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The Seguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.

The Seguin Annuloplasty Ring (SARP) is a semi-rigid or semi-flexible annuloplasty ring designed to support mitral valve repair. The ring is constructed from a polyethylene core covered by a knitted polyester sewing cuff. The Seguin Ring is sterilized by EO sterilization and supplied sterile. The Seguin ring is offered in sizes 24-40mm in increments of 2 mm.

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The Glucose2 assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ARCHITECT c System.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Glucose2 assay is an automated clinical chemistry assay.

Glucose is phosphorylated by hexokinase in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to its reduced form (NADPH). One micromole of NADPH is produced for each micromole of glucose consumed. The NADPH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.

Methodology: Hexokinase/G6PDH

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The Amplatzer™ Guidewire is intended to facilitate the introduction and exchange of a delivery system or catheter within the vasculature and chambers of the heart.

The Amplatzer™ Guidewire is 0.035-inch in diameter and made of a stainless steel core and a full length stainless steel spring coil coated with low-friction polytetrafluoroethylene (PTFE). The stainless steel core extends to the distal tip of the guidewire for one model (9-GW-001). Two models (9-GW-002 and 9-GW-003) have a stainless steel core that does not extend to the distal end of the wire. These models have an additional ribbon wire that runs parallel to the stainless steel core and extends to the distal end of the guidewire. The stainless steel core for all three models is tapered at the distal end of the guidewire to provide a smooth transition to the distal floppy segment.

The guidewires are available in two working lengths, 260 cm (9-GW-001 and 9‑GW‑002) and 300 cm (9-GW-003). The distal tip of the guidewire is available in two designs: a Modified J-Tip (9-GW-001) and a J-Tip (9-GW-002 and 9-GW-003). The J-straightener can be used to straighten the distal tip for all models. Model 9-GW-003 can also be manually straightened. The guidewire is sterile and for single use only.

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The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.

The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.

The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV.

Alinity m HCV is an in vitro polymerase chain reaction (PCR) assay for both the detection and quantitation of HCV RNA in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals.

This device is similar to the predicate device originally approved (PMA P190025) with the exception that the subject device may use a new DNA Polymerase as an alternative to the original DNA Polymerase and a new Reverse Transcriptase as an alternative to the original Reverse Transcriptase in the reagent formulation of the assay. This formulation difference does not introduce any changes to sample processing, assay procedure, or data reduction.

Additional studies were initiated to support the formulation of the assay with alternative DNA Polymerase and Reverse Transcriptase. Supplemental data from these studies were used with data previously obtained from the analytical and clinical testing studies submitted in P190025.

The steps of the Alinity m HCV assay consist of sample preparation, real-time PCR assembly, amplification/detection, result calculation, and reporting. All steps of the Alinity m HCV assay procedure are executed automatically by the Alinity m System. Manual dilutions may be performed for low-volume specimens to meet the minimum volume requirement and for high-titer specimens above the upper limit of quantitation (ULoQ). The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m HCV assay in parallel with other Alinity m assays on the same instrument.

Alinity m HCV requires three separate assay specific kits as follows:

• Alinity m HCV AMP Kit (List No. 08N50-095), consisting of 2 types of multi-well assay trays. The amplification trays (AMP Trays) contain lyophilized, unit-dose RT-PCR amplification/detection reagents and lyophilized, unit-dose IC in separate wells, and the activation trays (ACT Trays) contain liquid activation reagent. The intended storage condition for the Alinity m HCV AMP Kit is 2°C to 8°C.

• Alinity m HCV CTRL Kit (List No. 08N50-085), consisting of negative controls, low positive controls, and high positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m HCV CTRL Kit is –25°C to –15°C.

• Alinity m HCV CAL Kit (List No. 08N50-075), consisting of 2 calibrator levels, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m HCV CAL Kit is –25°C to –15°C.

HCV RNA from human plasma or serum is extracted automatically on-board in the Alinity m System using the Alinity m Sample Prep Kit 2, Alinity m Lysis Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with liquid unit-dose Alinity m HCV activation reagent and lyophilized unit-dose Alinity m HCV amplification/detection reagents and transferred into a reaction vessel. Alinity m Vapor Barrier Solution is then added to the reaction vessel which is then transferred to an amplification/detection unit for PCR amplification, and real-time fluorescence detection of HCV targets.

