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For vascular access devices flushing only. Sterile fluid path only. Not for use on a sterile field.

The Praxiject™ SP 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume of 10mL with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. The Praxiject™ SP 0.9% NaCl prefilled syringe is designed to maintain a sterile fluid path only and is individually packaged in a clear flexible plastic film, flow-wrapped heatsealed pouch that functions only as a protective barrier (dust cover). The device is terminally sterilized by gamma irradiation.

The provided text is a 510(k) Pre-market Notification for a medical device called Praxiject™ SP 0.9% NaCl, a prefilled saline flush syringe. The document describes the device, its intended use, comparison to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence. It explicitly states that "Clinical testing was not required for device evaluation."

Therefore, based on the information provided, it's not possible to answer questions related to clinical studies, human reader performance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth for a test set or training set in the context of an AI/algorithm-driven device. This document describes a medical device, not an AI/ML algorithm.

However, I can extract information related to the acceptance criteria and the non-clinical study that proves the device meets those criteria, as detailed in the "Summary of Non-Clinical Testing" section.

Here's the breakdown of the acceptance criteria and reported device performance from the non-clinical testing:

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)

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

The document provides a table outlining performance characteristics, the applicable performance standards, and the acceptance criteria. It then states, "The design and manufacturing of the Praxiject™ SP 0.9% NaCl prefilled syringe is subject to risk assessment per ISO 14971 and verification and validation testing in conformance with regulatory guidance and consensus standards applicable to this device type." This implies that the device successfully met all listed acceptance criteria through this testing, although specific "reported device performance" values are not explicitly given in the table beyond the acceptance limits.

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

The document does not specify sample sizes for each non-clinical test beyond implication from standard compliance. These tests are typically conducted on batches of manufactured devices following established quality control procedures. Given the manufacturing details, data provenance would be MedXL Inc., Canada. The testing is prospective in nature, as it's part of the pre-market validation for the device.

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. This is not an AI/ML device requiring human expert annotation or ground truth establishment in the traditional sense. The "ground truth" for non-clinical testing of a physical medical device refers to the objective, measurable properties and performance standards themselves, verified by laboratory testing protocols and validated analytical methods (e.g., chemical assays, sterility tests, physical integrity tests).

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

Not applicable, as this is not a study involving subjective human interpretation or multi-reader scenarios. The testing involves objective, measurable criteria.

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. The device is a prefilled saline flush syringe, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. The "device" itself is a physical medical product, not an algorithm.

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

For non-clinical testing of this device, the "ground truth" is defined by established consensus standards and pharmacopeial specifications (e.g., USP standards, ISO standards) for chemical composition, sterility, physical integrity, and biological safety. These are objective, measurable parameters.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.

The Praxiject™ family of 0.9% NaCl prefilled syringes marketed in the U.S.A. includes the following models: 37043US (3 mL/5 cc), 3704US (5 mL/5 cc), 37053US (3 mL/10 cc), 37055 US (5 mL/10 cc), 3705CUS (10 mL/10 cc), 3705-1US (10 mL/10 cc) and 3706US (20 mL/20 cc). These devices are single use plastic piston syringes with a Luer lock connection fitting, prefilled to labeled volume with 0.9% Sodium Chloride Injection USP, with no preservatives (normal saline), and capped with a plastic tip cap. Model 3705-1US (10 mL/10 cc) is individually packaged in a heat-sealed foil pouch, all other models are individually packaged in a heat-sealed peel pouch. All Praxiject™ 0.9% NaCl prefilled syringes are terminally sterilized by gamma irradiation.

The provided document is a 510(k) Pre-Market Notification for a medical device called Praxiject™ 0.9% NaCl, which is a prefilled saline flush syringe. The purpose of this notification is to demonstrate that the modified device is substantially equivalent to legally marketed predicate devices.

The document does not describe a study involving an AI/ML device, a "test set" of data, or "ground truth" as typically understood in the context of evaluating AI/ML performance. Instead, it details the analytical and performance testing conducted for a physical medical device to ensure its safety and effectiveness.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to this document as they are specific to AI/ML device evaluation.

However, I can extract information related to acceptance criteria and device performance based on the non-clinical testing summary.

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

The document provides a comprehensive table of "Device Specification," "Standard," and "Acceptance Criteria" under the "Summary of Non-Clinical Testing" section. The "reported device performance" is implicitly stated as meeting these acceptance criteria, as the conclusion states, "The conclusions drawn from the non-clinical testing demonstrate that the modified Praxiject™ 0.9% NaCl prefilled syringe, is as safe, as effective, and performs as well as or better than the legally marketed primary predicate device." This implies all listed acceptance criteria were met.

