection bag is sold as part of the Codman EDS 3 System, as well as sold separately.

The principle of operation of the proposed Codman EDS 3 system is identical to the currently marketed Codman EDS 3 system. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain or lumbar region through the patient line and enters into the 100 mL graduated drip chamber assembly, where it is collected over a period of time to calculate a flow rate. The drip chamber assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the drip chamber height is set, the collected CSF is then drained into the attached 700 mL collection bag.

The Codman EDS 3 CSF External Drainage System Collection Bag is a sterile, vented 700 mL capacity bag that is graduated in 50 mL increments for accurate measurement. A microbial-retentive atmospheric vent facilitates CSF flow into the bag. One bag is provided with the system and replacement bags are sold separately as an accessory to the drain.

The EDS 3 system is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.

Here is a summary of the acceptance criteria and study information for the CODMAN EDS 3 CSF External Drainage System and Collection Bag, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document describes only bench testing for design verification and validation. It does not explicitly state a 'test set' in the context of patient data or clinical trials. The evaluation was primarily based on comparing the performance of the modified device components against the predicate device in a laboratory setting. No data provenance in terms of country of origin or retrospective/prospective study type is applicable here, as no human data was used.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The study involved bench testing and engineering verification, not a clinical study requiring expert consensus for ground truth establishment.

4. Adjudication Method for Test Set

Not applicable. There was no clinical test set requiring adjudication. The verification and validation activities were based on standardized engineering and performance testing methods.

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

No MRMC comparative effectiveness study was done. The submission relies on bench testing demonstrating substantial equivalence to a predicate device, not on comparative clinical performance with human readers.

6. Standalone Algorithm Performance

Not applicable. This device is a medical drainage system, not an AI or algorithm-based device.

7. Type of Ground Truth Used

The "ground truth" for this submission was established through engineering design specifications, industry standards (e.g., ISO 11135-1:2014, ISO 10993-1:2009), and performance of the legally marketed predicate device. The modified components' performance was compared against these established benchmarks.

8. Sample Size for the Training Set

Not applicable. There was no machine learning or AI component, thus no training set was used.

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

Not applicable, as there was no training set.

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The Codman HAKIM Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

The Codman HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainages of cerebral spinal fluid (CSF) for the management of hydrocephalus.

The Codman HOLTER Lumboperitoneal (LP) Shunt is indicated for shunting cerebrospinal fluid when the lumboperitoneal route is the procedure of choice in the treatment of communicating hydrocephalus.

The Codman HOLTER Atrial Catheters are indicated for use to shunt cerebrospinal fluid, when shunting of cerebrospinal fluid to the atrium is the procedure of choice in the treatment of hydrocephalus.

The Codman HOLTER Ventricular Catheters are indicated for use to gain access to the ventricles for diagnostic purposes and in the treatment of hydrocephalus.

The Codman Medos Ventricular Catheter is 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 UNI-SHUNT System is indicated for use as a one-piece ventriculo-peritoneal shunt system for the palliative treatment of hydrocephalus. No other use is recommended.

The Codman 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.

Codman HAKIM Precision and Programmable Valves:
The Codman HAKIM Precision and Programmable Valves are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. Both the Codman HAKIM Precision and Programmable Valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The Codman HAKIM Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges. The Codman HAKIM Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman HAKIM Programmable Valves can be adjusted to 18 different opening pressure settings.

Codman HOLTER Catheters:
The HOLTER Catheter, is a barium-impregnated silicone rubber open-ended catheter. Two stainless steel Type "A" Fixation and Joining Connectors are included with each catheter to use in rejoining the catheter if it has been cut for lengthening or revision. The HOLTER Catheter, Salmon Design, is a barium-impregnated silicone rubber catheter. Four longitudinal slits (90° apart) near the closed distal tip of the catheter are for drainage of cerebrospinal fluid. Two stainless steel Type "A" Connectors are included with each catheter to use in rejoining the catheter if it has been cut for lengthening or revision.

