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Geo Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit cement-retained prosthesis in the mandible or maxilla. Geo Abutments are compatible with the following implants. All digitally designed custom abutments for use with Geo Abutments are to be sent to a GeoMedi Co. Ltd. validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Geo Abutment from GeoMedi Co., Ltd. a line of titanium base abutments (identified as Multibase) and machinable blank abutments (identified as CMFit) to interface with compatible dental implants from four (4) manufacturers, and a total of seven (7) implant-abutment connections. The compatible implant body diameters range from 3.0 mm to 8.0 mm. The subject device prosthetic platform diameters range from 4.0 mm to 4.6 mm. All patient-specific abutments prepared from subject device Geo Abutment are to be manufactured at a GeoMedi validated milling center.

Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). They are not intended for angulation correction, as the design parameters for the superstructure are restricted to straight abutments only.

These abutments are made of titanium alloy (Ti-6Al-4V) with a titanium nitride (TiN) coating on the coronal portion of the external surface, not including the implant-abutment interface.

The Geo Multibase abutment and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory or separately, for the clinician to bond together chairside, using the cement required in the labeling (3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP).

All patient-specific custom zirconia superstructure fabrication is by prescription on the order of the clinician.

The design parameters for zirconia superstructures to be used with Geo Multibase abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height of the superstructure – 0 mm (Geo Multibase abutments have minimum gingival height of 1.0 mm)
• Maximum gingival height – 5.0 mm
• Maximum angle – 0° (straight only)

All zirconia copings (superstructures) for use with the subject device Geo Multibase abutment will be made at a GeoMedi Co., Ltd. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engaging connections.

All patient-specific abutment fabrication is by prescription on the order of the clinician. The design parameters for all CMFit patient-specific abutments are:

• Minimum wall thickness – 0.65 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 5.0 mm
• Maximum angle – 30°

Manufacture of the Geo Abutment CMFIT patient-specific abutment is to be performed at an GeoMedi Co., Ltd. validated milling center.

The provided text is a 510(k) clearance letter for a dental implant abutment, not an AI/ML medical device where performance characteristics like sensitivity, specificity, or reader studies are typically discussed.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

• Indications for Use (IFU) comparison: Showing that the intended use of the Geo Abutment is the same as already cleared devices (supporting prosthetic devices in edentulous patients, compatible with various implants).
• Technological characteristics comparison: Detailing similarities in design, materials (titanium alloy, TiN coating, zirconia for superstructures), manufacturing processes (CAD/CAM, milling center), mechanical properties, and sterilization methods.
• Non-clinical performance data: This section lists types of tests conducted (e.g., mechanical testing per ISO 14801, shear/tension testing per ASTM F1044/F1147, sterilization validation per ISO 17665-1/2, biocompatibility per ISO 10993-5/12) to ensure the device meets safety and performance standards equivalent to the predicate. However, it does not provide acceptance criteria or specific numerical results from these tests. It only states that these tests were done to "demonstrate that the subject devices... have sufficient strength for the intended use" and "characterize the mechanical properties."

Therefore, based on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This detailed information is typically part of the test reports submitted to the FDA, but not usually summarized in the publicly available 510(k) clearance letter or summary in this level of detail (i.e., the specific pass/fail thresholds and the measured values for each test). The document only states what was tested and the conclusion that it demonstrated "sufficient strength."
2. Sample sizes used for the test set and the data provenance: This information is not present in the 510(k) summary. These details would be in the specific test protocols and reports.
3. Number of experts used to establish the ground truth... and their qualifications: This is not applicable as this is a physical device, not an AI/ML diagnostic aid requiring human expert annotation for ground truth.
4. Adjudication method for the test set: Not applicable for this type of device.
5. MRMC comparative effectiveness study: Not applicable for a physical dental abutment. This is typically for AI/ML diagnostic devices.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable for a physical device.
7. The type of ground truth used: For a physical device like a dental abutment, "ground truth" relates to material properties, mechanical strength, dimensional accuracy, and biocompatibility, as demonstrated through engineering tests and material characterization, not clinical outcomes or expert consensus in an AI sense. The document refers to ISO and ASTM standards, which define the test methods and what constitutes acceptable performance (the "ground truth" for material and mechanical properties).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document demonstrates substantial equivalence for a physical dental device through comparison to predicate devices and adherence to established engineering and material standards, rather than through clinical study formats typically seen for AI/ML diagnostic tools.

