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The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor.

The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

The provided text is a 510(k) summary for a medical device called SecurAcath. It focuses on demonstrating substantial equivalence to a previously cleared device, not on proving the device meets general acceptance criteria through a specific clinical study with detailed performance metrics like sensitivity, specificity, or accuracy, which is typical for AI/ML-based medical devices or diagnostics.

The changes described are primarily related to manufacturing processes and materials (e.g., laser marking instead of pad printing, slight material formulation change in polypropylene, different anti-block additive in packaging, and an extended shelf life). The "performance data" section mentions engineering tests to confirm the device still meets product specifications after these changes.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth types, training set details) are not applicable (N/A) for this type of submission because the device is a physical medical device (catheter securement system), not an AI/ML diagnostic or imaging device. The "acceptance criteria" here refer to ensuring the manufacturing changes do not negatively impact the device's original functionality and safety.

Here's an attempt to answer the questions based on the provided text, indicating N/A where information is not present or relevant to this type of device:

Description of Acceptance Criteria and Proving Device Meets Criteria (SecurAcath Device)

The device in question, SecurAcath, is a physical medical device (a catheter securement system), not a software or AI/ML-based diagnostic device. The acceptance criteria and "study" described in the provided document revolve around demonstrating that manufacturing/material changes to the device do not negatively impact its performance, safety, or effectiveness compared to its predicate device. The study performed is a series of engineering performance tests and material characterizations, not a clinical trial or AI model validation study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with specific thresholds (e.g., tensile strength > X N) alongside numerical reported performance values. Instead, it states that tests were performed to demonstrate the device "meets product specifications" and "is not negatively impacted by the material change or marking process change." The acceptance is qualitative in the sense that the new device performs "as intended" and "continues to meet the same specifications as its predicate devices."

• Joint Tensile Strength
• Base & Cover Interaction
• Hinge performance
  (No specific numerical data provided, but it states results demonstrate "device functions as intended.") |
  | Marking Durability | Testing performed per IEC 60601-1 for durability of markings. The laser marking does not impact safety and effectiveness. |
  | Biocompatibility | Meets ISO 10993-1. (Same as predicate) |
  | Sterilization & Sterility | EtO and SAL of 10-6. (Same as predicate, new packaging configuration passed testing) |
  | Shelf Life | Extended to 4 years. Shelf life product was 2X sterilized, passed design verification testing including pouch seal peel and bubble leak tests. The extension does not impact safety and effectiveness. |
  | Packaging Integrity | New packaging configuration passed ISTA 2A, ASTM D4169, sterile barrier performance testing and ISO 10993-7 testing. The new configuration does not impact safety and effectiveness. |

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML model. The "tests" mentioned are engineering and material verification tests (e.g., dimensional, functional, durability). The number of samples used for these engineering tests is not specified in this summary.
• Data Provenance: N/A for this type of device; no patient data or clinical data is mentioned for performance evaluation in this premarket notification. The tests are lab-based.

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

• N/A. This is an engineering/manufacturing change submission for a physical device. There is no "ground truth" derived from expert interpretation (e.g., radiologists, pathologists) in the context of a diagnostic or imaging study. The "truth" is established through engineering specifications and industry standards.

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

• N/A. No expert adjudication of data is mentioned or relevant.

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:

• N/A. This is a physical medical device, not an AI/ML-assisted diagnostic device. No MRMC study was performed.

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

• N/A. Not an algorithm.

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

• N/A. The "ground truth" for this device's "performance" is its adherence to engineering specifications, material compatibility standards (e.g., ISO 10993), and functional requirements that ensure continuous safe and effective operation after manufacturing changes.

8. The sample size for the training set:

• N/A. This is a physical device, not an AI/ML model that requires training data.

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

• N/A. Not applicable as no training set exists for this type of device submission.

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The SecurAcath device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short or long-term securement of percutaneous indwelling catheters for abscess/general drainage

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

The provided text is a 510(k) Summary for the SecurAcath device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI/ML device.

Therefore, I cannot fully answer your request as it pertains to AI/ML device evaluation criteria. The document describes a medical device for catheter securement and its equivalence to a predicate, not an AI/ML system.

However, I can extract the general type of performance data mentioned and explain why it doesn't fit the AI/ML framework you've outlined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Performance tests" that were conducted, but it does not provide specific acceptance criteria or quantitative performance metrics for these tests. Instead, it makes a general statement: "Test results demonstrate that the device functions as intended."

