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VasQ is intended for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery.

VasQ is designed for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery. The design of the device is intended to promote outward remodeling of the AVF vein and ultimate usability of the fistula by aiding in the maintenance of optimal hemodynamic flow profile and relieving excessive mechanical stress at the anastomotic connection. Implantation of the device does not interfere with the standard surgical techniques required to create the AVF (i.e. dissection, mobilization and suturing the anastomosis).

The provided text is a 510(k) summary for the VasQ device, an extravascular support for arteriovenous fistulas. It describes the device, its intended use, technological characteristics, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the document explicitly does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in terms of AI/algorithm performance. The "Performance Data" section solely refers to design verification tests (Biocompatibility, Device integrity, Kink, Crush, corrosion) related to the physical changes in the device (braiding contractor and manufacturing changes for the braid component), and a risk analysis (FMECA).

The request asks for information related to:

1. Acceptance criteria and reported device performance (table format): Not available in the document.
2. Sample size and data provenance for a test set: Not applicable as no AI/algorithm performance study is described.
3. Number and qualifications of experts for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study and effect size: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

Therefore, based solely on the provided text, I cannot fulfill the request as it pertains to AI/algorithm performance criteria or associated studies. The document only covers the substantial equivalence of a physical medical device (VasQ) to its predicate, focusing on physical and material properties, not an AI or software component requiring the detailed performance metrics outlined in the prompt.

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VasQ is intended for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery.

VasQ is a nitinol implant that is used to provide external support for arteriovenous fistulas (AVF) created by means of vascular surgery. VasO is comprised of a braid and a brace that are welded together (Figure 1). The braid is woven nitinol mesh that provides structural support to the segment of the vein that must be mobilized from its natural supporting tissue to allow surgical anastomosis to the artery. The brace is a laser cut nitinol structure intended to maintain geometric properties at the juxta-anastomosis region of the AVF.

The VasQ device, an extravascular support for arteriovenous fistulas, was assessed through a pivotal clinical study and various non-clinical tests.

1. Table of Acceptance Criteria & Reported Performance:

2. Sample Size for the Test Set and Data Provenance:

• Sample Size for Clinical Test Set:
  • Total Enrolled: 144 subjects (129 in main cohort for brachiocephalic fistula (BCF), 15 in supplementary cohort for forearm AVF).
  • Evaluated for Primary Endpoint (6-month primary patency): 134 subjects (120 in main cohort).
• Data Provenance: Prospective, multi-center, single-arm, open-label study conducted at 15 US sites.

3. Number of Experts Used to Establish Ground Truth for Test Set & Qualifications:

• The document does not explicitly state the number and qualifications of experts formally establishing "ground truth" for the clinical endpoints (e.g., patency, maturation).
• However, it mentions:
  • Core laboratory evaluation: For X-ray imaging (device integrity observations like brace breakage, braid/brace detachment).
  • Independent Clinical Events Committee and Data Safety Monitoring Board: Reviewed safety events.
  • Study site's standard of care: Used for baseline vessel diameter measurements.
  • Doppler ultrasound and clinical assessment: Used for confirming fistula patency.

4. Adjudication Method for the Test Set:

• The document explicitly mentions:
  • "Safety events were reviewed by an independent Clinical Events Committee and Data Safety Monitoring Board." This implies an adjudication process for safety events.
• For effectiveness endpoints like primary patency defined by Doppler ultrasound or clinical assessment, the adjudication method is not explicitly detailed but would likely involve established protocols for these assessments within the multi-center study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was NOT done in the primary clinical study.
• The pivotal study was a single-arm study without a control group.
• The sponsor did conduct propensity-matched comparative analyses against historical controls (Medicare beneficiary data and retrospective chart review data), but these were not MRMC studies and did not involve human readers using AI assistance. These were comparisons of device outcomes against historical standard-of-care outcomes.
• Effect Size of Human Readers with AI vs. without AI: Not applicable, as no MRMC study with AI assistance was performed.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. The device is a physical implant (extravascular support), not an algorithm or AI software. The performance studies described evaluate the device's physical and functional performance in in-vivo and in-vitro settings.

