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510(k) Data Aggregation
(56 days)
DePuy Synthes Variable Angle Locking Patella Plating System
The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.
The DePuy Synthes Variable Angle Locking Patella Plating System is comprised of single-use, sterile implants which will be placed on the lateral rim and on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers both a small and a large plate to provide fixation for various patella fracture patterns. The subject plates are available sterile and are manufactured from implant grade stainless steel or titanium.
The system also consists of sterile, non-implantable templates that correspond to the implants. Templates are intended to help determine proper sizing and help predict contoured shape of the implant.
The provided text ("K210408") is a 510(k) premarket notification for a medical device: the DePuy Synthes Variable Angle Locking Patella Plating System. This type of FDA submission is for devices seeking substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, or MRMC studies.
The "Non-clinical performance data" section refers to:
- Mechanical testing: This is to demonstrate "substantially equivalent" performance to the predicate device under static and dynamic loading conditions. This is not a clinical study and doesn't involve "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.
- Magnetic Resonance compatibility testing: To establish MR Conditional parameters.
- Endotoxin testing: To meet specified endotoxin requirements.
The "Clinical performance data" section explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
In summary, the provided document does not describe the kind of study and acceptance criteria you're asking about, which are typically associated with AI/ML-driven diagnostic or image analysis devices. This document is for a mechanical orthopedic implant demonstrating substantial equivalence based on engineering and material performance, not clinical outcome or algorithmic performance.
Therefore, I cannot populate the table or answer the specific questions about AI/ML study design and performance metrics based on the provided text.
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(90 days)
DePuy Synthes Variable Angle Locking Patella Plating System
The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.
The DePuy Synthes Variable Angle Locking Patella Plating System is comprised of implants which will be placed on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers three plate configurations, in two sizes, to provide fixation for various patella fracture patterns and are available in implant grade stainless steel and titanium. The system also consists of sterile, non-implantable templates that correspond to the implants. Templates are intended to help determine proper sizing and help predict contoured shape of the implant.
Here's an analysis of the provided FDA 510(k) summary regarding the DePuy Synthes Variable Angle Locking Patella Plating System:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating non-inferiority of the subject device (DePuy Synthes Variable Angle Locking Patella Plating System) compared to a predicate device (Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System (K100776)) through mechanical testing.
| Acceptance Criteria (Implicit) | Reported Device Performance Statement |
|---|---|
| Mechanical Performance: The subject devices (plate with screws) must demonstrate mechanical performance that is at least non-inferior to the predicate device under static and dynamic loading conditions. | "Testing of constructs (plate with screws) under static and dynamic loading conditions have been performed to compare the proposed DePuy Synthes Variable Angle Locking Patella Plating System to the predicate device. This information supports that the mechanical performance of the subject devices is at least non-inferior to that of the predicate device." |
| MR Compatibility: The subject device must establish MR Conditional parameters, indicating safe use in specific Magnetic Resonance environments. | "Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes Variable Angle Locking Patella Plating System." |
| Endotoxin Content: The subject device must meet specified endotoxin requirements (e.g., 20 EU/device). | "Endotoxin testing has been performed using to the LAL test method to establish that the subject DePuy Synthes Variable Angle Locking Patella Plating System meet the specified endotoxin requirement of 20 EU/device." |
| Substantial Equivalence: Features of the subject device should not raise new questions of safety and effectiveness compared to the predicate device, based on similarities in intended use and design, and non-clinical performance data. | "The non-clinical performance data as well as the comparison of design features included in this premarket notification demonstrate that any differences in technological characteristics of the subject device compared to the predicate device do not raise any new questions of safety and effectiveness. It is concluded that the information provided herein supports substantial equivalence of the subject devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical performance testing (e.g., number of plates/screws tested). It mentions "testing of constructs (plate with screws)," implying multiple test units.
- Test Set Sample Size: Not explicitly stated for mechanical testing.
- Data Provenance: The tests are described as "non-clinical performance data," indicating laboratory-based testing rather than patient data. The country of origin for the data is not specified, but the sponsor is Synthes (USA) Products, LLC in Pennsylvania, USA. The data is prospective as it was generated to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation is based on non-clinical, mechanical, and safety (MR compatibility, endotoxin) testing, not on clinical interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation is based on non-clinical, objective measurements rather than expert review of clinical cases.
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
There was no MRMC comparative effectiveness study done. This device is a medical implant (bone fixation system) and not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a mechanical implant, not software or an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily based on:
- Engineering Standards and Measurements: For mechanical performance (e.g., force, displacement, fatigue life), MR compatibility parameters, and endotoxin levels, the "ground truth" is defined by established engineering and safety standards, test methodologies, and measurable physical properties.
- Predicate Device Performance: The primary comparison is against the mechanical performance of a legally marketed predicate device, which serves as a benchmark for expected performance and safety.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" in the context of this mechanical device's evaluation. It is not an AI/machine learning product.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this mechanical device.
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