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The Sonopet iQ Sterilization Tray is intended to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The Sonopet iQ Sterilization Tray is intended for use in any of the following standard sterilization cycles:

The maximum product load for the tray is as follows:

| Tray Description | Catalog Number | Maximum Tray
Product Load | Maximum Tray
Weight |
|-------------------------------|----------------|---------------------------------------------------------------------|------------------------|
| Sonopet iQ Sterilization Tray | 5500-800-278 | Handpiece (Qty 1)
Cleaning Wire (Qty 1)
Torque Wrench (Qty 1) | 6.85 lb |

The Sonopet iQ Sterilization Tray is a reusable device manufactured of perforated stainless steel for the base and lid to allow for sterilization of the enclosed devices. The tray is used to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The tray is compatible with pre-vacuum steam sterilization. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The tray is provided in a non-sterile condition, and must be sterilized prior to use.

The provided text describes the 510(k) summary for the Sonopet iQ Sterilization Tray, focusing on its substantial equivalence to a predicate device. It includes details on the device's indications for use, technological characteristics, and a summary of nonclinical testing.

Here's an analysis of the acceptance criteria and study data based on the provided document:

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

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

The document does not explicitly state the specific sample sizes for the test sets in the non-clinical performance testing (sterilization, cleaning, biocompatibility, design verification, life cycle testing). It mentions that "All results of performance testing met acceptance criteria."

• Sterilization Validation: Tests were performed using "an autoclave cycle" and evaluated "Biological Indicators (BIs)." The number of cycles performed and the number of BIs used per cycle are not specified.
• Cleaning Validation: "A manual and automated cleaning validation" was performed. The number of cycles, number of trays, or specific soil coupon types are not mentioned.
• Biocompatibility: "Biocompatibility testing was conducted on all materials used in construction." It doesn't specify the number of test articles or replicates.
• Life Cycle Testing: "Life cycle testing was performed to verify that the Sonopet iQ Sterilization Tray maintained functional quality requirements... after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles and simulated functional use." While it mentions "repeated...cycles," the exact number of test units or total cycles for each unit is not given. However, the predicate device mentions "Life cycle testing to 100 worst-case processing cycles," and the subject device states "Same" for this characteristic, implying a similar number of cycles were performed.

The data provenance would be considered prospective as these are specific tests conducted by the manufacturer (Paragon Medical, Pierceton, IN, USA) to demonstrate the safety and effectiveness of their new device for regulatory submission. The country of origin of the data would be the USA (Indiana).

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)

This device is a sterilization tray, which is a medical device accessory, not an AI or diagnostic tool. The ground truth for its performance is established through objective, standardized laboratory testing (e.g., biological indicator kill rates, gravimetric soil removal, cytotoxicity assays, mechanical strength tests) against established industry standards (ANSI/AAMI/ISO 17665-1, AAMI TIR 30:2011, ISO 10993-5, ANSI/AAMI ST77, DIN EN 868-8, ANSI/AAMI HE75). Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (like radiologists for image interpretation) is not directly applicable here. The "experts" involved would be qualified laboratory technicians, microbiologists, and engineers conducting and interpreting these standardized tests, ensuring compliance with the cited standards. Their qualifications are inherent in their ability to conduct such validated testing.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review processes for subjective outcomes (e.g., radiology reads). For the objective, laboratory-based performance testing of a sterilization tray, such external adjudication methods are not typically used. The "adjudication" is inherent in the pass/fail criteria defined by the relevant industry standards and internal protocols, and the tests are performed to verify compliance with these objective criteria. Any discrepancies or failures would lead to investigation and retesting by the laboratory performing the validation.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images (e.g., AI in radiology). The Sonopet iQ Sterilization Tray is a mechanical device accessory for sterilization, and its evaluation does not involve "human readers" or "AI assistance" in the diagnostic pipeline.

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

This refers to the performance of an AI algorithm without human involvement. Since the Sonopet iQ Sterilization Tray is not an AI-powered device, this question is not applicable. The equivalent "standalone performance" for this device would be its ability to pass the specified sterilization, cleaning, biocompatibility, and mechanical tests on its own, which was done (its performance was evaluated independently).

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

The ground truth for the performance of the Sonopet iQ Sterilization Tray is based on objective, verifiable scientific and engineering principles and established industry standards:

• Sterilization: The "ground truth" for sterilization is the inactivation of a specified challenge organism (biological indicator spores) to a statistically defined sterility assurance level (SAL), as demonstrated through validated cycles and confirmed by microbial testing.
• Cleaning: The "ground truth" for cleaning is the removal of a specified soil load to analytically undetectable or clinically acceptable levels, as demonstrated by validated cleaning protocols and analytical testing (e.g., protein, hemoglobin assays).
• Biocompatibility: The "ground truth" for biocompatibility (cytotoxicity) is the absence of unacceptable cellular toxicity as quantified by standardized cell culture assays against clear international standards (ISO 10993-5).
• Mechanical Integrity/Life Cycle: The "ground truth" for handle strength, latch force, stacking, and life cycle performance is the demonstration that the device meets predefined physical and functional specifications after repeated use and processing, validated against established engineering standards (e.g., ANSI/AAMI ST77, DIN EN 868-8, ANSI/AAMI HE75).

8. The sample size for the training set

This question is applicable to AI/ML devices where a model is trained on a dataset. The Sonopet iQ Sterilization Tray is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in this context.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated figid sterliization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle:

'The validated load configuration for the Stryker Chestin Tray System included single-use implants (plates, bone screws, etc.), single-use instruments (drills), reusable surgical instruments (benders, etc.) and lumened instruments.

