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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

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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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The Alinity m CMV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate cytomegalovirus (CMV) DNA in human EDTA plasma. The Alinity m CMV assay is intended for use as an aid in the management of Hematopoietic Stem Cell Transplant and Solid Organ Transplant patients who are undergoing anti-cytomegalovirus therapy. The Alinity m CMV assay can be used to assess virological response to anti-cytomegalovirus therapy.

The results from the Alinity m CMV test must be interpreted within the context of all relevant clinical and laboratory findings. The Alinity m CMV test is not intended as a screening test for the presence of CMV DNA in blood or blood products.

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

This device is similar to the predicate device originally approved (PMA P210022) with the exception that the subject device may use a new DNA Polymerase as an alternative to original 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 alternative DNA Polymerase. Supplemental data from these studies were used with data previously obtained from the analytical and clinical testing studies submitted in P210022.

The steps of the Alinity m CMV consist of sample preparation, real-time PCR assembly, amplification/detection, result calculation, and reporting. All stages of the Alinity m CMV procedure are executed automatically by the Alinity m System. Manual dilutions may be performed for low-volume specimens to meet the minimum volume requirement.

The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m CMV assay in parallel with other Alinity m assays on the same instrument.

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

• Alinity m CMV AMP Kit (List No. 09N46-095), 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 CMV AMP Kit is 2°C to 8°C.

• Alinity m CMV CTRL Kit (List No. 09N46-085), 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 CMV CTRL Kit is –25°C to –15°C.

• Alinity m CMV CAL Kit (List No. 09N46-075), consisting of 2 calibrator levels, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m CMV CAL Kit is –25°C to –15°C.

CMV 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 CMV activation reagent and lyophilized unit-dose Alinity m CMV 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 CMV targets.

At the beginning of the Alinity m CMV 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 CMV amplification/detection reagents consist of enzymes, primers, probes, and activation reagents that enable polymerization and detection.

A CMV calibration curve is required for determination of CMV DNA concentration. Two levels of calibrators are processed through sample preparation and PCR to generate the calibration curve. The concentration of CMV 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 CMV assay also utilizes the following:

• Alinity m CMV Application Specification File, (List No. 09N46-05B)
• 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)

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter for the Alinity m CMV assay:

The core of this submission is to demonstrate that a new formulation of the Alinity m CMV assay (using an "alternative DNA Polymerase") is substantially equivalent to the previously FDA-approved Alinity m CMV assay (using the "original DNA Polymerase"). Therefore, the acceptance criteria for the new formulation are implicitly that its performance characteristics (LoD, Linearity, Precision, Reproducibility, Method Comparison) are comparable to, and meet the established claims of, the original predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating equivalence to an already approved device, the acceptance criteria are not explicitly stated as pass/fail thresholds in this document, but rather as meeting or being comparable to the performance of the predicate device (P210022). The reported performance shows that the new formulation did meet these implicit criteria.

• ≤ 0.25 Log IU/mL for 500-100,000,000 IU/mL
• ≤ 0.50 Log IU/mL for 50-

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The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to rubella virus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system.

The Alinity i Rubella IgG assay is to be used as an aid in the determination of immune status to rubella in individuals including women of child-bearing age.

The Alinity i Rubella IgG assay has not been cleared for use in screening blood, plasma, or tissue donors.

The performance of this device has not been established for cord blood or neonatal samples. Likewise, performance has not been established for populations of immunocompromised or immunosuppressed individuals.

The Alinity i Rubella IgG assay is an automated, two-step immunoassay for the quantitative determination of anti-rubella IgG in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.

Sample, partially purified rubella virus-coated paramagnetic microparticles, and assay diluent are combined and incubated. The anti-rubella IgG present in the sample bind to the rubella virus coated microparticles. The mixture is washed. Anti-human IgG acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added.

The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of anti-rubella IgG in the sample and the RLU detected by the system optics.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for the Alinity i Rubella IgG assay.

Overview of the Device and its Purpose:

The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to the rubella virus. It's intended to aid in determining the immune status to rubella, particularly in women of child-bearing age. It is a diagnostic device, not an AI/ML-driven one, so some of the requested points regarding AI/ML studies (like MRMC studies, training set details, expert ground truth establishment for AI) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a diagnostic assay and not an AI/ML device, the acceptance criteria are related to the analytical and clinical performance of the immunoassay itself rather than metrics like AUC, sensitivity/specificity for object detection, or F1 scores inherent to AI. The key performance indicators are Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a composite comparator method.

Acceptance Criteria (Implied by Performance Targets in Context of 510(k) Equivalence):

For a 510(k) substantial equivalence determination, the new device must demonstrate performance that is as safe and effective as a legally marketed predicate device. While explicit numerical acceptance criteria for PPA and NPA are not stated in the summary, typical expectations for diagnostic assays like this are high agreement rates (e.g., >90% or 95%) with the comparator method, especially in categories such as "Reactive" and "Nonreactive." The confidence intervals should also demonstrate a reasonable level of certainty around these agreement rates. The acceptance of the listed performance values below implies that these meet the FDA's criteria for substantial equivalence to the predicate.

