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The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professionals in either a professional medical or home environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.

PADnet Xpress, like the PADnet 2.0 aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial/Dorsalis Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Artery Disease (PAD). Following each test PADnet Xpress provides documented results, including waveforms, as part of the final report, which may be viewed on the system display, in printed form, and/or digitaly saved. PADnet Xpress was designed, in response to consumer feedback, to perform a subset of tests, namely PAD screening, which the predicate PADnet 2.0 device is capable of in a smaller, more portable form factor. The design modifications did not alter the intended use and are modest departures from the existing, previously cleared technological characteristics of the PADnet 2.0. While the intended use is not altered, there are minor modifications for use to remove elements of the indication not associated with arterial pulse contour analysis, and segmental systolic blood pressure measurements, as well as to allow for home use by a trained operator.

When performing an assessment, the clinician places a sensor and takes a measurement on each lower extremity. The sensor detects changes in arterial blood volume. This signal is digitized and sent to a computer via a wired connection, where it runs a proprietary software application calculates the result, which is based on the features of the volume plethysmographic signals from the Brachial, Anterior Tibial arterial distributions. The indications for use are almost identical to the PADnet 2.0, the predicate device, but PADnet Xpress has also been tested for compliance with IEC 60601-1-11 home use electrical safety standards and is indicated for use in that environment as well with no change to the safety or effectiveness of the device. The PADnet Xpress sensor used with the predicate, is made from Makrolon plastic.

This document is a 510(k) summary for the PADnet Xpress device. It outlines the device's indications for use, comparison to a predicate device (PADnet 2.0), and provides a summary of non-clinical and/or clinical tests. However, the document explicitly states that no additional performance testing was needed to demonstrate substantial equivalence for the PADnet Xpress because the underlying technology is unchanged from the predicate device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document as a study proving the device meets acceptance criteria was not conducted for the PADnet Xpress due to the nature of this 510(k) submission.

The document indicates:

• Non-Clinical and/or Clinical Tests Summary & Conclusions: "Since the underlying technology for aiding in the disease is unchanged between the predicate PADnet 2.0 device and the modified PADnet Xpress, a risk analysis determined that additional performance testing was not needed to demonstrate the substantive equivalence of the safety and effectiveness of the device."

This means that the information you are requesting about a study proving the device meets acceptance criteria, including details about sample sizes, experts, ground truth, etc., is not present because such a study was deemed unnecessary for this 510(k) submission. The FDA cleared the device based on its substantial equivalence to a previously cleared predicate device whose performance data would have been evaluated during its initial clearance.

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The BioMedix PADnet 2.0 is a non-invasive device used to assess the lower and upper extremity arterial and venous circulatory systems in order to assist in the identification of vascular disease. To assess the arterial system, PADnet 2.0 uses pulse volume recording, arterial pulse contour analysis, and segmental systolic & diastolic blood pressure measurements. To assess the venous valvular system, PADnet 2.0 measures venous refilling time. For identification of venous obstruction in the deep venous (below knee) system, PADnet 2.0 measures venous outflow rate. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.

The primary goal of the PADnet 2.0 system is to assess the blood vascular system and assist on the diagnosis of arterial and venous vascular disease. The currently released PADnet+ system already provides this type of functionality. With focus on the venous system, PADnet+ permits the assessment of venous reflux in the venous valvular system of the lower extremity. Its native functionality also permits the assessment of venous obstruction in the deep venous system. It accomplishes these ends using photo-plethysmography. Photo-plethysmography refers to a technique whereby localized volume changes due to an optically scattering/absorbant substance (e.g. blood) are measured. PADnet 2.0 adds the air plethysmography modality to the pre-existing venous test suite. Thus, only the methodology used for testing has been augmented. Indications for use are unchanged. With focus on the arterial system, PADnet+ permits the assessment of arterial insufficiency. It accomplishes this end using pneumo-plethysmography (air plethysmography). Pneumo-plethysmography refers to a technique whereby localized volume changes as measured by pressure changes in an inflated blood pressure cuff are recorded. This signal is assessed for waveform morphology and amplitude. Additional information regarding arterial insufficiency may be obtained by measurement of peak arterial systolic blood pressure. . PADnet 2.0 uses oscillometry to assess limb blood pressure.