At the beginning of the Alinity m HCV sample preparation process, a lyophilized unit-dose IC on the AMP Tray is rehydrated by the Alinity m System and delivered into each sample preparation reaction. The IC is then processed through the entire sample preparation and real-time PCR procedure along with the specimens, calibrators, and controls to demonstrate proper sample processing and validity.

The Alinity m HCV amplification/detection reagents consist of enzymes, primers, probes, and activation reagents that enable reverse transcription, polymerization, and detection.

An HCV calibration curve is required for determination of HCV RNA concentration. Two levels of calibrators are processed through sample preparation and RT-PCR to generate the calibration curve. The concentration of HCV RNA in specimens and controls is then calculated from the stored calibration curve.

Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remains satisfactory. During each control event, a negative control, a low-positive control, and a high-positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens.

The Alinity m HCV assay also utilizes the following:

• Alinity m HCV Application Specification File, (List No. 08N50-03B)
• Alinity m System and System Software (List No. 08N53)
• Alinity m Sample Prep Kit 2 (List No. 09N12-001)
• Alinity m Specimen Dilution Kit I (List No. 09N50-001)
• Alinity m System Solutions, (List No. 09N20):
  • Alinity m Lysis Solution (List No. 09N20-001)
  • Alinity m Diluent Solution (List No. 09N20-003)
  • Alinity m Vapor Barrier Solution, (List No. 09N20-004)
• Alinity m Tubes and Caps (List No. 09N49):
  • Alinity m LRV Tube (List No. 09N49-001)
  • Alinity m Transport Tubes Pierceable Capped (List No. 09N49-010)
  • Alinity m Transport Tube (List No. 09N49-011)
  • Alinity m Pierceable Cap (List No. 09N49-012)
  • Alinity m Aliquot Tube (List No. 09N49-013)

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EnSite™ X EP System

The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

EnSite™ X EP System Contact Force Software License

When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ X EP System Surface Electrode Kit

The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

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The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.

The Assert-IQ™ ICM is designed to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review. The Assert-IQ ICM system, cleared under K230286 on May 17, 2023, includes implantable and remote care components. The implantable components include the Assert-IQ™ ICM device models DM5000, DM5300, or DM5500. The remote care portion consists of the Merlin.net™ Software model MN7000 and myMerlin™ mobile apps (Android (APP1000) and iOS (APP1001)).

The subject of this premarket notification is the integration of two new artificial intelligence (AI) algorithms utilizing machine learning (ML) techniques for the evaluation of atrial fibrillation (AF) and Pause episodes within the Assert-IQ™ ICM remote care component, Merlin.net MN7000. The goal of the AI-enabled function in Merlin.net is to reduce non-actionable clinical review burden due to false Pause and false AF episodes presented for clinician review. Specifically, this premarket submission pertains to the addition of the proposed deep neural network AI models as integrated sub-components of the Merlin.net software, MN7000, resulting in MN7000 version v2.0. There are no other proposed changes to the Assert-IQ device hardware, device firmware, device detection algorithms or other components of the system cleared in K230286.

The two new AI algorithms (CARE: Classification using AI for Rhythm Evaluation) classify AF and pause EGM episodes detected by Assert-IQ ICM devices as either true or false detection. Episodes classified as "true" will be retained in the transmission data and displayed to clinicians for review in Merlin.net web application, whereas episodes classified as "false" will be removed and not displayed to the user. These two AI algorithms, CARE-AF and CARE-Pause, are designed to significantly reduce false episodes, while maintaining true arrhythmic episodes detected by the Assert-IQ devices.

Here's a summary of the acceptance criteria and study details for the Assert-IQ ICM System with AI, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The core purpose of the AI algorithms (CARE-AF and CARE-Pause) is to reduce non-actionable clinical review burden due to false pause and false AF episodes while maintaining true arrhythmic episodes. The acceptance criteria are therefore focused on "relative sensitivity" and "false positive reduction."

