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The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement. It is inserted into peripheral venous circulation by way of a peel away introducer. The catheter is intended for use with the Aquadex FlexFlow® and Aquadex SmartFlow® Systems in attaining vascular venous access for ultrafiltration treatment of patients with fluid overload. It has two models, 320101 and 320102, with identical hub designs but different shaft lengths, 12 cm and 16 cm, to adapt to the patient's body size.

The catheter has a radiopaque polyurethane shaft with two equal-sized inner lumens designed in a "double D" configuration. The shaft has a reverse-tapered design to minimize resistance to flow. Its outside diameter starts at 6F on the distal end and tapers back to 7F on the proximal end. The shaft with the coil reinforcement, designed based on the FDA cleared 5.2F dELC via K041791, provides kinking resistance and ensures consistent flow. Depth markings are provided in 0.5cm increments along the insertable length of the catheter shaft. The proximal end of the catheter shaft and clear polyurethane extension tubes are over-molded into a polyurethane hub, which has suture wings for securement to the skin.

Additionally, the catheter has female ISO 80369-compliant luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. When the catheter is not in use, two yellow male locking caps can be placed on the female luer connectors for reducing the risk of infection. Each extension tube has a clamp: blue on the blood withdrawal tube (marked by the withdrawal ID ring) and white on the blood infusion tube (marked by the infusion ID ring). The blood is drawn up through the withdrawal lumen, which is proximal to the infusion lumen. The skived offset tip is designed to minimize blood recirculation.

An attached MRI tag indicates the device is MR unsafe.

The provided FDA 510(k) clearance letter (K252226) describes a medical device, the Dual Lumen Extended Length Catheter (dELC), and details the rationale for its substantial equivalence to a predicate device. This submission focuses on a material change to an existing cleared device, rather than a de novo submission for a novel AI/software device. Therefore, the information typically requested regarding acceptance criteria and study proving performance for an AI/software device (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment) is not applicable in this context.

The acceptance criteria here pertain to the safety and effectiveness equivalency of the modified medical device (specifically, the change in material for the Female Luer Lock Connector) compared to its predicate. The study conducted is non-clinical performance testing rather than a clinical trial or AI model validation.

Here's a breakdown of the available information relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this specific 510(k) submission:

Acceptance Criteria and Reported Device Performance (for a Material Change)

The core acceptance criterion for this 510(k) submission is to demonstrate that the change in material for the Female Luer Lock Connector does not raise new questions of safety and effectiveness and that the modified device remains substantially equivalent to the predicate device.

Information NOT APPLICABLE to this 510(k) (as it's a material change, not an AI/software device):

The following points are standard for AI/software device clearances but are not relevant to this specific 510(k) for a material change in a physical medical device.

2. Sample sizes used for the test set and data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing non-clinical bench testing, not a dataset for an algorithm. Data provenance (country, retrospective/prospective) is typically for patient data used in AI validation.
3. Number of experts used to establish ground truth for the test set and qualifications: Not applicable. There is no "ground truth" to establish in the context of an algorithmic output. The performance tests are specific to the mechanical and chemical properties of the device.
4. Adjudication method for the test set: Not applicable. No human interpretation or adjudication of an algorithm's output.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are used to assess the impact of AI on human reader performance, which doesn't apply to this physical device change.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable. Ground truth typically refers to a verified diagnosis or measurement used to evaluate an AI model's accuracy. For this device, "ground truth" would be established through calibrated instruments measuring physical properties.
8. The sample size for the training set: Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) demonstrates substantial equivalence through non-clinical bench testing to affirm that a material change to a connector on a physical medical device does not compromise its safety or effectiveness when compared to the previously cleared predicate device. It specifically avoids the need for clinical studies by establishing this equivalence.

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HydroPICC Single Lumen: Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0 ml/s

HydroPICC Dual Lumen: Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for a maximum power injection flow rate of 5.0 ml/s

HydroMID Single Lumen: Indicated for short term access(

The HydroMID catheters are a family of midline catheters comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The HydroPICC catheters are a family of peripherally inserted central catheter (PICC) comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The purpose of this 510(k) is to add an additional statement to the indications for use.