This 510(k) summary does not contain sufficient information to describe specific acceptance criteria and detailed study data in the way typically required for AI/ML device submissions. This document is a 510(k) for a medical device (PADnet 2.0) that primarily describes hardware and software modifications of an existing plethysmograph, and its safety and effectiveness are established through technological comparison to a predicate device and compliance with general safety and EMC standards. It does not describe a study involving specific performance metrics for an AI/ML algorithm or human reader performance.

Therefore, many of the requested data points (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of submission.

However, I can extract the information that is present and indicate where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way for specific disease identification performance in the context of an AI/ML model compared to a gold standard. Instead, it relies on the device meeting established standards and being "as safe, as effective, and performs as well as or better than the non-modified device" (the predicate).

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

• Sample Size: Not specified. This document refers to compliance with standards (IEC, EN) and performance comparison to a predicate device, rather than a clinical study with a defined test set for a new algorithm's diagnostic performance.
• Data Provenance: Not applicable/not specified for a clinical performance test set in this context. The testing mentioned relates to electrical safety and EMC.

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

• Not applicable. There is no mention of a test set with expert-established ground truth for diagnostic accuracy in this submission.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring adjudication is 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:

• No. This is not an AI/ML device submission that would typically involve an MRMC study comparing human reader performance with and without AI assistance. The device is a plethysmograph, an instrument for physiological measurements.

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

• Not applicable. This is not an AI/ML algorithm submission. The device is a measurement system.

7. The Type of Ground Truth Used:

• Not applicable for diagnostic accuracy in this context. The "ground truth" for the device's acceptable performance is its adherence to recognized electrical safety and EMC standards and demonstrating equivalence in functionality to its predicate device.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" as this is not an AI/ML algorithm submission.

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

• Not applicable. See point 8.

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The BioMedix PADnet+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non intact skin.

The BioMedix PADnet+ is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere or in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab+.

The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements:

• Windows 2000 Operating System or Higher .
• 128 MB RAM .
• 20 GB Free Hard Disk Space .
• 600 MHZ Processor or Higher .

This 510(k) summary does not contain sufficient information to describe the acceptance criteria, the study proving the device meets the acceptance criteria, or most of the requested details about the study. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through descriptive comparisons of features and intended use, rather than a detailed performance study with acceptance criteria.

Here's what can be extracted and what is missing:

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

This information is not provided in the document. The document primarily describes the device and its similarities/differences to predicate devices, but does not state specific performance metrics (e.g., accuracy, sensitivity, specificity) for the PADnet+ or the acceptance criteria it was evaluated against.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document makes no mention of a specific test set or clinical data used to evaluate the PADnet+ performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. No test set and thus no ground truth establishment by experts is described.

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

This information is not provided. No test set is 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

This information is not provided. The device is described as a "non invasive cardiovascular blood flow monitor" and not as an AI-powered diagnostic tool intended to assist human readers. Therefore, an MRMC study related to AI assistance is unlikely and not mentioned.

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

This information is not provided. While the PADnet+ is a diagnostic device, the document does not present any standalone performance metrics or studies.

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

This information is not provided. No performance study with ground truth is mentioned.

8. The sample size for the training set

This information is not provided. As this document doesn't describe the development or evaluation of an AI/machine learning model, there is no mention of a training set.

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

This information is not provided. No training set is mentioned.

Summary of available information related to the device and its acceptance/clearance:

The document is a 510(k) Summary, which is typically used to demonstrate substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a de novo study.