2. Sample Size for Test Set and Data Provenance: Not applicable as this is not an AI/ML study. The document refers to "Performance tests" but does not detail the sample sizes for these tests or the provenance of any data.

3. Number of Experts and Qualifications for Ground Truth: Not applicable as this is not an AI/ML study. The device's performance evaluation would involve engineering and clinical testing, not expert adjudication of AI outputs.

4. Adjudication Method: Not applicable.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone (Algorithm Only) Performance: Not applicable as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used: Not applicable in the AI/ML sense. The "ground truth" for this device would be established through engineering specifications, biomechanical testing outcomes, and clinical observations of catheter securement effectiveness, rather than expert interpretation of data.

8. Sample Size for Training Set: Not applicable as there is no AI/ML training involved for this device.

9. How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided FDA 510(k) summary is for a physical medical device (catheter securement device) and therefore does not contain the information requested regarding acceptance criteria and studies for an AI/ML device. The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and general performance testing (e.g., dimensional verification, functional tests, securement reliability, human factor design validation).

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The SecurAcath Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.

The SecurAcath is a single use, sterile device for securing indwelling catheters. The device is a standalone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SecurAcath device:

Based on the provided text, the device is a catheter securement device, and the submission is a Special 510(k) for a device that is substantially equivalent to a previously cleared predicate device (K092306). Special 510(k)s typically involve modifications to a company's own legally marketed device for which design control activities have been completed. This means the focus of the submission is often on demonstrating that the changes do not raise new questions of safety or efficacy and that the device still meets its established performance specifications.

Due to the nature of a Special 510(k) and the content provided, the level of detail regarding acceptance criteria and a deep statistical study may be less extensive than for a novel device or a Traditional 510(k) where new clinical data might be required.

Acceptance Criteria and Reported Device Performance

Note: The provided text does not explicitly state numerical acceptance criteria (e.g., minimum tensile strength, specific pull-out force resistance values). Instead, it makes general statements about meeting specifications and demonstrating intended function. This is common for Special 510(k) submissions where the changes are often minor and the primary goal is to ensure the modified device performs comparably to the predicate.

Study Details

Based on the provided text, a comprehensive clinical study with human subjects, a test set, and ground truth established by experts, as typically seen for AI/ML devices or novel therapies, was not performed or reported in this 510(k) summary. The evaluation primarily relied on non-clinical performance testing to demonstrate substantial equivalence to the predicate device.

Here's why some requested sections cannot be filled:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   • Not applicable / Not provided. The text refers to "Performance tests" including "dimensional verification" and "securement reliability." These are laboratory-based engineering tests, not clinical studies with a patient test set.
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):
   • Not applicable / Not provided. Ground truth, in the context of expert consensus on patient data, is not relevant for the type of engineering performance tests described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   • Not applicable / Not provided. Adjudication methods are used in clinical studies when multiple human readers interpret data, which is not described here.
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:
   • No. This is not an AI/ML device, nor is it a device that directly assists human readers in interpreting clinical data. Therefore, an MRMC study is not relevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable. This is a physical medical device (catheter securement), not an algorithm or AI system.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   • Engineering Specifications. The "ground truth" for the performance tests would be the established engineering specifications and design requirements that the device was tested against (e.g., a specific pull-out force standard).
7. The sample size for the training set:
   • Not applicable / Not provided. As this is not an AI/ML device, a "training set" in that context does not exist. The development and testing would follow standard engineering design and verification principles.
8. How the ground truth for the training set was established:
   • Not applicable / Not provided. See above.

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The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.

The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.

The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.

The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.

The intravenous extension tubing kits will consist of an intravenous extension tubing set, a Vital-Hold catheter stabilization device, two foam tape strips and an APLICARE skin protectant prep pad. The intravenous extension sets may contain any of Baxter's cleared access ports (e.g., Interlink Injection Site, Clearlink Luer Activated Valve or V-Link Luer Activated Valve).

The IV extension tubing set is used with a vascular access device for administration and withdrawal of fluids.

The Vital-Hold catheter stabilization device is used to help anchor medical intravenous tubes and lines requiring mechanical stability while installed on the skin surface of a patient.

The two foam tape strips with release liners are used to assist with line stabilization.