The provided FDA 510(k) clearance letter (K243458) details the HydroPICC and HydroMID catheters. The focus of this submission is to add a statement to the indications for use regarding the anti-thrombogenic properties of the MIMIX® Technology incorporated into these catheters. The acceptance criteria and supporting studies are described below:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission is to demonstrate that the expanded Indications for Use statement, specifically concerning the anti-thrombogenic properties of the MIMIX® Technology, does not introduce new questions of safety or effectiveness and is supported by non-clinical data. The reported device performance is based on in vitro studies.

Note: The FDA letter explicitly states: "The clinical impact has not been evaluated in human clinical trials. This device is not intended for the treatment of existing vein thrombosis." This indicates that the acceptance criteria are based solely on in vitro performance for the anti-thrombogenic claims, not on in vivo clinical outcomes.

Study Details for Acceptance Criteria

The provided document does not fully delineate separate "test sets" for the in vitro studies in the way one might for an AI/algorithm-based device. Instead, the "studies" themselves are the performance evaluations for the stated acceptance criteria.

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

   • The document lists several in vitro tests.
   • Sample Size: The specific number of devices or experimental replicates used in each in vitro test is not explicitly stated in the provided text.
   • Data Provenance: All studies are indicated as "in vitro" (meaning conducted in a test tube, culture dish, or other controlled environment outside of a living organism). The country of origin is not specified but is presumably where Access Vascular Inc. conducts its research and development or contracts with testing facilities.

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

   • For in vitro studies of this nature (evaluating properties like thrombus accumulation), the "ground truth" is typically established by the experimental setup, validated measurement techniques, and potentially statistical analysis.
   • No specific number of experts or their qualifications are mentioned as having established "ground truth" for these in vitro tests in the context of expert consensus, as might be the case for image-based diagnostic devices. The results are based on objective physical or biological measurements.

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

   • Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective expert review (e.g., radiology image interpretation) to resolve discrepancies in independent assessments. As these are in vitro physical/biological tests, such adjudication methods are not relevant or mentioned.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a medical catheter, not an AI software/algorithm requiring human reader interpretation. No MRMC study was conducted or is relevant for this device.

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

   • Not applicable. This device is a physical medical device (catheter) with a material technology, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

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

   • The ground truth for the in vitro studies described (e.g., "Assessment of PICC Catheter Thrombosis," "Thrombosis Accumulation Report") is based on objective measurements of physical and biological phenomena (e.g., quantification of thrombus accumulation, pressure required to remove occlusions) within controlled laboratory environments. This is a form of empirical scientific measurement, rather than expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" because this is a physical medical device, not an AI/machine learning model that requires training data.

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

   • Not applicable. As no training set is mentioned, the method for establishing ground truth for it is also not applicable.

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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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cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).

cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.

The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.

Not Found

The provided FDA 510(k) Clearance Letter for cmAngio® (V1.6) does not contain the detailed information required to answer most of your questions about the acceptance criteria and the study that proves the device meets them. This document is primarily a clearance letter, indicating that the device has been deemed substantially equivalent to a predicate device and outlining regulatory obligations. It does not typically include the specifics of performance studies.

However, based on the information that is available, here's what can be extracted:

Indications for Use:

cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). It is an AI-based software intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC) in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization. It is to be used by qualified interpreting physicians in parallel with breast screening mammography workflow and is not intended for primary interpretation or for making diagnosis/treatment decisions alone.

Given the typical content of a 510(k) clearance letter versus a full submission, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance for the test set.
• Number of experts used to establish ground truth for the test set.
• Qualifications of those experts.
• Adjudication method for the test set.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
• The effect size of human readers improving with AI vs. without AI assistance.
• Whether a standalone (algorithm-only) performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set.
• How the ground truth for the training set was established.

To obtain this information, one would typically need access to the full 510(k) submission document, which includes the detailed clinical and technical performance studies. The clearance letter only summarizes the outcome of the FDA's review.

