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The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard Bifurcated Needle to deliver vaccine or allergen to the patient.

The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism.

I am sorry, but based on the provided document, I cannot answer your request. The document is an FDA 510(k) clearance letter for a medical device (Univec Bifurcated Sliding Sheath Syringe), which confirms its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria for device performance, specific studies proving performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The document primarily focuses on regulatory classification and general compliance with FDA regulations, not detailed performance validation data.

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The UNIVEC Sliding Sheath Syringe (K993996) is an Active Safety Feature for a hypodermic syringe. The Sliding Sheath Mechanism is used with a traditional disposable syringe or the Univec Auto-Destruct syringe. The Univec Sliding Sheath Syringe is used to aid in the prevention of needle stick injuries. After an injection, the shield is easily moved from an unextended to an extended position with one hand so that the needle tip is covered by a 360 degree enclosure. The scale is printed on the barrel in a way that allows the Healthcare worker to read through the sheath or from the backside of the sheath.

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The provided document is a 510(k) clearance letter from the FDA for a medical device (UNIVEC Sliding Sheath Syringe), and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This type of information is typically found in study reports, design validation documents, or specific sections of a 510(k) submission that are not included here. Therefore, I cannot fulfill the request based on the provided text.

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The UNIVEC Nonreusable Locking Syringe with Coupling Assembly can be used by health care professionals, diabetics and other persons for injection of insulin, tuberculin, immunization serum, and other injectible medications.

The UNIVEC Nonreusable Syringe with Coupling Assembly provides a single use function. This assembly, inserted between the syringe plunger and the syringe rubber stopper, will decouple the plunger from the stopper (and disable the syringe) after injecting one dosage of serum. The assembly materials will be fabricated from the same polypropylene as the syringe.

This 510(k) submission describes a physical medical device (a syringe), not an AI/ML powered software device. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance, ground truth, and training sets is not applicable.

The submission focuses on comparing the new device to a predicate device based on its physical characteristics and intended use. The "acceptance criteria" for a device like this would typically involve meeting performance standards for syringes (e.g., proper delivery of medication, prevention of reuse, material biocompatibility, structural integrity, etc.) as defined by relevant standards and regulations, rather than metrics like AUC or sensitivity/specificity for an AI algorithm.

Here's a breakdown of why this information is inapplicable and what the existing submission does provide:

• 1. A table of acceptance criteria and the reported device performance: This request is for quantitative performance metrics typically associated with AI/ML or diagnostic devices. For a syringe, acceptance criteria would be based on mechanical and functional tests defined by international standards (e.g., ISO, ASTM) for syringes. The submission doesn't contain specific performance data tables because it's establishing substantial equivalence, not conducting a performance study against novel metrics.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical device like a syringe. Test sets and data provenance are concepts for evaluating data-driven models.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a physical device. Ground truth is a concept for evaluating the accuracy of a diagnostic or predictive system.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is used to resolve disagreements among human annotators or experts.
• 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 is specific to AI-assisted diagnostic tools.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to the performance of an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable. Training sets are for machine learning models.
• 9. How the ground truth for the training set was established: Not applicable.

What the provided text does tell us about the device:

• Device Name: UNIVEC Nonreusable Locking Syringe with Coupling Assembly
• Intended Use: For injection of insulin, tuberculin, immunization serum, and other injectable medications by health care professionals, diabetics, and others.
• Key Feature: Single-use function, disengaging the plunger from the stopper after one dose to prevent reuse.
• Technological Characteristics: Similar to the predicate device (K 943679) except for a stainless steel locking clip; otherwise, same material, chemical composition, energy source.
• Predicate Device: K 943679, UNIVEC Nonreusable Locking Syringe with non-aspirating plunger.

The submission aims to demonstrate "substantial equivalence" to the predicate device, meaning it's as safe and effective as the legally marketed predicate. This is typically achieved by showing similar technological characteristics and intended use, and if there are differences, demonstrating that those differences do not raise new questions of safety or effectiveness.

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This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.

The UNIVEC Model 884 Umbrella Nonreusable Syringe is a sterile piston syringe with 1 cc or 0.5 cc capacitivs fabricated of polypropylene. It has a locking device made of the same polypropylene material. The "umbrella" describes the locking mechanism which emulates the shape and functioning of an umbrella.

Functioning in the traditional manner, this syringe is capable of aspirating and mixing various serums in its barrel by health practitioners and individuals for subsequent injection. It can be locked or prevented from further use by depressing the plunger toward the foward end of the barrel (and past noticeable resistance) in order to activate the locking device. Further use of the syringe is thus prevented.

This document describes a medical device, the UNIVEC Model 884 Umbrella Nonreusable Syringe, and its intended use. However, it does not contain any information about acceptance criteria, device performance, or any studies conducted on the device's performance in relation to acceptance criteria.

Therefore, I cannot provide the requested information in a table or answer the specific questions about studies, sample sizes, ground truth, or expert qualifications. The provided text is solely a device description and a statement of intended use, likely part of a regulatory submission (e.g., 510(k)).

To answer your questions, I would need a document that includes:

• Specific performance metrics and their target values (acceptance criteria).
• Details of a study conducted to evaluate the device against these criteria. This would include methodology, results, statistical analysis, and information regarding ground truth and expert involvement.

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