Study Details

The document describes two primary studies for assessing the performance of the AI algorithms:

1. Retrospective Observational Cohort Study (for independent AI algorithm performance)

• Sample Size (Test Set):
  • CARE-Pause: 1498 Assert-IQ ICM patients
  • CARE-AF: 911 Assert-IQ ICM patients
• Data Provenance: Retrospective, observational cohort study. Patients were from 504 clinics across the United States (for CARE-Pause) and 360 clinics across the United States (for CARE-AF). Data was from Assert-IQ ICM patients who had AF or Pause detection over 30 days of remote monitoring post device implant.
• Number of Experts & Qualifications: Not explicitly stated. The document refers to "the overall system performance of Assert IQ with CARE-AF is assessed using data collected from the Assert-IQ post-market study (NCT06172699) comparing device detection against a Holter monitor." For the retrospective study, the ground truth establishment method implies expert review, but the number and qualifications of these experts are not provided.
• Adjudication Method: Not explicitly stated. The description mentions "AF and Pause EGM episodes detected by Assert-IQ ICM devices as either true or false detection," implying expert review to establish ground truth for these episodes. The method of achieving consensus among experts for this ground truth is not detailed (e.g., 2+1, 3+1).
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This study focuses on standalone AI algorithm performance relative to the predicate device's detections, and then overall system performance without explicit human-in-the-loop comparison.
• Standalone Performance: Yes. The "relative sensitivity" and "false positive reduction" metrics directly assess the independent performance of the AI algorithms (CARE-AF and CARE-Pause) in classifying episodes as true or false, relative to the existing device detection. The "overall system performance" metrics also reflect the algorithm's influence on the final output presented to clinicians.
• Type of Ground Truth: The ground truth for individual episodes was established by classifying EGM episodes as "true" or "false." This likely refers to expert consensus interpretation of the EGM data, but this is not explicitly detailed.
• Sample Size (Training Set): Not provided in the text. The document only states that "Patients whose ICM data have been utilized in algorithm training and preliminary performance evaluation were completely excluded from this study" (referring to the test set).
• Ground Truth for Training Set: Not provided in the text. It can be inferred that ground truth was established for training data in a similar manner to the test set, likely through expert review of EGM episodes.

2. Assert-IQ Prospective, Multicenter Post-Market Study (NCT06172699) - for Overall System Performance of CARE-AF

• Sample Size (Test Set): 151 patients enrolled, with 135 patients having analyzable data.
• Data Provenance: Prospective, multicenter post-market study (NCT06172699). Patients had symptomatic, drug-refractory paroxysmal or persistent AF.
• Number of Experts & Qualifications: Not explicitly stated.
• Adjudication Method: Not explicitly stated. The study compared Assert-IQ ICM AF detection against Holter assessment (up to 7 days per patient). This indicates that the Holter assessment served as a primary reference for ground truth for AF detection, likely interpreted by experts.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, not explicitly described as such. The study compares the Assert-IQ system with CARE-AF against Holter assessment, not human readers with and without AI.
• Standalone Performance: The "overall system performance" metrics for Assert-IQ with CARE-AF from this study represents the performance of the algorithm-enhanced system.
• Type of Ground Truth: Holter assessment (likely interpreted by experts) served as the ground truth comparator for AF detection.
• Sample Size (Training Set): Not provided.
• Ground Truth for Training Set: Not provided.

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The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

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The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

The provided FDA 510(k) clearance letter for the EnSite™ X EP System (K251234) details the device's regulatory pathway and general testing conducted. However, it does not contain the specific information required to populate a table of acceptance criteria and reported device performance. It focuses on the regulatory aspects, substantial equivalence to a predicate device, and the general types of testing performed (e.g., software verification, amplifier design verification, system design validation) to demonstrate that the device meets user requirements and its intended use.

The document states: "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., a numerical threshold for accuracy or precision) and the reported device performance values against those criteria are not presented in this public clearance letter.

Similarly, the letter does not provide details regarding:

• Sample sizes used for test sets (beyond stating "design verification" and "system design validation" were performed).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for any test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How ground truth for the training set was established.

This type of detailed performance data is typically found within the confidential 510(k) submission itself, not routinely published in the public clearance letter.

Therefore,Based on the provided FDA 510(k) clearance letter for the EnSite™ X EP System, the following information can be extracted regarding the device's acceptance criteria and the study that proves it meets those criteria:

Key Takeaway: The provided FDA 510(k) clearance letter asserts that acceptance criteria were met through various design verification and validation activities, demonstrating substantial equivalence to a predicate device. However, it does not disclose the specific numerical acceptance criteria or the quantitative results of the device's performance against those criteria. The details below are based on what is stated or can be inferred from the document.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific numerical acceptance criteria and reported device performance data are not explicitly stated or detailed. The document generally states:

"Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."