Codman Medos Ventricular Catheter:
The Medos Ventricular Catheter is made from barium-impregnated silicone tubing. The catheter is 140 mm in length and is supplied with 24 inlet holes, 3 rows of 8 holes, at the proximal end. The catheter, with stainless steel stylet and right angle adapter, is supplied sterile.

UNI-SHUNT® System:
The UNI-SHUNT® system with Reservoir incorporates a double dome access port to facilitate injections and aspirations of CSF samples. It is a continuous length of barium-impregnated silicone tubing with an access reservoir made of self-sealing silicone which can be punctured with a 25 gauge or smaller Huber type needle.

Codman BACTISEAL Catheters:
The BACTISEAL Catheters are made of radiopaque (barium-impregnated) silicone tubing and are supplied sterile. BACTISEAL Catheters are subjected to a treatment process by which the silicone tubing is impregnated with rifampin and clindamycin hydrochloride. The catheter is 14 cm in length and is supplied with 24 inlet holes (3 rows of 8 holes) at the proximal end. Depth marks have been added to the catheter (one dot at 5 cm and two dots at 10 cm). A stainless-steel stylet and right angle adapter are packaged with the ventricular catheter. The peritoneal catheter has a beveled tip at one end and the other end of the catheter has a flat tip. The catheter is 120 cm long and may be trimmed to the proper length.

This document, K172022, primarily discusses the substantial equivalence of updated Codman Hydrocephalus Shunt Systems to previously cleared predicate devices. The changes noted are related to labeling updates for MRI compatibility and compliance with ISO 7197 standards for pressure flow characteristics. The performance data provided is entirely from bench testing; there are no human studies (clinical or multi-reader multi-case) described for proving device performance.

Therefore, many of the requested elements regarding human studies (like MRMC studies, expert ground truth adjudication, and clinical study sample sizes) are not applicable to this specific submission as presented in the document.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are based on bench testing for various aspects of the device, primarily related to MRI safety and conformity to specific ISO and ASTM standards.

Study Details for Device Performance

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

   • Sample Size: Not specified in terms of number of devices tested. The document refers to "the devices" being tested.
   • Data Provenance: The studies are bench tests, meaning they were conducted in a laboratory setting. There is no information about country of origin for the data or whether it was retrospective or prospective.

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

   • Not Applicable. Ground truth, in this context, would typically refer to clinical diagnosis or expert annotations for an AI/diagnostic device. This submission describes physical device testing against engineering standards. The "ground truth" is defined by the technical specifications outlined in the ASTM and ISO standards and the performance of the device against those specifications. No human experts were involved in establishing the "ground truth" for the bench tests.

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

   • Not Applicable. As this is bench testing against specified engineering criteria, there is no need for human adjudication of test results.

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. The document explicitly states "No clinical studies were required". This device is a hydrocephalus shunt system, not an AI, diagnostic imaging, or reader-assisted device.

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

   • Not Applicable. This is a physical medical device (shunt system), not a software algorithm.

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

   • The "ground truth" for these bench tests are the established engineering and safety specifications defined by the relevant ASTM and ISO standards (e.g., maximum allowable temperature increase, force/torque limits, pressure flow characteristics).

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

   • Not Applicable. See point 7.

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The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 Mini Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable.

The provided document describes the development and testing of the GALAXY G3 Mini Microcoil Delivery System. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document reports several performance tests, and for each, the result is "PASS: Samples passed the established acceptance criterion." The specific numerical acceptance criteria are generally not explicitly stated, but the passing result indicates they were met.

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

The document does not explicitly state the exact sample sizes used for each individual performance test (test sets). It generally refers to "samples" being tested.

The data provenance is bench testing, which implies the data was collected within a laboratory setting, likely in the US, given the submission to the FDA. It is retrospective in the sense that it's testing a finished device against predetermined criteria.

