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510(k) Data Aggregation
(21 days)
The ALP® 501 RB Pump system is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both.
The ALP® 501 RB Pump System is intended for use by patients and medical professionals in treating many conditions, such as:
- Reduce the incidence of deep vein thrombosis (DVT) and pulmonary embolism due to the presence of risk factors for thrombosis formation
- Enhancement of arterial blood flow
- Reduction of post-operative pain and swelling
- Reduction of compartmental pressure after tissue trauma
The ALP® 501 RB Pump is a prescriptive, pneumatic compression device designed to apply compression to the lower limb. The ALP® 501 RB pump is compact this making it a portable ambulant system. The ALP® 501 RB pump provides the user with an option of battery operation in addition to the operation from the mains option. The ALP® 501 RB pump is easy to use and provides the user with three treatment options: compression of the foot, compression of the calf, or combined compression of both (one foot and one calf).
The foot and calf compression program fills a garment bladder and decompresses. The device is composed of three main sub-systems:
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- A portable pneumatic pump unit,
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- A pair of garments (calf and/or foot) and
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- Pneumatic connecting tubes.
Inflation and deflation of the garments are controlled by the pump system. The inflation and deflation produces a massage on the patient limb in order to stimulate the natural flow of the body fluids.
The provided text describes a 510(k) premarket notification for the ALP® 501 RB Pneumatic Compression System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria for performance metrics.
However, based on the information provided, we can infer the "acceptance criteria" and "device performance" in the context of demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety and Performance Equivalence to Predicate Device | "A series of safety and performance testing including comparative analysis between the ALP® 501 RB Pump system and the ALP® 501 Pump System demonstrated that the ALP® 501 RB Pump System is substantially equivalent to the ALP® 501 Pump System without raising new safety and/or effectiveness issues." |
| Functional Equivalence (Technological Characteristics) | The ALP® 501 RB is described as "substantially equivalent in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., to the commercially available ALP® 501 Pump System." The changes noted are "the addition of an optional battery operated unit and change in inner components." |
| Intended Use Equivalence | The Indications for Use for the ALP® 501 RB are identical to those of the predicate device (ALP® 501 Pump System) as listed in the document. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an evaluative study with a distinct sample size. The testing conducted was a "series of safety and performance testing including comparative analysis" between the new device and its predicate. No specific number of devices or subjects is mentioned for this comparative analysis.
The data provenance is not explicitly stated, but given that both devices are commercial products or prototypes from Currie Medical Specialties Inc. in the USA, it is highly likely the testing was conducted prospectively by the manufacturer, possibly in a laboratory or simulated clinical setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes a submission for substantial equivalence based on engineering and performance testing, not a clinical study requiring expert assessment for ground truth determination (like image interpretation or pathology).
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There was no expert "ground truth" to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a comparison between two medical devices, one being the predicate for the other, and does not involve human readers interpreting cases with and without AI assistance.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device described is a physical pneumatic compression system, not an AI algorithm. Its performance is inherent in its mechanical operation, not a computational output that would precede human interaction.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety of the predicate device (ALP® 501 Pump System). The new device (ALP® 501 RB) was deemed to meet acceptance criteria by demonstrating that its performance and safety were equivalent to this existing, legally marketed device. The specific metrics for performance (e.g., pressure, cycle times, comfort, durability) are not detailed but would have been part of the internal safety and performance testing.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
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