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Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.

The provided text is an FDA 510(k) summary for a medical device called "Needle Stimulator." It details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the provided text does not contain any information about a study that proves the device meets specific performance acceptance criteria for an AI/ML-based device. The information is primarily focused on electrical safety, essential performance, and electromagnetic compatibility tests as per general medical device standards, and not on the performance metrics of an AI system detecting or classifying something.

The recurring phrases like "Similar Note 1," "Similar Note 2," etc., refer to explanations for minor differences between the subject device and the predicate device in terms of hardware specifications and compliance with voluntary standards. They are not related to an AI/ML performance study.

Specifically, the section "6. Clinical Test" states, "Clinical data were not included in this submission." This strongly indicates that no clinical study was performed for this 510(k) submission, and therefore, no AI/ML performance data against ground truth or human readers would be available within this document.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device based on the information provided. The document describes a standard medical device (an electro-acupuncture stimulator), not an AI/ML product requiring the detailed performance study you've outlined.

If this was a misunderstanding and you expected a generic answer for an AI/ML device based on typical FDA requirements, please clarify. But based solely on the provided text, the requested information is absent.

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CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.

CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus.

CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transfering to the uterine cavity.

CaseBioscience® HTF w/HEPES is intended for use in short-term handling gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavitv.

CaseMONO Culture, CaseMONO w/HEPES, CaseBioscience HTF, and CaseBioscience HTF w/HEPES are intended for use during in vitro procedures for gamete/embryo culture and one step media.

CaseMONO Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device is a one-step media and can be used for transfer of embryos to the uterus.

CaseMONO w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).

CaseBioscience HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device is not a one-step medium but can be used for transfer of embryos to the uterus.

CaseBioscience HTF w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).

CaseMONO Culture and CaseMONO w/HEPES have almost identical composition with differences in amount of NaHCO3 and Phenol red and presence of HEPES in CaseMONO w/HEPES. Similarly, CaseBioscience HTF and CaseBioscience HTF w/HEPES have an almost identical composition with the exception of HEPES present in CaseBioscience HTF w/HEPES and minor difference in composition for NaCl, Sodium L-lactate and Phenol red. CaseMONO Culture and CaseMONO w/HEPES contain EDTA. All media formulations contain antibiotic gentamicin.

The four solutions are aseptically filtered (storage vials sterilized by radiation) and provided in PETG square media bottles with HDPE screw-style caps. They have a shelf-life of 90 days when stored at 2-8°C. Media in the vials can be used for up to seven days after vial opening.

Acceptance Criteria and Device Performance Study for CaseBioscience Assisted Reproduction Media

This document outlines the acceptance criteria and the study conducted to prove that the CaseBioscience® Assisted Reproduction Media (CaseMONO™ Culture, CaseMONO™ w/HEPES, CaseBioscience® HTF, and CaseBioscience® HTF w/HEPES) meet these criteria, as detailed in the K242107 510(k) Summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each variant of the CaseBioscience Assisted Reproduction Media are based on various non-clinical performance tests. The reported device performance met these acceptance criteria.

2. Sample Size and Data Provenance

The provided document details non-clinical performance testing for assisted reproduction media. The sample sizes for each specific test (e.g., number of embryos in MEA, number of samples for pH/Osmolality) are not explicitly stated in this summary.

The data provenance is from non-clinical laboratory testing and is retrospective in nature, as it was conducted to support a 510(k) submission for an existing product. The country of origin of the data is not specified, but the testing would have been conducted by or for CaseBioscience, Inc., which is based in Canada.

3. Number of Experts and Qualifications for Ground Truth

This submission pertains to in vitro reproductive media. The ground truth for performance (e.g., embryo development, chemical properties, sterility) is established through standardized laboratory assays and specifications, rather than expert human interpretation of images or patient data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis by multiple medical professionals is not applicable here. The "experts" would be the scientists and quality control personnel in the laboratory performing the assays, adhering to validated methods.