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

No individual experts or their qualifications are mentioned for establishing ground truth for the bench tests. The "ground truth" for these tests is based on established engineering specifications, industry standards (e.g., USP788, ISO standards), and clinical relevance/simulated use scenarios. For the "Overall Coil Performance" test, "physician's satisfaction rating" was evaluated, implying input from medical professionals, but the number and qualifications are not specified.

4. Adjudication Method for the Test Set

Not applicable for the reported tests. The tests are primarily objective measurements against established criteria, or visual inspections by qualified personnel (not specified as "experts" in the context of adjudication).

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not required as appropriate verification and validation of the GALAXY G3 Mini Microcoil Delivery System was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing."

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 (microcoil delivery system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. The performance tests are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth for the bench tests is based on:

• Engineering specifications and design requirements: For dimensional checks, material properties, and functional performance (e.g., spring constant, detachment force, tensile strength).
• Industry standards: Such as USP788 for particulate matter, ISO 11607 for packaging, ISO 10993-1 for biocompatibility, and ISO 11135-1 for sterilization.
• Simulated use in clinically relevant models: For tests like track force, coil durability, detachment durability, resheathing reliability, fluoro saver marker durability, and distal outer sheath durability.
• Physician satisfaction rating: For "Overall Coil Performance" compared to a predicate device, which implies a subjective expert assessment.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set." The listed studies are verification and validation tests for the device itself.

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

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

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MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 FILL Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3 FILL, GALAXY G3 XSFT Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The devices in this submission include minor design changes only to the Device Positioning Unit's introducer sheath (introducer). There are no modifications to components or materials of the micro-coil or the ENPOWER Detachment Control System. Minor dimensional and design modifications to the introducer will help improve deliverability of the micro-coils.

The document describes the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3 FILL, and GALAXY G3 XSFT Microcoil Delivery Systems. These devices are intended for endovascular embolization of intracranial aneurysms, various neurovascular abnormalities, and arterial and venous embolizations in the peripheral vasculature. The submission is for minor design changes to the introducer sheath component of the delivery system's device positioning unit.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table of verification and validation testing, which includes the tests performed, a summary of the test methods, and the results. The acceptance criterion for all tests was "Pass," meaning the samples met the established criteria.

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

• Test Set Sample Size: The document repeatedly states "Samples passédes the established acceptance criterion" but does not specify the numerical sample sizes used for each individual bench test (Visual Inspection, Tracking Force, Re-sheathing Reliability, Dimensional Inspection, Particulate Testing, Introducer Fuse Joint Testing). It mentions "statistical sampling methods" were used for all testing as required by Codman & Shurtleff, Inc. Design Control procedures. For the animal study, it states "an acute in-vivo animal study" was performed in "swine," but the number of animals or tests performed is not specified.
• Data Provenance: The document does not specify the country of origin for the data generated from the verification and validation testing. The studies are described as prospective testing conducted in a laboratory setting for the bench tests, and an acute in-vivo animal study for the performance assessment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not applicable to the type of testing described. The tests are engineering and biological performance evaluations of a medical device, not diagnostic evaluations requiring expert interpretation of images or patient data to establish ground truth.

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

• This information is not applicable. The tests performed are objective measurements and evaluations of device performance characteristics, not subjective assessments requiring adjudication by multiple experts.

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. This device is a microcoil delivery system, not an AI or imaging-related diagnostic tool that would typically involve human readers or AI assistance in interpretation.

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

• Not applicable. This device is a physical medical instrument, not a software algorithm.

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

• The "ground truth" for the bench tests was established through objective engineering specifications and validated test methods. For example, for "Tracking Force," the ground truth is a specific force measurement threshold. For "Biocompatibility," the ground truth is adherence to internationally recognized standards (ISO 10993-1, FDA guidance). For the animal study, the ground truth was "acceptable overall performance" in delivering the embolic coil, implying pre-defined success criteria for deployment and functional integrity within the in-vivo model.

8. The sample size for the training set:

• Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set. The device itself is "trained" through prior design iterations and predicate device experience, and then validated through non-clinical testing.

