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510(k) Data Aggregation
(90 days)
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:
| Method | Parameter | Cycle | |
|---|---|---|---|
| Cycle 1 | Cycle 2 | ||
| Pre-vacuumSteam | Enclosure | Double Wrap orRigid Container | Double Wrap orRigid Container |
| Temperature | 132°C(270°F) | 134°C(273°F) | |
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | 30 minutes | 30 minutes |
The maximum product load for the tray is as follows:
| Tray Description | Catalog Number | Maximum TrayProduct Load | Maximum TrayWeight |
|---|---|---|---|
| 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
| Acceptance Criteria Category | Acceptance Criteria (typically from relevant standards or internal protocols) | Reported Device Performance |
|---|---|---|
| Sterilization Effectiveness | Biological Indicators (BIs) with Geobacillus stearothermophilus spores must be inactivated after pre-vacuum steam autoclave half-cycle exposures, demonstrating effective sterilization. | Sterilization validations were performed using an autoclave cycle with pre-vacuum air removal. The study evaluated the resistance of biological indicators (BIs) with Geobacillus stearothermophilus spores to pre-vacuum steam autoclave half cycle exposures. The Sonopet iQ Sterilization Tray was validated per ANSI/AAMI/ISO 17665-1, indicating successful sterilization. |
| Dry Time | The device must achieve proper dryness after sterilization cycles. | Dry time was evaluated after sterilization, implying successful achievement of dryness within specified parameters (specific results not detailed, but overall "All results of performance testing met acceptance criteria" suggests it passed). |
| Cleaning Effectiveness | Cleaning methods must be effective in removing soil from all designated surfaces of the tray, as validated per AAMI TIR 30:2011. | A manual and automated cleaning validation was performed per AAMI TIR 30:2011. The results indicate that the recommended cleaning methods were effective in removing soil from all designated surfaces of the Sonopet iQ Sterilization Tray that might be accessible to the end user. |
| Biocompatibility (Cytotoxicity) | Materials of construction must be non-cytotoxic, generally showing grade 2 or less cell lysis and reactivity per ISO 10993-5. | Biocompatibility testing was conducted on all materials used in construction per ISO 10993-5 using the MEM Elution method. Test article extracts showed grade 2 or less cell lysis and reactivity, indicating the materials met acceptable cytotoxicity levels. |
| Handle Strength | Handle strength must meet the requirements of ANSI/AAMI ST77:2013. | Design verification testing included handle strength, which "met the requirements of ANSI/AAMI ST77" (for the predicate, and subject stated as "Design verification testing included handle strength... All results of performance testing met acceptance criteria"). |
| Latch Force | Latch force must meet the requirements of ANSI/AAMI HE75:2009. | Design verification testing included latch force, which "met requirements of ANSI/AAMI HE75:2009" (for the predicate, and subject stated as "Design verification testing included... latch force. All results of performance testing met acceptance criteria"). |
| Stacking | Stacking features must meet requirements per DIN EN 868-8. | Design verification testing included stacking features which were tested per DIN EN 868-8 (for the predicate, and implicitly passed for the subject as "All results of performance testing met acceptance criteria"). |
| Weight | The tray's weight must be verified and supported by its design. | Design verification testing included weight verification (implicitly passed as "All results of performance testing met acceptance criteria"). The maximum tray weight is specified as 6.85 lb. |
| Life Cycle Testing (Durability and Integrity) | The device must maintain functional quality, material integrity, and traceability (artwork and UDI legibility) after repeated worst-case processing cycles (e.g., 100 cycles). | Life cycle testing was performed to verify that the Sonopet iQ Sterilization Tray maintained functional quality requirements, material integrity, and traceability (artwork and UDI legibility) after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles, and simulated functional use of the components (kitting, latch and handle actuation). "All results of performance testing met acceptance criteria." |
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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(127 days)
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:
| Pre-vacuum Steam | |
|---|---|
| Enclosure | Rigid Container |
| Temperature | 132°C (270°F) |
| Sterilization Time | 4 minutes |
| Minimum Dry Time | 30 minutes |
| Maximum Weight1 | 19.23 lb. / 8.72 kg |
'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.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Validation |
|---|---|---|
