(177 days)
To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.
The ClearMedical/Huntleigh DVTs are accessory devices to a DVT System which is used for the prevention of deep vein thrombosis. The DVT Garment is designed with inflatable bladders that fill with air to provide compression to the calf and thigh. A connector tubing system attaches the DVT to the pump system. The DVT Garments are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, an anatomical bladder and molded polyethylene tubing with a polypropylene colder snap-lock connector.
The provided text is related to a 510(k) summary for a medical device called "ClearMedical/Huntleigh Deep Vein Thrombosis (DVT) Garments." This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in a way that would allow for a table of acceptance criteria and reported device performance, or answer the specific questions about standalone performance, MRMC studies, training/test set details, or ground truth establishment.
The document focuses on demonstrating substantial equivalence to a previously approved device (Huntleigh DVT Garments) based on bench testing and non-clinical performance data, rather than reporting on a clinical study with specific performance metrics against defined acceptance criteria.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states: "For all established indicators of substantial equivalence, the ClearMedical devices demonstrated equality in safety and performance." and "Based on an assessment of bench tests and non-clinical performance data, we believe that in all relevant safety and performance indicators the ClearMedical/ Huntleigh DVT Garments demonstrates substantial equivalence to the predicate devices, the Huntleigh DVT Garments."
- It mentions "Technological indicators of substantial equivalence were identified and included method of infection control, fit/attachment, bladder function, velcro adhesion, and connector function." but does not provide quantitative acceptance criteria or reported performance figures for these indicators.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. The document refers to "bench tests and non-clinical performance data" but does not specify sample sizes or data provenance.
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):
- Cannot be provided. This type of information is not relevant for a substantial equivalence submission based on bench testing of physical device characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. Not relevant for this type of 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:
- Cannot be provided. This document describes a physical medical device (DVT garments), not an AI/software-as-a-medical-device (SaMD) that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. Not applicable to this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. The "ground truth" in this context would be the performance benchmarks of the predicate device for the technological indicators mentioned (infection control, fit, bladder function, velcro, connector function). These are physical properties, not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Cannot be provided. This is not an AI/machine learning device, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable.
Summary of available information regarding performance:
The document states that the ClearMedical/Huntleigh DVT Garments are "substantially equivalent" to predicate devices (Huntleigh DVT Garments, DVT 10, DVT 20, DVT 30, and DVT 40). This determination was reached based on:
- Evaluation and analysis of the predicate device's technical and promotional labeling.
- Specific bench testing.
The document claims that the ClearMedical devices "demonstrated equality in safety and performance" for all established indicators of substantial equivalence.
Technological indicators of substantial equivalence evaluated:
- Method of infection control (ClearMedical's methods meet or exceed CDC and APIC Guideline standards for this class of device).
- Fit/attachment
- Bladder function
- Velcro adhesion
- Connector function
Conclusion: The provided text is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It does not contain the detailed performance metrics, study designs, or ground truth establishment methods typically associated with clinical trials or AI/SaMD submissions that would be required to answer most of your specific questions.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).