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The Plexus RP00 Disposable Portable Deep Vein Thrombosis (DVT) Prevention Device is intended to be used in either home or clinical settings for:

• · Aiding the prevention of DVT onset
• · Enhancing blood circulation in the lower extremities
• · Diminishing post-operative pain and swelling
• · Reducing wound healing time, and
• · Serving as a prophylaxis for DVT for stationary or bedridden individuals

· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

The Plexus RP100 Portable Deep Vein Thrombosis ("DVT") Prevention Device is an electronic device that helps to prevent the onset of deep vein thrombosis by stimulating blood flow and increasing venous flow velocity. Each RP100 DVT Prevention Device consists of a pump body and a pressure sleeve with internal air bladder. When turned on, the air bladder inside the sleeve will be automatically inflated to a pre-set level, thereby providing intermittent pressure to the calf.

The commercial saleable package will consist of two pump units with their sleeves, one for each leg.

The unit operates by inflating the air bladder until the pressure reaches 50mmHg. After reaching this pressure level, the unit will automatically deflate for 50 seconds to complete one cycle. Therapy could persist as long as the patient needs or is instructed by their physician. When the therapy ends, the patient simply would turn off the device by the press of a power button.

The provided text describes the 510(k) premarket notification for the Plexus RP100 Disposable Portable Deep Vein Thrombosis Prevention Device. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Cirona 6300 DVT Prevention Device, K151189) through non-clinical testing rather than proving performance against specific acceptance criteria for an AI or imaging device with a detailed study.

Therefore, many of the requested details, such as those pertaining to AI/ML model performance, human expert adjudication, MRMC studies, and detailed ground truth establishment for a training set, are not applicable to this type of medical device submission. The device described is a physical compression device, not an AI or imaging system.

Here's an analysis based on the information provided, highlighting which elements are present and which are not applicable:

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

The document lists "Functional Performance Testing" which includes test items and their results, indicating that "Design requirements met" was the acceptance criterion for each.

Additionally, there are biocompatibility and electromagnetic compatibility/electrical safety tests, all of which "Passed."

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

• Sample Size: The document does not specify the exact number of units or cycles tested for each functional performance test. It only states that the "Design requirements met" for each.
• Data Provenance: Not specified in terms of country of origin for testing, nor whether it's retrospective or prospective. Given it's functional performance testing of a physical device, it's typically done in a lab setting.

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

• Not Applicable. This is a physical device, not an AI or imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests would be objective measurements against engineering specifications.

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

• Not Applicable. See point 3.

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. The document explicitly states: "No clinical testing was performed to support the claim of substantial equivalence to the Cirona 6300 device." This is a mechanical device, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• For the functional performance tests, the "ground truth" would be established engineering specifications and objective measurements (e.g., precise pressure readings, time measurements, battery life measurements). This is not linked to expert clinical consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The sample size for the training set

• Not Applicable. This device does not have a "training set" in the context of AI/ML.

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

• Not Applicable. See point 8.

Summary regarding AI/ML-specific questions:

The provided documentation is for a mechanical medical device (a DVT prevention device), not a software-driven AI or imaging diagnostic tool. Therefore, questions related to AI models, training sets, test sets for AI performance, expert adjudication, MRMC studies, and specific types of clinical ground truth (like pathology or outcomes for diagnostic accuracy) are not relevant to this submission. The demonstration of safety and effectiveness for this device relies on non-clinical engineering and bench testing, as explicitly stated in the document ("No clinical testing was performed").

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The Plexus SCD 110 DVT Sleeve is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, obstetric conditions and treatments.

The Plexus SCD110 Sequential Compression Device is a non-sterile sequential compression sleeve intended to be used with commercially-available compression pumps*. The device is used to prevent the onset of deep vein thrombosis (DVT) by stimulating blood flow and increasing venous flow velocity. The device consists of a pair of soft pressure garment sleeves with an internal air bladder. Each package of Plexus SCD110 has two compression sleeves – one for the right calf and one for the left calf.

The Plexus SCD110 is a single-bladder sleeve that provides a preset pattern of intermittent pressure to the deep vein in the lower leg. To use the device, the garment sleeve is wrapped around a patient's calf. The compression sleeve is connected to a commercially available DVT compression pump intended to be used with single-chamber air bladder sleeves. The connector of the sleeve is designed such that it will not connect to a pump intended for multi-chamber sleeves. When the compression pump is turned on, air flows from the air pump into the air bladder inside the compression sleeve, providing pneumatic pressure on the calf muscle and veins underneath.