4. Adjudication Method for the Test Set

As the evaluation is based on objective laboratory measurements and standardized assays (e.g., pH meters, osmometers, bacterial growth cultures, embryo development rates), an "adjudication method" in the sense of a consensus process among human readers (e.g., 2+1, 3+1) is not applicable. The results are quantitative and binary (pass/fail against a threshold).

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

An MRMC comparative effectiveness study is typically performed for AI/CADe systems where human readers interpret medical images. Since this submission is for in vitro assisted reproduction media, which do not involve human interpretation of images or AI assistance in the diagnostic process, an MRMC comparative effectiveness study was not performed. Therefore, effect size of human improvement with AI assistance is not relevant or measurable in this context.

6. Standalone (Algorithm Only) Performance Study

This submission is for a medical device that is a consumable media, not a software algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance is assessed based on the physical, chemical, and biological properties of the media itself.

7. Type of Ground Truth Used

The ground truth used for proving the device meets the acceptance criteria is based on:

• Laboratory-established specifications and thresholds: For parameters like pH, osmolality, bacterial endotoxin, and appearance.
• Standardized biological assays: Specifically, the Mouse Embryo Assay (MEA), where the "ground truth" for success is a predefined percentage of embryos reaching a certain developmental stage (expanded blastocyst) within a specified timeframe.
• Compliance with international standards: For sterilization, aseptic processing, and biocompatibility testing (e.g., ISO, USP, ASTM).

8. Sample Size for the Training Set

This product is an in vitro medical device, not an AI/ML software. Therefore, there is no "training set" in the context of machine learning model development. The product is manufactured and tested according to established quality control procedures and specifications.

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

Since there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the performance of the media is established by validated laboratory methods and industry/regulatory standards.

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Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Pacing Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits. The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle in then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The provided text is a 510(k) Summary for a medical device (Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)). It describes the device, its intended use, and comparability to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.

The text focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of Technological Characteristics: Tables comparing the subject device and the predicate device in terms of design, materials, and dimensions.
• Performance Data Summary: A list of various performance tests conducted (e.g., biocompatibility, electrical safety, mechanical tests, functional testing to standards like ISO 10555-1, IEC 60601-1, ISO 80369 series, ISO 11070). The document states that the devices met the requirements of the above standards and performance endpoints.

Therefore, I cannot provide the specific details requested in your prompt (a detailed table of acceptance criteria and reported device performance with numerical values, sample sizes for test sets, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment).

The document explicitly states that the device "met the requirements of the above standards and performance endpoints," implying that the acceptance criteria are defined by these referenced standards and internal specifications, but the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.

If you have a document that contains the detailed study results and acceptance criteria, please provide it.

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The Aptima® CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther® system.

The Aptima CMV Quant Assay is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from Aptima CMV Quant assay must be interpreted within the context of all relevant clinical and laboratory findings.

The Aptima CMV Quant Assay is not intended for use as a screening assay for the presence of CMV in blood or blood products.

The Aptima CMV Quant Assay is an in vitro nucleic acid amplification test that uses real-time transcription mediated amplification (TMA) technology on the Panther Fusion system to quantify CMV DNA, genotypes 1, 2, 3, and 4. The primer design targets the highly conserved UL56 gene to ensure accurate quantitation of the CMV DNA. The assay is standardized to the WHO International Standard for human cytomegalovirus. The Aptima CMV Quant Assay is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients.

The addition of a protocol to treat specific plasma samples with proteinase K in the assay package insert will allow the retesting of those samples to obtain a valid result.

The provided text describes a 510(k) premarket notification for the "Aptima CMV Quant Assay" and specifically details an update to the assay's package insert to include a protocol for retesting plasma samples that initially yield an "ML2 flag" invalid result. This retesting involves a manual pretreatment with proteinase K. The information provided is for a diagnostic assay, not an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML development, such as training sets, ground truth establishment for AI/ML, expert consensus for imaging, MRMC studies, and effect sizes of AI assistance, are not applicable.

However, I can extract information related to the acceptance criteria and the study that proves the device (specifically, the proteinase K pretreatment protocol) meets the acceptance criteria within the context of a diagnostic assay's performance and validation.

