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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.

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