(29 days)
The PreludeSYNC DISTAL™ is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.
The PreludeSYNC DISTAL™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial artery following catheterization procedures. It consists of a soft wristband and thumb saddle strap with secure hook and loop fasteners. The band delivers adjustable compression of the puncture site with an inflatable balloon, and a check valve for easy inflation and deflation with the accompanying 10mL syringe inflator. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement. PreludeSYNC DISTAL is available in a variety of graphic designs and a right or left-hand configuration.
The provided text is a 510(k) Summary for the PreludeSYNC DISTAL™ Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria for clinical performance.
Therefore, the following information cannot be extracted directly from the provided text:
- A table of acceptance criteria and reported device performance related to clinical efficacy.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance (this is an AI-specific question, and the device is a physical medical device, not an AI system).
- If a standalone (algorithm only) performance study was done (again, not applicable to this type of device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical performance.
- The sample size for the training set.
- How the ground truth for the training set was established.
What can be extracted and inferred from the text regarding acceptance criteria and performance study:
The document states that "Performance testing of the subject PreludeSYNC DISTAL Radial Compression Device was conducted based on the risk analysis and based on the requirements of the following international standard". It then lists several international standards for various types of testing, along with a list of "Performance Testing-Bench" tests and "Biocompatibility Testing."
The conclusion states: "The results of the testing demonstrated that the subject PreludeSYNC DISTAL met the predetermined acceptance criteria applicable to testing the safety and efficacy of the device." However, the specific quantitative acceptance criteria for each test and the detailed results are not provided in this summary.
In summary, this document is a regulatory filing for substantial equivalence, not a detailed report of a clinical performance study with explicit acceptance criteria for efficacy in patients. It describes bench testing and biocompatibility studies to demonstrate safety and equivalent performance to a predicate device based on its design and materials.
Here's a breakdown of what the document does provide, modified to fit the request where possible, but acknowledging limitations:
1. A table of acceptance criteria and the reported device performance:
| Test Category | Test Name | Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|---|---|
| Performance Testing | Bubble Emission Packaging | Meet applicable standards (implied by ISO references) | Met predetermined acceptance criteria |
| Visual Inspection - Packaging | Meet applicable standards | Met predetermined acceptance criteria | |
| Adapted Connector Torque | Meet ISO 80369-7: 2016 requirements | Met predetermined acceptance criteria | |
| Dimensions - Band Sizing Verification | Conform to specified dimensions | Met predetermined acceptance criteria | |
| Side Load and Leak Test | Withstand side load and prevent leaks (implied by device function) | Met predetermined acceptance criteria | |
| Indicator Mark Adherence | Marks adhere securely | Met predetermined acceptance criteria | |
| Hook and Laminate Integrity Test | Maintain integrity | Met predetermined acceptance criteria | |
| Balloon Burst Test | Withstand specified pressure before bursting | Met predetermined acceptance criteria | |
| Adapted Cap to Valve Attachment | Secure attachment | Met predetermined acceptance criteria | |
| Tensile Test Hook and Loop | Withstand specified tensile force | Met predetermined acceptance criteria | |
| Tensile Test Band to Backer Plate | Withstand specified tensile force | Met predetermined acceptance criteria | |
| Band Compliance | Function as intended | Met predetermined acceptance criteria | |
| Simulated Use | Perform safely and effectively in simulated use (implied) | Met predetermined acceptance criteria | |
| Biocompatibility | Biocompatibility Assessment | Materials are biocompatible or identical to predicate materials | No further testing required (due to material equivalence) |
| Sterilization | Sterilization (Ethylene Oxide) | Meet ISO 11135:2014 requirements | Met predetermined acceptance criteria |
| Packaging Stability | Packaging Conditioning / Performance Testing | Meet ISO 2233:2000 and ASTM D4169:2016 requirements | Met predetermined acceptance criteria |
Note: The specific quantitative acceptance criteria are not detailed in this summary; only a general statement that they were "met" is provided.
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the performance or biocompatibility tests.
- Data Provenance: The tests are "Performance Testing-Bench" and "Biocompatibility Testing," implying lab-based, pre-clinical testing presumably conducted by the manufacturer, Merit Medical Systems, Inc. No country of origin for clinical data is mentioned as no clinical studies are referenced. The nature of these tests suggests they are prospective, following established protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The "ground truth" here refers to engineering specifications and international standards, not expert clinical interpretation.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. This typically relates to clinical studies or assessments requiring human interpretation.
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 physical medical compression device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical compression device, not an AI algorithm.
7. The type of ground truth used:
- For Performance Testing-Bench: Engineering specifications, design requirements, and international standards (e.g., ISO 80369-7, ISO 11135, ISO 10993-1, ISO 10993-7, ISO 2233, ASTM D4169).
- For Biocompatibility Testing: The "ground truth" was established based on the materials being identical to those of a legally marketed predicate device with the same intended use and contact, making further testing unnecessary.
8. The sample size for the training set:
- Not applicable/Not mentioned. This refers to algorithm training, not relevant to this physical device.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).