(30 days)
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).
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1 (General Requirements for Safety) | Met (implied by "tested" and "complies") |
| EMC | Compliance with EN/IEC 60601-1-2 (Electromagnetic Compatibility) | Met (implied by "tested" and "complies") |
| Effectiveness (General) | As safe, as effective, and performs as well as or better than the predicate device. | Device performs as well as or better than the predicate (PADnet+). |
| Functionality (Venous) | Addition of air plethysmography modality to venous test suite (compared to PADnet+). | PADnet 2.0 adds air plethysmography for venous tests. (Difference noted) |
| Functionality (Arterial) | Use oscillometry to assess limb blood pressure (same as predicate). | PADnet 2.0 uses oscillometry to assess limb blood pressure. (Same as 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.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).