And

"System Design Validation to confirm the system could meet user requirements and its intended use after modifications"

Without specific numerical cut-offs or performance metrics (e.g., accuracy, precision, error rates), a table cannot be populated as requested. The clearance indicates that internal testing demonstrated the device met pre-defined acceptance criteria, but those criteria and the actual performance results are not publicly available in this document.

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

• Sample Size Used for Test Set: Not specified in the provided document. The document mentions "Design verification activities" and "System Design Validation" but does not give the number of cases, patients, or data points used for these tests.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • (It's common for electrophysiology systems that ground truth would be established by electrophysiologists, but this document does not confirm that.)

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none)

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

• MRMC Study: No indication that an MRMC comparative effectiveness study was performed or required for this 510(k) clearance. The focus of this submission is on substantial equivalence to a predicate device, which often relies on non-clinical testing for software updates or minor changes, rather than clinical efficacy studies comparing human readers with and without AI assistance.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable/Not provided, as an MRMC study is not mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The document describes "Software Verification at unit, software and system level" and "Amplifier Design Verification," which are types of standalone-like algorithmic or component-level testing. However, the exact metrics and results for pure "algorithm-only" performance (e.g., for automated mapping or analysis features if present) are not detailed. The system is described as a "diagnostic tool" that "provides information" and "displays catheter location," implying human interaction is integral.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. Given the nature of an EP system, ground truth would likely involve a combination of:
  • Validated phantom models: For physical accuracy of catheter tracking and mapping.
  • Clinical expert consensus: For validating the interpretation of electrical activity and the accuracy of generated 3D maps or anatomical models.
  • Reference measurements: From other validated systems or direct measurements during testing.
  • The document implies ground truth was used for "Design verification" and "System Design Validation," which "confirm the system could meet user requirements."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. This 510(k) is for a software update (v5.0) to an existing system (EnSite™ X EP System, predicate K242016). The document describes changes related to compatibility with new catheters and ultrasound systems, rather than the development of entirely new AI/ML algorithms requiring a "training set" in the conventional sense of deep learning. While software is involved, the primary testing discussed is verification and validation, not model training.

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

• Ground Truth for Training Set Establishment: Not applicable/Not specified, as the document does not indicate the use of a "training set" in the context of machine learning model development. The 'ground truth' concept would apply more to the test and validation steps, as discussed in point 7.

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Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Epstein-Barr Virus (EBV) DNA in human EDTA plasma on the automated Alinity m System.

Alinity m EBV is intended for use as an aid in the management of EBV in transplant patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment.

The results from Alinity m EBV must be interpreted within the context of all relevant clinical and laboratory findings.

Alinity m EBV is not cleared for use as a screening test for donors of blood, blood products, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for EBV.

Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of EBV DNA in human plasma.

This device is similar to the predicate device originally cleared (K212778) with the exception that the subject device may use MomentaTaq DNA Polymerase as an alternative to KAPA2G DNA Polymerase in the reagent formulation of the assay. This formulation difference does not introduce any changes to sample processing, assay procedure, or data reduction.

Additional studies were initiated to support the formulation of the assay with MomentaTaq DNA Polymerase. Supplemental data from these studies were used with data previously obtained from the analytical and clinical testing studies submitted in K212778.

The steps of the Alinity m EBV consist of sample preparation, real-time PCR assembly, amplification/detection, result calculation, and reporting. All stages of the Alinity m EBV procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m EBV assay in parallel with other Alinity m assays on the same instrument.

Alinity m EBV requires three separate assay specific kits as follows:

• Alinity m EBV AMP Kit (List No. 09N43-095), consisting of 2 types of multi-well assay trays. The amplification trays (AMP TRAY 1) contain lyophilized, unit-dose PCR amplification/detection reagents and lyophilized, unit-dose IC in separate wells, and the activation trays (ACT TRAY 2) contain liquid unit-dose activation reagent. The intended storage condition for the Alinity m EBV AMP Kit is 2°C to 8°C.

• Alinity m EBV CTRL Kit (List No. 09N43-085), consisting of negative controls, low positive controls, and high positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m EBV CTRL Kit is –25°C to –15°C.

• Alinity m EBV CAL Kit (List No. 09N43-075), consisting of 2 calibrator levels, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m EBV CAL Kit is –25°C to –15°C.

