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The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.

The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a while shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.

The Blood Culture Holder is a single-use, non-sterile, plastic holder with threads which are compatible with male luer adapters. The holder can be used with all VACUETTE® Multiple Sample Luer Adapters and Safety Blood Collection Sets for routine venipuncture into various manufacturers' evacuated blood culture bottles and tubes. It is supplied alone or with the Greiner sterile Safety Blood Collection Set with Luer Adapter.

The Blood Culture Holder does not come into contact with the blood specimen. It is an external holder for the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Safety Blood Collection Set consists of tubing with a blood collection needle at one end and a female luer at the other. The VACUETTE® Multiple Sample Luer Adapter consists of a male luer at one end and a cannula covered with a sheath. The luer adapter is threaded into the Blood Culture Holder, with the male luer end on the outside and the covered cannula on the inside of the holder barrel. The blood flows through the blood collection needle and tubing of the Safety Blood Collection Set, into the male luer of the VACUETTE® Multiple Sample Luer Adapter, through the luer into the cannula, and into the blood culture tube or holder when punctured by the cannula. The fluid path consists of the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Blood Culture Holder never comes into contact with the blood specimen during conditions of use.

When the Blood Culture Holder is supplied attached to the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter, it undergoes sterilization as part of the entire system because the fluid path must be sterilized. However, when the Blood Culture Holder is provided alone, it is not sterilized and the user attaches their own sterile blood collection needle and luer adapter.

The Safety Blood Collection Set with Blood Culture Holder is non-pyrogenic and tested according to ISO-10993-11 rabbit pyrogen test. The devices also are below the limit for endotoxin and tested according to ISO-10993-11 LAL Turbidimetric Method.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blood Culture Holder:

Acceptance Criteria and Device Performance Study for Greiner Bio-One North America, Inc. Blood Culture Holder

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Twenty (20) Blood Culture Holders were connected to 20 Safety Blood Collection Sets with Luer Adapters.
• Data Provenance: The study was a simulated blood draw testing conducted by the manufacturer, Greiner Bio-One North America, Inc. The country of origin of the data is not explicitly stated but can be inferred as the USA, where Greiner Bio-One North America, Inc. is located. It is a prospective study as it involved testing new devices.

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

• The document does not mention the use of experts to establish ground truth for the simulated blood draw testing. The evaluation of proper fit, leakage, and function appears to have been performed internally by the manufacturer's testing personnel, based on pre-defined criteria.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. The evaluation seems to be a direct assessment against the defined acceptance criteria.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This study focuses on the performance of a medical device (Blood Culture Holder) in a standalone, mechanical/functional context, not on the comparative effectiveness of human readers with or without AI assistance. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study

• Yes, a standalone study was done. The "Product Performance" section describes a study of the Blood Culture Holder and Safety Blood Collection Set with Luer Adapter's performance in simulated blood draws. This study evaluates the algorithm's (in this case, the device's) function without human intervention influencing the fundamental mechanical performance being assessed.

7. Type of Ground Truth Used

• The ground truth used was based on pre-defined engineering and functional specifications/acceptance criteria for fit, leakage, and function. This is a form of empirical ground truth where the device's physical performance is directly observed and measured against established performance standards. For pyrogenicity and endotoxin, the ground truth was based on adherence to ISO-10993-11 standards.

8. Sample Size for the Training Set

• The document does not mention a training set as this is a physical medical device, not an AI or algorithmic system that requires machine learning training. The focus is on product performance validation, not algorithm development.

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

• As there is no training set mentioned or required for this type of device, this question is not applicable.

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The VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® SAFETY Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The Greiner VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged infusion and blood collection needle bonded to flexible tubing with a female luer adapter. The VACUETTE® SAFETY Infusion Set is used for short-term administration of intravenous fluids and/or for blood collection. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with manufacturer's instructions. It can be used in conjunction with an intravascular administration set or with a syringe or other device in order to administer fluids. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.

Here's an analysis of the provided text regarding the Greiner VACUETTE® SAFETY Infusion Set (K121908), focusing on the acceptance criteria and the study that proves the device meets them.

It's important to note that the provided documents are 510(k) Pre-market Notification summaries and FDA letters, not a detailed study report. Therefore, information typical of a comprehensive study (like specific sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or training set details) is generally not present in these types of regulatory submissions, especially for device modifications. These submissions primarily demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance (as inferred from the submission)

The primary acceptance criteria for this 510(k) submission are related to demonstrating substantial equivalence to the predicate device, specifically after a modification. This means the modified device must perform equivalently, without raising new questions of safety or effectiveness.

Study Details to Prove Acceptance Criteria:

Given the nature of the primary document (510(k) Summary for a device modification involving different sizes), a "study" in the traditional sense of a clinical trial with human subjects testing AI performance is not applicable here. The "study" is more accurately a design verification and validation process, primarily relying on non-clinical performance testing and comparison to a legally marketed predicate device.

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

   • Sample Size: Not specified in the provided documents. For device modifications involving physical dimensions (like needle gauge and tubing length), the "test set" would typically involve multiple units of each new configuration manufactured and subjected to various engineering and performance tests (e.g., flow rate, safety activation force, material integrity, bond strength). The specific number of units tested would be detailed in the sponsor's test reports, which are not included in this summary.
   • Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Greiner Bio-One North America, Inc. at their facilities or through qualified contract labs, consistent with manufacturing quality systems. This would be prospective testing of the modified device's technical specifications.

