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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 AP Harness is to be used as a safety line between a patient and a medical machine which are connected by a medical line, (ie IV tubing, oxygen tubing, enteral tubing, etc. ). This device would be used when the patient or caregiver cannot maintain an adequate level of safety for an important catheter or other medical line.

The A.P. Harness System facilitates increased safety and comfort of the active child or other patient while he/she is hooked-up to TPN, IV, enteral tube feed or other medical lines. This safety is accomplished by providing the maximum distance between the child and pump stand, determined by the length in the medical lines. This allows the child better access to his/her environment. The harness also limits kinking and subsequent occlusion in the medical lines. This frees the child from interruptions in play, while the caregiver searches for the location of an occlusion in the medical lines. Another benefit is increased safety and lowered stress for the caregiver. This means the supervision of the medical lines is done less intensively, and therefore the caregiver's attention can be directed to the child as a whole person and not just as a patient.

This system is comprised of a harness, a tether strap, an anchor strap, and a zipper sleeve. It is equipped with buckles that are small, low profile, strong, and secure. The shoulder straps are moveable along the chest strap; this facilitates infinite adjustability for a growing patient or for multiple patient use. The chest strap is worn directly underneath the axillas (armpits), which facilitates unhindered diaper changes and avoids soiling. The harness's location high on the chest puts the minimum amount of restriction on the respiratory system, as well as keeping access for common medical evaluations and nursing procedures. The chest strap is made of soft tubular webbing, which contours to the patients chest, preventing abrasion and pinching.

This document is a 510(k) summary for the AP Harness, a safety harness for medical lines, and does not include information about acceptance criteria or a study proving the device meets those criteria. The provided text is a regulatory submission for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device, not a performance study.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: What the AP Harness is and how it works.
• Intended Use: The purpose and application of the device.
• Regulatory Classification: Its classification details and a determination of substantial equivalence by the FDA.
• Contact Information: For the applicant and FDA.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm-only) performance study.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Ask a specific question about this device

Ask a specific question about this device