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510(k) Data Aggregation
(28 days)
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
The VasoPress DVT Leg Garment (sterile) consists of a brushed nylon outer material bonded to a foam inner liner bonded to an inner lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The devices are terminally sterilized with Ethylene Oxide (EO) gas.
The provided text describes the acceptance criteria and performance testing for the VasoPress DVT Garment (sterile). It does not contain information about a study proving the device meets the acceptance criteria in the context of clinical effectiveness or performance against a ground truth. Instead, the performance testing focuses on manufacturing quality control.
Here's the breakdown of the information that can be extracted:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bladder integrity: pressurize to 120 mmHg | Bladders are pressurized to 120 |
| Dwell for 30 seconds | Dwell for thirty (30) seconds |
| Drop in pressure not above 20 mmHg | No drop in pressure above 20 mmHg |
(Note: The reported performance is a statement of the test methodology and expected outcome rather than specific numerical results from a study.)
2. Sample Size Used for the Test Set and Data Provenance
The document states "100% verification of bladder integrity via leak test." This implies a sample size of 100% of manufactured devices for this specific test.
Data Provenance: The data provenance is not explicitly mentioned as coming from a specific country or being retrospective/prospective in a clinical research sense. It relates to manufacturing quality control checks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance testing described is a technical test of bladder integrity, not a clinical assessment requiring expert interpretation or ground truth establishment in the traditional sense of a medical device study (e.g., image analysis, diagnosis).
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is a pass/fail technical test, not a subjective assessment requiring consensus among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in the provided text. The document focuses on manufacturing and technological equivalence.
6. Standalone Performance Study
No, a standalone (algorithm-only without human-in-the-loop performance) study was not done. This device is a physical, pneumatic compression device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this performance test is the physical property of bladder integrity per the specified pressure and leak parameters. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. The device is a physical product, and the performance testing described relates to manufacturing quality, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device and performance testing.
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(43 days)
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
The VasoPress Reprocessed DVT Leg Garment consists of a brushed nylon outer material bonded to a foam inner liner bonded to a tricot lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress Reprocessed DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The reprocessed devices are cleaned, inspected and tested, packaged and exposed to Ethylene Oxide (EO) gas wash. The VasoPress Reprocessed DVT Garments are provided non-sterile.
The provided text describes the regulatory clearance for the VasoPress Reprocessed DVT Garment. This submission is for the reprocessing of an existing device, not the development of a new AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, ground truth establishment for AI training/test sets, expert adjudication, etc.) are not applicable to this document.
The acceptance criteria and performance testing described relate to the physical and functional integrity of the reprocessed medical device compared to new, unused garments, to demonstrate substantial equivalence.
Here's an attempt to answer the questions based only on the provided text, indicating "Not Applicable" where the information is absent or irrelevant to a physical reprocessing claim.
Acceptance Criteria and Device Performance for VasoPress Reprocessed DVT Garment
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Reprocessed Garments) | Reported Device Performance (compared to new, unused garments) |
|---|---|
| Bladder Fatiguing (worst-case simulated use) | Demonstrated robust performance after reprocessing. |
| Leak Testing of the Bladders | 100% verification of bladder integrity. Bladders pressurized to 240mmHg for 30 seconds with allowed pressure drop not above 20 mmHg. |
| Inflation / Deflation Curve Analysis | Performance substantially equivalent to new, unused garments. |
| Velcro Adhesion Evaluation | Performed, (implied to be acceptable, as substantial equivalence was established). |
| Cleanliness (soil removal) | Validated cleaning process based on AAMI TIR30 standards. |
| End of Life Evaluation | 100% verification during reprocessing cycle by leak testing. |
| Marking | Clearly marked with an indicator that it has been reprocessed. |
| Packaging | Packaged in an identical manner as new, unused garments. |
| Sterilization | Exposed to Ethylene Oxide (EO) gas wash (provided non-sterile). |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify the exact sample sizes for each performance test (e.g., number of garments subjected to fatiguing, leak tests, etc.). It only states that "several performance tests were implemented" and "100% verification of bladder integrity is performed on reprocessed VasoPress garments."
