(177 days)
Prevention of deep vein thrombosis. Enhancement of venous and arterial circulation. Prevention of venous stasis. Assist in healing of cutaneous ulcers, including venous stasis ulcers. Reduction of acute and chronic edema. Reduction of lower limb pain due to trauma or surgery. Reduction of compartmental pressures.
The ClearMedical/Huntleigh Foot Garments are an accessory device to a Foot Garment System which is used for the prevention of deep vein thrombosis. The Foot Garment is designed with an inflatable bladder that fills with air to provide compression to the feet. A connector tubing system attaches the Foot Garment to the pump system. The Foot Garments are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, a vented bladder and molded polyethylene tubing with a polypropylene colder snap-lock connector.
The provided text describes a 510(k) summary for ClearMedical/Huntleigh Foot Garments, which were deemed substantially equivalent to predicate devices. However, the document does not contain specific acceptance criteria for performance or detailed study results beyond a general statement that "bench tests and non-clinical performance data" were assessed to establish substantial equivalence.
Therefore, many of the requested details about acceptance criteria, study sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not available in the provided text. The document focuses on regulatory equivalence rather than a detailed clinical performance study with defined acceptance criteria.
Based on the available information, here is what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance |
|---|---|
| Methods of infection control: Meets/exceeds CDC and APIC standards | ClearMedical's infection control methods meet or exceed the CDC and APIC standards for this class of device. The device is labeled "High Level-Disinfected." |
| Fit/attachment: Substantial equivalence to predicate | Demonstrated equality in safety and performance to predicate device. |
| Bladder function: Substantial equivalence to predicate | Demonstrated equality in safety and performance to predicate device. |
| Velcro adhesion: Substantial equivalence to predicate | Demonstrated equality in safety and performance to predicate device. |
| Connector function: Substantial equivalence to predicate | Demonstrated equality in safety and performance to predicate device. |
| Safety and performance (general): Substantial equivalence to predicate | In all relevant safety and performance indicators, the ClearMedical/Huntleigh Foot Garments demonstrate substantial equivalence to the predicate devices. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions "bench tests and non-clinical performance data."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The assessment was based on "bench tests and non-clinical performance data" against a predicate device, not on diagnostic accuracy requiring expert ground truth in a clinical setting.
4. Adjudication method for the test set
- Not applicable/Not specified. The assessment was based on comparison to a predicate device via bench testing.
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-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (Foot Garments) for DVT prevention, not a standalone algorithm.
7. The type of ground truth used
- Reference standard/Comparison: The predicate device (Huntleigh Foot Garments) was used as the basis for comparison to demonstrate substantial equivalence. The "ground truth" was largely established through technical and functional equivalence to this legally marketed device.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).