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The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.

The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to prevent accidental needle sticks and automatically activate during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A non-removable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged.

The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

The provided text is related to a 510(k) premarket notification for a medical device called the "Pro-Lock CT Safety Infusion Set." This document describes the device, its intended use, and a comparison to a predicate device, along with a list of performance tests conducted.

However, the document does not describe a study that uses a test set, ground truth established by experts, or any of the metrics (like sensitivity, specificity, or AUC) typically associated with AI/ML device performance. It also does not mention an AI algorithm, human readers, or any multi-reader multi-case (MRMC) comparative effectiveness study.

The document focuses on the mechanical and material performance of a physical medical device (an infusion set) against established international standards for medical devices and biocompatibility. The acceptance criteria are the successful completion of these specified tests according to the outlined standards.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device's performance because the provided text is about a physical medical device and its traditional regulatory submission.

Here's what I can extract from the provided text regarding the performance evaluation of the physical device:

The document describes the performance testing of the Pro-Lock™ CT Safety Infusion Set to demonstrate its substantial equivalence to a predicate device.

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

The document does not explicitly present a table of acceptance criteria alongside reported numeric device performance results. Instead, it lists the tests performed and the standards adhered to, implying that meeting these standards constitutes the acceptance criteria. The narrative states that the results of these tests "effectively demonstrate the proposed device... is equivalent to the predicate device."

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

• Sample Size: Not specified in the provided text for individual tests. The testing seems to be laboratory-based verification and validation.
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from "non-clinical testing performed" at Medcomp®.

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

• This is not applicable to the type of device and testing described. Performance is based on meeting engineering and biocompatibility standards, not expert clinical assessment of diagnostic output.

4. Adjudication method for the test set:

• Not applicable. Performance is measured against physical standards, not through 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 is a physical medical device, not an AI/ML diagnostic tool.

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

• Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used:

• The "ground truth" here is adherence to national and international engineering and biocompatibility standards (e.g., ISO, ASTM, FDA Guidance). These standards define acceptable physical properties and safety profiles for the device.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm that requires a training set.

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

• Not applicable. There is no AI/ML algorithm requiring a training set and its associated ground truth establishment.

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The Medcomp® Pro-Lock CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp Pro-Lock CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.

The 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to aid in the prevention accidental needle sticks when manually activated during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A nonremovable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged. The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Pro-lock™ CT Safety Infusion Set). It focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility.

Therefore, many of the requested criteria, such as those related to AI algorithm performance studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device submission. This document describes a physical medical device, not an AI/ML software device.

However, I can extract information related to the device's acceptance criteria and studies to demonstrate its performance where applicable from the document.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the listed tests and the demonstration of substantial equivalence to the predicate device. The document does not explicitly state quantitative acceptance limits for each test in a table, but rather lists the tests performed to ensure the device meets relevant standards and performs similarly to the predicate.

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

The document does not specify the exact sample sizes (number of units tested) for each of the performance and biocompatibility tests. It only lists the tests performed and the relevant standards. These tests are laboratory-based, non-clinical tests.

• Data Provenance: The tests are "bench / performance data / non-clinical testing" conducted by the manufacturer, Medcomp®, located in Harleysville, Pennsylvania, USA. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate the device's characteristics.

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

This question is not applicable. The "ground truth" here is established by the accepted international and internal test methods and standards (e.g., ISO, ASTM), not by expert consensus in a clinical scenario. The tests are designed to objectively measure physical, chemical, and biological properties.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly for imaging studies where subjective interpretation is involved. These are objective, quantitative, non-clinical laboratory tests where the results are measured against defined criteria within the standard.

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 question is not applicable. This is a physical medical device (an infusion set), not an AI/ML diagnostic or assistive device. No human-in-the-loop study with AI was performed.

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

This question is not applicable. This is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" or basis for evaluation is defined by:

• Established Industry Standards: ISO and ASTM standards (e.g., ISO 10555-1, ISO 10993 series, ASTM F2052, etc.) that specify test methods and acceptable limits for medical devices of this type.
• Internal Test Methods: Where no specific external standard exists, internal test methods are used, and their validity is implicitly accepted by the FDA's clearance.
• Substantial Equivalence: The primary "ground truth" for 510(k) clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device (K132880) through comparison of design, materials, indications for use, and performance testing.

8. The Sample Size for the Training Set

This question is not applicable. This device does not involve a "training set" for an AI/ML algorithm.

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

This question is not applicable, as there is no training set for an AI/ML algorithm.