| Sterilization Efficacy | Effective steam sterilization of fully loaded tray. | Sterilization Validation: Demonstrated effective steam sterilization using a fully loaded Stryker ChestShield Sterilization Tray System sterilized in a rigid sterilization container with a pre-vacuum air removal autoclave cycle. Evaluated resistance of biological indicators (BIs) with 10^6 Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half-cycle exposures. Validated per ANSI/AAMI/ISO 17665-1:2006. |
| Dry Time Efficacy | Adequate dry time after sterilization. | Dry Time Validation: Evaluated dry time after sterilization cycles. (Specific performance value for dry time is 30 minutes, likely met based on successful validation). |
| Material Compatibility | Compatible with steam sterilization process. | Material Compatibility with Sterilization Process: Subject device is compatible with steam sterilization. Confirmed by direct testing. |
| Biocompatibility | Non-cytotoxic. | Biocompatibility (ISO 10993-5): "Subject device is identical in formulation and processing to the predicate device; therefore, cytotoxicity results of the predicate are applicable to the subject device." Predicate tested as non-cytotoxic (Grade 2 or less cell lysis and reactivity) using MEM Elution method. |
| Functional Quality/Durability | Maintained functional quality, material compatibility, and traceability after repeated cycles and simulated use. | Lifecycle Testing: Leveraged from predicate device. Performed on predicate device to verify maintenance of functional quality requirements, material compatibility, and traceability after repeated pre-vacuum steam sterilization cycles, automated washing cycles, and simulated functional use. |
| Design Compliance/Safety | Complies with AAMI/ANSI ST77:2013 for handle strength. | Design Verification: Leveraged from predicate device. Performed on predicate device to demonstrate compliance with AAMI/ANSI ST77:2013 for handle strength. Also included containment verification during transport and simulated use, stacking verification, and edge sharpness testing. |
| Cleaning Efficacy | Effective removal of soil from all designated surfaces. | Cleaning Validation: Leveraged from predicate device. Manual and automated cleaning validations performed on predicate device using worst-case configured tray system per AAMI TIR 30:2011. Results met acceptance criteria of residual protein < 6.4 µg/cm² and residual hemoglobin < 2.2 µg/cm². |
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 numerical sample sizes for each test (e.g., how many trays were tested for sterilization validation, how many cycles for lifecycle testing, etc.). However, it refers to "biological indicators (BIs) with 10^6 Geobacillus stearothermophilus spores" for sterilization validation. This implies testing with a sufficient number of BIs to demonstrate a certain sterility assurance level.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of medical device testing for 510(k) clearance, these are typically prospective, controlled laboratory or simulated environment studies conducted by the manufacturer or a contracted lab.
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 category does not apply as the device is a sterilization tray system, not an AI or diagnostic tool that requires expert interpretation for ground truth establishment. The "ground truth" here is objective physical and biological performance (e.g., sterility, cleanliness, material integrity) measured against established scientific standards and regulatory requirements for sterilization.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This category does not apply. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations of medical data (e.g., imaging reads by radiologists). For device validation tests like sterilization efficacy or material biocompatibility, results are objective measurements against predefined acceptance criteria, not subject to expert consensus or 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 category does not apply. MRMC studies are used for evaluating diagnostic performance of AI-assisted systems where human readers interpret cases. The Stryker ChestShield Sterilization Tray System is a physical medical device (sterilization tray), not a diagnostic tool or AI assistance system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This category does not apply to a physical device like a sterilization tray.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluation of the Stryker ChestShield Sterilization Tray System is based on:
- Biological Standards: For sterilization efficacy, the "ground truth" is the inactivation of a specified challenge organism (Geobacillus stearothermophilus spores) to a statistically determined sterility assurance level, as measured by biological indicators.
- Physical/Chemical Standards: For dry time, material compatibility, cleaning validation (residual protein/hemoglobin), and design verification (handle strength, containment), the "ground truth" is measured against established physical and chemical limits and engineering specifications defined by recognized consensus standards (e.g., ANSI/AAMI/ISO 17665-1, AAMI TIR 30, ISO 10993-5, AAMI/ANSI ST77) or internal design requirements.
8. The sample size for the training set
This category does not apply. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This category does not apply, as there is no training set for this type of device.