EBV DNA from human plasma is extracted automatically on-board in the Alinity m System using the Alinity m Sample Prep Kit 2, Alinity m Lysis Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with liquid unit-dose Alinity m EBV activation reagent and lyophilized unit-dose Alinity m EBV amplification/detection reagents and transferred into a reaction vessel. Alinity m Vapor Barrier Solution is then added to the reaction vessel which is then transferred to an amplification/detection unit for PCR amplification, and real-time fluorescence detection of EBV targets.

At the beginning of the Alinity m EBV sample preparation process, a lyophilized unit-dose IC on the AMP Tray is rehydrated by the Alinity m System and delivered into each sample preparation reaction. The IC is then processed through the entire sample preparation and real-time PCR procedure along with the specimens, calibrators, and controls to demonstrate proper sample processing and validity.

The Alinity m EBV amplification/detection reagents consist of enzymes, primers, probes, and activation reagents that enable polymerization and detection.

An EBV calibration curve is required for determination of EBV DNA concentration. Two levels of calibrators are processed through sample preparation and PCR to generate the calibration curve. The concentration of EBV DNA in specimens and controls is then calculated from the stored calibration curve.

Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remains satisfactory. During each control event, a negative control, a low-positive control, and a high-positive control are processed through sample preparation and PCR procedures that are identical to those used for specimens.

The Alinity m EBV assay also utilizes the following:

• Alinity m EBV Application Specification File, (List No. 09N43-05B)
• Alinity m System and System Software (List No. 08N53-002)
• Alinity m Sample Prep Kit 2 (List No. 09N12-001)
• Alinity m Specimen Dilution Kit I (List No. 09N50-001)
• Alinity m System Solutions, (List No. 09N20):
  • Alinity m Lysis Solution (List No. 09N20-001)
  • Alinity m Diluent Solution (List No. 09N20-003)
  • Alinity m Vapor Barrier Solution, (List No. 09N20-004)
• Alinity m Tubes and Caps (List No. 09N49):
  • Alinity m LRV Tube (List No. 09N49-001)
  • Alinity m Transport Tubes Pierceable Capped (List No. 09N49-010)
  • Alinity m Transport Tube (List No. 09N49-011)
  • Alinity m Pierceable Cap (List No. 09N49-012)
  • Alinity m Aliquot Tube (List No. 09N49-013)

This document, K243489, is a 510(k) clearance letter for the Alinity m EBV assay, specifically focusing on the use of MomentaTaq DNA Polymerase as an alternative to KAPA2G DNA Polymerase. The primary goal of the studies described is to demonstrate that the device formulated with MomentaTaq DNA Polymerase performs equivalently to the previously cleared device formulated with KAPA2G DNA Polymerase (K212778).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes several additional studies conducted specifically for the MomentaTaq formulation, referring back to the K212778 submission for other characteristics.

• Limit of Detection (LoD):
  • Sample Size: For EBV type 1, tested dilutions with 3 lots of amplification reagents across multiple days. For 20 IU/mL, there were 142 replicates (47-48 per lot). Total replicates across all concentrations and lots were higher (e.g., 143 for 15 IU/mL, 142 for 100 IU/mL).
  • Data Provenance: Prepared in EBV negative human plasma using the 1st World Health Organization (WHO) International Standard for Epstein-Barr Virus. This suggests controlled laboratory samples.
• Linearity:
  • Sample Size: 16 panel members spanning the intended quantitation range.
  • Data Provenance: Prepared from plasmid DNA, cultured virus, and clinical specimens. The specific origin country for clinical specimens is not provided, but the use of the WHO International Standard points to internationally recognized reference material.
• Precision:
  • Sample Size: 8 panel members, with 270 replicates per panel member (3 lots x 3 operators x 15 days x 2 runs/day x 3 replicates/run, then averaged).
  • Data Provenance: Panel members prepared by diluting EBV-positive clinical specimens, EBV cultured virus, or synthetic DNA in human plasma. Quantitation traceable to the 1st WHO International Standard. Specific origin country not provided.
• Lower Limit of Quantitation (LLoQ):
  • Sample Size: Calculated from detected samples in the LoD study.
  • Data Provenance: Prepared in EBV-negative plasma using the 1st WHO International Standard.
• Clinical Reproducibility:
  • Sample Size: 9-member reproducibility panel (8 positive, 1 negative). 1 lot of kits used. Testing performed at 3 clinical sites on 5 non-consecutive days with 2 runs per day. 4 replicates of each panel member tested, ensuring a minimum of 3 valid replicates. For the positive panels, N ranged from 113 to 120. For the negative panel, N = 119 for all sites combined.
  • Data Provenance: Positive panel members were prepared using EBV positive clinical specimen, cultured virus, or plasmid DNA diluted in human EDTA plasma. Specific origin country for clinical specimens not provided.
• Clinical Performance (Method Comparison):
  • Sample Size: 124 samples with results within the common quantitation range of both assays.
  • Data Provenance: Samples used for method comparison between the MomentaTaq formulation and the KAPA2G formulation. Implies ex vivo clinical samples. Specific origin country not provided.