• Predicate Devices: Flostat Vascular Lab (K973644, cleared Dec 23, 1997) and PADnet Lab (K042616, cleared Oct 12, 2004).
• Basis for Substantial Equivalence: The BioMedix PADnet+ is considered substantially equivalent because:
  • It has the same intended use as the predicate devices.
  • It has the same technical characteristics as the predicate devices and does not raise any new types of safety or effectiveness concerns.
  • It combines features (PPG from Flowstat Vascular Lab) with the original design of the PADnet Lab.
• Intended Use (from the Indications for Use statement): "The BioMedix PADnet+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non intact skin."
• Standards Met (indicating safety and some functionality):
  • EN60601-1 Electrical Safety
  • EN60601-1-2 EMC
  • ISO 10993-1 Biological Evaluation

In essence, the "acceptance criteria" in this context are more about demonstrating that the new device is as safe and effective as the predicate devices, rather than meeting specific quantifiable performance thresholds outlined in a novel clinical study. The FDA's clearance (NOV 21 2007) signifies their agreement with this substantial equivalence claim.

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The BioMedix PADnet Lab is a non invasive device used to record physiological data from the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures for use by the Physician in the identification of vascular pathology. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.

The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere nor in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab. The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements: Windows 2000 Operating System or higher, 128 MB RAM, 20 GB Free Hard Disk Space, 600 MHz Processor or higher.

The provided document is a 510(k) premarket notification for the BioMedix PADnet Lab, which aims to demonstrate substantial equivalence to a predicate device, the Flostat Vascular Lab. This type of submission focuses on comparing the new device's characteristics and intended use to an already legally marketed device, rather than providing extensive clinical study data a standalone performance device. The document primarily highlights similarities and differences between the new device and the predicate device, emphasizing that the PADnet Lab's differences do not raise new safety or effectiveness concerns.

Therefore, many of the requested criteria, particularly those pertaining to acceptance criteria with reported performance, detailed study design, ground truth establishment, a human-in-the-loop study, or a multi-reader multi-case study are not typically part of a 510(k) submission for this type of device. The acceptance criteria in this context are primarily about demonstrating equivalence to the predicate device in terms of technology, safety standards compliance, and intended use.

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

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

The acceptance criteria for this 510(k) are implicitly based on demonstrating substantial equivalence to the predicate device (Flostat Vascular Lab) in various technical and operational aspects, and adherence to relevant safety standards. The document doesn't present a table of numerical performance targets with corresponding measured values for the PADnet Lab's diagnostic capabilities. Instead, it compares features.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail a specific "test set" in the context of clinical performance evaluation studies for the PADnet Lab. The submission is a 510(k) for substantial equivalence based on technical and functional comparison to a predicate device, along with adherence to recognized safety and EMC standards. Clinical data (e.g., from a test set of patients) for this specific device's diagnostic performance is not provided as the primary method to demonstrate substantial equivalence in this filing. The term "Clinical Reports" under the comparison table refers to the device's ability to generate such reports, not the submission of clinical study data for FDA review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set with ground truth established by experts is described in this 510(k) submission.

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

Not applicable. No clinical test set and adjudication method are described in this 510(k) submission.

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 device is a "Blood Flow Monitor" and a "Plethysmograph", likely providing physiological measurements rather than interpretive "AI assistance" to human readers. No MRMC or human-in-the-loop study is mentioned.

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

Not applicable. The PADnet Lab is a measurement device, not an "algorithm-only" or AI-driven diagnostic system in the sense of an imaging analysis tool. Its performance is based on the accuracy of its physiological measurements, for which a specific standalone performance study is not detailed here beyond compliance with general electrical and biological safety standards.

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

Not applicable. No ground truth is specified as no clinical performance study for diagnostic accuracy is detailed in this 510(k). The basis for "ground truth" in this context would implicitly be the validated performance of the predicate device and the accepted physiological principles behind plethysmography and oscillometric measurements.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring such.

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

Not applicable. No training set is discussed.

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