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510(k) Data Aggregation
(270 days)
The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).
The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.
The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes
The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration.
The Synthes Graphic Case & Tray System is a medical device intended for storing, organizing, and transporting orthopedic instruments and implants during sterilization and surgical procedures. It is designed to be used with an FDA-cleared sterile barrier. The device's performance was evaluated through non-clinical testing.
Here's a breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy with FDA cleared sterilization wrap | Validation for the efficacy of the dynamic air removal steam sterilization process in attaining a sterility assurance level (SAL) of 10-6 via the overkill method using a half cycle for the Synthes Graphic Case and Tray System when processed in two layers of blue sterilization wrap. | All biological indicator test samples shall be negative for growth of the indicator organism following the minimum incubation period. The positive controls shall be positive for growth. The negative and environmental controls should be negative for growth. The Chemical Integrators shall demonstrate steam penetration. The sterilizer cycle tapes shall verify that the specified parameters were achieved. | Pass, all acceptance criteria met. Each product BI test location was negative for growth. Each positive control BI type was positive for growth. Each negative and environmental control BI type was negative for growth. All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved. |
| Sterilization Efficacy with FDA cleared rigid sterilization container | Validation for the efficacy of the dynamic air removal steam sterilization process in attaining a sterility assurance level (SAL) of 10-6 via the overkill method using a half cycle for the Synthes Graphic Case and Tray System when processed in a rigid sterilization container. | All biological indicator (BI) test samples shall be negative for growth of the indicator organism following the minimum incubation period. The positive controls shall be positive for growth. The negative and environmental controls should be negative for growth. The Chemical Integrators shall demonstrate steam penetration. The sterilizer cycle tapes shall verify that the specified parameters were achieved. | Pass, all acceptance criteria met. Each product BI test location was negative for growth. Each positive control BI type was positive for growth. Each negative and environmental control BI type was negative for growth. All integrators demonstrated steam penetration. The sterilizer cycle tapes verified that the cycle parameters were achieved. |
| Dry Time and Thermal Profiling with FDA cleared sterilization wrap | Validation of the efficacy of thermal profile and dry time for the Synthes Graphic Case and Tray System when processed in two layers of blue sterilization wrap. | The system shall demonstrate an average pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion. The sample shall demonstrate no visible moisture present on the outside of the sample or on the instruments contained inside following the thirty (30) minute cooling period. At the end of each cycle, the temperature sensors shall be found to have remained in position. The internal temperature profiles shall demonstrate that the minimum sterilization cycle lethality value (F0) of 12.0 minutes is achieved at each of the product thermocouple locations during the dwell time (plateau) phase of the cycle. The chemical integrators shall demonstrate steam penetration. Cycle tapes shall confirm that the required cycle parameters were achieved for each cycle. | Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time: Cycle 1: -0.085%, Cycle 2: 0.093%, Cycle 3: 0.062%. No visible moisture was present. Temperature sensors remained in position. F0 results of >12.0 achieved for Cycle 1, 2, and 3 for all locations. All integrators demonstrated steam penetration. The sterilizer cycle tapes verified cycle parameters. |
| Dry Time and Thermal Profiling with FDA cleared rigid sterilization container | Validation of the efficacy of thermal profile and dry time for the Synthes Graphic Case and Tray System when processed in a rigid sterilization container. | The system shall demonstrate an average pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion. The sample shall demonstrate no visible moisture present on the outside of the sample or on the instruments contained inside following the thirty (30) minute cooling period. At the end of each cycle, the temperature sensors shall be found to have remained in position. The internal temperature profiles shall demonstrate that the minimum sterilization cycle lethality value (F0) of 12.0 minutes is achieved at each of the product thermocouple locations during the dwell time (plateau) phase of the cycle. The chemical integrators shall demonstrate steam penetration. Cycle tapes shall confirm that the required cycle parameters were achieved for each cycle. | Pass, all acceptance criteria met. For Autoclave Parameter of 20 Minute Dry Time: Cycle 1: 0.00%, Cycle 2: 0.00%, Cycle 3: 0.00%, Cycle 4: 0.00%, Cycle 5: 0.00%, Cycle 6: 0.00%. No visible moisture was present. Temperature sensors remained in position. F0 results of >12.0 achieved for all cycles and locations. All integrators demonstrated steam penetration. The sterilizer cycle tapes verified cycle parameters. |
| Cleaning (Manual) | To validate the manual cleaning method for device challenge features, using clinically relevant soil and worst-case process parameters, and analyzed for protein and hemoglobin. | The extraction efficiency shall be greater than or equal to 70%. Test samples show no visible soil after cleaning. The overall result of the protein analyte test is a level of < 6.4µg / cm². The overall result of the hemoglobin analyte test is a level of < 2.2µg / cm². | The extraction efficiency was greater than or equal to 70% at each sample location. There was no visible soil after cleaning. For all cycles, the acceptance criteria were met with an observed protein analyte level of < 6.4µg/cm². For all cycles, the acceptance criteria were met with an observed hemoglobin analyte test level of < 2.2µg/cm². |
| Cleaning (Automated) | To validate the automated cleaning method for device challenge features, using clinically relevant soil and worst-case process parameters, and analyzed for protein and hemoglobin. | The extraction efficiency shall be greater than or equal to 70%. Test samples show no visible soil after cleaning. The overall result of the protein analyte test is a level of < 6.4µg / cm². The overall result of the hemoglobin analyte test is a level of < 2.2µg / cm². | The extraction efficiency was greater than or equal to 70% at each sample location. There was no visible soil after cleaning. For all cycles, the acceptance criteria was met with an observed protein analyte level of < 6.4µg/cm². For all cycles, the acceptance criteria were met with an observed hemoglobin analyte test level of < 2.2µg/cm². |
| Biocompatibility assessment (ANSI/AAMI/ISO 10993-5:2009 – Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity) | The biocompatibility testing evaluated the materials of construction (aluminum, stainless steel and silicone) as well as the silkscreen inks and anodization dyes to ensure no cell toxic substances will be transferred to medical devices. | Pass is a score of less than 2. | There was no cytotoxic reaction observed (Grade 0) in any of the sample extracts. |
| Durability (Limits of Reuse) | To verify the limits of reuse (durability) of the subject device, demonstrating it can withstand repeated clinical reprocessing cycles without unacceptable effects to material, function, or safety. | After 100 cycles of clinical processing, the subject device should show no signs of damage (corrosion, fading, scratches, flaking, cracks, bent corners, burs or sharp edges) and continue to function properly (bending of flexible devices, movement of hinges/joints, sticky/jammed latch/handles). | All acceptance criteria were met, and the results demonstrate that the subject devices continue to function as intended after 104 clinical reprocessing cycles. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes (number of devices, number of tests for each criterion) for each test. For many tests (e.g., Sterilization Efficacy, Dry Time, Cleaning), the results often refer to "Each product BI test location" or "For all cycles," suggesting that multiple test units or cycles were performed to represent the device.