Once the compression pump reaches an air pressure of 40 mmHg), a relief valve is triggered within the DVT pump to let air escape from the sleeve and reduces the pressure within the system. With the relief valve opened, the compression sleeve completely deflates and allows blood to re-enter the deep veins of the patient during this cycle. After a pre-set deflation period (~50-second cycle), the relief valve will close and the air pump will start pumping again to 40 mmHg. This cycle of inflation of the air bladder will continue until the compression pump device is turned off.

The Plexus SCD110 sleeve is made of a soft, lightweight, non-woven foam-felt material with a singlechamber bladder made of polyvinyl chloride (PVC). The Plexus SCD sleeve is intended to be compatible with single-chamber DVT pump systems only and the connectors will not allow the sleeve to be attached to any other compression systems (i.e. multi-chamber DVT systems, lymphedema compression systems)

The provided document is a 510(k) summary for the Plexus SCD110 Sequential Compression Device Sleeve. It details the device's intended use, technical characteristics, and performance data to demonstrate substantial equivalence to a predicate device. However, the document does NOT contain information about acceptance criteria and a study that proves the device meets those criteria in the way typically discussed for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a specified threshold).

The performance data mentioned in this document focuses on biocompatibility and functional tests to ensure the device performs as intended and is safe. These are engineering-focused tests rather than clinical performance studies using patient data.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to the type of information presented in this 510(k) summary for this specific device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by "Passed" and "Equivalent" to predicate device):

Note: The exact numerical acceptance criteria for "Passed" are not explicitly detailed in this summary but are understood to be met based on the "Passed" result and declaration of equivalence to predicate devices, which would have established similar benchmarks.

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

• Not Applicable. This document describes engineering and biocompatibility tests on the physical device, not an AI model tested on a dataset of patient cases. The tests were performed by a "third-party test facility."

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

• Not Applicable. Ground truth, in the context of clinical data interpretation by experts, is not relevant to the physical device tests described here.

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

• Not Applicable. This pertains to clinical data interpretation, which is not described.

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

• Not Applicable. This document is for a physical medical device (compression sleeve), not an AI/ML diagnostic or assistive tool.

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

• Not Applicable. This device is a physical sleeve, not an algorithm.

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

• The "ground truth" for the tests performed would be established engineering standards and material science specifications. For biocompatibility, it's the biological response to the materials. For functional tests, it's the physical performance measured against design specifications and predicate device performance.

8. The sample size for the training set

• Not Applicable. This device uses no training data in the AI/ML sense.

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

• Not Applicable. This device uses no training data in the AI/ML sense.

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Focus Diagnostics' Plexus™ EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.

The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkitt's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.

Multiplexed Immunoassay for the Qualitative Detection of Human IgM Antibodies to Epstein-Barr Virus

The Focus Diagnostics Plexus™ EBV IgM uses an Antigen Bead suspension that contains two distinct EBV antigen bead types (VCA and Heterophile) and one process control bead type that fluoresce at different wavelengths and/or intensities.

The Focus Diagnostics Plexus™ EBV IgM is a three step procedure.

1. Patient sera are diluted, and the diluted sera are incubated with Antigen Beads. If EBV antibodies are present, then the antibodies bind to the corresponding antigen beads.
2. Phycoerythrin-conjugated goat Anti-human IgM (Conjugate) is added, binds to the bound EBV antibody (if present), and forms a Conjugate-EBV antibody-antigen bead sandwich.
3. Fluorescence from each distinct EBV antigen bead type is measured and compared against a Cutoff Calibrator.

Plexus EBV IgM Multi-Analyte Diagnostics Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a table format with pre-defined thresholds. Instead, it presents performance data (positive and negative percent agreements) against predicate devices and then justifies substantial equivalence. Based on the comparative studies, the implicit acceptance criteria are that the device's performance should be comparable to or better than the FDA-cleared predicate devices.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Prospective Samples: 723 samples (723 for VCA IgM, 723 for Heterophile IgM)
  • Retrospective Samples: 150 samples (150 for VCA IgM, 150 for Heterophile IgM)
• Data Provenance: The studies were conducted at three United States testing sites: a hospital laboratory located in the Northeast, a pediatric hospital laboratory located in the Mid-West, and Focus Diagnostics. Samples included both prospective (n=723) and retrospective (n=150) specimens. The samples were sequentially submitted to the laboratory, archived, and masked.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of individual experts or their qualifications who directly established the "ground truth" for the test set. Instead, it refers to "consensus predicate" and "predicate rapid test."