The APLICARE skin protectant prep pad is a sterile pad saturated in skin prep solution. The prep solution prepares the skin prior to application of a dressing or bandage. When dry, the prep agent leaves a thin polymer film on the skin surface providing a clean surface for adhesion and a barrier to the natural body oils that can affect adhesion.

The IV extension tubing set, the Vital-Hold catheter stabilization device, the two foam tape strips and the APLICARE skin protectant prep pad will be integrated into one sterile unit blister package to provide the user with a "ready-to-use" set up avoiding the need to acquire/assemble components from various manufacturers)

The provided text describes an Intravenous Extension Tubing Kit and its components, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Summary, which is a premarket notification submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It focuses on the device's description, intended use, and comparison to existing devices, rather than detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information. The sections you asked for, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not present in this document.

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The Medisystems Hemodialysis Fistula Needle Securement Device, SiteGuard, is intended for use to secure the fistula needle to the patient's skin.

The SiteGuard needle securement device has the following features:
a. It allows the needle to be held at a consistent angle during treatment;
b. It secures wing/hub to the patient's skin and helps prevent movement and/or dislodgement of the needle during use; and,
c. It helps to immobilize the patient's vein or access during cannulation so that it is not necessary for caregivers to hold the vein or access with their fingers.

The subject of this 510(k) is a removable, rigid plastic securement device that is attached to the AVF needle set by the care giver. The SiteGuard securement device will be included in the unit packaging pouch with the Medisystems AVF needle set and also will be available for purchase as an individually packaged accessory.

Because the tape, the AVF wing, and the patient's skin are flexible, the needle may dislodge or move within the patient's access during treatment due to this inherent flexibility. The securement device adds a rigid structure to increase the ability of the tape to prevent the needle from accidentally dislodging or moving within the patient's vascular access.

This accessory also will immobilize the patient's vein during insertion of the cannula so that it is not necessary for caregivers to hold the vein or access with their fingers. The channel along the bottom of the securement device is designed to immobilize the patient's vein during insertion. This feature is especially helpful for patients who have newly created fistulas or implanted grafts because new accesses tend to move during cannulation.

This 510(k) summary does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.

Instead, this document focuses on establishing substantial equivalence to legally marketed predicate devices rather than demonstrating performance against specific acceptance criteria through a comparative study.

Here's a breakdown of why the requested information is absent and what the document does provide:

• Acceptance Criteria and Reported Device Performance: These are not mentioned. The document states that "all finished products are tested and must meet all required release specifications before distribution" and that "The required testing is defined by written and approved procedures that conform to the product design specifications." However, what these specifications or acceptance criteria are, or the quantitative results of such testing, are not provided in this 510(k) summary.

• Study That Proves the Device Meets Acceptance Criteria: No such specific study is described. The document refers to "risk analysis, test and design considerations, and verification and validation testing processes" as part of product development, but it doesn't detail a study designed to demonstrate performance against acceptance criteria.

Let's address the specific points you asked for, indicating where the information is not present in this document:

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

   • Not present. The document mentions "required release specifications" and "product design specifications" but does not enumerate them or report specific performance metrics against them.

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

   • Not present. No specific test set or data from a performance study is described.

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 present. There is no mention of ground truth establishment or experts for a test set.

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

   • Not present. No test set or adjudication method 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 present. This device is a physical securement device, not an AI or imaging device, so an MRMC study is not relevant and not discussed.

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

   • Not present. As this is a physical device, this concept does not apply.

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

   • Not present. No ground truth type is mentioned as no performance study is detailed.

8. The sample size for the training set:

   • Not present. There is no mention of a training set, as this is not an AI/machine learning device.

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

   • Not present. Not applicable, as there's no training set mentioned.

Summary of what the document does convey regarding "Safety and effectiveness":

The document states:

• "To assure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution."
• "The required testing is defined by written and approved procedures that conform to the product design specifications."
• "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and verification and validation testing processes."
• The primary justification for safety and effectiveness is "substantial equivalence" to legally marketed predicate devices (TNT Moborg Intl., LTD, Immobile Non-sterile and Immobile A/C t non-sterile (K941850); and, TNT Immobile sterile and Immobile A/C sterile (K941940)). The document explicitly states, "There are no new issues of safety or effectiveness resulting from the inclusion of this accessory in the legally marketed needle set."

In essence, this 510(k) relies on the argument that the SiteGuard device is similar enough to already approved devices that it shares their established safety and effectiveness profile, without needing to conduct new, explicit performance studies detailed in this summary.

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