7. Type of Ground Truth Used:

• Clinical Endpoints: Defined by objective criteria such as:
  • Doppler ultrasound measurements: For flow rates and vessel diameters (e.g., for primary patency, maturation).
  • Clinical assessments: Palpable thrill, audible bruit (for primary patency).
  • Patient outcomes: Receiving dialysis through the fistula (for primary patency), intervention data, adverse event occurrences.
  • X-ray imaging: For device integrity observations (evaluated by a core laboratory).
• Animal Study Endpoints: Angiography findings, histopathologic evaluation.
• Bench Test Endpoints: Direct measurements against engineering tolerances, visual inspection, mechanical testing results.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set. The clinical study was a pivotal study for device approval, not a dataset for training a model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. (See point 8 above).

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The Alternating Leg Pressure® (ALP®) VasQcare™ System is a non-invasive system for reducing the incidence of deep vein thrombosis. The application of external intermittent pneumatic compression has six effects:

1. Increases blood flow velocity
2. Reduces the risk of deep vein thrombosis
3. Enhances blood circulation
4. Reduces pain and swelling
5. Reduces wound healing time
6. Aids in the treatment and healing of stasis dermatitis, venous stasis, arterial and diabetic leg ulcers, chronic vein insufficiency and reduction of edema in the lower limbs

The ALP® VasQcare™ System consists of a pump and a pair of single use calf sleeves. The pump provides intermittent cycles of compressed air, which alternately inflate the calf sleeves. The compression, when applied properly to the patient, increases blood velocity back to the heart and helps to prevent deep vein thrombosis.

The pump operates on timed cycles consisting of approximately 12 seconds of inflation where the calf sleeve compresses the limb followed by approximately 48 seconds of deflation where there is no pressure applied to the limb. Each limb compresses once per minute.

The ALP® VasQcare™ System may be used on patients at risk for developing deep vein thrombosis and in conjunction with medical therapy for high-risk patients.

Currie Medical Specialties (CMS) ALP® VasQcare™ System provides intermittent pneumatic pressure to a patient's leg for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse, which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The VasQcare™ pump controller predicates the inflation and deflation sequence.

This FDA 510(k) summary for the ALP® VasQcare™ System does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria in the manner requested.

The document states that "Bench testing was conducted to ensure that the new design did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices." It also mentions testing against standards like IEC 60601-1-1, 60601-1-6, and 60601-1-11 for electrical safety, EMC, mechanical integrity, and environmental/life cycle. However, it does not provide specific acceptance criteria or the reported device performance measurements for these tests.

The document explicitly states: "Per the requirements of 21 CFR 807, clinical data, non-clinical bench testing and the information provided within this 510(k) pre-market submission, Currie Medical Specialties, Inc., concludes that the ALP® VasQcare™ System performs in a manner that is substantially equivalent to the predicate devices listed above." This indicates clinical data was part of the submission, but its details are not included in this summary.

Given the information provided, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, expert involvement, or adjudication methods, as these details are not present in the provided text.

Here's what can be inferred and what cannot:

Information NOT available in the provided text:

• Specific Acceptance Criteria and Reported Device Performance: No explicit numerical acceptance criteria or performance metrics (e.g., specific pressure ranges, flow rates, failure rates) are mentioned. The document relies on a general statement of "no compromise" and "substantially equivalent."
• Sample sizes used for the test set and data provenance: No information on the number of devices or subjects tested, or where the data came from.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no ground truth establishment for a test set is described.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No mention of such a study or any associated effect sizes.
• Standalone (algorithm only) performance: Not applicable, as this is a medical device, not an AI algorithm in the typical sense.
• Type of ground truth used: Not applicable, as specific clinical or performance studies with defined ground truth are not detailed.
• Sample size for the training set: Not applicable, as this is not an AI/ML device in the context of a training set.
• How the ground truth for the training set was established: Not applicable.

What little can be extracted from the document related to "acceptance criteria" and "study":

1. Table of Acceptance Criteria and Reported Device Performance

Details of the "Study" (Bench Testing and Equivalence Rationale):

• Study Type: Non-clinical bench testing. The document states "clinical data" was part of the 510(k) submission, but details of any clinical study are not provided in this summary.
• Objective: To ensure the new design "did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices."
• Specific Tests Mentioned:
  • Electrical safety
  • EMC (Electromagnetic Compatibility)
  • Mechanical integrity
  • Environmental testing
  • Life cycle testing
  • Biocompatibility assessment (based on material equivalence)
• Standards Used: IEC 60601-1-1, 60601-1-6, and 60601-1-11.
• Accreditation: Tests were "confirmed by an accredited third-party."

In summary, this document is a 510(k) summary for FDA submission, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with specific acceptance criteria and performance metrics for a novel technology. The "study" described is primarily bench testing to ensure the new device performs similarly and safely to existing, legally marketed devices.

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