To answer your question, if this were an AI/ML device document, the "acceptance criteria" and "reported device performance" would typically be found in sections describing performance metrics like:

• Sensitivity, Specificity, Accuracy
• Area Under the Receiver Operating Characteristic (ROC) Curve (AUC)
• Positive Predictive Value (PPV), Negative Predictive Value (NPV)
• F-score or Dice coefficient (for segmentation tasks)
• Comparison to a "clinical standard of care" or "expert performance."

And the "study that proves the device meets the acceptance criteria" would be a clinical validation study (often a retrospective or prospective reader study or a standalone algorithm performance study) with clearly defined ground truth, reader qualifications, and statistical analysis. None of these elements are present because the device is a physical dental abutment.

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Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.

Geon Nasal Aspirator, model S2, is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geon (S2) Nasal Aspirator is intended for over-the-counter (OTC) use at home environment. The main principle of operation is to utilize a pump to generate negative pressure in the suction system, which allows nasal secretions to flow into the device container.

The Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a separate "test set" in the context of clinical or comparative studies with a patient population. Instead, the performance evaluations were conducted through verification testing of the device's technical specifications.

• Sample Size: The document doesn't explicitly state the number of units tested for suction vacuum and noise. However, it indicates that "For Model S2, no individual differences exceed the spective tolerance of suction vacuum and noise after the cleaning and disinfection procedure," implying multiple units or multiple measurements were taken to confirm consistency.
• Data Provenance: The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as the testing described appears to be bench-top engineering verification rather than a clinical study.

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

Not applicable. The ground truth for this device's performance is based on engineering specifications and direct physical measurements (suction vacuum and noise levels) rather than expert interpretation of clinical findings.

4. Adjudication Method for the Test Set:

Not applicable. As a bench-top engineering verification, there was no subjective judgment from experts requiring an adjudication method. The measurements against the specified tolerances determined success or failure.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The Geon (S2) Nasal Aspirator is a therapeutic/extraction device, and its performance is evaluated based on physical parameters like suction and noise, not diagnostic accuracy requiring human interpretation.

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

Yes, the testing described is a standalone performance evaluation of the device. The device's performance (suction vacuum and noise) was measured directly on the device itself without human intervention in operating it beyond standard use, or human interpretation of outputs.

7. Type of Ground Truth Used:

The ground truth used was engineering specifications and direct physical measurements. The device's suction vacuum was measured in kPa and its noise level in dB, and these measurements were compared against pre-defined tolerance ranges established by the manufacturer.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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Geonic Nasal Aspirator (Model Name: AH2, S1) and Geonic Nasal Cleaner (Model Name: H2) are hand-held, noninvasive, electronic medical devices that pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geonic Nasal Cleaner (Model Name: H2) additionally provide positive pressure to moisturize the nasal cavities by using saline solution in the form of spray for adults and pediatrics (3 years old). The nasal aspirator and nasal cleaner are intended for over-the-counter (OTC) use at home environment.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is an FDA 510(k) clearance letter for the "Geonic Nasal Aspirator" and "Geonic Nasal Cleaner," which grants market authorization based on substantial equivalence to predicate devices, rather than an evaluation of specific performance metrics against pre-defined acceptance criteria.

The document includes:

• Device Name and Regulation Information
• Indications for Use: Describes the intended use of the devices (removing nasal secretions and mucus from children for the aspirator, and additionally moisturizing nasal cavities for the cleaner).
• Type of Use: Specifies Over-The-Counter (OTC) use.

It does not provide the following information from your request:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery.

The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System consists of anatomically contoured, lowprofile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking Extremity Plating System (EPS) screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. Screws lengths are offered in 10-40mm for the 2.7mm diameter plate screws and in 10 – 60mm in 3.5mm and 4.0mm diameter plate screws. All components (implants and the associated instruments) are provided sterile and for single use only.

The provided document does not describe an AI/ML device or software. It pertains to the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System, which is a metallic bone fixation appliance used for surgical fusion in the foot.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable and cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and engineering analysis for a physical medical implant.