- Sample Size: Not explicitly stated for all tests, but "100% verification" implies a large sample for leak testing for every reprocessed garment.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal performance validations by the manufacturer, Compression Therapy Concepts, Inc., located in Eatontown, NJ, USA.
- Retrospective or Prospective: Not explicitly stated, but typical of internal validation studies conducted before submission for regulatory approval.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This is a performance validation for a medical device's physical and functional properties after reprocessing, not an AI/ML diagnostic device requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not Applicable. This relates to human expert review for diagnostic classifications, not physical device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
Not Applicable. This is a study type for evaluating the impact of an AI system on human reader performance, which is irrelevant for the physical performance validation of a reprocessed DVT garment.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not Applicable. This term usually applies to AI algorithms. The "standalone performance" here would be the physical testing of the garment itself, which was indeed done. The tests mentioned (fatiguing, leak, inflation/deflation, Velcro) are exactly the standalone, algorithm-only type of tests for a physical device.
7. The Type of Ground Truth Used
The ground truth for this submission is the functional and material equivalence to new, unused VasoPress DVT Garments. The performance of new garments serves as the benchmark against which the reprocessed garments are compared.
8. The Sample Size for the Training Set
Not Applicable. The concept of a "training set" is relevant for machine learning models. This submission is for a reprocessed medical device. The data used to establish the reprocessing parameters might be considered analogous to a training set in a broad sense, but the specific number is not provided. The performance testing is analogous to a "test set" for the reprocessed garments.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As above, the concept of ground truth for a "training set" is not directly applicable to this type of device. The "ground truth" for developing the reprocessing method would have been based on established engineering principles, material science, and regulatory standards (like AAMI TIR30 for cleaning) to ensure the reprocessed device performs like a new one.
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(108 days)
The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential Garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential Garments.
The provided documents are a letter from the FDA to Compression Therapy Concepts, Inc. regarding the 510(k) premarket notification for the VasoPress Sequential DVT Pump, and the "Indications for Use Statement" for the same device. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a study report or clinical trial summary.
Therefore, I cannot provide the requested information based on the given text. The documents confirm the device's regulatory clearance and its intended use but do not describe the scientific studies or data supporting its performance.
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(27 days)
The VasoGrad DVT Compression Garment is an external pneumatic compression device for use with VasoPress DVT Pumps, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Not Found
The provided text is a 510(k) summary for a medical device (VasoGrad DVT Garment, Model-VG530). This type of document primarily focuses on regulatory clearance by demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study with acceptance criteria, performance metrics, and specific ground truth methodologies in the way a clinical trial report or a performance study would.
Therefore, the requested information elements related to detailed study design and acceptance criteria for demonstrating device performance (like specific accuracy metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not present in this document.
However, I can extract the following relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal "acceptance criteria" with quantitative targets (e.g., sensitivity > X%, specificity > Y%) or device performance metrics against such criteria. The FDA review determined that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is the primary "acceptance criterion" met for 510(k) clearance.
| Acceptance Criterion (Implied for 510(k)) | Reported Device Performance (Implied by FDA Clearance) |
|---|---|
| Substantial Equivalence to Predicate Device | Device determined to be substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The 510(k) process typically relies on demonstrating equivalence through design, materials, and intended use, often supported by bench testing and sometimes limited clinical data, but not necessarily a large-scale, independent test set similar to diagnostic AI studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified.
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
- MRMC Study: Not applicable. This device is a physical, external pneumatic compression device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable in the context of device performance in a diagnostic sense. The "ground truth" for the 510(k) clearance is that the device's design, materials, and intended effect are substantially equivalent to a predicate device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This device does not involve a machine learning training set.