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The BinaxNOW COVID-19 Ag Card is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the BinaxNOW COVID-19 Ag Card and followed up with a molecular test.

A negative test is presumptive and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.

Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

The BinaxNOW COVID-19 Ag Card is an immunochromatographic membrane assay that uses antibodies to detect SARS-CoV-2 nucleocapsid protein from anterior nasal swab specimens. SARS-CoV-2 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card.

To perform the test, an anterior nasal swab specimen is collected from the patient, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.

The provided document is a 510(k) summary for the BinaxNOW COVID-19 Ag Card. It does not describe a study proving a device meets acceptance criteria in the manner typically associated with AI/ML-driven medical devices, which would involve measures like sensitivity, specificity, or AUC against a ground truth, often with human readers involved (MRMC studies).

Instead, this document describes the validation of an immunochromatographic assay (a rapid antigen test) for COVID-19. The "acceptance criteria" here are typically performance targets for analytical and clinical characteristics (e.g., Limit of Detection, cross-reactivity, Positive Percent Agreement, Negative Percent Agreement). The "study" refers to the analytical and clinical studies conducted to demonstrate these performance characteristics.

Therefore, the following response will interpret "acceptance criteria" as the performance benchmarks for a diagnostic assay and describe the validation studies for the BinaxNOW COVID-19 Ag Card based on the provided text.

Here's a breakdown of the information requested, interpreted in the context of a rapid antigen test (not an AI/ML device):

Acceptance Criteria and Device Performance for BinaxNOW COVID-19 Ag Card

The BinaxNOW COVID-19 Ag Card is a lateral flow immunochromatographic assay, not an AI/ML diagnostic device. Therefore, the "acceptance criteria" are based on the analytical and clinical performance characteristics typical for such an in-vitro diagnostic (IVD) device, rather than metrics like AUC, sensitivity/specificity of an AI algorithm, or human reader improvement with AI assistance.

1. Table of Acceptance Criteria and Reported Device Performance

• Day 0: 69.23% (Omicron Study)
• Day 1: 94.12% (Original), 88.24% (Omicron)
• Day 2: 73.33% (Original), 97.22% (Omicron)
• Day 3: 76.00% (Original), 100.00% (Omicron)
• Day 4: 88.89% (Original), 66.67% (Omicron)
• Day 5: 100.00% (Original), 100.00% (Omicron) |
  | | Invalid Rate | Low invalid rate. | 0.68% overall (5/730). |
  | User/Environmental Factors | Flex Studies (Robustness) | Device performs accurately under various usage and environmental conditions. | Demonstrated robustness to usage variation and environmental factors. Identified that direct exposure of test strip to wet cleaning solutions or excessive glove powder may cause erroneous results, leading to specific instructions for use. |

2. Sample Sizes and Data Provenance (Clinical Studies)

• Clinical Test Set Sample Size:
  • Study 1 (Original): 295 evaluable subjects.
  • Study 2 (Omicron): 309 evaluable subjects.
  • Combined Clinical Data: 604 evaluable nasal swabs from symptomatic patients (within 5 days of symptom onset).
• Data Provenance: Clinical studies were conducted within the United States.
  • Study 1: November 2020 through March 2021 (when Delta and Omicron were dominant).
  • Study 2: February 2022 to July 2022 (when Omicron and its variants were prevalent).
• Retrospective/Prospective: Both clinical studies were prospective.

3. Number of Experts and Qualifications for Ground Truth for Test Set

This type of diagnostic device (lateral flow immunoassay) does not typically utilize human experts in the same way an AI/ML device would for image interpretation or clinical diagnosis. For the BinaxNOW COVID-19 Ag Card, the ground truth for the clinical studies was established by a comparator molecular test (RT-PCR). The experts involved would be the laboratory personnel performing and interpreting the RT-PCR assays. Their specific qualifications are not detailed in this summary but are implicitly assumed to be standard for clinical laboratory professionals performing EUA-authorized RT-PCR tests.

4. Adjudication Method for the Test Set

Not applicable in the typical sense for an AI/ML study involving human interpretation. The comparator method (RT-PCR) serves as the reference standard. The document mentions for the serial testing study's composite comparator method that in cases of discordant RT-PCR results, a third RT-PCR test was performed, and the final result based on majority rule.

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

No. This is a rapid antigen test, not an AI/ML system where human readers would interpret results "with vs. without AI assistance." The test is visually read by the user, and its performance is assessed against a molecular gold standard.

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

This question is not applicable in the context of this device. The BinaxNOW COVID-19 Ag Card is a manually read, qualitative visual assay. There is no AI algorithm to evaluate for standalone performance. The "performance" tables provided in the document (PPA and NPA) essentially represent the "standalone" performance of the rapid antigen test itself when interpreted visually.

7. Type of Ground Truth Used

• For Clinical Studies: The primary ground truth for clinical performance (PPA, NPA) was an FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assay for the detection of SARS-CoV-2.
• For Serial Testing Study: A composite comparator method was used, involving at least two highly sensitive EUA RT-PCRs. If discordant, a third RT-PCR was performed, and the final result was based on majority rule.
• For Analytical Studies: Ground truth was established by known concentrations of heat-inactivated SARS-CoV-2 virus or WHO International Standard for SARS-CoV-2 Antigen (NIBSC 21/368) for LoD and inclusivity studies, and known presence/absence of specific microorganisms for cross-reactivity.

