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The Surecan Safety II power-injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Surecan Safety II safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.

For power injection of contrast media, the maximum flow rates at 325 psi are 5mL/s for 19 gauge and 20 gauge needles and 2mL/s for the 22 gauge needles.

The Surecan Safety II power-injectable safety non-coring needle is a single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. This device contains a non-coring angled needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle tip during removal. The intended patient population is for patients with implanted intravenous access ports.

The Surecan Safety II needles are available in different sizes from 19 gauge to 22 gauge and have an overall needle length ranging from 0.5-1.5 inches (12mm-38mm). The Surecan Safety II needles will be available in two configurations:
-with a Y-site and a preconnected Caresite luer access device
-without Y-site or Caresite luer access device

When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.

The Surecan Safety II is designed with flexible wings which allow the user to securely hold the device for insertion and removal of the needle. The base and bottom plate are made of clear plastic that allow the user to visualize placement of the needle. A foam pad is present on the patient-contacting side of the safety mechanism. The overall assembly has a low profile to assist with the placement of a securement dressing following insertion of the needle into the port.

The provided document describes the Surecan Safety II, a power-injectable safety non-coring needle. The document states that the device has met all established acceptance criteria for performance testing and design verification testing. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted. For most of these, the "reported device performance" is implicitly that the device met the criteria, as stated in the "CONCLUSION" section: "The Surecan Safety II has met all established acceptance criteria for performance testing and design verification testing." Specific quantitative values for acceptance criteria or performance numbers are generally not provided in this summary, but rather the type of test and the standard referenced.

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

The document does not specify exact sample sizes for each performance test. It only lists the types of tests performed. The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These are typical of a device rather than software premarket notification.

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 and not provided in the document. The tests performed are engineering and biocompatibility tests on a physical device, not related to medical image analysis or clinical interpretation needing expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The tests are objective measurements and evaluations against established standards, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or similar AI applications, not for a physical medical device like a hypodermic needle.

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

No, this is not applicable. The device is a physical medical device, not an algorithm. Performance tests directly evaluated the physical characteristics and safety features of the device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance tests are the established standards and specifications for various physical and biological properties. For example, for "Freedom from leakage," the ground truth is "no part of the set leaks when connected to 150kPa of water pressure for 15 minutes." For biocompatibility, the ground truth refers to the acceptance criteria within the referenced ISO standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a "training set."

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

This information is not applicable. As stated above, there is no "training set" for this type of device.

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The Caresite Luer Access Device (LAD) is a needleless connector intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Caresite Luer Access Device (LAD) may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 15 mL/sec.

The Caresite Luer Access Device (LAD) is a positive displacement needleless connector intended to provide needle-free access to IV gravity sets, extension sets and catheters for the administration of IV fluids and blood. The Caresite Luer Access Device (LAD) is a 3-piece assembly containing an elastomeric piston with a slit septum, which is housed within a clear, rigid body. The Caresite Luer Access Device (LAD) requires swabbing to disinfect prior to insertion of a male luer connector. The Caresite Luer Access Device (LAD) does not require a specific clamping sequence or technique in order to be used safely. The Caresite Luer Access Device (LAD) may be used with power injectors with a maximum pressure rating of 400 psi and a maximum flow rate of 15mL/sec. The Caresite Luer Access Device (LAD) is individually packaged and is supplied as a sterile, non-pyrogenic, single use, disposable device.

The input document describes a 510(k) submission for a medical device (Caresite Luer Access Device), which is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Crucially, a 510(k) filing for a device like a needle-free luer access device typically does NOT involve the kind of elaborate clinical studies (MRMC, expert consensus for AI training/testing, etc.) that would lead to the specific information requested in your prompt. These studies are far more common for novel, high-risk devices, or AI-driven diagnostic/therapeutic tools.

The document states:

• "Performance testing was performed to demonstrate safety and effectiveness."
• "Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Caresite Luer Access Device (LAD) is considered substantially equivalent to the predicate device and is safe and effective for its intended use."

The performance testing mentioned here likely refers to bench testing, engineering verification, and perhaps some in-vitro studies to confirm properties like:

• Pressure resistance (e.g., 400 psi)
• Flow rate (e.g., 15 mL/sec)
• Durability (e.g., number of activations)
• Leakage prevention
• Microbial ingress prevention
• Biocompatibility (in accordance with ISO 10993-1)

Therefore, many of your requested points cannot be directly answered from the provided text. The document is for a physical medical device, not an AI/algorithm-driven one, hence the absence of metrics like "effect size of how much human readers improve with AI vs without AI assistance" or "number of experts used to establish ground truth."

Here's an attempt to address your prompt based on the provided text, and explicitly stating where the information is not applicable (N/A) or not provided (N/P) given the nature of a 510(k) for this type of device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Principle)

The acceptance criteria for a 510(k) submission like this are primarily to demonstrate substantial equivalence to a predicate device in terms of:

1. Indications for Use: The Caresite Luer Access Device has similar indications for use to the predicate device.
2. Technological Characteristics: Similar physical and technical characteristics, materials, and components as the predicate.
3. Performance: Safety and effectiveness demonstrated through performance testing, showing it performs at least as well as the predicate for its intended use, and meets specific functional requirements.

Given the absence of specific quantitative acceptance thresholds in the provided text for "performance testing," the table below reflects what can be inferred or is explicitly stated as characteristics of the device. The "acceptance criteria" here are implied by the device's functional specifications and the successful 510(k) clearance, meaning it performs acceptably for its intended use compared to the predicate.

Study Details (As Applicable for this Device Type)

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

   • N/P. For a physical device of this nature, "test set" would refer to the number of devices tested during performance (bench) and biocompatibility testing. This information is not typically detailed in the 510(k) summary provided, but would be in the full submission. The data provenance would be from manufacturing/testing facilities, likely in the US (where the applicant is based). These would be prospective tests.

2. 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):

   • N/A. This device is not an AI/diagnostic imaging device, so the concept of "experts establishing ground truth" in the context of clinical images or algorithmic output is not applicable. The "truth" here is engineering specification, material safety, and functional performance as observed in bench tests.

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

   • N/A. Adjudication methods are relevant for subjective interpretations of data (e.g., radiological reads) or clinical outcomes. Not applicable for this physical device's performance testing.

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:

   • N/A. This is a physical medical device, not an AI/diagnostic tool. MRMC studies are not relevant for its clearance.

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

   • N/A. This is a physical medical device, not an algorithm.

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

   • For this type of device, "ground truth" would be established through:
     • Engineering Specifications/Standards: Performance measured against predefined industry standards (e.g., ISO for biocompatibility) and engineering design specifications (e.g., pressure, flow rates).
     • Predicate Device Performance: The predicate device's established performance serves as a benchmark for substantial equivalence.
     • Biocompatibility Standards: Adherence to ISO 10993-1.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/machine learning device.

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

   • N/A. There is no "training set" as this is not an AI/machine learning device.

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