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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 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, 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 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 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and 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.

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. 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).

For the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT microcoils: The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical.

For the GALAXY G3 Mini microcoils: 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.

For all Microcoil Delivery Systems: 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, catalog no. DCB2000500, works with the ENPOWER Control Cable and with the standard connecting cable.

The provided text describes a 510(k) premarket notification for microcoil delivery systems, which are medical devices, not an AI/ML powered device. Therefore, a study proving an AI/ML device meets acceptance criteria is not presented in this document.

The document discusses non-clinical performance data for the microcoil delivery systems, specifically focusing on verification and validation testing of minor design modifications related to the Device Positioning Unit's core wire.

Here's the information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text, adapted for the context of a medical device rather than an AI/ML system:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "Samples" in the results, but doesn't quantify the number of units tested for each criterion.
• Data Provenance: The tests were conducted internally as "bench testing." The country of origin is not specified, but the applicant, Medos International SARL, is located in Le Locle, Switzerland. The testing is retrospective, as it's part of a 510(k) submission for an already manufactured device with minor modifications.

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

This is not applicable as the study involved non-clinical bench testing of a physical medical device, not a diagnostic or prognostic system requiring expert interpretation of data or images. The "ground truth" here is determined by the physical properties and performance measured during the tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements of physical performance and do not involve human adjudication in the typical sense of reviewing subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical studies were not required as appropriate verification and validation of the minor design modifications was achieved based on the bench testing."

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by objective physical measurements and engineering specifications, which determine whether the device meets its design requirements. For example, "tracking force" would have a specified maximum force for successful delivery, and "microcatheter stability" would have an acceptable range of movement.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML context.

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

Not applicable. As above, there is no AI/ML training set.

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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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Intended for the relaxation of muscle spasms, temporary relief of minor muscle and joint aches, pain and stiffness, temporarily relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.

The HealthLight Footbed Model HL-FB is specifically indicated for treatment of the feet and lower legs.

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It appears there might be a misunderstanding or misinterpretation of the provided document. The document is a 510(k) Premarket Notification from the FDA for the HealthLight Footbed LED Light Therapy System Model HL-FB.

This document is a marketing clearance letter, not a clinical study report or a technical performance evaluation. It does not contain information about acceptance criteria, device performance against those criteria, or details of a study that proves the device meets specific performance metrics.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document.

The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, often without requiring new clinical performance studies of the type you're asking about if the technological characteristics and indications for use are similar.

If you have a different document that describes a study for this device, please provide that.

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The Audit® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, callbration verification of reportable range for the HE4 and HER2 analytes.

The Audit® MicroControlsTM Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic device consisting of sets of 5 levels of freeze-dried, linearity material and additives in human based serum. The product contains the following analytes: HE4 and HER2. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

This document describes the Audit® MicroControls™ Linearity FD Tumor Markers II, an in-vitro diagnostic device. The provided text, however, focuses on the substantial equivalence review for a regulatory submission (510(k)) and details the device's characteristics, intended use, and performance data from stability studies. It does not present a study designed to prove the device meets specific acceptance criteria in terms of diagnostic accuracy or clinical effectiveness, as it is a quality control material.

The "acceptance criteria" discussed here relate to the stability and value assignment of the control material, not to diagnostic performance metrics like sensitivity or specificity for a medical imaging device. The "performance" refers to the stability of the control material and its ability to provide target values.

Therefore, many of the requested points are not applicable to this type of device and submission. I will address the relevant points based on the provided text.

Acceptance Criteria and Reported Device Performance

As this device is a quality control material, the acceptance criteria relate to its stability and the establishment of target values for its analytes (HE4 and HER2).

HER2/Siemens Centaur XP (ng/ml) Target Values and Ranges:
Level A: 5.1 (Range 4.1-6.1)
Level B: 74.0 (Range 59.2-88.8)
Level C: 146.0 (Range 116.8-175.2)
Level D: 241.3 (Range 193.1-289.6)
Level E: 303.0 (Range 242.4-363.7) |
| Linearity (expected) | The "Levels B, C and D produced according to the following dilution scheme:" suggests that the material is designed to demonstrate a linear relationship between levels. | The dilution scheme is provided:
Level B = 0.75(Level A) + 0.25(Level E)
Level C = 0.5(Level A) + 0.5(Level E)
Level D = 0.25(Level A) + 0.75(Level E) |

Additional Information based on request:

1. 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: Not explicitly stated in terms of number of distinct samples for the stability studies or value assignment. The studies involved analyzing "vials representative of the entire lot" and "multiple times" for value assignment.
   • Data Provenance: The studies were conducted by Aalto Scientific, Ltd. in Eatonton, GA, USA. The data would be considered prospective for the stability studies. The origin of the human serum matrix is not specified beyond "human serum."

