(242 days)
The Pegasus Medical Supply Inc. ANGIO-PRESS IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.
ANGIO-PRESS DVT Compression Device that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). ANGIO-PRESS DVT Compression Device is a non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as ant embolic stockings and anticoagulants.
ANGIO-PRESS DVT Compression Device is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, ANGIO-PRESS DVT Compression Device is identified as a compressible limb sleeve.
This document describes the ANGIO-PRESS DVT Compression Device, Model IPCS, and its substantial equivalence to a predicate device. As such, the information provided is focused on regulatory compliance and comparison, rather than a clinical study with detailed performance metrics against acceptance criteria generally seen in machine learning or diagnostic device studies.
Therefore, many of the requested points related to advanced AI/ML device studies (e.g., sample sizes for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not directly applicable or available in this type of submission.
Here's an attempt to address the request based on the provided text, highlighting where information is not present:
Acceptance Criteria and Device Performance Study for ANGIO-PRESS DVT Compression Device
The ANGIO-PRESS DVT Compression Device's acceptance criteria and proven performance are primarily established through non-clinical safety and performance testing to recognized standards, demonstrating substantial equivalence to a legally marketed predicate device (VasoPress DVT Supreme Mini, Pump Model No. VP500DM, K101915).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single table detailing specific numerical acceptance criteria (e.g., a specific pressure range) alongside reported numerical performance for each criterion. Instead, it refers to conformity with applied standards and general device specifications.
General Device Performance (Comparison to Predicate):
| Item | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ANGIO-PRESS DVT Compression Device) |
|---|---|---|
| Regulation Number | 870.5800 | 870.5800 |
| Classification | Class II | Class II |
| Product Code | JOW | JOW |
| Prescription Use | Yes | Yes |
| Indications for Use | Lower the risk of DVT / increase venous blood flow to help prevent DVT | Increase venous blood flow to help prevent DVT |
| Pressure Range | 40 and 80 mmHg (for Calf/Thigh and Foot respectively) | Same (implies adherence to predicate's pressure range specifications) |
| Input Rating | AC 100-240V, 50/60Hz | Same |
| Operating Humidity | 30 - 75% | Same |
| Operation Temperature | 15°C - 35°C | Same |
| Applied Part | Garment and Air Hose | Same |
| Applied Mode of Pressure | Intermittent | Same |
| Number of Chambers in Garment | No (This appears to be a misinterpretation; likely means 'not specified' or 'variable') | Same (This also appears to be a literal match to the predicate's entry, likely implying the same lack of specific chamber count if not applicable to the pump itself). |
| Inflation time per chamber | 12 seconds | Same |
| Deflation time per chamber | 48 seconds | Same |
| Fuse Rating | 1A or T1AH 250V | 1A/250V |
| Biocompatibility | Conformity to ISO 10993 series and USP Biological reactivity tests | All tests met requirements. |
| Software | Conformity to IEC 62304 | All tests met requirements. |
| EMC & Electrical Safety | Conformity to EN/IEC 60601-1-2 and IEC 60601-1 | All tests met requirements. |
| Performance (Environmental) | Conformity to IEC 60068-2-6, -2-27, -2-14; ISTA 2A | All tests met requirements. |
| Risk Management | Conformity to ISO 14971, IEC 60812 | All tests met requirements. |
| Usability | Conformity to IEC 60601-1-6, IEC 62366 | All tests met requirements. |
The acceptance criteria for each "Testing Item" (e.g., Biocompatibility, Software, EMC, Electrical Safety, Performance, Risk Management, Usability) were defined by the respective international standards and regulations listed. The "Reported Device Performance" for these items is universally stated as: "All the test results demonstrate ANGIO-PRESS DVT Compression Device meet the requirements of its pre-defined acceptance criteria and intended uses."
2. Sample size used for the test set and the data provenance
This is a physical medical device, not an AI/ML diagnostic system. The "test set" refers to physical units of the device and components subjected to engineering and safety testing. The document does not specify the exact sample size (number of devices/components tested) for each non-clinical test. The data provenance is from the manufacturer's internal testing or contracted testing laboratories, located in Taiwan (R.O.C.). The testing is prospective for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For non-clinical device testing, "ground truth" is established by adherence to specified engineering standards, measurement protocols, and safety requirements. Expert judgment might be involved in test design or interpretation of results, but not in the sense of clinical "ground truth" for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations in clinical studies or AI/ML evaluations. For non-clinical device testing, results are typically objective measurements against technical specifications and standard compliance.
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 a DVT compression device, not an AI-assisted diagnostic or interpretive system. No human reader involvement or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For non-clinical testing, the "ground truth" is adherence to established international standards and regulations (e.g., ISO, IEC, USP standards for biocompatibility, electrical safety, software, performance, risk management, usability). Measurements and observations during testing are compared against these standards for compliance.
8. The sample size for the training set
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No machine learning training set exists for this device.
§ 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).