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(147 days)
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
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Effectiveness (Biological Indicators) | Worst-case configuration: 10^6 Geobacillus stearothermophilus spores killed after 132°C pre-vacuum steam autoclave half cycle exposures. | Verified effective, with reduction of 10^6 Geobacillus stearothermophilus spores. |
| Dry Time | Defined minimum dry time based on validated sterilization configurations (e.g., 30 minutes for 132°C/4 min and 135°C/3 min cycles). | Achieved and maintained sterility following minimum dry times. |
| Cleaning Validation | Effectiveness in removing soil from all designated surfaces. | Effective in removing soil using recommended cleaning methods and neutral pH detergent. |
| Containment Verification | Ability to contain devices during transport and simulated use. | Verified to contain devices. |
| Handle Strength | Met ASTM F2111 (K163279, P.) and EN 868-8:2009 standards. | Met handle strength requirements per AAMI ST77:2013 and EN 868-8:2009. |
| Stacking Verification | Ability of trays to stack securely. | Verified to stack. |
| Edge Sharpness | No sharp edges impacting user safety. | Met edge sharpness requirements. |
| Maximum Weight | Sustained maximum validated weight (25 lbs / 11.36 kg). | Verified for maximum weight. |
| Life Cycle Testing | Maintained functional quality, material integrity, and traceability (artwork, UDI legibility) after repeated sterilization, washing, and simulated functional use. | Maintained functional quality, material integrity, and traceability. |
| Biocompatibility (Cytotoxicity) | Grade 2 or less cell lysis and reactivity (non-cytotoxic) per ISO 10993-5. | Test article extracts showed Grade 2 or less cell lysis and reactivity, indicating non-cytotoxic materials post-sterilization. |
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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(83 days)
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:
| No | Method | Cycle |
|---|---|---|
| 1 | Ethylene Oxide (EtO) | Preconditioning Parameters |
| Temperature (°C) | ||
| 55°C (131°F) | ||
| Chamber Humidity | ||
| 70% RH | ||
| Vacuum Set Points | ||
| 1.3 psia | ||
| Time | ||
| 30 minutes | ||
| Exposure | ||
| Concentration | ||
| 725 mg/L, 100% EO | ||
| Temperature (°C) | ||
| 55°C ±2°C (131°F ±5°F) | ||
| Time | ||
| 1 hour | ||
| Chamber Humidity (%) | ||
| 70% RH (50-80%) ±5% | ||
| Aeration | ||
| Aeration Time | ||
| 12 hours | ||
| Temperature | ||
| 35°C - 54°C (95°F - 129°F) | ||
| 2 | Prevacuum Steam | Cycle 1 |
| Cycle 2 | ||
| Wrapping | ||
| Double | ||
| Double | ||
| Temperature | ||
| 132°C (270°F) | ||
| 134°C (273°F) | ||
| Sterilization Time | ||
| 4 minutes | ||
| 3 minutes | ||
| Dry Time | ||
| 30 minutes | ||
| 30 minutes | ||
| 3 | Gravity Steam | Cycle 1 |
| Cycle 2 | ||
| Wrapping | ||
| Double | ||
| Double | ||
| Temperature | ||
| 132°C (270°F) | ||
| 134°C (273°F) | ||
| Sterilization Time | ||
| 15 minutes | ||
| 10 minutes | ||
| Dry Time | ||
| 30 minutes | ||
| 30 minutes | ||
| 4 | STERIS® V-PRO® 1 | Standard |
| 5 | STERIS® V-PRO® 1 Plus | Non-Lumen or Lumen |
| 6 | STERIS® V-PRO® maX | Non-Lumen or Lumen |
| 7 | STERRAD® 100S | Standard |
| 8 | STERRAD® NX® | Standard |
| 9 | STERRAD® 100NX® | Standard |
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.
| Method | Cycle | Cycle 1 | Cycle 2 |
|---|---|---|---|
| Immediate Use SteamSterilization (“Flash”)Prevacuum Steam | Wrapping | None | None |
| Temperature | 132°C(270°F) | 134°C(273°F) | |
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | None | None |
The maximum product loads for the trays are as follows:
| Tray Description | Catalog Number | Maximum TrayProduct Load | Total LoadedTray 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
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Not explicitly defined with quantitative metrics, but implicitly: devices enclosed in the tray must be sterile after designated cycles. Compatibility with specific cycles is the main criterion. | The trays are compatible with and were validated for a range of sterilization methods and cycles, including: - 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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(112 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effective sterilization during steam sterilization and drying cycles | "Various sizes of double wrapped Cases and Trays from the System, fully loaded with medical instrumentation including some with lumens(cannulae) of up to 15" in length x 0.093 dia. have been demonstrated to be effectively sterilized using bioindicators and thermocouples in a 132°C Prevacuum 4 minute cycle. Drying time is from 20-40 minutes." |
| Protection of medical instrumentation during sterilization and storage | (Implied by the device's main function and statement that "The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation." The performance testing focuses on sterilization efficacy, suggesting protection is assumed if sterilization occurs effectively within the container.) |
| Compatibility with appropriate sterilization wrap | "They are to be used with an appropriate sterilization wrap." (This is a condition of use rather than a performance metric proved by the study itself, but essential for the system's function.) |
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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