Acceptance Criteria and Study for the Proteinase K Pretreatment Protocol

The primary acceptance criterion for this change is to demonstrate that the proteinase K pretreatment protocol effectively resolves the "ML2 flag" invalid results and does not negatively impact the accuracy of the CMV quantification.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Test Set Sample Sizes:
  • Without Proteinase K: 1039 plasma specimens
  • With Proteinase K: 4098 plasma specimens
• Data Provenance: The plasma specimens were collected from the transplant patient population by the National Institute of Health (NIH). This suggests a retrospective analysis of archived samples or a prospective study conducted at the NIH. The location is the USA.

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

• Not applicable as this is a quantitative diagnostic assay for DNA detection, not an image-based AI/ML device requiring expert interpretation of images for ground truth. The "ground truth" here is the actual CMV DNA concentration, which the assay is designed to measure.

4. Adjudication Method for the Test Set:

• Not applicable for a quantitative diagnostic assay. The performance is assessed against the ability to produce a valid quantitative result for CMV DNA and maintain accuracy, not against human consensus.

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

• No, this is not an MRMC study. MRMC studies are typically performed for visual diagnostic aids (e.g., medical imaging AI) to compare human reader performance with and without AI assistance. This device is a direct quantitative assay.

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

• Yes, in a sense. The study validates the protocol (which includes a manual pretreatment step) and its effect on the automated assay system's ability to produce a valid result. The "performance" refers to the assay's output after the sample preparation, not an AI algorithm's independent decision. The core assay itself operates in a "standalone" fashion once the sample is loaded onto the Panther system.

7. The type of ground truth used:

• The implicit ground truth is the actual CMV DNA concentration in patient samples (or spiked controls used in accuracy assessments), as determined by a reference method or known concentrations. The study's focus, however, is on resolving an assay technical issue (ML2 flag) and demonstrating that the resolution method maintains the accuracy of CMV quantification. The reference to the NIH demonstrating that "using proteinase K for pretreatment of specimens did not impact the accuracy of CMV quantification" confirms that accurate quantitation (the ground truth outcome) was assessed.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for such an assay would be its initial development and optimization, which isn't described in terms of a specific "training set" size for this modification. The data provided refers to validation/test sets for the new protocol.

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

• Not applicable, as it's not an AI/ML device with a training set for model development.

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Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s

The HydroPICC 4F Single Lumen Catheter is comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the clamp. HydroPCC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions f thrombus accumulation and thrombotic occusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The provided text is a 510(k) summary for the HydroPICC 4Fr Single Lumen Marked catheter, where the purpose of the submission is to modify the power injection ratings in the indications for use. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study against specific acceptance criteria for a new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document discusses "comprehensive data demonstrating the safety and efficacy" and "rigorous testing protocols" including "in vitro" data to support the modified power injection rating, and states that "the form, fit, and function of these devices have not changed from their previous clearances." However, it does not provide specific details of these tests or their results in a measurable, quantifiable way that would allow for the completion of the requested table and study breakdown.

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Cercare Medical Neurosuite (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians.

The CMN software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant imaging devices. CMN provides viewing capabilities of datasets acquired with CT and MRI.

The Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.

The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. For MRI, one clinical application is to visualize the apparent blood perfusion and diffusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.

For CT, one clinical application is to visualize the apparent blood perfusion and to calculate rCBF threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.

Areas of decreased perfusion appear as areas of changed signal intensity:

• Lower signal intensity for CBF and CBV
• Higher signal intensity for TTP, MTT, and Tmax

Cercare Medical Neurosuite is a software-only device designed to streamline medical inage processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC, or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data.

CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions.

The software is intended to visualize and study neuroimaging by image viewing and registration of medical images. CMN works with MRI (Magnetic Resonance Image) and CT (computed tomography) technologies.

CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee.

CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function.

CMN Capillary Function:
Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images.

Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI or perfusion CT series can be processed to yield information relevant for assessment of the hemodynamic status of a patient.

Capillary Function generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors.

