Search Results

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.

Ask a specific question about this device

The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks.

The SterilContainer with PrimeLine Pro Lid is used in conjunction with Aesculap's Sterilcontainer Systems (K792558/K944864/K053389/K112671). The SterilContainer with PrimeLine Pro Lid is designed to be compatible for use with pre-vacuum steam and IUSS sterilization. The lid is manufactured from anodized aluminum and utilizes a reusable polytetrafluoroethylene (PTFE) filter. The SterilContainer with PrimeLine Pro Lid is offered in a various colors and range of sizes as the predicates including full, ¾, and half sizes lids.

The Aesculap SterilContainer with PrimeLine Pro Lid is a reusable sterilization container system designed to sterilize and maintain the sterility of medical devices. The device was found to be substantially equivalent to its predicate devices based on non-clinical performance testing.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and 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 used for each test. It mentions that "Test were performed in best/mid/worst case sized regarding vent to volume ratio and container size." The data provenance is not specified, but the testing was conducted by a "qualified testing laboratory" in accordance with FDA guidance and AAMI standards. This indicates a prospective and controlled experimental design.

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 not an AI/imaging device requiring expert interpretation for ground truth. The performance testing involves objective measures of sterilization efficacy, microbial challenge, sterility maintenance, and cleaning effectiveness, which do not typically rely on expert consensus for ground truth establishment in the same way an AI diagnostic tool would.

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

Not applicable. As noted above, this device does not involve human interpretation or subjective assessment that would require an adjudication method.

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 is not an AI device, so MRMC studies and the concept of human readers improving with AI assistance are not relevant.

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

Not applicable. This is not an algorithm-based device. The testing focuses on the physical and functional performance of the sterilization container system.

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

The ground truth for the performance testing is based on established scientific and regulatory standards for sterilization, microbial challenge, sterility maintenance, and cleaning efficacy.

• Sterilization Efficacy: Ground truth is a 6 log reduction and SAL of $10^{-6}$ as per biological indicator results and half-cycle validations.
• Microbial Aerosol Challenge: Ground truth is the absence of microbial growth in the contents after exposure to a defined amount of aerosol microorganisms.
• Event Related Sterility Maintenance: Ground truth is the absence of microbial growth in the contents after storage periods, indicating sterility was maintained.
• Cleaning Effectiveness: Ground truth is a protein level of less than $6.4 \mu g/cm^2$ and a hemoglobin level of less than $2.2 \mu g/cm^2$ per device, as determined by laboratory analysis.

These are objective, measurable outcomes based on established scientific principles and regulatory benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable. As there is no training set for this device, a method for establishing its ground truth is not relevant.

Ask a specific question about this device

The Aesculap SterilContainer System is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.

The Aesculap SterilContainer is designed as a container system that will allow for sterilization and storage of other medical devices. This system consists of full, three-quarter, half, quarter, and extra long and wide body container system. There are a variety of accessories also available for this container system. This container is designed to be compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO sterilization. The container bottom is manufactured in anodized aluminum and has stainless steel handles on each end. There are two types of lids for the container bottom. There are anodized aluminum lids that have removable retention plates to hold the filter and a stainless steel latch on each end to lock the lid only to the container bottom. There are also Prime Line lids available for use that are manufactured in the material commonly known as Radel R. The PrimeLine lids have a reusable filter system. The reusable filter is for Pre-vac steam and Immediate Use steam sterilization only.

The provided text describes the Aesculap SterilContainer System for sterilization. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with pass/fail thresholds in a formal table separate from the performance results. Instead, it presents the validated sterilization cycle parameters and states that the device was "fully validated" according to FDA and AAMI standards. The reported device performance is that it meets these validated parameters and achieves a 360-day event-related shelf life.

• Pre-vacuum steam (270°F, 4 min. exposure, 30 min. dry)
• Pre-vacuum immediate use steam (270°F, 3 min. (non-porous) / 4 min. (porous) exposure)
• Ethylene Oxide (130°F, 60 min exposure, ≥ 50% RH, 725 mg/L gas pressure) | Achieved: "fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes." |
  | Shelf Life | Maintain sterility for 360 days. | Achieved: "360 days of event related shelf life testing has been conducted." |
  | Compatibility | Compatible with specified lids, filters, and accessories for each sterilization method. | Achieved: Detailed tables provided for compatibility across various configurations and accessories. |
  | Max Load Weight | Accommodate maximum load weights of 25 pounds or less (AAMI/AORN recommendation). | Achieved: "Max total weight 25 pounds." |
  | Vent to Volume Ratio | Meet predetermined standards for the "worst case vent to volume ratio" to ensure sterilization. | Achieved: "This container represents the worst case vent to volume ratio for the SterilContainer System," and validation was successful. |
  | Reuse Testing | Maintain performance after repeat sterilization cycles. | Achieved: "100 cycles minimum" for container, "2,200 cycles (lid)" for reusable filter. |

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

The document does not explicitly state the numerical sample size used for the test set in terms of number of containers or cycles. However, it does state:

• "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Aesculap SterilContainer was completed on this new three-quarter size 8" (187mm) container of the worst case vent to volume ratio..."
• The testing was conducted by "a qualified testing laboratory."