8. Sample Size for the Training Set

This information is not applicable for this type of IVD device. The BinaxNOW COVID-19 Ag Card is a laboratory-developed lateral flow assay, not an AI/ML model that is 'trained' on data. Its 'training' is the fundamental assay development and optimization process, not a computational training set.

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

Not applicable for this device type. The manufacturing process and quality control of the reagents and test strip govern its 'performance' characteristics, which are then analytically and clinically validated.

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The Agilis™ NxT Steerable Introducer Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Agilis™ NxT Steerable Introducer Dual-Reach™ is a sterile, single-use device that con-sists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter intro-duction and/or exchange. It has a sideport with three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

This FDA 510(k) clearance letter (K251211) and its accompanying 510(k) summary pertain to a change in workflow for several existing cardiovascular catheters, specifically allowing for a "Zero/Low Fluoroscopy Workflow."

The key phrase here is "Special 510(k) – Zero/Low Fluoroscopy Workflow". This type of submission is for modifications to a previously cleared device that do not significantly alter its fundamental technology or intended use, but rather introduce a change in how it's used or processed.

Crucially, this submission does NOT describe a new AI/software device that requires extensive performance testing against acceptance criteria in the manner you've outlined for AI/ML devices. Instead, it's about demonstrating that existing devices, when used with a new, less-fluoroscopy-dependent workflow, remain as safe and effective as before.

Therefore, many of the questions you've asked regarding acceptance criteria, study details, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) document. The document explicitly states:

• "Bench-testing was not necessary to validate the Clinical Workflow modifications."
• "Substantial Equivalence of the subject devices to the predicate devices using the zero/low fluoroscopy workflow has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods."

This indicates that the "study" proving the device (or rather, the new workflow) meets acceptance criteria is a summary of existing clinical data where alternative visualization methods were already employed, rather than a prospective, controlled study of a new AI algorithm.

Based on the provided document, here's what can be answered:

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

• Acceptance Criteria: The implicit acceptance criterion is that the devices, when used with "zero/low fluoroscopy workflow," maintain substantial equivalence to their predicate devices in terms of safety and effectiveness. This means they must continue to perform as intended for visualizing cardiac structures, blood flow, mapping, or introducing catheters.
• Reported Device Performance: The document states that "Substantial Equivalence... has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods." This implies that the performance (e.g., adequate visualization, successful mapping, successful catheter introduction) was maintained. Specific quantitative metrics of performance (e.g., accuracy, sensitivity, specificity, or inter-reader agreement for a diagnostic AI) are not provided or applicable here as this is not an AI/ML diagnostic clearance.

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

• Sample Size: Not specified. The document refers to "a summary of clinical data across multiple studies." This suggests an aggregation of results from existing (likely retrospective) patient data where alternative visualization techniques (allowing for "zero/low fluoroscopy") were already utilized clinically. It's not a new, single, prospectively designed test set for an AI algorithm.
• Data Provenance: Not specified regarding country of origin or specific patient demographics. It is implied to be clinical data collected from studies where these types of procedures were performed using alternative visualization. The data would be retrospective as it's a "summary of clinical data" that already exists.

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

• Not applicable in the context of this 510(k). Ground truth in an AI/ML context typically refers to adjudicated labels for images or signals. Here, the "ground truth" is inferred from standard clinical practice and outcomes in the historical data summarized. There's no mention of a specific expert panel for new ground truth establishment for a diagnostic AI.

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

• Not applicable. This is not a study requiring adjudication of diagnostic outputs by multiple readers.

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. This is not an AI-assisted diagnostic device. The workflow change is about using alternative non-fluoroscopic imaging modalities (e.g., intracardiac echocardiography, electro-anatomical mapping systems), not about AI improving human reader performance.

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

• No. This is not an AI algorithm. The predicate devices are physical catheters.

7. The type of ground truth used:

• The "ground truth" is inferred from clinical outcomes and established clinical practice using the devices with alternative visualization methods in real-world scenarios. It's not a specific, adjudicated dataset for an AI algorithm. The performance of the devices (such as successful navigation, visualization, and mapping) under the "zero/low fluoroscopy" workflow is assumed to be equivalent to their performance under full fluoroscopy, as demonstrated by prior clinical use where such methods were employed.

8. The sample size for the training set:

• Not applicable. There is no AI model being trained discussed in this document.

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

• Not applicable. No training set for an AI model.

In summary:

This 510(k) is for a workflow modification for existing medical devices (catheters), not for an AI/ML diagnostic or assistive software. Therefore, the detailed data performance evaluation typically required for AI models against specific acceptance criteria (as requested in your template) is not presented or relevant in this clearance letter. The "proof" relies on the concept of substantial equivalence to previously cleared predicate devices, supported by a summary of existing clinical data that used alternative visualization methods, implying that the devices function safely and effectively even with reduced fluoroscopy.

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