(13 days)
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.
§ 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).