The Stryker ChestShield Sterilization Tray System is a tray system designed to store implants and surgical instrumentation. The tray system consists of an anodized aluminum implant module with an inlay which stores the implantable components and stainless steel instrument trays, which have stainless steel and silicone brackets to contain the reusable and singleuse instruments. Both the implant module and instrument trays have laser-etched and silkscreened artwork to assist the end user in correct placement of the contents. The tray components have stainless steel lids which feature a slide latch. The trays and implant module are organized and stored in a stainless steel rack. The tray system does not maintain sterility; the rack is placed in a rigid sterilization container to act as a sterile barrier for sterilization. The tray system provided in a nonsterile condition and must be sterilized prior to and after each use.

The provided document is a 510(k) summary for the Stryker ChestShield Sterilization Tray System. It describes the device, its intended use, and comparative information with a predicate device. The document also details the non-clinical performance testing conducted to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

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

The acceptance criteria for the Stryker ChestShield Sterilization Tray System are primarily tied to its functionality as a sterilization tray within a specific sterilization cycle. The performance is demonstrated through validation against established standards.

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The Stryker Universal Select Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles:

Pre-vacuum Steam
Enclosure: Rigid Container1
Temperature: 132°C (270°F), 135°C (275°F)
Sterilization Time: 4 minutes, 3 minutes
Minimum Dry Time: 30 minutes, 30 minutes
Maximum Weight: 25 lbs / 11.36 kg, 25 lbs / 11.36 kg

1 Tray System has been validated in the following Aesculap SterilContainer cleared for pre-vacuum steam sterilization under K792558: Full DIN JK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid).

The maximum validated product loads for the trays in containers are as follows:
Configuration: 3-Level Rack - Qty. 2 (29-13910) in a Full DIN Rigid Sterilization Container3
Maximum Validated Load Set Contents: 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941), 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941), 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941), 29-17901 1.7 Mid-Face Plates Module with Lid (29-13941), 29-17903 1.7 Orthognathic Plates Inlay, 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921), 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921), 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941), 29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941), 29-23905 2.0/2.3 Mini Plates Inlay, Large, 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921)

Configuration: 3-Level Rack – Qty. 1 (29-13910) in a ½ DIN Rigid Sterilization Container4
Maximum Validated Load Set Contents: 29-13905 Trocar Instrument Tray with Lid (29-13921), 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941), 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941), 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay, 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921), 29-13905 Trocar Instrument Tray with Lid (29-13921), 29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921), 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921)

1 Model numbers shown in table are Stryker® model numbers
2 Contents in the validated Tray System inplants (plates, meshes, bone screws, etc.), single-use instruments (drills), and revable surgical instruments (benders, forceps, handles, depth gauges, trocars, etc.)
3 Tray system components part of the worst-case configuration Container validation in an Aesculap SterilContainer Base (K446) and Lid (JK489) cleared under K792558
4 Tray system components part of the worst-case configuration in a 1/2 DN Rigid Sterilization in an Aesculap SteriliContainer Base (K346) and Lid (JK389) cleared under K792558
5 No lumened devices were validated within the tray system as part of the Stryker Universal Select Sterilization Tray System does not have any lumen claims.

The Stryker Universal Select Sterilization Tray System consists of anodized aluminum implant modules and inlays to store single-use titanium implants and stainless steel instrument and accessory trays for surgical instrumentation. The implant modules and trays have stainless steel lids which have a slide latch feature. Instrument trays are specific to a set configuration and have stainless steel and silicone brackets, removable screw caddy (for the 90° screwdriver instrument tray), and silkscreened artwork to assist the end user in correct placement of the instruments. Accessory trays are not specific to a set configuration, and have an open area designed for placement of commonly used instruments such as cutters, benders and forceps. The individual components of the system can be organized and stored in a 2-level or a 3-level stainless steel rack. The rack is designed to fit in an Aesculap rigid sterilization container (K792558). The tray system is reusable and provided in a non-sterile condition.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the test set in terms of individual devices or sterilization cycles. Instead, it refers to "worst case configured tray system" and "Both full size and ½ size rigid sterilization containers." This implies a representative selection of configurations rather than a large statistical sample.

The data provenance is from non-clinical performance testing conducted by Paragon Medical (the manufacturer) in the United States, as indicated by the company information and the FDA submission. This would be considered prospective for the device's validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the test set. The validation for sterilization, cleaning, and design verification appears to be based on adherence to established standards and scientific testing protocols (e.g., ANSI/AAMI/ISO 17665-1:2006, AAMI TIR 30:2011, ISO 10993-5, AAMI ST77:2013, EN 868-8:2009) rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, laboratory-based evaluations against predetermined criteria and standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes the testing for a medical device (sterilization tray system), not an AI algorithm for diagnostic imaging. Therefore, MRMC studies are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests is derived from:

• Microbiological standards: For sterilization effectiveness, the ground truth is the complete inactivation of a specified challenge organism (Geobacillus stearothermophilus spores) as defined by biological indicator testing (ANSI/AAMI/ISO 17665-1:2006).
• Chemical/Physical standards: For cleaning validation, the ground truth involves objective measurements of soil removal based on AAMI TIR 30:2011.
• Engineering and material standards: For design verification (handle strength, stacking, edge sharpness, maximum weight) and material compatibility/biocompatibility, the ground truth is adherence to established industry standards and test methods (e.g., AAMI ST77:2013, EN 868-8:2009, ISO 10993-5).
• Functional performance: For life cycle testing, the ground truth is the continued functional operation and integrity of the device after simulated use and repeated processing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a training set. The device is a physical product, and its performance is validated through non-clinical laboratory testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device validation.

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