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

• Not applicable. As stated above, this is not a machine learning algorithm. The "ground truth" for the design and manufacturing of the device stems from established engineering principles, material science, regulatory standards (e.g., ISO, FDA guidance), and the performance history of predicate devices.

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The YOGA Microcatheter is intended for use in peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

The YOGA Microcatheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. The catheter shaft is composed of a variable pitch stainless steel braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with a polymer material, which encapsulates the stainless steel braid construction. The distal end of the catheter has a radiopaque marker band and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a hub and an ID band is placed at the distal end of the hub over a strain relief. A steam shaping mandrel is provided in the package. The two new YOGA Microcatheters are provided in back up (XB) and extra backup (XXB) configurations, i.e. a stiffer distal end to provide additional support.

The provided text is for a 510(k) premarket notification for a medical device called the "YOGA Microcatheter". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.

Therefore, the document does not contain the detailed information necessary to answer the prompt's questions. The prompt is designed to elicit information about a study that assesses AI/algorithm performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance), which typically involves a test set, ground truth experts, and statistical analysis against predefined acceptance criteria. This 510(k) submission, however, details the physical and functional characteristics of a medical catheter and demonstrates its similarity to a previously approved device through bench testing, not a diagnostic study involving AI or image analysis.

Here's why the information isn't present:

• Device Type: The YOGA Microcatheter is a physical medical device (a catheter), not a software algorithm, diagnostic imaging tool, or AI system. Its performance is evaluated through physical and functional characteristics (e.g., stiffness, trackability, biocompatibility, sterilization) rather than diagnostic accuracy metrics.
• Regulatory Pathway: A 510(k) submission seeks to establish "substantial equivalence" to a predicate device. This often involves demonstrating similar technological characteristics and performance through bench testing, not necessarily conducting large-scale clinical trials or diagnostic accuracy studies like those performed for AI/CAD devices.
• Nature of Testing: The "Performance Data" section describes "Bench Test Summary" including Linear Stiffness, Lateral Stiffness, and Track Testing. These are engineering tests, not studies involving human readers, ground truth consensus for imaging data, or AI performance metrics.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria for an AI/algorithm, sample sizes for test/training sets, expert qualifications, or MRMC studies, as this information is not present in the provided 510(k) document.

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The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

The YOGA Microcatheter is a variable stiffness, end to end braided single lumen catheter designed to access small, tortuous vasculature. The microcatheter has an outer hydrophilic coating that provides lubricity during navigation of vessels. The lubricious PTFE lined inner lumen is designed to facilitate movement of guide wires and other devices. A radiopaque marker band is provided at the catheter tip to aid fluoroscopic visualization. A luer fitting located on the proximal end of the catheter hub is used to attach accessories. A steam shaping mandrel is provided in the package.

The provided document describes the substantial equivalence determination for the YOGA Microcatheter (K162563) based on its comparison to a predicate device, the ENVOY DA Guiding Catheter (K140080), and other reference devices. The focus of the provided text is on demonstrating the device's functional integrity and biological compatibility through various performance tests, rather than clinical efficacy as would be seen with an AI/ML device.

Here's an analysis of the "acceptance criteria and the study that proves the device meets the acceptance criteria" based on the provided text, structured to address your specific points:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the YOGA Microcatheter are implicitly defined by the "PASS" results for each of the performance tests listed. The device is deemed to meet these criteria if its performance matches or is equivalent to established standards or those of the predicate device.

Study Details

The provided document describes physical and biological performance testing for a medical device (microcatheter), not an AI/ML device. Therefore, many of your specific questions regarding AI/ML studies (like ground truth, experts, MRMC, standalone performance) are not applicable to this submission. However, I will answer the relevant points based on the provided text.

