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The Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

The Terumo Venoject Lucr Adapter is a sterile, single use device consisting of a cannula joined to a screw connector which is connected to a male luer taper. The cannula is covered with a synthetic isoprene rubber tip for stopping blood flow. When blood is collected using an evacuated blood collecting system, the collection container is placed over the cannula, pushing the rubber tip back, allowing blood flow. When the collection container is removed, the rubber tip extends back over the cannula, stopping blood flow. The luer adapter has no direct patient contact.

The provided text describes a 510(k) submission for the Terumo Venoject Luer Adapter, demonstrating its substantial equivalence to a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a performance study outlining acceptance criteria and detailed device performance results.

The document focuses on:

• Intended Use and Description: What the device is and what it does.
• Substantial Equivalence: Comparing the proposed device to an already cleared predicate device (K983490) based on intended use, description/specifications, technology/principles of operation, materials, and performance.
• Safety Information: Sterility, biocompatibility screening, and expiration dating.
• Regulatory Conclusion: FDA's substantial equivalence determination.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not available in the provided text, as this type of information is usually presented in specific performance testing reports, not a summary of a 510(k) submission for a non-invasive, substantially equivalent device.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:

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

   The document states: "The performance of the Venoject Luer Adapter has been evaluated and the device performs according to the specification. There are no significant differences in specifications and performance between proposed device and predicate."

   It specifies material composition and operational principles as being identical to the predicate. The performance evaluation is generic and does not provide specific quantitative acceptance criteria or detailed performance metrics.

   Acceptance Criteria (Implied)	Reported Device Performance
   Sterility Assurance Level	10⁻⁶ SAL (Validated per EN 550, ISO 11135)
   Biocompatibility	No indication for additional testing from screening tests
   Expiration Dating	Established at 30 months
   Functionality (General)	Performs according to specification
   Equivalence to Predicate	No significant differences in specifications and performance to K983490 (Implies it meets predicate's performance)

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

   • Sample size for test set: Not specified. The document refers to "evaluation" of performance but does not provide details on specific test sample sizes.
   • Data provenance: Not specified. The manufacturer is Terumo Europe N.V. (Belgium), but the source of specific performance data is not detailed. Given the nature of a 510(k) for a basic medical device, much of this "evaluation" would likely involve internal engineering tests, material testing, and potentially some simulated use or bench testing rather than clinical trials.

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 or not specified. This device is a blood collection accessory. Performance evaluation for such a device typically involves engineering and laboratory testing for physical properties, sterility, and functionality (e.g., flow rates, leak testing, ease of use with other components), rather than expert assessment of patient outcomes or image interpretation.

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

   Not applicable or not specified. As mentioned above, the performance evaluation is not described in terms of a clinical study requiring expert adjudication.

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 device is a mechanical blood collection adapter, not an AI-powered diagnostic or imaging device, and therefore, MRMC studies are irrelevant.

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

   Not applicable. This device is a mechanical blood collection adapter, not an algorithm.

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

   Not specified explicitly. For device performance, the "ground truth" would likely be engineering specifications, material standards, and functional requirements (e.g., no leaks, proper sealing, specified sterility level) rather than clinical "ground truth" like pathology or outcomes data. The document states its performance was "evaluated" against "the specification."

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

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The Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

The Terumo Venoject Luer Adapter is a sterile, single use device consisting of a cannula joined to a female connector (hub) which is connected to a luer taper. The cannula is covered with a synthetic isoprene rubber tip for stopping blood flow. When blood is collected, the collection container is placed over the cannula, pushing the rubber tip back, allowing blood flow. When the collection container is removed, the rubber tip extends back over the cannula, stopping blood flow. The luer adapter has no direct patient contact.

The provided document describes a 510(k) premarket notification for the TERUMO® VENOJECT® Luer Adapter, seeking substantial equivalence to a predicate device, the B-D® Vacutainer® Luer Adapter (K931367). This type of submission focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a novel device.

Therefore, the information you've requested about acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance metrics, multi-reader studies, and detailed ground truth establishment, is not applicable to this specific document. This document describes a medical device (a blood collection accessory), not an AI/ML diagnostic or measurement tool. The evaluation centers on material comparability and basic functional performance tests, not AI algorithm performance.

Here's an analysis of the provided text in relation to your request, highlighting why many points are not present:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document. The performance evaluation focuses on confirming the device "performs according to specification" without detailing what those specifications are in quantitative terms.
• Reported Device Performance:
  • Tests Performed:
    • Cannula elasticity
    • Cannula/barrel adherence
    • Bending strength
    • Visual
    • Dimensional
    • Extraction
  • Results: The document generally states, "The performance of the TERUMO® VENOJECT® Luer Adapter has been evaluated and the device performs according to specification." No specific numerical results or detailed qualitative outcomes for each test are provided.
  • Sterility: Validated according to ISO 11137 to a sterility assurance level (SAL) of 10-6.
  • Biocompatibility: Screening tests performed, "gave no indication that additional biocompatibility testing was necessary."
  • Expiration Dating: Established at 30 months.

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. The "test set" in this context refers to the physical devices undergoing engineering and bench tests, not a clinical data set for an AI/ML algorithm. The document does not specify the number of physical units subjected to each test.
• Data Provenance: Not applicable for this type of device evaluation.

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 relates to human interpretation of diagnostic data, which is not relevant for a luer adapter. Ground truth here (if the term were applied) would come from engineering measurements and inspections. No expert panel is mentioned.

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

• Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of medical images or clinical data, which is irrelevant for this device's evaluation.

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. MRMC studies are for evaluating diagnostic image interpretation performance. This document is about a blood collection accessory.

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

• Not applicable. This device does not involve an algorithm.

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

• Not applicable/Implicit. The "ground truth" for a physical device like this is its adherence to engineering specifications and international standards (e.g., ISO 11137 for sterility). The document states the device "performs according to specification," implying that these engineering specifications serve as the "ground truth."

8. The sample size for the training set

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

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

• Not applicable. There is no "training set" for this device.

Summary of what is present:

The document focuses on demonstrating substantial equivalence to a predicate device (B-D® Vacutainer® Luer Adapter, K931367) based on:

• Intended Use: Identical.
• Design: Similar (cannula, hub, luer taper, rubber tip).
• Principle of Operation: Both operated manually.
• Materials: Largely similar, with some differences (e.g., Polypropylene vs. Polystyrene for the hub, Synthetic Isoprene Rubber vs. Dipped Latex Rubber for the rubber tip). The document implies these material differences are not significant enough to raise new safety/effectiveness concerns.
• Performance Tests: A list of basic physical/mechanical tests were performed (cannula elasticity, adherence, bending strength, visual, dimensional, extraction), and the device was reported to perform "according to specification." No specific numerical "acceptance criteria" or quantitative results are provided in this summary.
• Safety Information: Sterility validation (ISO 11137 to SAL 10-6), biocompatibility screening (no further testing needed), and established expiration dating (30 months).

In essence, this 510(k) submission relies on demonstrating that the new device is fundamentally the same as a previously cleared device, backed up by standard engineering tests and safety protocols, rather than a clinical study with detailed performance metrics.

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