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The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.

The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.

The provided text does NOT contain information regarding the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria for an AI/ML medical device.

The document is a 510(k) premarket notification for a physical medical device called the "GEO Bone Screw System." It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K161904).

Therefore, I cannot provide the requested information. The document explicitly states:

"No additional performance testing was required. The GEO Bone Screw System components have been subjected to design controls and previously tested to appropriate device-specific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device system."

This indicates that no new studies were conducted to prove this specific submission of the device met acceptance criteria, but rather it relies on prior testing of its predicate device and general design controls.

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The GEO 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion or revision surgery.

The GEO 188 MTP Joint Arthrodesis Plating System consists of anatomically contoured, low- profile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. All screws are offered in lengths of 10-40mm. The system also includes associated instrumentation consisting of plate tacks, quide-wire, drill bit, drill bit, drill guides (locking and non-locking), AO driver tip, reamers, depth gauge, non-locking drill guide handle, AO driver handle, and templates for plate and reamer sizing. All GEO 1ª MTP Joint Arthrodesis Plating System components (implants and instruments) are provided sterile and for single use only.

This document is a 510(k) premarket notification for a medical device called the "GEO 1st MTP Joint Arthrodesis Plating System." As such, it describes a mechanical device for internal fixation of bones, not a software algorithm or AI-powered diagnostic tool. Therefore, the questions related to AI/algorithm performance, such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training sets, are not applicable to the content provided.

The performance data section for this type of device focuses on physical and mechanical testing to ensure its safety and effectiveness when used for bone fixation.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document highlights compliance with these standards and concludes substantial equivalence, implying the device met the performance requirements outlined in these standards. Specific numerical results or pass/fail thresholds against explicit acceptance criteria are not detailed in this summary document.

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

Not applicable for this type of mechanical device testing. The testing would involve physical samples of the plates and screws, not patient data.

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

Not applicable. Ground truth for a mechanical device is established through physical and mechanical testing against recognized standards.

4. Adjudication method for the test set

Not applicable. Mechanical testing is typically objectively measured against established engineering standards.

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, as this is a mechanical bone fixation device, not an AI or diagnostic imaging device.

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

Not applicable, as this is a mechanical bone fixation device, not an algorithm.

7. The type of ground truth used

For a mechanical device, the "ground truth" is typically defined by the established performance requirements and specifications outlined in the referenced ASTM standards (ASTM F382-17-17 and ASTM F543-17). These standards detail specific tests (e.g., bending strength, fatigue, pull-out strength for screws) and criteria that the device must meet.

8. The sample size for the training set

Not applicable, as this is a mechanical bone fixation device, not an AI or machine learning model that requires a training set.

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

Not applicable.

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Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.

This document is a 510(k) summary for the Geomed Vascular Dilators, a surgical instrument. It is NOT for an AI/ML powered device, therefore most of the requested information regarding AI/ML studies is not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) are not detailed in this summary. The summary states that "Acceptance criteria were met for all tests performed," implying that the device successfully passed these tests.

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

The document does not specify the sample sizes for the individual tests (tensile strength, dimensional verification, cleaning, sterilization, drying time). The data provenance is not explicitly mentioned but can be inferred as internal testing performed by the manufacturer, Geomed Medizin-Technik GmbH & Co. KG, as part of their 510(k) submission. These are device performance tests, not clinical studies with human data.

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

This information is not applicable as this is not a study involving human interpretation of data or a clinical study. The "ground truth" for these tests would be established by engineering specifications, validated cleaning protocols, and sterilization standards.

4. Adjudication method for the test set

This information is not applicable for device performance testing. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in observations or diagnoses.

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 information is not applicable. The device is a physical surgical instrument (vascular dilator), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm.

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

For the device performance tests, the "ground truth" is based on:

• Engineering specifications and standards: For tensile strength and device dimensions.
• FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (03/17/2015): For cleaning and sterilization validation.
• Established industry standards for sterilization and drying: For sterilization and drying time validation.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model being trained.

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

This information is not applicable. There is no "training set" for this type of device submission.

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The GEO Staple System is intended for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis.