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The All Safe Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The All Safe Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries. The All Safe Huber Safety Infusion Sets are also indicated for power injection of contrast media into the central venous system with implanted vascular ports indicated for power injection. The maximum recommended infusion rate at 11.8 cps is 5 ml/sec for 19 and 20 gauge. Maximum pressure is 325 psi for all gauge sizes.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for the "All Safe Huber Safety Infusion Set" does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the specific details outlined in your request (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, or training set information).

The document is primarily a notification of a substantial equivalence determination by the FDA for a medical device. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It details the device's indications for use and classification.

To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a more detailed 510(k) summary that includes information about specific performance tests and their results against predefined acceptance criteria.

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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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The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

The device consists of a protector cap, female luer lock, PVC tubing, two each 4 inch tubing length, a pinch clamp, with a needle free y-site, a butterfly wing, a safety needle guard, an AISI 304 (19 ga) stainless steel needle and a needle sheath.

The components and the processes use to manufacture these solution administration sets are the same as the currently legally marketed by Command Medical, K033515 HuberPRO™ Safety Huber Infusion Set.

Cook Vascular, Inc. will label and sterilize the final product. The proposed device is manufactured exactly the same as the currently marketed device. (K033515)

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Cook Vascular VITAL-JECT™ Power Injectable Safety Infusion Set:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria with specific pass/fail thresholds for each test. Instead, it describes general conclusions about performance. The key performance aspect highlighted is the ability to withstand power injection.

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

• Sample Size for Test Set:
  • For the performance tests (Dynamic Failure Flow, Instantaneous Burst, Static Pressure, Life Cycle Power Injection Tests), a specific sample size is not explicitly stated in the provided summary.
  • For Bioburden testing, nine individual infusion sets were tested.
• Data Provenance: The data appears to be prospective testing conducted by Cook Vascular, Inc. or its contractors. The country of origin is implicitly the USA, where Cook Vascular, Inc. is based and the submission was made to the FDA.

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

• Not applicable for this type of device and study. The testing described involves engineering and microbiological performance metrics, not clinical interpretation by experts to establish a "ground truth." The ground truth is objective performance characteristics measured through laboratory testing.

4. Adjudication Method for the Test Set:

• Not applicable. This study involves objective laboratory tests with measurable outcomes, not subjective assessments requiring adjudication by multiple experts.

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:

• No. This document describes a 510(k) submission for a physical medical device (infusion set), not an AI/software-as-a-medical-device. Therefore, no MRMC study or AI-related comparative effectiveness was performed or applicable.

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

• No. As mentioned, this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" for the performance tests (flow, pressure, burst, life cycle) are engineering specifications and physical measurements designed to assess the device's functional integrity under intended use conditions.
• The "ground truth" for sterilization tests (Bioburden, Endotoxin, EO Residuals, Sterility) are established microbiological and chemical standards for medical device sterilization.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The design, components, and manufacturing processes leverage those of a previously cleared predicate device (K033515 HuberPRO™ Safety Huber Infusion Set), which serves as a benchmark for substantial equivalence rather than a training set in the AI sense.

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

• Not applicable. As there is no training set, there's no ground truth established for one. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by the described physical and microbiological testing.

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The PowerLoc* Clear Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports.

The PowerLoc* Clear Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with the PowerPort* device, the PowerLoc* Clear Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 Ga. and 20 Ga. needles and 2 ml/s for 22 Ga. needles.

The PowerLoc* Clear Safety Infusion Set is comprised of a standard non-coring Huber type needle and administration set with an integral needle-stick safety mechanism.

The PowerLoc* Clear Safety Infusion Set is a standard intravascular administration set with a non-coring Huber right angle needle and a manually activated needle-stick safety mechanism which reduces the risk of accidental needle-stick injuries by shielding the needle after use. The device is used to access surgically implanted vascular ports and indicated for use in the administration of fluids and drugs, as well as blood sampling.

The PowerLoc* Clear Safety Infusion Set is also indicated for power injection of contrast media into the central venous system through the Bard PowerPort* device family. The maximum recommended infusion rate is 5 mils for 19 gauge and 20 gauge, and 2 mils for 22 gauge needles.

The device functions in a similar manner to the predicate devices. The insertion site is prepared and the device is primed using a syringe containing normal saline and inserted into the port septum. Patency is confirmed and the device is dressed per institutional protocol. Removal of the device is accomplished by flushing per institutional protocol, stabilizing the implanted port with non-dominant hand and removing the device while simultaneously activating the needle-stick safety mechanism with the dominant hand.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard PowerLoc* Clear Safety Infusion Set.

Important Note: This document is a 510(k) summary, which is a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical trial or performance study with specific device performance metrics in the way one might expect for a novel AI or diagnostic device. The "acceptance criteria" here refer more to meeting established engineering and regulatory standards rather than performance metrics like sensitivity/specificity for a diagnostic.