The generated output maps can be viewed by standard DICOM image viewers. In addition, Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI and CT technologies.

CMN Virtual Expert:
Virtual Expert, when activated in the installed CMN Capillary Function, provides further functionalities for reading, writing, visualizing, and studying medical images.

Virtual Expert provides automatic delineation of regions of interest (ROI) relevant for stroke patient assessment based on perfusion and diffusion image output generated by the Capillary Function module. Specifically, diffusion MRI images are used to generate threshold masks of perceived core lesions, whereas MRI or CT perfusion images are used to generate threshold masks of perceived perfusion restriction. For CT perfusion, derived perfusion images are used to generate threshold masks of perceived core lesions. Virtual Expert thus works with MRI and CT technologies.

The generated masks can be combined into a mismatch region of interest.

Volumetric calculations and ratios can be calculated from the computed regions of interest.

The provided document describes the acceptance criteria and the study conducted for the Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert device.

Acceptance Criteria and Device Performance Study

The acceptance criteria for the CMN Capillary Function with Virtual Expert device were established through performance validation testing, encompassing both simulated digital phantoms and retrospective clinical data. The document states that "The established acceptance criteria were reached in all tests conducted" (page 10).

1. Table of Acceptance Criteria and Reported Device Performance

For the Capillary Function module, the acceptance criteria focused on quantitative comparisons using digital phantoms, ensuring accuracy under varying hemodynamic parameters and experimental conditions. For the Virtual Expert module, the acceptance criteria involved volumetric and spatial agreement for lesion identification and secondary clinical application assessments like the DEFUSE3 criteria.

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

• Capillary Function Module:

  • Test Set: Included simulated digital phantoms with variations of hemodynamic parameter combinations, as well as retrospective clinical data primarily for visual inspection (page 10). No specific numbers for the retrospective clinical data sample size are provided, and no country of origin is explicitly stated, though it's typically global or multi-center for such studies. The data from digital phantoms is synthetic.
  • Provenance: "retrospective clinical data" and "simulated digital phantoms" (page 10).

• Virtual Expert Module:

  • Test Set: "retrospective patient CT perfusion imaging" (page 10). The specific sample size is not stated in the provided text.
  • Provenance: "retrospective patient CT perfusion imaging" (page 10). The associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)) might contain details on data provenance, but it's not present in this document.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. However, for the Virtual Expert module, it references a published study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)) which would typically involve expert consensus for ground truth. For the Capillary Function module, ground truth for the simulated phantoms is "known" (inherent to the phantom design), and clinical data was used for "visual inspection" which implies expert review.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For quantitative phantom testing, adjudication is not typically needed as the ground truth is predefined. For retrospective clinical data, particularly for "visual inspection" and comparison to a published study, it is common to have multiple readers involved, but the specific adjudication protocol is not detailed here.

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

The provided text does not indicate that an MRMC comparative effectiveness study was performed to evaluate human reader improvement with AI assistance versus without. The studies described are performance validation tests of the device itself (standalone or comparative to predicate/reference), not human-in-the-loop clinical utility studies.

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

Yes, the performance validation testing described for both the Capillary Function module (using digital phantoms and visual inspection of clinical data) and the Virtual Expert module (volumetric and spatial agreement, DEFUSE3 criteria) appears to be focused on standalone algorithm performance. The comparative testing against a predicate and reference device also implies standalone performance evaluation.

7. The Type of Ground Truth Used

• Capillary Function Module: For simulated digital phantoms, the "true parameter combinations were known" (page 10), indicating a simulation-based (synthetic) ground truth. For retrospective clinical data, it was primarily used for "visual inspection," implying a clinical expert-derived visual ground truth.
• Virtual Expert Module: For retrospective patient CT perfusion imaging, the ground truth for volumetric and spatial agreement would likely be expert consensus or highly delineated clinical ground truth based on expert review of the images. The reference to the DEFUSE3 criteria also points to clinically relevant ground truth.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. It focuses on the performance validation testing.

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

The document does not specify how the ground truth for the training set was established, as it does not elaborate on the training process or data.

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