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

   • Not Applicable. This is a medical device modification related to physical dimensions and core safety features, not a diagnostic AI tool requiring expert image interpretation. Ground truth would be established by objective measurements (e.g., flow rates, force measurements, dimensional checks) against engineering specifications and regulatory standards, not expert consensus on diagnostic interpretations.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective data (e.g., imaging reads). For this device, performance is evaluated against objective, measurable criteria and pre-defined acceptance limits in a controlled testing environment.

4. 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 manual medical instrument (an infusion set), not an AI diagnostic tool. Therefore, MRMC studies are irrelevant.

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

   • Not Applicable. No algorithms or AI are mentioned or implied for the function of this infusion set.

6. The type of ground truth used:

   • The "ground truth" for this device modification would be based on objective engineering specifications, material properties, performance standards (e.g., ISO standards for medical devices), and a comparison to the established performance of the predicate device. This involves:
     • Dimensional measurements for new needle gauges and tubing lengths.
     • Mechanical strength tests (e.g., bond strength of tubing to luer, integrity of safety mechanism).
     • Flow rate testing for infusion and blood collection (to ensure new dimensions don't hinder performance outside acceptable ranges).
     • Safety mechanism activation/lock tests to confirm user-friendliness and security.
     • Sterility testing (biological indicators or validated sterilization processes).
   • These are all objective, verifiable data points rather than subjective expert consensus.

7. The sample size for the training set:

   • Not Applicable. As this is not an AI/ML device, there is no "training set."

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

   • Not Applicable. No training set.

Summary of the "Study" (Design Verification & Validation):

The documentation states that the device is "substantially equivalent to the predicate device in fundamental scientific technology, intended use, and materials." This is the core "proof" presented in a 510(k) for a minor modification.

For this specific modification (additional needle gauges and tubing length), the sponsor (Greiner Bio-One) would have conducted various non-clinical performance tests to demonstrate that these changes maintain the safety and effectiveness profile of the cleared predicate device (K080235). These tests would typically include:

• Mechanical testing: To ensure the integrity of the new configurations and the safety mechanism.
• Flow rate testing: To confirm the functionality for blood collection and fluid infusion across the new sizes.
• Dimensional verification: To ensure manufacturing accuracy.
• Material compatibility: Confirmation that the materials for the new sizes are the same or equivalent to the predicate.
• Biocompatibility: (If new materials were introduced, though not implied here).
• Sterilization validation: To confirm the sterilization process remains effective for the new sizes.

The FDA's clearance (JUL 25 2012) indicates they reviewed these underlying test results (summarized by the sponsor) and agreed that substantial equivalence was demonstrated, and the modifications did not raise new safety or effectiveness concerns.

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VACUETTE® PREMIUM Safety Blood Collection Set is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated automatically to cover the needle immediately following blood collection thus preventing accidental needlestick injury.

The Vacuette Premium Safety Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system (e.g. Holdex®). It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is free of PVC, DEHP, Latex.

The provided document describes the VACUETTE® PREMIUM Safety Blood Collection Set, but it does not contain detailed acceptance criteria and a study proving the device meets those criteria in a format applicable to AI/ML device performance.

The document discusses substantial equivalence to predicate devices based on design and safety features. It mentions "Simulated Use Testing" and "Material Testing" but does not provide the quantitative acceptance criteria or the study results of these tests in a way that would allow filling out the requested table and detailed information about AI/ML device performance.

Therefore, I cannot fulfill your request as the necessary information (explicit acceptance criteria, detailed study methodology, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in the provided text for an AI/ML device.

The document primarily focuses on the physical design, intended use, and demonstration of substantial equivalence for a medical device (a safety blood collection set), not an AI/ML system.

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The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the shortterm infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. The VACUETTE® Safety Infusion Set will be available in 2 configurations of needle gauge (21G and 23G) and one tubing length (7.5 inches). The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices. The devices were tested for sterility, pyrogenicity and systemic injection testing and were found to be biocompatible.

The provided text describes a 510(k) submission for the VACUETTE® Safety Infusion Set. This is a medical device application that demonstrates substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the same way one would for a novel AI algorithm or diagnostic test.

Therefore, many of the requested categories in your prompt (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth) are not applicable to this type of regulatory submission. The submission focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Explanation: The "acceptance criteria" for a 510(k) are primarily demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The performance is assessed against the predicate and established standards for medical devices (like sterility and biocompatibility).

Study Details (as applicable)

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing performance on a "test set" in the context of an AI algorithm or diagnostic test. The evaluation is based on comparison to a predicate device and standard device testing.
2. 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 sense of expert consensus for a diagnostic outcome, is not relevant here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 physical medical device, not an AI or diagnostic tool involving human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is regulatory compliance, established manufacturing standards, and the safety and effectiveness profile of the predicate device. For specific tests like sterility and biocompatibility, the ground truth is defined by validated testing methodologies and acceptable limits for those tests.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary based on the document:

The VACUETTE® Safety Infusion Set gained 510(k) clearance by demonstrating substantial equivalence to a predicate device, the Nipro® SafeTouch Safety Scalp Vein Set (K011297). Furthermore, its design, safety feature mechanism, raw materials, biocompatibility, and overall performance were declared identical to the previously FDA-cleared Greiner VACUETTE® Safety Blood Collection Set (K011786), which serves as a "new intended use" predicate for those specific aspects.

The submission confirms that the device underwent standard testing for sterility, pyrogenicity, and systemic injection, and was found to be biocompatible. These tests are presumably performed on a representative sample of manufactured devices, according to established medical device standards, to ensure they meet predefined safety thresholds. The document does not specify the sample sizes for these tests, which is typical for 510(k) summaries where detailed test protocols are not typically disclosed. The data provenance for these tests would almost certainly be internal company testing.

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