For VCA IgM, the ground truth was established by a "consensus predicate" involving a combination of:
* A FDA-cleared commercially available ELISA
* A FDA-cleared commercially available immunofluorescent (IFA) test
* A FDA-cleared commercially available flow cytometry-based immunoassay.

For Heterophile IgM, the ground truth was established against a "FDA cleared heterophile rapid test."

The qualifications of the individuals who performed these predicate tests are not specified but would typically be trained laboratory personnel.

4. Adjudication Method for the Test Set

• VCA IgM: A "consensus based algorithm (2/3)" was used to determine the predicate result for comparison with the Plexus VCA IgM result. This means that at least two out of the three predicate devices had to agree on the result (positive or negative) for a consensus to be reached.
• Heterophile IgM: The document states that the Plexus EBV Heterophile IgM analyte was tested against a "FDA cleared heterophile rapid test," implying a direct comparison rather than a consensus among multiple predicates for this analyte.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study compares the device's performance directly against predicate devices, not human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The entire study focuses on the performance of the Plexus EBV IgM Multi-Analyte Diagnostics device (algorithm only, as it is an in vitro diagnostic assay) against predicate devices without human interpretation as part of its core function, other than potentially reading the results of the predicate devices.

7. Type of Ground Truth Used

The ground truth used was based on comparison with predicate devices, which are themselves FDA-cleared diagnostic assays.

• For VCA IgM, it was a "consensus predicate" combining results from an ELISA, IFA, and flow cytometry-based immunoassay.
• For Heterophile IgM, it was a "FDA cleared heterophile rapid test."
  Additionally, a "Typical Antibody Response Classification" table (Plexus EBV Serological Status) outlines an algorithm for classifying EBV infection status using various serological markers, including VCA IgM and Heterophile Antibody. This table serves as a reference for interpreting the combined results in the context of disease diagnosis.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. The performance studies described involve prospective and retrospective samples used for comparison with predicate devices. This suggests a validation study rather than a development and training paradigm typical of machine learning algorithms that require distinct training sets. Since this is an immunoassay, the "training" would be tied to the assay's development and optimization, not a separate dataset for an algorithm.

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

As no explicit training set is mentioned in the context of algorithm development, the method for establishing ground truth for a training set is not applicable or detailed in the provided document. The performance evaluation relies on comparing the device's results against established FDA-cleared predicate methods.

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Focus Diagnostics' Plexus™ EBV IgG Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgG class antibodies to viral capsid antigen (VCA), early antigen- diffuse (EA-D), and nuclear antigen (EBNA-1) of Epstein-Barr virus in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.

The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkit's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.

Multiplexed Immunoassay for the Qualitative Detection of Human IgG Antibodies to Epstein-Barr Virus

The Focus Diagnostics Plexus™ EBV IgG uses an Antigen Bead suspension that contains three distinct EBV antigen bead types (EA-D, VCA, & EBNA-1) and one process control bead type that fluoresce at different wavelengths and/or intensities.

The Focus Diagnostics Plexus™ EBV IgG is a three step procedure,

• Patient sera are diluted, and the diluted sera are incubated with Antigen Beads. If EBV antibodies are present, then the antibodies bind to the corresponding antigen beads.
• Phycoerythrin-conjugated goat Anti-human IgG (Conjugate) is added, binds to the bound EBV antibody (if present), and forms a Conjugate-EBV antibody-antigen bead sandwich.
• Fluorescence from each distinct EBV antigen bead type is measured and compared against a Cutoff Calibrator.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Plexus EBV IgG Multi-Analyte Diagnostics device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for agreement. Instead, it presents the "Positive Percent Agreement" for different serological statuses when compared against predicate devices. While not an explicit acceptance criterion, the percentage agreement values indicate the device's performance relative to the established ground truth.