The data provenance is not explicitly mentioned as a country of origin. The sponsor is "Synthes GmbH Luzernstrasse 21 Zuchwil, Switzerland," indicating the device manufacturer is based in Switzerland, but the location where the non-clinical testing was conducted is not specified. The study is non-clinical testing, which implies it's laboratory-based and not involving human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The tests performed are non-clinical, laboratory-based evaluations against objective, measurable criteria (e.g., absence of microbial growth, weight difference, concentration levels of analytes, visual inspection for damage, cytotoxicity scores). There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. As noted above, the tests are objective, measurable non-clinical evaluations, not interpretive assessments that would require 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 non-clinical evaluation of a sterilization case and tray system, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these non-clinical tests is based on established scientific and regulatory standards and methods appropriate for sterilization and cleaning efficacy, biocompatibility, and durability. For example:
* Sterilization Efficacy: Negative growth of biological indicators, steam penetration verification (objective measurements).
* Dry Time and Thermal Profiling: Weight difference percentage, absence of visible moisture, F0 values, temperature sensor stability (objective measurements).
* Cleaning: Extraction efficiency percentage, absence of visible soil, quantifiable levels of protein and hemoglobin (objective measurements).
* Biocompatibility: Cytotoxicity score (objective, laboratory-derived evaluation).
* Durability: Absence of specific types of damage (visual inspection against defined criteria) and continued proper function (functional testing).
8. The sample size for the training set:
Not applicable. This is a physical medical device undergoing non-clinical validation, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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(146 days)
The DePuy Synthes MatrixSTERNUM Fixation System is indicated for use in adults with normal bone quality.
MatrixSTERNUM Sternal Body Plates are indicated for internal fixation of bone discontinuities following sternotomy.
MatrixSTERNUM Thoracotomy Plates are indicated for internal fixation of bone and/or cartilage discontinuities following thoracotomy.
The DePuy Synthes MatrixSTERNUM Fixation System consists of two families of plates, namely the MatrixSTERNUM Sternal Body Plates and MatrixSTERNUM Thoracotomy Plates, and two families of screws, namely the MatrixSTERNUM Self-Drilling Locking and Non-Locking Screws.
The DePuy Synthes MatrixSTERNUM Fixation System is intended for the stabilization and fixation of bones in the anterior chest wall. The subject plates are available in different shapes and sizes and are made from Titanium Alloy or commercially pure Titanium. The system also consists of non-implantable dedicated use screw guides, a screw guide handle, trays and modules, as well as general use instruments to be used as accessories with the subject implants.
The provided text describes a 510(k) premarket notification for the DePuy Synthes MatrixSTERNUM Fixation System, which is a metallic bone fixation appliance.
It is crucial to understand that this document describes a submission for a medical device (hardware), not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.
Therefore, the information regarding acceptance criteria and studies that prove the device meets acceptance criteria are focused on the mechanical, material, and biological performance of physical implants, not on the performance of an AI algorithm in tasks like image interpretation or diagnosis.
Because the request is specifically about AI/SaMD performance criteria (e.g., sample size for test set, expert ground truth establishment, MRMC studies, standalone performance, training set data), the provided text does not contain the information needed to answer these questions for an AI/SaMD product.
The document states:
- "Clinical testing was not necessary for the determination of substantial equivalence." This directly indicates that no clinical performance study, multi-reader multi-case (MRMC) study, or standalone algorithm performance study (as would be typical for AI/SaMD) was conducted.
- The performance data provided is under "Non-clinical Performance Data" and includes:
- Mechanical performance evaluation and testing: Comparing the subject plates to predicate devices.
- Magnetic resonance compatibility assessment.
- Endotoxin testing.
- Biocompatibility evaluation and testing (in accordance with ISO 10993-1).
These are standard non-clinical tests for orthopedic implants to demonstrate safety and effectiveness and substantial equivalence to existing devices. They are not metrics or study designs relevant to AI/SaMD performance.
Therefore, I cannot populate the requested table and answer the subsequent questions in the context of an AI/SaMD product, as the provided text pertains to a physical medical device.
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