The GEO Stable System consists of symmetric, barbed and smooth, superelastic Nitinol allov compression bone staples in varying lengths and widths. The System also includes associated instrumentation consisting of a stable inserter, drill bit and locator pins. The nitinol implant material conforms to ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. GEO Staples are offered in widths ranging from 8mm – 25mm. To facilitate implantation, GEO Staples are provided preloaded in the Staple Inserter. All GEO Staple System components (implants and instruments) are provided sterile and for single use only.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "GEO Staple System" does not contain any information about a study involving software or AI performance, acceptance criteria for such a study, or details about ground truth establishment or expert involvement.

The document is purely related to the clearance of a physical medical device (bone staples) and its equivalence to predicate devices based on material properties, mechanical testing, and biocompatibility.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the context of an AI/software-driven medical device. The information you are asking for (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) is not present in this document, as it pertains to the validation of a different type of medical device (AI/Software as a Medical Device).

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The George King Coumadin® Plasma is an assayed control plasma derived from a single donor on Coumadin® therapy and is intended for in vitro diagnostic use in monitoring the accuracy of the coagulation analyzer and thromboplastin using the clottable prothrombin time/INR on an optical instrument with appropriate commercial reagents. George King Coumadin® Plasma may be used when evaluating a new lot of thromboplastin reagent or new coagulation analyzer.

Each lot of George King Coumadin® Plasma is from a single human donor stabilized on at least 6-weeks of Coumadin® therapy. The donor plasma is obtained via plasmapheresis using 4.0% sodium citrate and frozen immediately at -70°C.

The INR of the donor plasma is determined using the ACL Top 500 using RecombiPlastin 2G and each plasma is then categorized into one of the three INR levels of control material based on the testing results obtained using the following INR calculation: INR = (Patient PT / Mean of normal range) ISI.

Level 1 - INR Control: 1.5-2.8
Level 2 - INR Control: 2.9-4.0
Level 3 - INR Control: >4.0

The George King Coumadin® Plasma is an assayed control plasma for in vitro diagnostic use in monitoring the accuracy of coagulation analyzers and thromboplastin using the clottable prothrombin time/INR.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Study: For each of the three INR ranges, three different lots of GK Coumadin® Plasma were tested. For each lot, 80 replicates (n=80) were analyzed (20 days with 2 runs per day and 2 replicates per run). The study was conducted in-house. Data provenance is therefore in-house, prospective testing.
• Reproducibility Study: For each of the three INR ranges, three different lots were tested. For each lot, samples were assayed for 5 days, one run per day, for a total of N=75 samples. This study was performed across three different clinical laboratories, implying prospective, external data, presumably from the US.
• Stability Studies: Three lots of GK Coumadin® Plasma were used for both open vial and shelf-life stability studies. Data provenance is in-house, prospective testing.

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

This information is not provided in the document. The studies conducted are analytical performance studies (precision, reproducibility, stability) for a control plasma, not diagnostic accuracy studies that rely on expert ground truth. The "ground truth" here is the measured INR or Prothrombin Time value.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are analytical performance studies of a control material and do not involve human diagnostic interpretation or adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The George King Coumadin® Plasma is a control material for laboratory instruments.

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

Yes, the studies presented (precision, reproducibility, stability) evaluate the performance of the device (George King Coumadin® Plasma) in a standalone manner, as measured by laboratory instruments (ACL TOP series) using specified reagents (RecombiPlastin 2G). There is no "human-in-the-loop" component being evaluated for the performance of the device itself; rather, it is a control used to monitor the accuracy of an instrument.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance studies is the measured INR and Prothrombin Time values obtained from the specified laboratory instruments and reagents. For the initial categorization of donor plasma into INR levels, the INR was determined using the ACL Top 500 and RecombiPlastin 2G.

8. The Sample Size for the Training Set

There is no explicit mention of a separate "training set" in the provided document. The development of a control plasma does not typically involve a machine learning algorithm that is trained on a dataset. The document describes the manufacturing and analytical validation of a control material.

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

As there is no explicit training set mentioned for an algorithm, the concept of "ground truth for the training set" is not applicable in the context of this device. The INR of the donor plasma is determined by standard laboratory methods using a calibrated instrument for categorization into control levels.

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