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510(k) Data Aggregation
(30 days)
GRIDLOCK PLATING SYSTEM
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and the necessary instruments to facilitate the placement of these implants.
The provided text describes a 510(k) submission for the Gridlock Plating System, a medical device for orthopedic trauma and reconstructive procedures. Based on the document, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to predicate devices rather than meeting specific performance criteria against a predefined standard. The acceptance criteria essentially revolve around demonstrating that the new components (additional plates and screws) within the Gridlock Plating System do not alter the fundamental safety and effectiveness profile such that new clinical testing would be required.
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Intended Use | The Gridlock Plating System (including the new plates) is intended for trauma and reconstructive procedures of small bones in the hand/foot, ankle, and other bones appropriate for the device size. This matches the predicate devices. |
| Design | The new plates are for the first metatarsal phalangeal joint. The system maintains features like low profile, limited contact, dynamic/manual compression capability, and angulated-locking threaded screw holes. This is considered substantially equivalent to the predicate devices. |
| Materials Used | CP Titanium per ASTM F67 and Titanium alloy per ASTM F136. This is stated to be the same as the predicate Gridlock plates. |
| Mechanical Safety & Performance | Verified through engineering analysis. No specific performance metrics (e.g., fatigue strength, pull-out force) or thresholds are provided in this summary, but the general statement implies equivalence to predicate mechanical properties. |
| Manufacturing, Packaging, and Sterilization Methods | The manufacturing, packaging, and sterilization methods for the new plates are the same as the predicate Gridlock plates. |
| Risk Profile | Not explicitly stated as a separate criterion, but implied to be equivalent to the predicate devices due to similarities in design, materials, and intended use. |
Study Details
The provided document largely lacks information on clinical studies or detailed performance trials in the way one might expect for a novel device or one requiring extensive performance validation against acceptance criteria with empirical data.
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Sample size used for the test set and the data provenance:
- No clinical test set was used. The document explicitly states: "No clinical studies were performed."
- Data provenance: Not applicable.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth establishment by experts was performed for this 510(k) submission. The assessment relies on engineering analysis and comparison to predicate device characteristics.
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Adjudication method for the test set:
- Not applicable. No clinical test set or adjudication process was performed.
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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 such study was performed. This device is a metallic bone plating system, not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not a software algorithm.
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The type of ground truth used:
- Engineering Analysis and Substantial Equivalence to Predicate Devices: The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate devices (OsteoMed Foot Plating System K091614, and previous versions of Gridlock Plating System K121452, K123525). The new components are asserted to be similar enough to fall under the same safety and effectiveness profile.
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The sample size for the training set:
- Not applicable. No training set for an algorithm was used.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
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(92 days)
GRIDLOCK PLATING SYSTEM
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
The provided text describes a physical medical device (Gridlock Plating System), not an AI/software device. Therefore, the questions related to AI/software performance criteria, ground truth, expert consensus, and multi-reader studies are not applicable.
This 510(k) submission is for a Special 510(k), meaning it's for a modification to a previously cleared device (Gridlock Plating System, K121452). The change from the predicate is the addition of two specific plates for the first metatarsal phalangeal joint. The submission aims to demonstrate substantial equivalence to the predicate device.
Here's the relevant information based on the provided text, modified to address the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria were based on substantial equivalence to predicate devices, particularly regarding mechanical performance.
| Acceptance Criteria Category | Specific Test / Standard | Performance Goal | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static compression testing | Equivalent to predicate devices | The results of this testing indicate that the current Gridlock Plating System is equivalent to predicate devices. |
| Mechanical Performance | Dynamic compression testing per ASTM F382-99, Annexes 1 and 2 | Equivalent to predicate devices | The results of this testing indicate that the current Gridlock Plating System is equivalent to predicate devices. |
| Materials | CP Titanium per ASTM F67 | Same as predicate devices | Manufactured from the same material. |
| Materials | Titanium alloy per ASTM F136 | Same as predicate devices | Manufactured from the same material. |
| General Design | Features (low profile, limited contact, dynamic/manual compression, angulated-locking threaded screw holes) | Same as predicate devices | Systems are similar in principles of operation, technology, and indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical data. For mechanical testing, the number of samples tested per condition is not provided.
- Data Provenance: The mechanical testing was performed in a laboratory setting. There is no mention of data from human subjects or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. For a physical medical device proving mechanical equivalence, "ground truth" related to expert assessment of data is not relevant. The relevant "experts" would be engineering/materials scientists conducting and interpreting the mechanical tests according to standards.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert assessment of clinical data, which is not relevant here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. No clinical studies were performed. This submission relies on mechanical testing and substantial equivalence to a predicate 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 an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance demonstration is based on established engineering standards (ASTM F382-99) and comparison against the known performance of legally marketed predicate devices. In essence, the "truth" is that the new plates perform mechanically equivalently to the previously cleared plates.
8. The Sample Size for the Training Set
Not Applicable. No training set for an algorithm is involved.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. No training set for an algorithm is involved.
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(96 days)
GRIDLOCK PLATING SYSTEM
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.
The plates and screws are intended for single use only.
The Gridlock Plating System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited bone contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters.
Materials:
CP Titanium per ASTM F67 Titanium alloy per ASTM F136
The provided document is limited to a 510(k) summary for the Gridlock Plating System, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies typically associated with AI/ML diagnostic tools.
Therefore, the document does not contain information relevant to AI/ML device acceptance criteria or studies proving device performance in the context you've outlined. Specifically:
- No AI/ML components: The Gridlock Plating System is a metallic bone fixation appliance, not an AI/ML diagnostic or assistive device.
- No acceptance criteria for AI/ML performance: The testing described (static four-point bending, dynamic bending, pull-out, torque) are mechanical performance tests for implants, not metrics like sensitivity, specificity, or accuracy relevant to AI/ML.
- No data provenance, ground truth, expert review, MRMC studies, or training/test sets: These concepts are entirely absent because the device is a physical implant, not a software algorithm.
- No clinical studies: The document explicitly states, "No clinical studies were performed." Substantial equivalence was based on non-clinical (mechanical) testing.
In summary, the Gridlock Plating System is a traditional medical device, and the provided 510(k) summary does not contain any information related to the acceptance criteria or study methodologies typically associated with AI/ML-powered devices.
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