Acceptance Criteria and Device Performance

There is no table of specific acceptance criteria and reported device performance in the traditional sense of a diagnostic or risk-based AI device accuracy. Instead, the document states that the device was evaluated against various recognized standards and guidance documents. The "acceptance criteria" were met if the device demonstrated compliance with these standards and showed equivalence to predicate devices.

Study Details

It is important to understand that this is a 510(k) submission, not a detailed clinical study report for a diagnostic algorithm. The "study" here refers to "design verification evaluations through testing examination."

1. Sample Sizes Used for Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated in the provided text. The document refers to "verification testing" being performed but does not specify the number of devices or units tested for each standard.
   • Data Provenance: Not applicable in the context of clinical patient data. The provenance relates to laboratory and engineering testing under controlled conditions, likely conducted by the manufacturer (Bard Access Systems, Inc.) or its designated testing facilities, presumably in the US (Salt Lake City, Utah). The testing would be prospective in the sense that new devices were manufactured and then tested according to the protocols.

2. Number of Experts and Qualifications for Ground Truth:

   • Not applicable. This device is not a diagnostic system requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" here is adherence to engineering specifications and regulatory standards.

3. Adjudication Method for the Test Set:

   • Not applicable. This is not a situation where expert adjudication of conflicting interpretations is required. Compliance with standards and specifications is typically determined by objective measurements and predefined pass/fail criteria.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The PowerLoc* Clear Safety Infusion Set is a physical medical device (needle and administration set) and does not involve human readers interpreting data.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device does not contain an AI algorithm. Its performance is entirely mechanical and material-based. The "algorithm" here is the design of the physical device itself and its interaction with the human user in terms of safety features.

6. Type of Ground Truth Used:

   • The "ground truth" is defined by the FDA recognized standards (e.g., ISO 11135, ISO 10993-1, ISO 11607-1, etc.) and guidance documents referenced in Section 6.8. Compliance with these standards, through objective measurements and predefined acceptance criteria during verification testing, serves as the "ground truth" that the device is safe and effective for its intended use.

7. Sample Size for the Training Set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

8. How Ground Truth for the Training Set Was Established:

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

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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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The Smartport CT MPPort Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.

The Smartport CT MP port can accommodate a 3 ml/sec injection rate of contrast agent when used with a 19 or 20 gauge power injectable infusion set.

The 19 or 20 gauge LifeGuard Infusion Set can accommodate power injection when used with Smartport CT ports.

The LifeGuard® CT Safety Infusion Set is indicated for use in the access of implanted vascular ports for the administration of fluids and drugs, as well as blood sampling.

The 20ga and 19ga LifeGuard® CT Safety Infusion Sets are also indicated for power injection of contrast media when used with Smartport CT power injectable port access systems.

Not Found

The provided text is a 510(k) summary for a medical device (Smartport CT MP Port Access System and LifeGuard® CT Safety Infusion Set) and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

• Device Identification: Proprietary and common names, classification, product codes, regulatory class.
• Legally Marketed Predicate Devices: Devices to which equivalence is claimed.
• Intended Use / Indications: What the device is designed for.
• FDA Communication: The clearance letter from the FDA confirming substantial equivalence to predicate devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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The EZ Huber Safety Infusion Set is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks. The EZ Huber Safety Infusion Set is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks. The EZ Huber Safety Infusion Set is compatible with power injection procedures up to 300 psi.

The EZ Huber Safety Infusion Set is used to access implanted septums for the purpose of drug and IV infusion. The Needle is constructed so that after patient use and upon needle removal, the needle can be removed and the safety mechanism will be activated. The product is designed so that the practitioner activates the safety mechanism during normal needle removal following typical removal procedures used for non-safety Huber needles. Upon activation of the safety mechanism, the total function of the EZ Huber Safety Infusion Set is complete and the unit is discarded in accordance with hospital protocol. Components will be assembled into standard configurations or configurations specified by the customer and packaged. Types of components that may be contained in a set include: Huber Housing, Huber Wing, Spring, Needle Cannula, Needle Sheath Tubing, PE lined Foam Pad, Pinch Clamp, Female Luer Dust Cap, Y-site, Swabable Y-site, Medegen.

The provided text is a 510(k) Summary of Safety and Effectiveness for the EZ Huber Safety Infusion Set. This document is for a medical device (intravascular administration set) and primarily focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a performance study with detailed acceptance criteria and statistical analysis.

