Search Results

Indication for Use: The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of Resistance Syringe is intended for use in conjunction with an epidural needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration.

The Syringe will be sold sterile individually packaged, and as part of a sterile kit.

The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers. It consists of a Barrel and Plunger. It has ISO 80369-6 NRFit™ and ISO 80369-7 LUER connectivity. The markings area is 0ml - 10ml and the priming volume is 10ml.

The provided text is a 510(k) summary for the Pajunk VPC (Visual Pressure Control) NRFit and LUER Loss of Resistance Syringe. It details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.

Key takeaway: This document describes the physical and functional performance testing of a medical device (a syringe), not the performance of an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML model evaluation (e.g., ground truth establishment, reader studies, training set size) are not applicable to this document. The "device" in this context refers to the physical syringe, not a software algorithm.

Here's the breakdown based on the provided document, addressing the relevant points and noting where information is not applicable:

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

The document lists various performance characteristics, standards, and their results. The acceptance criterion is implied by the "Pass" result for each test, indicating compliance with the specified standard or internal protocol.

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

• Sample Size: The document does not specify the exact sample sizes (number of syringes) used for each individual test. It mentions that "tests have been performed" on devices for shelf-life validation.
• Data Provenance: The tests are physical and chemical performance tests of a manufactured device, not data collection from patients or retrospective/prospective studies in the clinical sense. The manufacturer is Pajunk GmbH Medizintechnologie, located in Geisingen, Germany. The tests would have been performed in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable. The ground truth for this device is the physical and chemical properties and functioning according to established international standards (ISO) and the manufacturer's internal protocols. "Experts" in this context would be test engineers and scientists adhering to the specified test methods, not clinical experts establishing diagnostic ground truth.

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

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for establishing ground truth from multiple readers for image interpretation (e.g., in AI/ML studies). For mechanical and chemical device testing, results are typically objective measurements against predefined acceptance limits.

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

• This is not applicable. This document describes the performance of a physical medical device (syringe), not an AI/ML algorithm or a system involving human readers.

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

• This is not applicable. This document is about a physical medical device, not a software algorithm.

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

• The "ground truth" for this device's performance relies on objective measurements and adherence to specified international standards (ISO) and validated internal protocols for physical, chemical, and functional characteristics. Examples include measurable parameters for leakage, axial load, unscrewing torque, and adherence to sterilization parameters and residual limits.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is not an AI/ML algorithm.

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

• This is not applicable. There is no "training set."

Ask a specific question about this device

To obtain Nuclear Medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body.

The VPC-94 high-energy (511 KeV) collimators and cart is an option for the Apex VariCam and Millennium VG gamma camera (K953801). It comprises two high-energy collimators and a collimator cart.

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a detailed study proving performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The document states: "Bench data and Clinical data show that the VPC-94 option achieves its intended use," but it does not elaborate on the nature or results of these studies.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to generally as "Bench data and Clinical data."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned or described. This submission is for a collimator for a gamma camera, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not applicable/not discussed in the context of this device (a collimator). The device itself (collimator) is a physical component, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not specified. The "Clinical data" would likely involve patient imaging but the method for confirming findings (e.g., pathology, other imaging modalities, clinical follow-up) is not detailed.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable/not specified. This device is a passive component (collimator), not a machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of what is known about the study:

• The submission refers to "Bench data and Clinical data" as evidence that the device achieves its intended use.
• The device (VPC-94 collimator) is stated to have "better" resolution at comparable sensitivity compared to its predicate device (Dyna Camera 2C - 615-211 high-energy collimator), partly because the VPC-94 uses two detector heads instead of one.
• The overall conclusion is that the VPC-94 is "substantially equivalent" to the predicate device, has the "same intended use," and raises "no new safety or effectiveness concerns." This suggests the studies were primarily designed to demonstrate this equivalence rather than to establish new performance benchmarks against specified acceptance criteria.

Ask a specific question about this device