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The ACE/PP is intended to exercise the lower leg to help prevent vein thrombosis secondary to venous stasis and blood pooling in the leg. It also retains the exercise function for maintaining muscle tone and preventing stiffness in the ankle joints.

The ACE/PP is a compact portable exercise device with motor driven foot paddles. The product is controlled by the staff or the patient via an air switch. The paddles are driven in a natural and gentle dorsiflex motion.

This document, K952975, is a 510(k) summary for a medical device submitted in 1996. The information provided is very limited and predates many of the standardized reporting requirements for clinical studies now common in medical device submissions.

Therefore, the requested information regarding acceptance criteria, specific study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided text. The document focuses primarily on establishing substantial equivalence to predicate devices rather than providing detailed performance study data.

Here's an analysis based on the available information and an explanation of why most of your requested points cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Not Available. The document does not specify any quantitative "acceptance criteria" for device performance in terms of clinical outcomes (e.g., reduction in DVT rates, specific physiological measurements). It focuses on safety (meeting UL 544) and functional equivalence.
• Reported Device Performance: The primary stated performance aspects are:
  • "motor driven foot paddles."
  • "paddles are driven in a natural and gentle dorsiflex motion."
  • "offers the user a means to exercise the lower leg and to minimize venous stasis in bedridden and immobile patients."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. The document makes no mention of a "test set" or any clinical study details that would involve a sample size or data provenance. The 510(k) submission primarily relies on a comparison to predicate devices.

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 Available. Since no specific test set or clinical study is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable/Not Available. As no test set or clinical study is described, no adjudication method is mentioned.

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 exercise and phlebopump, not an imaging or diagnostic device that would typically involve "human readers" or "AI assistance." Therefore, an MRMC study is not relevant to this device's function or evaluation as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a mechanical exerciser, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Available/Not Applicable. No explicit "ground truth" is mentioned because the submission does not describe a clinical study measuring specific outcomes against a definitive standard. The "truth" in this context is likely implied by the predicate devices' established clinical utility for preventing venous stasis and maintaining muscle tone.

8. The sample size for the training set

• Not Applicable/Not Available. This device is a mechanical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission.

9. How the ground truth for the training set was established

• Not Applicable/Not Available. As above, no training set for an algorithm is involved.

Summary of What Is Present:

• Device Name: Prevent Products Ankle Calf Exerciser & Phlebopump (ACE/PP)
• Classification: Class II
• Intended Use: To exercise the lower leg to help prevent vein thrombosis secondary to venous stasis and blood pooling in the leg, and to maintain muscle tone and prevent stiffness in ankle joints.
• Safety Standard: Meets or exceeds UL 544.
• Method of Performance Evaluation (implied): Substantial equivalence to predicate devices (Ankle Calf Exerciser from Prevent Products, Inc., Toronto Lower Limb Model Mobilimb L2, PlexiPump from NuTech) based on similar indications for use and basic overall design.

In conclusion, the provided K952975 document focuses on establishing substantial equivalence for a mechanical device in the mid-1990s. The information requested regarding detailed study design, sample sizes, expert involvement, and specific acceptance criteria for clinical outcomes is not part of this type of submission from that era.

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