(48 days)
The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare®++ System is intended for use in:
- Preventing Deep Vein Thrombosis (DVT). .
- Enhancing blood circulation. .
- Diminishing post-operative pain and swelling. .
- Reducing wound-healing time. .
- Treatment and assistance in healing: stasis dermatitis; . venous stasis ulcers; arterial and diabetic leg ulcers.
- Treatment of chronic venous insufficiency. .
- Reducing edema. .
The ActiveCare®++ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the ActiveCare®++ is light and compact, thus making it a portable ambulant system. The ActiveCare®++ provides the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare®++ is easy to use and provides the user with several treatment options: compression of the foot - single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.
The foot compression program is sequential intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent gradient application of a pressure (s) a three-celled calf sleeve.
The provided text describes the Medical Compression Systems (DBN) Ltd ActiveCare®++ System, but it does not contain a table of acceptance criteria or a detailed study proving the device meets specific acceptance criteria in the manner requested.
Instead, the submission for K060146, filed in 2006, focuses on demonstrating substantial equivalence to previously cleared predicate devices. The changes made to the ActiveCare®++ system compared to its predecessors (ActiveCare® System, Wizair Compression System, Wizair DVT, or ProAir 3000) are primarily software updates, a new user interface, a compliance indicator, and a new calf sleeve.
The document states:
"A series of safety and performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare®++ System does not raise any new questions of safety and efficacy. These tests include:
- Electrical and electromagnetic testing
- Software verification and validation
- Performance testing of the output parameters and pressure profile"
However, it does not provide the specific acceptance criteria for these tests nor the detailed results or methodologies of the studies performed (e.g., sample sizes, expert involvement, particular metrics used for "performance testing of output parameters and pressure profile").
Therefore, I cannot fulfill all parts of your request based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." While it mentions compliance with voluntary standards (IEC 60601-1, IEC 60601-2, AAMI / ISO 14971-1), these are general safety and risk management standards and not specific performance criteria for the device's therapeutic effect. The "performance testing of the output parameters and pressure profile" is mentioned, but no specific criteria or results are given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "clinical comparison in healthy volunteers" as part of the safety and performance testing.
- Sample Size: Not specified.
- Data Provenance: The applicant is based in Israel (Medical Compression Systems (DBN) Ltd. and Biomedical Strategy (2004) Ltd.), suggesting the studies likely occurred there, but this is not explicitly stated for the "clinical comparison."
- Retrospective or Prospective: The "clinical comparison in healthy volunteers" 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)
- Not applicable/Not specified. The nature of the device (pneumatic compression for DVT prevention, circulation enhancement, etc.) does not typically involve image interpretation or diagnosis that would require expert "ground truth" establishment in the cognitive sense. The "performance testing" would likely involve objective biomechanical or physiological measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used when there is subjective interpretation or a need to resolve discrepancies in expert opinions, which does not appear to be the case for the described tests on a pneumatic compression device.
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 device is not an AI-powered diagnostic tool, so an MRMC study 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 an algorithm, so "standalone performance" in that context is not relevant. The "software verification and validation" would assess the algorithm's correct functioning within the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "performance testing of output parameters and pressure profile" in healthy volunteers, the ground truth would likely be objective physiological measurements (e.g., blood flow velocity, pressure readings, temperature changes) and device output parameters measured by calibrated equipment. The document does not elaborate on these specifics.
8. The sample size for the training set
- Not applicable. This device does not use machine learning in a way that would require a "training set" for an AI model. "Software verification and validation" would be based on established software engineering principles, not statistical training data.
9. How the ground truth for the training set was established
* Not applicable. See point 8.
§ 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).