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission for a new device, the testing would inherently be prospective in nature, specifically designed to validate the new device.

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

This type of information is not applicable to this submission. The "ground truth" for sterilization efficacy is established through standardized biological and physical indicator tests, not expert consensus on medical images or patient outcomes. The testing was performed in a laboratory setting per established standards (FDA and AAMI).

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple human reviewers independently assess data (e.g., medical images) and disagreements are resolved by an expert panel. Sterilization and shelf-life testing relies on objective, measurable scientific and engineering principles (e.g., microbial kill, barrier integrity), not subjective 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

Not applicable. This is a medical device for sterilization, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study is not relevant.

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

This refers to the performance of a device on its own, without human intervention in its function during testing. In this context, the device (the SterilContainer) was tested in a standalone manner as its primary function is to achieve and maintain sterility independently when subjected to specified sterilization cycles. The performance data presented (sterilization cycle parameters met, 360-day shelf-life) reflects the container's inherent capabilities.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for sterilization efficacy is typically established through:

• Biological Indicators (BIs): Contain a known number of highly resistant microorganisms (e.g., bacterial spores). A successful sterilization cycle renders the BI sterile, demonstrating microbial kill.
• Chemical Indicators (CIs): React to one or more sterilization parameters with a visible change in color or state.
• Physical Monitoring: Readings from sterilizer gauges, thermometers, pressure recorders, and timers confirm that the physical parameters (temperature, pressure, time) of the cycle were met.
• Barrier Integrity Testing: For shelf-life, tests ensure the container maintains a sterile barrier over time, often involving microbial ingress challenges or visual inspection for damage.

The document implicitly refers to these methods by stating: "These validations were conducted in accordance with FDA and AAMI standards by a qualified testing laboratory." These standards prescribe the use of BIs, CIs, and physical monitoring for sterilization efficacy, and specific tests for packaging integrity and shelf-life.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning or AI models. This device is a physical container, and its performance is evaluated through conventional engineering and microbiological testing, not by training an algorithm.

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

Not applicable, for the same reason as point 8.

Ask a specific question about this device

The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid and perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in pre-vacuum steam and flash sterilization. The SterilContainer System includes accessories such as silicon mats, baskets, trays, and racks.

The Aesculap SterilContainer with PrimeLine Lid is used in conjunction with Aesculap's Sterilcontainer System (K792558 & K944864). The PrimeLine Container Lid is designed to be compatible for use with pre-vacuum steam and pre-vacuum flash sterilization. The lid is manufactured from Radel R 5000/5008 and utilizes a reusable polytetrafluoroethylene (PTFE) filter.

The provided document is a 510(k) summary for the Aesculap SterilContainer with PrimeLine Lids. It's a premarket notification for a medical device and describes its substantial equivalence to existing predicate devices. The document highlights the device's technological characteristics and performance data related to sterilization, but it does not contain the specific information required to answer all sections of your prompt.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance data in terms of sterilization validation. However, it does not explicitly state "acceptance criteria" with numerical targets and then report performance against those targets in a formal table. Instead, it states that the device was "fully validated" against FDA guidance and AAMI standards for steam and flash sterilization.

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

The document states, "The Aesculap Sterilcontainer system was fully validated for the steam and flash sterilization in a prevacuum steam and flash cycle." It also indicates that this validation was conducted "by a qualified testing laboratory." However, specific sample sizes (e.g., number of cycles, number of containers tested) for the validation study are not provided. The provenance of the data is that it was generated during product validation (likely in the US based on the FDA submission) by a qualified testing laboratory, and it would be prospective data collected specifically for the purpose of demonstrating device performance.

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

This information is not available in the provided document. Sterilization validation typically involves scientific and engineering principles, often with industry standards (like AAMI) serving as the "ground truth" for successful sterilization. There is no mention of human experts establishing ground truth in the context of this device's performance data.

4. Adjudication method for the test set:

This information is not available in the provided document. Adjudication methods are typically relevant for studies involving human assessment or interpretation (e.g., medical imaging classification). For device performance validation related to sterilization, "adjudication" in the sense of expert consensus on an output is not typically a component. The success/failure of sterilization (e.g., through biological indicator testing) is typically objective.

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 to this device. The Aesculap SterilContainer with PrimeLine Lids is a medical device for sterilization, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not have been performed.

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

This is not applicable to this device. This is a physical medical device. It does not involve an algorithm or AI that would have standalone performance.

7. The type of ground truth used:

The ground truth used for this type of device validation would be based on established scientific principles of sterilization effectiveness and compliance with recognized standards (e.g., FDA guidance, AAMI standards for sterilization). This would involve demonstrating the killing of microbial spores (e.g., using biological indicators) and maintaining sterility over time. It's not "expert consensus" in the sense of diagnostic interpretation, nor is it pathology or outcomes data in the clinical sense.

8. The sample size for the training set:

This is not applicable. This is a physical device, not an AI model requiring a training set.

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

This is not applicable. As it's not an AI model, there is no training set or associated ground truth establishment process.

Ask a specific question about this device