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JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

• · Gravity steam at 250°F/121°C for 30 minutes
• · Pre-vacuum steam at 270°F/132°C for 4 minutes

Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A

Types of medical devices to be sterilized in the gravity cycle;
· General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusionrestricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.

Types of medical devices to be sterilized in the pre-vacuum cycle are;
· General purpose reusable metal and nonmetal devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
· Up to 2 single channel stainless steel lumened devices of the following dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter;

Color of wrap: Blue Size of wrap: 48 in x 48 in

The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.

The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.

JAMBRO Single Core A is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. JAMBRO Single Core A provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. JAMBRO Single Core A is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice.

The Maximum Recommended Wrapped Package Content Weights for the JAMBRO Single Core A (63g/m²) is 25 lbs.

The Intended Load for the JAMBRO Single Core A (63g/m²) is moderate to heavy weight package (e.g., general use medical instruments) and the JAMBRO Single Core A can maintain sterility of sterilized devices for 90 days.

The provided document does not describe the performance of an AI/ML powered medical device. Instead, it describes a sterilization wrap (JAMBRO Single Core A Sterilization wrap) and the performance testing conducted to demonstrate its safety and effectiveness.

Therefore, many of the requested categories related to AI/ML device performance (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth for training) are not applicable to this type of medical device.

I can, however, extract the acceptance criteria and reported device performance for the sterilization wrap based on the provided text.

Acceptance Criteria and Device Performance for JAMBRO Single Core A Sterilization Wrap

This document describes the validation and performance testing for a medical device called "JAMBRO Single Core A Sterilization wrap," which is used to enclose other medical devices for sterilization and maintain their sterility. The studies conducted are non-clinical (laboratory/testing based) and focus on the physical and barrier properties of the sterilization wrap under various sterilization conditions.

Given the nature of the device (a sterilization wrap), the requested information pertaining to AI/ML device performance (such as sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable.

The "acceptance criteria" for this device are implicitly tied to the "Description/Criteria" column in the table, with "Pass" in the "Results" column indicating that the criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device, the following points are not applicable (N/A):

2. Sample sizes used for the test set and the data provenance: N/A (Not an AI/ML device; testing involves physical and biological challenges to the wrap).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth derived from laboratory test results against established physical/biological standards, not human expert consensus for AI model evaluation).
4. Adjudication method: N/A (No human interpretation or adjudication as typically done for AI/ML diagnostic outputs).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: N/A (Not an AI/ML device; no human-in-the-loop performance is being evaluated).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/ML device).
7. The type of ground truth used: For this device, the "ground truth" is established by adherence to internationally recognized consensus standards (e.g., AAMI, ISO, ASTM, Pharmacopeia) for sterilization, barrier integrity, and biocompatibility. This involves laboratory measurements, microbial challenge tests, and physical property assessments rather than clinical outcomes or expert consensus on image interpretation.
8. The sample size for the training set: N/A (Not an AI/ML device).
9. How the ground truth for the training set was established: N/A (Not an AI/ML device).

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