Therefore, the information required to populate the requested table and answer the specific questions about acceptance criteria and study details for device performance is largely not present in the provided text. The document describes the device, its intended use, and biocompatibility, but it does not include a clinical study or performance testing with quantitative acceptance criteria.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the safety feature "aids in the prevention of accidental needle sticks" and that the device is "compatible with power injection procedures up to 300 psi." However, it does not provide specific quantitative acceptance criteria (e.g., a certain percentage of needle-stick prevention, or a specific performance metric for pressure) or the results of a study that objectively measured these performances against such criteria. The biocompatibility claim is a general statement, not a specific performance outcome against a numerical criterion.

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

• Test set sample size: Not specified.
• Data provenance: Not specified. The document does not describe a performance study with a test set.

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

• Not applicable. No performance study with ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable. No performance study with adjudication is described.

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 not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

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

7. The type of ground truth used

• Not applicable. No performance study requiring ground truth is described.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable. As above, this is for a physical device, not a machine learning model.

Summary of what is present:

• Device Name: EZ Huber Safety Infusion Set
• Intended Use: Administer fluids to a patient's vascular system through an implanted port, with an active safety feature to prevent accidental needle sticks. Compatible with power injection up to 300 psi.
• Equivalency: The submission establishes substantial equivalence to existing predicate devices (PFM Medical, Inc. K040533 and CR Bard, Inc. K060812).
• Biocompatibility: Materials are "used in legally marketed devices under comparable conditions of use," suggesting reliance on prior art and established material safety rather than new biocompatibility testing for this specific device.

The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. While performance data may be submitted, the provided summary focuses on the descriptive aspects and regulatory classification rather than a detailed performance study with quantitative acceptance criteria.

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The Vortex® CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.

When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19Ga sizes, the Vortex® CT Port Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

The LifeGuard® Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with the Vortex® CT Port Access System, the LifeGuard® Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, only models LG-19-75, LG-19-100, LG-20-75, LG-20-100, and LG-20-150 may be used at a maximum infusion rate of Sml/sec.

The Vortex® CT Port is a Titanium port with a self sealing silicone rubber septum designed to maintain integrity after punctures with a non-coring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration. The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter. The Vortex® Port Access systems offer models with single lumen 7.5 French to 9.6 French catheters made from either polyurethane or silicone. The catheters all contain radiopacifiers, and depth markings.

The LifeGuard safety infusion set is a port access needle set with an integrated proprietary safety feature to prevent re-bound injury. The safety infusion set includes a huber needle, a winged housing, non-DEHP PVC extension legs, and a luer standard connector.

This document describes the non-clinical performance data for the Vortex® CT Port Access System and LifeGuard® Safety Infusion Set, which is a medical device for vascular access and power injection of contrast media.

Here's the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific "reported device performance" values for each test, but rather indicates that the tests were performed to establish substantial equivalence, safety, and effectiveness. The "Required Results" column from the provided table serves as the acceptance criteria.

The study concludes that "The non-clinical tests demonstrate that the device is as safe, as effective for the modified intended use." This statement implies that the device met all the required results set as acceptance criteria for the non-clinical tests.

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

• Test Set Sample Sizes:
  • Sterilization exposure: All
  • Physiological exposure: All
  • Power injection Performance Test: 18
  • Simulated Power Injection: 30
  • Dynamic Failure Test: 18
  • Static Burst Test: 18
  • Life Cycle Power Injection Test: 10
  • Cyclic testing: 30, 10 cycles per port
  • Port Patency Verification: 5
  • Port Occlusion Test: 10
  • Puncture Life: 2
• Data Provenance: The data is from non-clinical testing. There is no mention of country of origin for the data (as it's laboratory-based testing, not human patient data) and it is inherently prospective as it involves conducting specific tests on the devices.

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

Not applicable. This is a submission for a physical medical device (Vortex® CT Port Access System and LifeGuard® Safety Infusion Set) and the testing performed is non-clinical/pre-clinical (laboratory-based physical and performance testing), not involving human interpretative tasks or diagnostic assessment. Therefore, no experts were used to establish ground truth in the context of diagnostic accuracy, and no qualifications of such experts are relevant.

4. Adjudication Method for the Test Set

Not applicable, for the same reasons as point 3. The tests are objective physical and performance measurements with defined pass/fail criteria, not subjective assessments requiring 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 physical medical port and infusion set, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

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

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

The "ground truth" for the non-clinical tests is based on pre-defined engineering specifications and performance requirements. These are objective, measurable outcomes (e.g., "no bursts, leaks, / plastic deformations allowed," "meet expected flow rate and pressure withstand requirements," "withstand 10 cycles").

8. The sample size for the training set

Not applicable. Since this is a physical medical device and not an AI/machine learning model, there is no "training set."

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

Not applicable, for the same reason as point 8.

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