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

   • Not Applicable. The "ground truth" for this device refers to the assigned target values and stability characteristics of the quality control material itself, determined through laboratory measurements, not human expert interpretation of clinical data.

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

   • Not Applicable. This is not a study requiring adjudication of diagnostic interpretations. The value assignment was based on "mean value" from "multiple measurements" using specific laboratory analyzers and reagents.

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

   • Not Applicable. This is a quality control material, not an AI diagnostic device that assists human readers.

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

   • Not Applicable. This is a quality control material. However, the performance assessment of the control material (stability, value assignment) is done in a "standalone" laboratory setting by measuring it on specified clinical chemistry analyzers.

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

   • The "ground truth" for this quality control material is the assigned target concentration values for HE4 and HER2 established through repeated measurements on specific reference instruments (Siemens Centaur XP for HER2 and Roche Cobas e411 for HE4) using their corresponding reagents. This is a form of analytical reference measurement.

7. The sample size for the training set

   • Not Applicable. This device is a quality control material and does not use a "training set" in the context of an AI/machine learning algorithm. The "value assignment" uses multiple measurements on specific instruments to determine the target values for each level.

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

   • Not Applicable. As there is no training set, this question is not relevant. However, the target values for the control material were established by measuring each analyte multiple times on the specified analyzers, and the mean value was used as the target concentration. "All supporting data is retained on file at Aalto Scientific, Ltd." (Page 6).

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The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration, and the verification of reportable range for the glucose analyte.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic device consisting of sets of 5 levels of liquid, linearity material and additives in human based serum. The product contains the following analyte: glucose. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

Here's a breakdown of the acceptance criteria and study information for the Audit® MicroControls™ Linearity DROP LQ Blood Glucose device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria for stability claims rather than performance metrics like sensitivity or specificity.

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

• The document mentions that multiple measurements were taken for the analyte at each level during value assignment and stability studies. However, specific sample sizes for a "test set" (e.g., number of unique samples or runs for a formal validation study) are not explicitly provided.
• Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. The data is retrospective for the completed accelerated stability study and real-time open vial stability, and prospective for the ongoing real-time shelf-life study. The country of origin of the data is not explicitly stated but can be inferred as the USA, where Aalto Scientific, Ltd. is located.

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

• This information is not applicable in the context of this device. The device is a quality control material used to verify the linearity, calibration, and reportable range of blood glucose measurement systems. The "ground truth" for this type of device is established through analytical value assignment based on measurements performed on a reference instrument, not through human expert interpretation of results.
• The document states: "Analyte value assignment for Level A through Level E was performed on Roche Cobas for the blood glucose analyte using the corresponding reagent. The analyte was measured multiple times. The mean value of the analyte was used to establish a target concentration value at each level."

4. Adjudication Method for the Test Set

• Not applicable. As the device is a quality control material and "ground truth" is established through analytical measurement, there is no human-based adjudication process for a test set in the conventional sense. The "adjudication" is inherent in the analytical measurement and statistical determination of mean values.

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 relevant for interpretative diagnostic devices (e.g., imaging AI) where human readers are making diagnoses. The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is a quality control material for analytical instruments, not an interpretative device.

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

• Not applicable. This device is a control material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm's accuracy without human intervention is not relevant. Its performance is measured by its stability and its ability to produce expected values when analyzed by a blood glucose measurement system.

7. The Type of Ground Truth Used

• The ground truth (or target values) for the device's glucose levels was established through analytical measurement on a reference instrument (Roche Cobas c501) with multiple measurements and calculation of the mean value. This is essentially an instrument-based reference value rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not explicitly stated and not directly applicable as this is a physical control material, not an AI/ML algorithm. The concept of a "training set" is typically used for machine learning models. For this device, the equivalent would be the data used for the "value assignment" to establish its target concentrations. The document mentions "The analyte was measured multiple times" for value assignment, but a specific number is not given.

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

• As explained in Point 7, the "ground truth" (target values) for the device's five levels (A-E) was established through repeated analytical measurements of the glucose analyte on a Roche Cobas c501 instrument. The mean of these multiple measurements was used to define the target concentration value for each level. Raw materials are subject to internal quality control.

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The Hilal Embolization MicroCoils™ are intended for arterial and venous embolization in the peripheral vasculature.

Hilal Embolization MicroCoils™ are manufactured from coiled platinum wire with equidistantly spaced nylon fibers and are available in straight, single-curl, and multiplecurl configurations. The Hilal coils are designed to be delivered by microcatheters with a minimum end hole diameter of 0.018 inch. The extended embolus lengths of the finished device range from 0.5 to 6.0 centimeters. The coiled embolus diameters range from 2 to 10 millimeters. The Hilal coils are loaded in a straight configuration into a loading cartridge. A loading stylet is also provided for loading this coil into the delivery catheter.