Here is a summary of the acceptance criteria:

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

This information is not provided in a way that is applicable to an AI/ML "test set." The document describes non-clinical testing of a physical device. While specific sample sizes and testing methodologies are implied by the listed standards (e.g., ISO, ASTM, USP), the exact sample sizes for each test are not explicitly enumerated in this summary. Data provenance, in terms of country of origin or retrospective/prospective collection, is not relevant for this type of device submission.

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. "Ground truth" and "experts" are terms used in the context of evaluating diagnostic AI/ML models. This document describes the physical and chemical testing of a medical device.

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

Not applicable. This refers to methods for resolving discrepancies in expert interpretations, which is not relevant for physical device testing.

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 a type of study specifically for evaluating AI/ML diagnostic tools.

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

Not applicable. This refers to the standalone performance of an AI/ML algorithm.

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

Not applicable. The "ground truth" for this device's performance is objective measurements against established international and USP standards for product quality, safety, and performance (e.g., pH, sterility, particle count, leakage, biocompatibility).

8. The sample size for the training set

Not applicable. This concept pertains to AI/ML model development.

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

Not applicable. This concept pertains to AI/ML model development.

Ask a specific question about this device

The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.

The Praxiject™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a heat-sealed pouch and terminally sterilized by gamma irradiation.

The provided text is a 510(k) summary for the Praxiject™ 0.9% NaCl prefilled syringe, a medical device. It describes the device, its intended use, and comparative non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's the information extracted from the document regarding acceptance criteria and the study that proves the device meets them:

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

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

The document does not explicitly state the specific sample sizes used for each individual test. It lists "non-clinical testing" as the study type. The reference to standards like ASTM and USP monographs implies that the testing was performed on physical samples of the device and its packaging.

• Data Provenance: The tests are described as "non-clinical testing" performed by MedXL Inc. The country of origin of the data is not specifically stated, but the manufacturer's address is in Pointe-Claire, Quebec, Canada. The data is retrospective as it was performed prior to the submission of the 510(k).

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

This information is not applicable. The studies performed are non-clinical (physical and chemical tests) and do not involve human interpretation or the establishment of ground truth by experts in a clinical context. The "ground truth" is determined by the results of the standardized tests against their defined acceptance criteria.

4. Adjudication method for the test set:

Not applicable. This concept applies to studies involving human interpretation or subjective assessments, which is not the case for these non-clinical tests.

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 a non-clinical device (prefilled saline syringe) and does not involve AI assistance, human readers, or clinical effectiveness studies in this context.

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

Not applicable. This device does not involve algorithms or AI.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests is established by pre-defined, objective acceptance criteria derived from recognized industry standards (ASTM, ISO) and pharmaceutical monographs (USP). For example, the definition of an acceptable seal, specific chemical concentrations, or maximum particulate matter levels.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML device, so there is no training set in the conventional sense.

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

Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.

The Praxiject™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled fill volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a plastic peel pouch and terminally sterilized by gamma irradiation.

This document is a 510(k) Pre-market Notification for a medical device called Praxiject™ 0.9% NaCl, which is a prefilled syringe. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through clinical studies or AI algorithm validation studies.

Therefore, many of the requested details about acceptance criteria, study types, sample sizes, and expert ground truth are not applicable to this document as it pertains to a traditional medical device (a prefilled syringe) and not an AI/ML-driven diagnostic or treatment device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the context of an AI algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it presents performance standards and results for the physical and chemical characteristics of the prefilled syringe.

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. This document describes testing for a physical medical device (syringe), not an AI algorithm. The "test set" would refer to samples of the manufactured syringes and their components, tested in a laboratory setting according to the listed standards. There is no mention of "country of origin of the data" or "retrospective/prospective" as these pertain to clinical data for AI/ML validation.

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

• Not applicable. Ground truth in the context of this document refers to established standards and laboratory measurements for chemical and physical properties, not expert clinical interpretation. The "experts" would be laboratory technicians and chemists performing the tests according to standardized protocols.

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

• Not applicable. This concept pertains to resolving discrepancies among expert readers in AI/ML validation studies. For direct physical and chemical testing, the results are typically objectively measured against pre-defined specifications in the performance standards.

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 a traditional medical device (syringe), not an AI/ML system, so such a study would not be performed.

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

• Not applicable. This is a physical device, not an algorithm.

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

• The "ground truth" for this device's performance is established by conformance to recognized consensus standards (e.g., USP, ISO standards) and laboratory testing methods that define acceptable ranges and limits for physical, chemical, and biological properties. This is an objective, standardized ground truth based on scientific principles and established testing methodologies.

8. The sample size for the training set

• Not applicable. This is a physical medical device. There is no "training set" in the context of this 510(k) submission.

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

• Not applicable. As there is no training set for an AI algorithm, this question does not apply.

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