The studies for the MomentaTaq formulation are analytical performance studies and a method comparison to an already cleared device, not direct clinical outcome studies. They appear to be retrospective as they involve testing banked or prepared samples. The reference to "3 clinical sites" for reproducibility suggests a multi-site testing environment, but it's an analytical reproducibility study, not a clinical trial on patient outcomes.

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

The provided document does not mention the number or qualifications of experts used to establish ground truth for the test sets. The ground truth for quantitation appears to be established by:

• Using the 1st World Health Organization (WHO) International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques (NIBSC code 09/260) for LoD, Linearity, and LLoQ.
• Using EBV-positive clinical specimens, cultured virus, or plasmid DNA for precision and reproducibility, with quantitation traceable to the WHO standard.
• The "comparator" assay (on-market Alinity m EBV with KAPA2G DNA Polymerase) as a reference for clinical performance (method comparison).

For a quantitative viral load test, the ground truth is typically defined by reference materials (like WHO standards) or highly characterized samples, rather than by expert consensus on interpretation of results.

4. Adjudication Method for the Test Set

Given that the ground truth for these quantitative assays is based on reference standards and characterized samples, no expert adjudication method (like 2+1, 3+1, none) is described or would typically be applicable in this context. The output is a quantitative value, not a subjective interpretation.

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 more common for imaging diagnostics where human readers interpret results with and without AI assistance. This document describes an in vitro diagnostic (IVD) quantitative PCR assay, which is an automated device producing numerical results, not something that human readers interpret in the conventional sense of an MRMC study.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, effectively, all the studies described are standalone performance studies. The Alinity m EBV device is an automated system that performs sample preparation, PCR, detection, and result calculation without human intervention in the actual assay run. The performance metrics (LoD, linearity, precision, reproducibility, method comparison) directly evaluate the algorithm's ability to accurately quantify EBV DNA in samples. There is no "human-in-the-loop" component in the performance of the assay itself.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily based on:

• Reference Materials: The 1st World Health Organization (WHO) International Standard for Epstein-Barr Virus (NIBSC code 09/260) is extensively used for establishing and verifying the quantitative values of the panel members.
• Characterized Samples: EBV positive clinical specimens, cultured virus, and synthetic plasmid DNA where their concentrations are known or precisely determined relative to the WHO standard.
• Comparison to Predicate Device: For the method comparison study, the performance of the new MomentaTaq formulation is benchmarked against the FDA-cleared Alinity m EBV assay (K212778), which serves as a clinical reference.

This is a form of "expert consensus" on the value of reference materials and highly characterized samples, rather than pathology or outcomes data in the usual sense for IVDs.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the Alinity m EBV assay. Regulatory submissions like 510(k) clearances typically focus on the validation (test set) rather than the development and training data of the algorithm itself, especially for established PCR technologies that do not heavily rely on machine learning requiring distinct training sets in the same manner. This assay is based on PCR technology, where the "training" would involve optimizing reagent concentrations, primer/probe design, and thermocycling conditions, rather than training a machine learning model on a "training set" of patient data.

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

As mentioned above, specific "training set" details are not provided. For PCR-based assays, the "ground truth" during development (analogous to training) would involve:

• Known Viral Copies: Using synthetic nucleic acids or viral stock solutions with precisely quantified viral load to optimize assay components and parameters.
• Spiked Samples: Spiking known amounts of virus or viral nucleic acid into negative matrix (e.g., human plasma) to simulate different concentrations and evaluate early performance.
• Clinical Samples with Confirmed Status: Using retrospectively collected clinical samples with well-established EBV positive/negative status and viral loads determined by highly accurate laboratory methods or other validated assays to refine and confirm assay performance.