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

   • Sample Size: The document states that "All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures." However, specific sample sizes for each test are not provided in this document.
   • Data Provenance: The tests are "bench" (in vitro) and "animal" (in vivo) tests conducted by the manufacturer, Codman & Shurtleff, Inc. The document does not specify the country of origin for the animal studies, but the manufacturer is based in Raynham, Massachusetts, USA. The studies are prospective as they were conducted to support the 510(k) 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 document describes performance testing for a physical medical device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests is based on established engineering and biological standards (e.g., ISO, ASTM, USP).

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

   • This is not applicable. Adjudication methods are typically relevant for human review of AI/ML outputs or clinical endpoints with subjective interpretation. For the physical and biological tests described, the determination of "PASS" or "FAIL" would be based on objective measurements against pre-defined acceptance criteria, not an adjudication process involving multiple human reviewers.

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:

   • This is not applicable. This document describes the clearance of a physical medical device and does not involve AI or human readers.

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

   • This is not applicable. The device is a microcatheter, a physical instrument, not an algorithm.

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

   • The "ground truth" for the device's performance is based on established engineering standards, international standards (ISO, ASTM, USP), and validated internal design control procedures. For example, tensile strength is measured against engineering specifications, biocompatibility against ISO 10993 standards, and flow rates against ISO 10555-1. For radiopacity, the ground truth is the visual confirmation by a qualified individual (presumably a radiologist or veterinarian during the animal study) that the catheter is visible under fluoroscopy.

7. The sample size for the training set:

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

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

   • This is not applicable. There is no "training set" for this physical device.

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Use of the Codman EDS3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

The Codman EDS3 CSF External Drainage System (Codman EDS3 System) is designed to collect cerebral spinal fluid (CSF) from the patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma. The EDS3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame burette tube assembly and a collection bag. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain through the patient line and enters into the 100 mL graduated burette tube assembly, where it is collected over a period of time to calculate a flow rate. The burette tube assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the burette tube height is set, the collected CSF is then drained into the attached 700 ml collection bag. The EDS3 System is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.

The provided document describes the Codman EDS3 CSF External Drainage System (K162437), which is essentially an updated version of a previously cleared device (K061568). The primary change in the subject device is the use of a different adhesive (Loctite 3924 instead of Loctite 3341) for bonding tubing lines. Therefore, the acceptance criteria and studies focus on demonstrating that this change does not negatively impact the device's safety and effectiveness.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each bench test (e.g., number of devices tested for tensile strength or shelf life). It's a summary document, and typically, detailed test reports would contain this information.

Regarding data provenance:

• Country of origin: Not specified, but likely the US given the submission to the FDA.
• Retrospective or prospective: The bench tests described are prospective in nature, as they involve testing newly manufactured devices with the new adhesive according to established protocols.

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

This question is not directly applicable in the context of this device and study. The "ground truth" for this type of device (a medical drainage system) is not established by expert consensus or interpretations in the same way it would be for an AI diagnostic algorithm. Instead, it's established by pre-defined performance specifications (acceptance criteria) based on engineering, material science, and regulatory standards. The "experts" involve the engineers and scientists who designed the tests and reviewed the results, but they are not adjudicating observational data.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective and based on measurable parameters (e.g., leak detection, force measurements, chemical analysis). There's no human "adjudication" of the test results in the way it's done for interpreting medical images. The results are directly compared to the pre-established numerical or qualitative "Pass/Fail" acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving image interpretation by human readers, potentially augmented by AI) to assess the impact on human performance. The Codman EDS3 CSF External Drainage System is a physical medical device, not a diagnostic tool where human reader performance is a direct output.

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

No, a standalone (algorithm-only) performance study was not done. This device is not an algorithm; it's a physical medical device. The "performance" refers to its physical and functional attributes.

7. The Type of Ground Truth Used:

The ground truth for this study is based on engineering specifications, material science standards (e.g., ISO 10993 for biocompatibility), and established medical device performance requirements. The acceptance criteria are essentially the "ground truth" against which the device's performance is measured. These are not pathology results, expert consensus on disease, or patient outcomes data in this context.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI, machine learning, or software algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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