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The Procedur-10 device is intended to be used to inject fluids into, or withdraw fluids from, the body

The Procedur-10 device is a piston syringe

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Procedur-10 device:

Analysis of Acceptance Criteria and Study Details for Procedur-10 Device

Based on the provided documents (K052075 510(k) Summary and associated FDA correspondence), the Procedur-10 is a piston syringe.

A crucial takeaway is that this submission relies on "substantial equivalence" to a predicate device (Avanca Medical Devices Procedur-10 device, K042486) rather than presenting a novel clinical study with explicit acceptance criteria and corresponding performance metrics. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not applicable or explicitly stated in this type of submission focused on substantial equivalence for a Class II medical device like a piston syringe. Such devices typically have well-established performance standards and a known safety profile, and substantial equivalence evaluations primarily involve demonstrating that the new device's technological characteristics, materials, and intended use are similar enough to a legally marketed predicate that it raises no new questions of safety or effectiveness.

Despite the lack of a dedicated performance study described in these documents, I will address each point based on what can be inferred or explicitly stated.

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria (Implied for a Piston Syringe for Substantial Equivalence)	Reported Device Performance (Implied by Substantial Equivalence)
   Functionality: Ability to inject and withdraw fluids.	Device performs as intended, similar to predicate syringe.
   Material Compatibility: Biocompatible materials.	Materials are appropriate for contact with body fluids.
   Dimension & Fit: Compatible with medical connectors (e.g., Luer).	Standard dimensions and fit.
   Sterility (if applicable): Maintain sterility for intended use.	Device designed to be sterile or sterilized appropriately.
   Leakage/Integrity: No leaks during use.	Device maintains integrity during injection/withdrawal.
   Ease of Use: Plunger movement, grip, visual clarity (if transparent).	User-friendly operation.
   Safety: No new safety concerns compared to predicate.	Considered safe for its intended use.
   Effectiveness: Achieve intended purpose of fluid transfer.	Effectively performs fluid transfer.

   Note: These are implied criteria for a piston syringe, not explicitly stated acceptance criteria from a performance study for this specific 510(k) submission. The "reported device performance" is essentially that it functions equivalently to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable (N/A). The provided documents do not describe a dedicated performance study with a test set, sample size, or data provenance. The submission relies on substantial equivalence to a predicate device already on the market.

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)

   • N/A. As no dedicated performance study with a test set is described, there's no mention of experts establishing a ground truth for such a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • N/A. No test set or adjudication method is described within these documents for a performance study.

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

   • N/A. This device is a piston syringe, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • N/A. This device is a mechanical piston syringe. There is no algorithm or AI component involved, so a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • N/A. Given the reliance on substantial equivalence for a simple mechanical device, the "ground truth" implicitly refers to the well-established performance and safety profile of the predicate device and the general understanding of how piston syringes function. No specific ground truth type for a novel study is mentioned.

8. The sample size for the training set

   • N/A. No training set is applicable or described for this type of submission for a mechanical device.

9. How the ground truth for the training set was established

   • N/A. No training set is applicable or described.

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The Procedur-SF device is used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

The Procedur-SF device is a piston safety syringe. The Procedur-SF device utilizes two syringes assembled in a plastic holder. The syringe plungers are connected by a pulley.

This looks like a 510(k) summary for a medical device called "Procedur-SF," which is a piston safety syringe. This document primarily focuses on the regulatory clearance process, specifically demonstrating "substantial equivalence" to predicate devices, rather than detailed performance study results with acceptance criteria.

Therefore, much of the requested information (like specific acceptance criteria, sample sizes for test sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and detailed training set information) is not present in the provided document. This is typical for a 510(k) summary, which generally doesn't include the granular details of performance testing unless it's a novel technology requiring extensive de novo clinical data.

However, I can extract what is available and indicate what is missing:

Here's an analysis of the provided 510(k) summary regarding the Procedur-SF safety syringe:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Typical acceptance criteria for a safety syringe might include:

• Force required for activation of the safety mechanism.
• Reliability of the safety mechanism (e.g., successful activation rate).
• Prevention of accidental needle sticks post-use.
• Prevention of syringe re-use.
• Fluid delivery/withdrawal accuracy.
• Compatibility with different needle gauges.
• Biocompatibility.
• Sterility assurance.
• Shelf life.

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

• Sample Size (Test Set): Not specified in the provided document.
• Data Provenance: Not specified. Based on the 510(k) process, this would typically involve in-vitro (bench) testing, and potentially some limited human factors or simulated use testing, but the document does not detail the specifics of such studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not applicable/not specified. The device is a physical medical device (syringe), not an AI/diagnostic tool requiring expert-established ground truth for image interpretation or diagnosis. Performance would be assessed through objective engineering and biological tests.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance testing for a syringe would involve objective measurements and observations rather than expert adjudication in the context of diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, this type of study is not relevant for a safety syringe. MRMC studies are typically performed for diagnostic imaging devices or algorithms where human readers interpret cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Standalone Performance: Not applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly detailed. For a device like a safety syringe, "ground truth" would be established through:
  • Engineering specifications and test standards: Conformance to established design parameters, material properties, and performance benchmarks (e.g., ASTM standards for medical devices).
  • Bench testing: Objective measurements of mechanical properties, fluid dynamics, and safety mechanism functionality.
  • Biocompatibility testing: Compliance with ISO 10993 standards.
  • Sterility testing: Assurance of sterilization methods.
  • Simulated use testing: To evaluate the safety mechanism's effectiveness in preventing sharps injuries and reuse under controlled conditions.
    The document states the device "utilizes two syringes assembled in a plastic holder. The syringe plungers are connected by a pulley," implying a mechanical design to achieve the safety features.

8. The Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set." Device design and development typically involve iterative prototyping and testing, rather than a formal "training set" in the AI sense.

9. How the Ground Truth for the Training Set was Established

• Ground Truth (Training Set): Not applicable.

Summary of What the Document Provides:

The provided 510(k) summary for the Procedur-SF safety syringe is a regulatory notification document. Its primary purpose is to demonstrate substantial equivalence to existing, legally marketed predicate devices (Becton Dickinson Single Use Hypodermic Syringes K980987 and Ret retractable Technologies, Inc. VanishPoint Safety Syringe K980069).

This means the applicant asserted that their device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The FDA's clearance (letter dated JAN 21 2005) indicates agreement with this assertion.

Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the set of engineering, safety, and performance tests (not detailed in this summary but required for 510(k) submission) that allowed the FDA to determine substantial equivalence to devices that have already met safety and effectiveness standards. The specific quantitative results and acceptance criteria from those underlying tests are not included in this high-level summary.

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The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.

The Procedur-10 device is a piston syringe

I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for a piston syringe called "Procedur-10." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer your request.

The K042486 submission is for a Class II medical device (Piston Syringe) and focuses on demonstrating substantial equivalence to a predicate device (Becton Dickinson Single-Use Hypodermic Syringes K980987). Substantial equivalence typically relies on comparing technological characteristics and intended use, rather than extensive clinical performance studies with acceptance criteria as you've requested for AI/software devices.

Therefore, I cannot extract the information required to fill out the table and answer your questions regarding acceptance criteria, study details, and AI-related aspects.

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