The provided text describes the Hilal Embolization MicroCoils™ and its substantial equivalence to a predicate device, the Cook Retracta® Detachable Embolization Coil. The information required for a detailed study description is somewhat limited in this document, as it summarizes performance data rather than providing a full study report.

Based on the available text, here's what can be extracted and inferred:

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

Note: For "Coil Tensile Testing," the document only states that testing characterized the uniaxial tensile strength, but does not explicitly mention acceptance criteria or if it was met.

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

• Wire Tensile Testing: Not specified.
• Coil Tensile Testing: Not specified.
• Animal Testing: Not specified, but performed using a "porcine model." The provenance is a laboratory setting.
• Leveraged Testing (Nester® and Tornado® Embolization Coils): Sample sizes for bench, MRI, and animal testing are not specified.

The data provenance is likely prospective for the tests performed directly on the Hilal Embolization MicroCoils™ as it's part of a premarket notification to establish substantial equivalence.

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

This information is not provided in the document. The animal testing results would likely be evaluated by veterinary or medical experts, but their number and qualifications are not disclosed.

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

This information is not provided in the document.

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:

This is not applicable. The device is an embolization microcoil, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

6. 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, not an algorithm.

7. The type of ground truth used:

• Wire Tensile Testing & Coil Tensile Testing: Mechanical measurements against engineering specifications.
• Animal Testing: Outcomes data based on direct observation of arterial damage or coil migration in a porcine model. This would be observed and assessed by researchers/veterinarians.

8. The sample size for the training set:

There is no training set mentioned for this device. The tests described are performance verification tests. The device is a physical medical device, not an algorithm that requires a training set.

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

As there is no training set, this question is not applicable.

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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 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, 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, 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 microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical. 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 device in this submission includes design changes only to the Device Positioning Unit (DPU) element of the microcoil system. There are no modifications to the microcoil components or to the EnPOWER Detachment Control system.

This document describes the premarket notification (510(k)) for the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems. The submission focuses on design changes to the Device Positioning Unit (DPU) element of the microcoil system, emphasizing that there are no modifications to the microcoil components or the detachment control system.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established as "PASS," indicating that the samples met the predetermined criteria for each test. Specific quantitative criteria are not explicitly detailed in this summary.

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

The document states that testing was conducted using "statistical sampling methods as required by the Codman & Shurtleff, Inc. Design Control procedures." However, specific numerical sample sizes for each test are not provided.

The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, being a premarket notification to the U.S. FDA, it can be inferred that the testing was conducted to meet U.S. regulatory standards, likely in a controlled laboratory environment. The testing is bench testing and biocompatibility testing, not human clinical data.

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

This information is not applicable as the studies described are bench tests and biocompatibility tests, not clinical studies involving human patients or expert interpretation of diagnostic images/data. The "ground truth" for these tests is defined by the technical specifications and performance requirements of the device, assessed through quantitative measurements and established protocols.

4. Adjudication Method for the Test Set

This information is not applicable for the bench and biocompatibility tests described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "A clinical study was not required as appropriate verification and validation of the modified Device Positioning Unit (DPU) was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing." Therefore, there is no effect size for human reader improvement with or without AI assistance.

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

This question is not applicable. The device described is a physical medical device (microcoil delivery system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the performance verification testing, the ground truth is established by engineering specifications, direct physical measurements, and adherence to established industry standards and regulatory guidance documents (e.g., ISO, FDA Guidance Document: "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices").
For biocompatibility testing, the ground truth is defined by established international standards (ISO 10993 series) and USP (United States Pharmacopeia) guidelines for biological response within acceptable limits.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical device.

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The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the Cystatin-C analyte.

The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) Premarket Notification for a Linearity LQ Cystatin-C quality control material (device). The goal of the submission is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Level A: 0.584-0.714 (Target 0.649)
• Level B: 2.09-2.56 (Target 2.33)
• Level C: 3.69-4.51 (Target 4.10)
• Level D: 5.08-6.21 (Target 5.65)
• Level E: 6.44-7.87 (Target 7.15) |
  | Non-reactivity for Infectious Disease Markers | Human-origin materials used must be tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2. | Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2. |

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

This document describes a quality control material used for linearity, calibration verification, and reportable range for a specific analyte (Cystatin-C). It's not a diagnostic device with a "test set" in the traditional sense of patient data.

