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The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are not intended to mantain sterlity; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles:

In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY.

The maximum product loads for the trays are as follows:

| Tray Description | Catalog Number | Maximum Tray
Product Load | Total Loaded
Tray Weight |
|----------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------|-----------------------------|
| Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1)
Light Cable (Qty. 1)
Coupler (Qty. 1)
Scope (Qty. 2)
Adapter (Qty. 2) | 10.58 lbs |
| Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1)
Light Cable (Qty. 1)
Coupler (Qty. 1)
Scope (Qty. 2)
Adapter (Qty. 2) | 10.58 lbs |
| Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1)
Light Cable (Qty. 1)
Coupler (Qty. 1) | 8.83 lbs |

• Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).

The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are stainless steel, perforated sterilization trays to allow sterilization gases to penetrate the tray and sterilize the enclosed devices. They are used to enclose and protect particular Stryker endoscopy products during sterilization. The tray is compatible with the following sterilization methods:

• Ethylene Oxide (EtO)
• Prevacuum Steam, Immediate Use Prevacuum Steam, and Gravity Steam .
• Steris V-PRO 1 (Standard Cycle), Steris V-PRO 1 Plus (Non-Lumen or Lumen Cycles), Steris V-. PRO maX (Non-Lumen or Lumen Cycles)
• STERRAD 100S, STERRAD NX, and STERRAD 100NX (all with Standard Cycle) .

The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The trays are comprised of a stainless steel base and removable stainless steel lid. The base includes silicone brackets for Stryker endoscopy device fixation within the tray and two (2) latches to affix the lid to the base. Handles on the sides of the base facilitate carrying of the trays are reusable and provided in a non-sterile condition.

This document describes the premarket notification for sterilization trays and does not concern a medical device that relies on algorithms or AI for its function. Therefore, the requested information about acceptance criteria for device performance, sample sizes, expert ground truthing, MRMC studies, or standalone algorithm performance is not applicable in the context of this submission.

The document focuses on demonstrating substantial equivalence of the sterilization trays to a predicate device through physical and chemical performance testing related to sterilization cycles and material biocompatibility.

Here's an overview of the information that is available in the provided text:

Acceptance Criteria and Reported Device Performance:

The document broadly states that "All results met acceptance criteria" for non-clinical testing and that "Performance testing demonstrated the subject device met pre-set acceptance criteria." However, it does not explicitly define specific numerical acceptance criteria for each test or detail the quantitative results beyond stating they were met.

For example, for biocompatibility:

• Cytotoxicity (pre-sterilization and post-sterilization): "no cytotoxicity or cell lysis using the grading system of ISO 10993-5, indicating the materials are non-cytotoxic" and "grade 2 or less cell lysis and none to mild reactivity, indicating the materials met acceptable cytotoxicity levels (grade 2 or less) post-sterilization."
• ISO intracutaneous reactivity: "overall mean difference in erythema and edema scores scores between control and test articles was 0.0 (0.9% sodium chloride extract) and 0.1 (sesame oil extract), indicating the materials are non-irritating."

The key performance aspect relates to the efficacy of various sterilization methods when used with the trays and the physical integrity/biocompatibility of the trays themselves.

1. Table of Acceptance Criteria and Reported Device Performance

• Ethylene Oxide (EtO)
• Prevacuum Steam (Cycle 1: 132°C/4min/30min dry; Cycle 2: 134°C/3min/30min dry)
• Gravity Steam (Cycle 1: 132°C/15min/30min dry; Cycle 2: 134°C/10min/30min dry)
• Immediate Use Steam Sterilization ("Flash")/Prevacuum Steam (Cycle 1: 132°C/4min/no dry; Cycle 2: 134°C/3min/no dry)
• STERIS® V-PRO® (1 Standard, 1 Plus Non-Lumen/Lumen, maX Non-Lumen/Lumen)
• STERRAD® (100S Standard, NX Standard, 100NX Standard)
  "Performance testing demonstrated the subject device met pre-set acceptance criteria." This implies successful sterilization outcomes using these methods with the trays. |
  | Cleaning Validation | Not explicitly defined, but implicitly: trays must be effectively cleaned. | "cleaning validations (automated and manual)" were conducted. "All results met acceptance criteria." |
  | Life Cycle Evaluation | Not explicitly defined, but implicitly: material and mechanical functionality must endure. | Life cycle evaluations of materials and mechanical functionality of the latch were performed. "All results met acceptance criteria." |
  | Strength Testing of Tray Handles| Not explicitly defined, but implicitly: handles must withstand typical use without failure. | "strength testing of tray handles" was conducted. "All results met acceptance criteria." |
  | Latch Force Testing | Not explicitly defined, but implicitly: latches must function correctly. | "latch force testing" was conducted. "All results met acceptance criteria." |
  | Biocompatibility: | | |
  | * Pre-sterilization Cytotoxicity* | No cytotoxicity or cell lysis (ISO 10993-5 grading system). | "test article extracts showed no cytotoxicity or cell lysis using the grading system of ISO 10993-5, indicating the materials are non-cytotoxic." |
  | * ISO Intracutaneous Reactivity* | Mean difference in erythema and edema scores between control and test articles must be minimal (based on ISO 10993-10). | "the overall mean difference in erythema and edema scores scores between control and test articles was 0.0 (0.9% sodium chloride extract) and 0.1 (sesame oil extract), indicating the materials are non-irritating." |
  | * Post-sterilization Cytotoxicity*| Acceptable cytotoxicity levels (grade 2 or less cell lysis). | "test article extracts showed grade 2 or less cell lysis and none to mild reactivity, indicating the materials met acceptable cytotoxicity levels (grade 2 or less) post-sterilization." |

