Search Results
Found 2 results
510(k) Data Aggregation
(112 days)
The PRO Plating System is indicated for:
· Fractures, non-unions, deformities and malunions of the pelvic ring and acetabulum
• Sacroiliac joint dislocations
The Stryker Trauma Pelvic Set (Matta) is indicated for:
• Fractures of the acetabulum, sacrum, illium, and entire pelvic ring;
• Revision surgery of pseudarthrosis, non-unions and mal-unions;
• Osteonomies;
• Arthrodeses;
• Sacroilic joint dislocations;
• Symphysis pubis disruptions
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the PRO Plating System, to align indication of the existing PRO Pelvis System and the new devices and add MRI labeling to the existing PRO Pelvis System and the Trauma Pelvic Set System (Matta). This submission encompasses multiple systems (PRO Pelvis System and Trauma Pelvic Set System (Matta)) that have similar intended use and/or will be used together during the surgical procedure.
The PRO Plating System (Pelvis II Implant System) is an internal fixation device that consists of different types of plates used with compatible screws to fit different types of fractures in the pelvis. All devices in the system are provided sterile and non-sterile.
The Stryker Trauma Pelvic Set System (Matta) consists of plate, screw, and washer components of various sizes. All are manufactured from stainless steel (ASTM F-138/139). All devices in the system are provided sterile and non-sterile.
This document describes a 510(k) premarket notification for the Stryker PRO Plating System and Stryker Trauma Pelvic Set (Matta). This submission is for a medical device (bone fixation appliances and accessories), not for an AI/ML powered device. As such, the sections regarding AI/ML performance criteria, ground truth, expert adjudication, and comparative effectiveness studies are not applicable.
Here's a summary of the non-clinical performance data provided, as relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Single Cycle Bend (per ASTM F382) | Demonstrated resistance to bending under single load. (Implicitly, to meet or exceed predicate device performance) | Performed: Testing conducted as per ASTM F382. (Specific numerical results are not provided in this summary but were presumably submitted to the FDA.) |
| Bending Fatigue (per ASTM F382) | Demonstrated durability under repeated bending loads. (Implicitly, to meet or exceed predicate device performance) | Performed: Testing conducted as per ASTM F382. (Specific numerical results are not provided in this summary but were presumably submitted to the FDA.) |
| MRI Compatibility: Magnetic Induced Displacement (per ASTM F2052) | Acceptable magnetic attraction in an MRI environment. | Performed: Testing conducted as per ASTM F2052. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: Magnetic Induced Torque (per ASTM F2213) | Acceptable torque in an MRI environment. | Performed: Testing conducted as per ASTM F2213. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: RF Heating (per ASTM F2182) | Acceptable temperature rise in an MRI environment. | Performed: Testing conducted as per ASTM F2182. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: Image Artifacts (per ASTM F2119) | Acceptable level of image distortion in an MRI environment. | Performed: Testing conducted as per ASTM F2119. (Specific results not provided but deemed acceptable for clearance.) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify the exact sample sizes used for each non-clinical test. For mechanical and MRI compatibility testing of medical devices, samples are typically chosen to represent the range of device types, sizes, and materials. The data provenance is implied to be from internal laboratory testing conducted by Stryker or a qualified testing facility, relevant to the manufacturing location (Selzach, Switzerland) and for the US market. The data is non-clinical/pre-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/ML device that requires expert-established ground truth for its performance assessment. The "ground truth" for this type of device is established through engineering and material science principles, and adherence to recognized standards like ASTM.
4. Adjudication Method for the Test Set
Not applicable. This device is not an AI/ML device requiring human adjudication of its output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done as this is not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm, so standalone performance in the context of AI/ML is irrelevant.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on established engineering principles, material science, and conformance to recognized consensus standards (e.g., ASTM F382, F2052, F2213, F2182, F2119). These standards define the methodologies and acceptable performance metrics for the tested properties.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."
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.
Ask a specific question about this device
(55 days)
Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions; and osteotomies of the femur
The subject device includes a total of 14 bones plates for internal fixation of the distal lateral femur. All LOQTEQ Distal Lateral Femur Plates 4.5 are available non-sterile.
The subject device is provided in anatomic designs in overall lengths of 153 mm, 207 mm, 243 mm, 279 mm, 314 mm, 350 mm, and 386 mm, for the left and right distal femur. The plates are provided with 4, 7, 9, 11, 13, 15, and 17 screw holes, respectively, in the shaft of the plate. Lengths of 153 mm, 207 mm, 279 mm, 279 mm, and 314 mm are identical to the plates previously cleared in K121494. Subject device plates in lengths of 350 mm and 386 mm are identical to the plates previously cleared in K121494, except for the length.
The subject device plates include screw holes designed to accommodate appropriately sized locking and non-locking cortical and periprosthetic bone screws, previously cleared in K121494 and K072411 and K-wires, previously cleared in K131459, presently marketed as part of the LOQTEQ Distal Lateral Femur Plate 4.5 System. The compatible screws are 4.5 mm in diameter. The subject device plates also are compatible with 2.0 mm diameter aap K-Wires.
The provided document is a 510(k) summary for the LOQTEQ® Distal Lateral Femur Plate 4.5 System, a Class II medical device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. This document does NOT describe a study involving an AI/software device that requires intricate acceptance criteria related to accuracy, sensitivity, or specificity, nor does it detail a multi-reader multi-case (MRMC) study or complex ground truth establishment processes typical for such devices.
Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/software performance study for which your template is designed. The document explicitly states: "Clinical data were not submitted in this premarket notification." and "Any differences in the technological characteristics among the subject and predicate devices do not raise different questions of safety and effectiveness."
Instead, the "performance data" section refers to:
- Biocompatibility referenced from K121494 and K153034.
- Validation of the recommended end-user moist heat sterilization cycle.
- Mechanical testing referenced from K121494.
The "acceptance criteria" here would relate to these engineering and material standards, not to diagnostic or prognostic performance metrics of an AI.
To answer your prompt truthfully based on the provided text, I must state that the information you requested regarding acceptance criteria and studies proving the device meets them (in the context of AI/software performance) is not present in this 510(k) summary. The document is for a traditional medical device (a bone plate system) and details its substantial equivalence based on material, design, and manufacturing similarities to existing devices, supported by non-clinical engineering tests, not AI performance studies.
Ask a specific question about this device
Page 1 of 1