• Test Set Description: The "test set" here refers to the actual device (Linearity LQ Cystatin-C) which comes in five levels (A, B, C, D, E) of a liquid material. Each level contains 1ml.
• Sample Size:
  • For stability studies: Vials from two lots of finished product were used for real-time stability (stored at 2-8℃ and -80℃). Measurements were taken at two different time points. The analyte values from these vials were tested in duplicate.
  • For value assignment: The Cystatin-C analyte was measured multiple times.
• Data Provenance: The document does not specify the country of origin of the data. The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA. These are prospective studies performed to characterize the device's stability and assigned values.

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

This type of device (quality control material) does not typically involve human "experts" establishing a ground truth for a test set in the way a diagnostic algorithm for medical images would. Instead, the ground truth (target concentration values) is established through technical laboratory measurements.

• Number of Experts: Not applicable.
• Qualifications: Not applicable. The "ground truth" (target values) is established through analytical testing methods on a specific instrument.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is not a diagnostic device where patient cases are reviewed and adjudicated. The "ground truth" (target analyte concentrations) for the quality control material is inherent to its formulation and confirmed through laboratory measurements.

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 quality control material, not an AI-powered diagnostic device, and therefore no MRMC study was conducted or relevant.

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

Not applicable. This is a laboratory quality control material, not an algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for this device, the Audit® MicroControls™ Linearity LQ Cystatin-C, is analytical reference measurement. Specifically:

• Analyte Value Assignment: "The mean value of the Cystatin-C analyte was used to establish target concentration value at each level." This refers to the measured concentration on a reference instrument (Beckman Immage) using a specific reagent.
• Stability: Measured values at different time points and storage conditions are compared against initial or expected values established through analytical testing.

8. The Sample Size for the Training Set

Not applicable. This is a quality control material, not a machine learning algorithm, and therefore does not have 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, the concept of establishing ground truth for it does not apply.

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The Linearity FD Tumor Markers II is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3).

The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity FD Tumor Markers II product is an in-vitro diagnostic device consisting of two sets of five levels of liquid, linearity/QC material. Set 1 contains the analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigentotal (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), and Carbonic Anhydrase 27-29 (CA27-29) (BR) and additives in human serum. Set 2 contains the analytes: free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3) and additives in human serum and bovine serum. For each set there are five levels labeled A, B, C, D and E. Both sets contain 1ml for each level. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

This document is a 510(k) summary for the Audit® MicroControls™ Linearity FD Tumor Markers II, a quality control material. It describes the device's intended use and compares it to a predicate device (K082717 Audit® MicroCV™ Tumor Markers Linearity Set). The primary focus of the performance data section is on stability studies and value assignment, not diagnostic accuracy or comparative effectiveness with human readers.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document outlines acceptance criteria for stability (shelf life and reconstituted vial stability) and expected value ranges for various analytes.

Acceptance Criteria and Reported Device Performance

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 does not specify a "test set" in the context of diagnostic accuracy. The performance data focuses on stability and value assignment of the quality control material itself.
  • For accelerated stability, it mentions "All supporting data is retained on file at Aalto Scientific, Ltd." but doesn't quantify the number of samples or lots.
  • For real-time stability, it states "Vials from two lots of finished product are stored at 2-8℃ (real time vials) and -80℃ (Dayl vials). Samples are taken at two different time points."
  • For value assignment, it mentions each analyte was "measured multiple times" on specific instruments (Siemens Advia Centaur and Abbott Architect i1000SR).
• Data Provenance: The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA, USA. The data would therefore be considered prospective as it relates to the manufacturing and testing of their product. The matrix for the product uses "Human Based Serum and bovine based serum," but this refers to the components of the QC material itself, not patient samples.

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 section is not applicable to this document. The device is a quality control material, not a diagnostic device that requires expert interpretation of results for ground truth. The "ground truth" for the QC material is its assigned target values based on measurements by calibrated instruments and established reference methods (implied through the use of specific analyzers and reagents).

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

This section is not applicable. There is no "test set" in the context of diagnostic 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

This section is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a quality control material, not an algorithm. What might be considered "standalone performance" for this device is its ability to maintain its assigned values over time (stability) and the accuracy of its initial value assignments, which are demonstrated through the described studies.

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

For this quality control material, the "ground truth" is established through:

• Reference Instrument Measurement: Analytes were measured multiple times on specific, high-precision clinical chemistry analyzers (Siemens Advia Centaur and Abbott Architect i1000SR) using corresponding reagents. These instruments themselves are calibrated against established reference standards.
• Mean Value Calculation: The mean value of multiple measurements for each analyte at each level was used to establish the "target concentration value."

8. The sample size for the training set

This section is not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the conventional sense. The development of the QC material involves formulation and initial testing, but not machine learning training.

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

This section is not applicable for the same reasons as point 8.

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