The development process would aim to ensure the assay accurately detected and quantified EBV DNA, aligning with established reference standards and biological knowledge of the virus.

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The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures.

The guide wires may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Hi-Torque Command™ 14 ST Guide Wire (guide wire with short taper) and Hi-Torque Command™ 14 MT Guide Wire (guide wire with medium taper) have a maximum diameter of 0.0144" (0.366 mm) and are provided in 210 cm and 300 cm lengths. The distal tip of the guide wire is available as a straight tip or an angled tip, both of which are shapeable.

The provided FDA 510(k) clearance letter pertains to guide wires, which are physical medical devices, not AI/software systems. Therefore, the questions related to AI/software performance (e.g., ground truth establishment, MRMC studies, training/test sets, expert adjudication) are not applicable to this document.

For a physical device like a guide wire, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to non-clinical performance testing to demonstrate that the device performs as intended and is substantially equivalent to a predicate device, ensuring its safety and effectiveness.

Here's an analysis based on the provided document for the guide wires:

Analysis of Acceptance Criteria and Performance for Abbott Medical Guide Wires (K250552)

The substance of this 510(k) clearance is that the subject devices are identical to predicate devices, and the submission is primarily for a labeling change. This means extensive new performance testing demonstrating equivalence to a new set of criteria beyond what was already established for the predicate is not explicitly detailed as part of "new" acceptance criteria in this document. Instead, the testing listed serves to confirm that the labeling changes do not negatively impact the device's safe and effective use, and that the subject device remains substantially equivalent to its predicate.

Given that the device design, materials, and technological characteristics are identical between the subject and predicate devices, the "acceptance criteria" for this specific 510(k) are implicitly tied to confirming that the existing performance characteristics (established for the predicate) are maintained and that the labeling changes introduce no new risks or compromises to performance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a device identical to its predicate and addressing labeling changes, the "acceptance criteria" are implied to be meeting established performance standards for guide wires and demonstrating no negative impact from labeling updates. Actual numerical performance data is not typically a part of the publicly available 510(k) summary, but rather part of the internal design verification and validation report submitted to the FDA.

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

• Sample Size: The document does not specify the sample sizes used for each of the non-clinical tests (Friction, Kink resistance, etc.). These details are typically found in the full test reports submitted to the FDA, not in the 510(k) summary.
• Data Provenance: The document does not specify the country of origin of the data. For physical device performance testing, this often occurs in internal labs or contract research organizations. It is inherently prospective for the specific tests performed to support the 510(k) submission, as new data is generated to demonstrate compliance.

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

This question is not applicable. For physical device testing (mechanical, durability, etc.), "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human interpretation like in medical imaging AI.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for subjective human interpretations of data, such as medical image readings, typically in AI/software performance studies. They are not used for objective physical device performance testing.

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

No, an MRMC study was not done. MRMC studies are specific to evaluating the diagnostic performance of software or imaging systems, often comparing human readers with and without AI assistance. This is a physical guide wire, so such a study is irrelevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. "Standalone performance" refers to the performance of an algorithm or software system without human interaction. This document describes a physical medical device.

7. The Type of Ground Truth Used

For physical device testing, the "ground truth" is based on:

• Engineering Specifications: The design parameters and tolerances the device is intended to meet.
• Industry Standards: Recognized standards for guide wire performance (e.g., ISO, ASTM).
• Predicate Device Performance: The established, acceptable performance of the legally marketed predicate device.
  Data from the listed tests (Friction, Kink resistance, etc.) are measured and compared against these objective criteria.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train AI models. This document describes a physical medical device.

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

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

In summary, the provided 510(k) clearance letter is for a physical medical device (guide wires) that is stated to be identical in design, materials, and characteristics to a legally marketed predicate device, with the clearance primarily relating to labeling changes. Therefore, the "acceptance criteria" and "proof" focus on demonstrating that these labeling changes do not adversely affect the device's established safety and performance, and that the device remains substantially equivalent to its predicate through standard non-clinical performance testing. The concepts of AI/software-specific studies, ground truth establishment by experts, and training/test sets are not relevant to this type of device and clearance.

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