(82 days)
The Phlebo Press DVT 603 is intended for use by medical professionals and patients who are under medical supervision, in treating conditions such as:
- Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
- Reduction of pain and swelling after injury and surgery
- Enhancement of venous circulation
- Prevention of venous stasis
- Assistance in healing of cutaneous ulcers
- Reduction of compartmental pressures
The device is intended for hospital, home and clinic use
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Phlebo Press DVT 603". This correspondence primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailing a specific clinical study with acceptance criteria and performance data for the Phlebo Press DVT 603 itself.
Therefore, I cannot directly extract the specific information requested about acceptance criteria and a study proving the device meets those criteria from this FDA letter. The letter confirms a regulatory determination of substantial equivalence, which is a different type of assessment than a detailed clinical performance study.
Typically, such information would be found in a separate clinical study report or a different section of the 510(k) submission that details performance testing.
However, based on the information provided:
I can state that the document does not contain the detailed information required to fill out the table about acceptance criteria and device performance, nor the specifics about sample size, data provenance, ground truth establishment, or clinical study design (MRMC, standalone) for the Phlebo Press DVT 603.
To answer your request, if this were a document that did contain the study details you're looking for, the information would ideally be presented as follows:
Acceptance Criteria and Device Performance Study for [Device Name - Hypothetical Example]
Since the provided document is a 510(k) clearance letter and does not contain the specific study details you've requested regarding acceptance criteria and performance, I will provide a framework of how this information would typically be presented in a suitable document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| [e.g., Sensitivity] | [e.g., ≥ 90%] | [e.g., 92.5% (95% CI: 90.1-94.4%)] |
| [e.g., Specificity] | [e.g., ≥ 80%] | [e.g., 85.2% (95% CI: 82.3-87.7%)] |
| [e.g., Accuracy] | [e.g., ≥ 85%] | [e.g., 88.0% (95% CI: 86.1-89.8%)] |
| [e.g., Cohen's Kappa] | [e.g., ≥ 0.70] | [e.g., 0.75] |
| [e.g., Time to Result] | [e.g., ≤ 5 minutes] | [e.g., Average 3.2 minutes] |
| [e.g., Mechanical Reliability (Cycles)] | [e.g., > 1,000,000 cycles] | [e.g., 1,500,000 cycles without failure] |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: [Insert number of cases/patients, e.g., 500 cases, 300 patients]
- Data Provenance: [e.g., Retrospective, multi-center data collected from hospitals in the United States, Germany, and Japan. OR Prospective, single-center study conducted in the United Kingdom.]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: [e.g., 3]
- Qualifications of Experts: [e.g., Board-certified Radiologists with 10-20 years of experience in diagnostic imaging, specializing in vascular studies. OR Board-certified Pathologists with 15+ years of experience in histopathology.]
4. Adjudication method for the test set
- Adjudication Method: [e.g., 2+1 adjudication (two experts independently review, with a third expert adjudicating discordant cases). OR Majority vote among 3 experts. OR Consensus meeting among all experts.]
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
- MRMC Study Done?: [Yes/No]
- Effect Size (if Yes): [e.g., "Human readers improved their AUC by an average of 0.08 (from 0.82 to 0.90) when using AI assistance, representing a statistically significant improvement (p
§ 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).