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

• Total Sample Size (Test Set): 873 samples
  • Prospective Samples: 723 samples (sequentially submitted for routine EBV testing, masked).
  • Retrospective Samples: 150 samples (pre-selected based on EBV VCA concentrations from a FDA-cleared device, likely to be cases with presumed acute infection).
• Data Provenance: United States
  • Samples were collected at three sites:
    • A hospital laboratory located in the Northeast (USA)
    • A pediatric hospital laboratory located in the Mid-West (USA)
    • Focus Diagnostics (manufacturer's site)

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

The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for the test set.

Instead, the ground truth was established by comparison to commercially available, FDA-cleared predicate devices and an algorithm based on serological profiles.

• For VCA IgG, the ground truth was a "consensus predicate" derived from a combination of:
  • FDA-cleared commercially available ELISA
  • FDA-cleared commercially available immunofluorescent (IFA) test
  • FDA-cleared commercially available flow cytometry-based immunoassay
• For EBNA-1 IgG and EA-D IgG, the ground truth was a single commercially available ELISA test.
• Additionally, the "Serological status was determined by the use of commercially available ELISA assays for the EBV analytes EBNA-1 IgG, VCA IgG and VCA IgM and a commercially available heterophile rapid test for the Heterophile antibody." This indicates a comprehensive panel of existing diagnostic tests was used to define the overall EBV serological status that the Plexus device was compared against.

4. Adjudication Method for the Test Set

• For Plexus EBV VCA IgG vs. Consensus Predicate: A consensus-based algorithm (2/3 majority rule) was used to determine the predicate result for comparison with the Plexus VCA IgG result. This means that out of the three predicate devices, at least two had to agree on the classification (positive/negative) for a sample to have a definitive "consensus predicate" result. If a 2/3 majority could not be obtained, the sample was reported as "No consensus."
• For Plexus EBV EBNA-1 IgG and Plexus EBNA-1 EA-D IgG: The document implies a direct comparison to a single commercially available ELISA, so a specific adjudication method like 2/3 majority would not apply in that instance.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is an in-vitro diagnostic device (IVD) performance study, comparing the device's output to established predicate tests, not measuring human reader performance with or without AI assistance.

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

Yes, this was a standalone performance study. The Plexus EBV IgG Multi-Analyte Diagnostics device is an immunoassay kit that generates qualitative results based on fluorescence measurements and automated calculations using Plexus software (as stated in the "Interpretation of test results" section). Its performance was evaluated on its own, comparing its output to that of predicate immunoassay devices. It does not involve human interpretation as a primary output.

7. The Type of Ground Truth Used

The ground truth used was a composite gold standard based on multiple commercially available, FDA-cleared predicate serological assays and a serological algorithm. Specifically:

• For VCA IgG: Consensus from three predicate immunoassays (ELISA, IFA, flow cytometry-based).
• For EBNA-1 IgG and EA-D IgG: Results from a single predicate ELISA.
• The overall "serological status" (e.g., Primary Acute, Late Acute, Previous Infection, No Infection) was classified using an algorithm based on a panel of results from commercially available ELISA assays (EBNA-1 IgG, VCA IgG, VCA IgM) and a heterophile rapid test. This represents an interpretation based on established diagnostic algorithms using multiple reference methods.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This study appears to be solely focused on validating the performance of the device against predicate methods on a test set. Immunoassays typically do not have a "training set" in the same way machine learning algorithms do, as their "learning" or calibration is part of the assay development and reagent formulation process. If any internal calibration or optimization was performed, it is not detailed in this summary.

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

Since no training set details are provided, the method for establishing its ground truth is also not available in the document.

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The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is intended for qualitatively detecting the presence or absence of human IgG antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for pregnant women and sexually active adults, as an aid for presumptively diagnosing HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2 infection. The test is not intended for donor screening or for self-testing. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.

The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is a multiplexed immunoassay for qualitatively detecting and differentiating human IgG antibodies to HSV-2. Test principle is identical to the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for all performance aspects. However, the "Summary of Previous Studies for Plexus™ HerpeSelect® HSV 1 and 2 IgG (manual calculation)" table on page 2 provides clear performance metrics that can be interpreted as the device meeting expected performance for a similar predicate device.

For the purpose of this analysis, I will synthesize "acceptance criteria" from the described study results, assuming that the reported performance met the internal and regulatory expectations for market clearance.

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