Regarding the other questions:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified in the document. These are physical product tests, not data-driven AI performance evaluations.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests would be objective measurements (e.g., sterility indicators, strength measurements, chemical analyses for biocompatibility).
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. These are physical product tests, not subjective expert reviews.
• 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 applicable. This document is not about an AI-powered diagnostic/interpretive device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI-powered device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests (sterilization, cleaning, lifespan, strength, latch force), the ground truth would be established by objective, verifiable measurements according to validated test protocols and industry standards (e.g., AAMI standards for sterilization, ISO standards for biocompatibility).
• 8. The sample size for the training set: Not applicable. This refers to an AI/machine learning context, which is not relevant here.
• 9. How the ground truth for the training set was established: Not applicable. This refers to an AI/machine learning context, which is not relevant here.

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Paragon Medical's Surgical Instrument Delivery Systems are containment devices for medical device sterilization, The Systems are constructed of metal and/or plastic with perforations to facilitate steam penetration. They are to be used with an approved sterilization wrap. Sterilization Cycle: Prevacuum 132°C for 4 minutes Dry Time 20-40 minutes

Paragon Medical Surgical Instrument Delivery Systems consist of various sizes of metal, plastic, and combination cases and trays with removable lids. The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation. The products are constructed of durable materials and designed with perforations or slots to allow for steam penetration. They are to be used with an appropriate sterilization wrap.

It looks like the provided text is a 510(k) summary for a medical device (Paragon Medical Surgical Instrument Delivery System), not a study report with detailed acceptance criteria and performance metrics for an AI/device algorithm.

Therefore, many of the requested items (sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of document, as it describes a physical sterilization container, not a diagnostic or AI-driven device.

However, I can extract the "performance testing" information that somewhat aligns with "acceptance criteria" for this specific type of device.

Here's an attempt to answer based on the provided text, focusing on the relevant sections:

Acceptance Criteria and Device Performance for Paragon Medical Surgical Instrument Delivery System

Given this is a 510(k) for a physical sterilization container, the "acceptance criteria" and "performance" relate to its ability to facilitate sterilization and protect instruments, rather than diagnostic accuracy.

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

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

• Sample Size for Test Set: The document mentions "Various sizes of double wrapped Cases and Trays from the System." It does not specify an exact number of cases/trays tested for sterilization efficacy.
• Data Provenance: The study was conducted by Paragon Medical, Inc. (device manufacturer) for the purpose of a 510(k) submission to the FDA. It is a prospective validation of the device's design and function. The country of origin of the data is implicitly the USA as the company and submission are based there.

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

This is not applicable to this type of device. The ground truth (effective sterilization) was established through objective measurements using bioindicators and thermocouples, not expert human interpretation.

4. Adjudication method for the test set

This is not applicable as the ground truth was established by objective measurements (bioindicators and thermocouples) rather than human interpretation requiring adjudication.

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

This is not applicable. This device is a physical sterilization container, not an AI-driven or diagnostic device that would involve human readers or AI assistance.

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

This is not applicable. This device is a physical sterilization container and does not involve an algorithm.

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

The ground truth for the performance testing was objective measurement of sterilization efficacy using:

• Bioindicators: To confirm microbial kill.
• Thermocouples: To confirm temperature attainment during sterilization.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This is not applicable for the reasons stated in point 8.

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