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510(k) Data Aggregation
(270 days)
Synthes GmbH
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 |
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(221 days)
Synthes GmbH
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(146 days)
Synthes GmbH
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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