(399 days)
- Prevention of deep vein thrombosis 1.
- Enhancement of venous & arterial circulation 2.
- Preventionof venous stasis 3 .
- Assist healing of cutaneous ulcers 4 ,
- -5 . Reduction of acute or chronic edema
- Reduction of lower limb pain due to surgery or trauma 6.
- 7 . Reduction of compartmental pressures
The FP5000 System is an external pneumatic compression system comprised of a pump which supplies compressed air to a pair of foot wrap garments. The garments alternately inflate to provide compression to the venous plantar plexus of the foot. Venous plantar plexus compression move blood out of the leg, and may be used to prevent deep vein thrombosis (DVT), and as part of the treatment regimen for venous and arterial conditions of the lower limbs.
The provided text for KCa65153 is a 510(k) summary for the FP5000 System, a device for external pneumatic compression. The summary focuses on establishing substantial equivalence to existing predicate devices rather than providing detailed acceptance criteria and a study to prove the device meets these criteria in the traditional sense of a clinical trial with specific performance metrics.
Based on the provided document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific quantitative targets (e.g., "sensitivity > X%", "accuracy > Y%"). Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance |
| A. Comparable therapy/performance to existing marketed devices | "Laboratory evaluation on healthy subjects documented that the venous outflow velocity, as measured at the common femoral vein, is comparable between the FP5000 System and the two predicate systems (A V 5000 system (Kendall) and the PlexiPulse system (NuTech/KCI))." |
| B. No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation compared to predicate devices. | "There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| C. Meet voluntary standards (e.g., UL listing, European Medical Directive for electromagnetic compatibility). | "Voluntary standards met include UL listing and compliance with the European Medical Directive for electromagnetic compatability." |
| D. Raise no new safety or effectiveness concerns. | "The FP5000 System raises no new safety or effectiveness concerns." (This is a general statement required for 510(k) clearance, rather than a quantifiable performance metric). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: The document only mentions "healthy subjects" for the laboratory evaluation. It does not specify the number of subjects (the sample size) used in this evaluation.
- Data provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly probable the study was conducted within the US or under internationally recognized standards accepted by the FDA. The nature of a "laboratory evaluation on healthy subjects" implies a prospective study.
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 section is not applicable to the type of device and study described. The study cited measured physiological parameters (venous outflow velocity) directly, rather than relying on expert interpretation of images or other subjective assessments that would require ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As the study measured objective physiological parameters directly, no adjudication method for expert consensus was required.
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
Not applicable. This device is an external pneumatic compression system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not a software algorithm. Its performance is evaluated through its mechanical action and physiological effects.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth or comparison standard was the direct measurement of venous outflow velocity in healthy subjects, using established methods to quantify the physiological effect of the device and comparing it to the same measurements obtained with predicate devices. This relies on quantitative physiological data rather than a subjective "ground truth" derived from expert consensus, pathology, or outcomes data in the traditional sense for diagnostic algorithms.
8. The sample size for the training set
Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning algorithm, this question is not relevant.
§ 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).