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510(k) Data Aggregation
(90 days)
Tyber Medical Distal Radius Plating System
The Tyber Medical Distal Radius Plating System includes Distal Radius, Forearm, and Fragment-Specific Plates, which are indicated for fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.
The Tyber Medical Distal Radius Plating System is not for spinal use.
This traditional 510K is a line extension to the Tyber Medical Distal Radius Plating System, previously cleared under K232693. The extension includes additional plates, screws, pegs, cases and trays, and instrumentation.
The Tyber Medical Distal Radius System provides fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.
The implants – delivered sterile or non-sterile – are:
- Various bone plates of different shapes and hole configurations.
- Variable angle locking and non-locking screws in various lengths and diameters.
The implants are manufactured from Stainless Steel per ASTM F138, from Titanium alloy per ASTM F136, or Commercially Pure Titanium grade 4 per ASTM F67.
The instruments – delivered sterile and non-sterile – are intended to support the implantation of the Tyber Medical Distal Radius Plating System implants. Specialized cases/trays are available specific to the Tyber Medical Distal Radius Plating System. Other ancillary instrumentation is available but not specific to the Tyber Medical Distal Radius Plating System.
The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.
The provided document is an FDA 510(k) clearance letter for the "Tyber Medical Distal Radius Plating System." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed acceptance criteria or a study proving the device meets said criteria in the way one would expect for a diagnostic or AI-driven medical device.
The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical trials as is the case for premarket approval (PMA).
However, I can extract the information that is present concerning device performance and testing.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in an "acceptance criteria" column and then "reported performance" against it for parameters like sensitivity, specificity, AUC, etc., as would be expected for a diagnostic device. Instead, it describes what mechanical tests were performed and what was concluded.
| Test Performed | Implied Acceptance Criteria (Based on "conformance" and "equivalent") | Reported Device Performance |
|---|---|---|
| Mechanical Testing per ASTM F543 for metallic bone screws (e.g., torsional strength, driving torque, and axial pullout) | Conformance with FDA-recognized version of ASTM F543 standards; equivalence to predicate devices. | "mechanical testing demonstrates the performance of the subject devices is equivalent to the predicate devices." |
| Engineering Analysis for plate designs | Improved resistance to bending compared to predicate devices. | "the subject plate designs have improved resistance to bending due to the higher moment of inertia." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The testing mentioned is mechanical and engineering analysis, not clinical testing with human subjects. The phrase "subject plate designs" and "subject devices" refers to the new devices being submitted for clearance.
- Data Provenance: Not applicable for mechanical and engineering analysis. These are laboratory tests and simulations. No country of origin for patient data is mentioned as no patient data was used.
- Retrospective or Prospective: Not applicable as no clinical data was used.
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)
Not applicable. This device is a bone fixation system (hardware), not a diagnostic tool requiring expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for mechanical properties is established by engineering standards and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No human adjudication was involved in the mechanical testing or engineering analysis described.
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 study was done. This is a physical medical device (bone plating system), not an AI-driven diagnostic or image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to AI or software performance. Not applicable to this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical testing would be defined by the specifications and tolerances established by the relevant ASTM standards (ASTM F543) and engineering principles for material strength and bending resistance.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve machine learning or data training sets.
9. How the ground truth for the training set was established
Not applicable.
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(90 days)
Tyber Medical Distal Radius Plating System
The Tyber Medical Distal Radius Plating System includes the Tyber Medical Distal Radius, Forearm, and Fragment-Specific plates, which are indicated for fixation for fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.
The Tyber Medical Distal Radius System is not for Spinal Use.
The Tyber Medical Distal Radius Plating System presented in this 510(k) submission consist of various bone plates, screws, and instruments.
Distal Radius Plating System
The Tyber Medical Distal Radius System provides fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.
The system will incorporate variable angle locking and non-locking screws in various lengths and diameters.
All plates and screws are composed of Ti-6Al-4V ELI (ASTM F 136) or Stainless Steel (316L).
A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system.
The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.
This FDA 510(k) summary describes a new medical device, the Tyber Medical Distal Radius Plating System, and its claim of substantial equivalence to predicate devices. The information provided heavily emphasizes mechanical and materials testing, typical for orthopedic implants, and explicitly states that no clinical testing was performed.
Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly regarding human-in-the-loop performance, expert ground truth, sample sizes for test/training sets, and MRMC studies, is not applicable in the context of this submission. The device is a physical implant, not an AI or software-based diagnostic tool that would typically involve such studies.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with reported device performance in the way one might expect for a software or AI device. Instead, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section serves this purpose for a mechanical device.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Material Composition | All plates and screws are composed of Ti-6Al-4V ELI (ASTM F 136) or Stainless Steel (316L). This implies meeting the compositional requirements of these recognized ASTM standards. |
| Mechanical Performance (Plates) | Tested with FDA currently recognized version of ASTM F382 for metallic bone plates. An engineering analysis showed that the subject plate improved resistance to bending due to the higher moment of inertia. This implies meeting or exceeding the mechanical performance standards set by ASTM F382. |
| Mechanical Performance (Screws) | Tested with FDA currently recognized version of ASTM F543 for metallic bone screws. Mechanical testing was unnecessary as the minor differences from the predicate screws did not create a new worst-case screw design (major diameter, minor diameter, and shaft thread shape are the same). This implies meeting the mechanical performance standards set by ASTM F543, with sufficient similarity to predicates to avoid re-testing. |
| Design Equivalence (Overall) | The Tyber Medical Distal Radius System is substantially equivalent to the predicate devices in material, basic design features, intended use, operation and performance. Differences between subject and predicate are considered minor and do not raise new questions of safety, performance, or effectiveness. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This device is a physical implant. The "testing" referred to is mechanical and engineering analysis, not data analysis on a test set of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth establishment by experts is relevant for diagnostic or AI devices evaluating patient data, not for the mechanical properties of an implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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 hardware device (bone plating system), not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device. No algorithm exists for standalone performance evaluation in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical aspects, the "ground truth" would be the material specifications (ASTM F 136, 316L Stainless Steel) and the established performance standards outlined in ASTM F382 and ASTM F543 for metallic bone plates and screws, respectively. The engineering analysis provided serves as evidence against these established standards.
8. The sample size for the training set
- Not Applicable. No training set is relevant for this type of mechanical device submission.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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