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(28 days)
The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
VasoPress DVT Supreme Mini, Pump Model No. VP500DM
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is a 510(k) premarket notification letter from the FDA to Compression Therapy Concepts regarding the VasoPress DVT Supreme Mini pump. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices for the indication of lowering the risk of deep vein thrombosis (DVT). It also outlines regulatory requirements but does not include any performance study details.
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(156 days)
The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
VasoPress DVT System, Pump Model VP500D
The provided document is a 510(k) premarket notification letter from the FDA for a medical device (VasoPress DVT System, Pump Model VP500D) that is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed information about acceptance criteria and specific study results proving the device meets those criteria.
The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but does not raise different questions of safety and effectiveness.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:
Information that can be extracted or inferred:
- Device Name: VasoPress DVT System, Pump Model VP500D
- Intended Use/Indications for Use: "The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk."
- Regulatory Class: Class II (two)
- Product Code: JOW
- Regulation Number/Name: 21 CFR 870.5800 / Compressible Limb Sleeve
- Type of Approval: Substantial Equivalence via 510(k) premarket notification. This implies that the device's performance was compared to a predicate device's performance, but the details of that comparison are not included here.
- Standalone Performance: Since it's a pneumatic compression pump, its performance would inherently be "standalone" in the sense that it operates mechanically without human-in-the-loop interpretation like an AI diagnostic tool.
Information that CANNOT be extracted from this document:
- Table of acceptance criteria and reported device performance: This document does not specify quantitative acceptance criteria or detailed performance metrics.
- Sample sizes used for the test set and data provenance: No test studies or their associated data are described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical studies with ground truth establishment are discussed.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a physical medical device, not an interpretative AI system.
- The type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device that involves a training set.
- How the ground truth for the training set was established: Not applicable.
Summary Table of Available Information (based on the limits of the provided document):
| Feature | Description / Data Point |
|---|---|
| Acceptance Criteria & Reported Performance | Not detailed in this document. The FDA has made a "substantial equivalence determination" based on comparison to a predicate device, meaning the device's technological characteristics and performance are considered equivalent for its intended use. Specific quantitative performance metrics or acceptance thresholds are not provided. |
| Sample size (test set) & data provenance | Not available in this document. |
| Number & qualifications of experts for ground truth (test set) | Not applicable for this type of device and document. |
| Adjudication method (test set) | Not applicable. |
| MRMC comparative effectiveness study (effect size human + AI vs. human only) | Not applicable. This is a pneumatic compression device, not an AI interpretive system. |
| Standalone performance (algorithm only) | Yes, the device ("VasoPress DVT System, Pump Model VP500D") is a standalone external pneumatic compression device. Its performance relates to its mechanical operation (e.g., pressure cycles, duration) as compared to a predicate, not an interpretive algorithm. The specific performance data for "standalone" operation is not detailed in this letter, beyond the FDA's statement of substantial equivalence. |
| Type of ground truth used | Not applicable in the context of ground truth for diagnostic imaging or similar AI systems. For a physical device, "ground truth" would relate to its physiological effect (e.g., actual reduction in DVT incidence), which would be assessed in clinical trials not detailed in this 510(k) summary. The basis for substantial equivalence is typically comparison to a predicate device, which implies the predicate's established safety and effectiveness forms the "ground truth" for the new device's regulatory pathway. |
| Sample size for training set | Not applicable, as this is not an AI/machine learning device. |
| How ground truth for training set was established | Not applicable. |
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(75 days)
The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
Not Found
The provided text is an FDA 510(k) clearance letter for the VasoQuential Model VQ530, a compressible limb sleeve designed to increase venous blood flow and prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
It states that the device has been found substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about the acceptance criteria, specific studies, sample sizes, expert qualifications, or ground truth establishment that would be required to answer your detailed questions.
Regulatory clearance letters typically confirm that a device meets the substantial equivalence criteria based on information submitted in a 510(k) premarket notification. The detailed performance data, acceptance criteria, and study designs are part of the submission itself, not usually included in the clearance letter.
Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) premarket notification document or related performance study reports for the VasoQuential Model VQ530.
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(86 days)
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