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510(k) Data Aggregation
(67 days)
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is used in routine venipuncture procedures. The Needle System is designed with an integrated, multiple sample needle and safety shield. The safety shield is automatically activated and released upon insertion of the first blood collection tube and covers the needle immediately following blood collection from patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is a single-use, sterile needle system, non-toxic, designed with an integrated, multiple use drawing needle and safety shield to provide protection against needlestick injury during venipuncture. This device has no components made of dry natural rubber.
The provided text describes a 510(k) submission for a medical device and does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a regulatory approval summary for the "VACUETTE® PREMIUM Safety Needle System Tube-Touch." It establishes substantial equivalence to a predicate device (VACUETTE® PREMIUM Safety Needle System, K072602) for its intended use and materials. This type of submission typically relies on demonstrating that the new device is as safe and effective as a previously cleared device, rather than requiring a detailed clinical study with specific acceptance criteria and performance data.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on the regulatory process for clearance, not on a detailed performance study of the device against specific acceptance criteria.
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(126 days)
VACUETTE® PREMIUM Safety Blood Collection Set is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated automatically to cover the needle immediately following blood collection thus preventing accidental needlestick injury.
The Vacuette Premium Safety Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system (e.g. Holdex®). It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is free of PVC, DEHP, Latex.
The provided document describes the VACUETTE® PREMIUM Safety Blood Collection Set, but it does not contain detailed acceptance criteria and a study proving the device meets those criteria in a format applicable to AI/ML device performance.
The document discusses substantial equivalence to predicate devices based on design and safety features. It mentions "Simulated Use Testing" and "Material Testing" but does not provide the quantitative acceptance criteria or the study results of these tests in a way that would allow filling out the requested table and detailed information about AI/ML device performance.
Therefore, I cannot fulfill your request as the necessary information (explicit acceptance criteria, detailed study methodology, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in the provided text for an AI/ML device.
The document primarily focuses on the physical design, intended use, and demonstration of substantial equivalence for a medical device (a safety blood collection set), not an AI/ML system.
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(278 days)
The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.
The provided text is a 510(k) summary for the VACUETTE® PREMIUM Safety Needle System. This document focuses on establishing substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies.
Therefore, I cannot provide the requested information from the given text. The document acts as a regulatory submission for market clearance, not a clinical or performance study report.
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