(19 days)
The modified plates designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The modified plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Commercially pure titanium plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxilloffacial bony tissue. The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards.
The provided text describes a 510(k) premarket notification for a medical device, the "Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." This submission focuses on modifications to existing predicate devices.
Crucially, this document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way one might expect for a new AI/software device or a device requiring clinical performance validation.
Instead, this 510(k) summary is centered on demonstrating substantial equivalence to previously cleared predicate devices. The "study" here is essentially a comparison to existing devices, asserting that the modified plate designs are functionally the same and raise no new safety or efficacy concerns.
Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
Here's a breakdown based on the provided text, indicating where information is present and where it is absent/not applicable:
Acceptance Criteria and Device Performance Study for Bioplate® Rigid Fixation Bone Plating System
As this is a 510(k) premarket notification affirming substantial equivalence for device design modifications, the "acceptance criteria" and "study" are framed around similarity to predicate devices rather than novel performance benchmarks.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|
| Material Composition: Adhere to accepted standards. | The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards. |
| Intended Use: Match predicate devices. | The modified plate design for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery has the same indications for use as the predicate devices (K021684, K980983, K972463, K953273, and K943071), specifically for "treatment of craniofacial fractures, reconstructive procedures, and non-load bearing fixation including, maxillofacial fixation, cranial bone fixation and orbital fixation." Intended for single use only and in conjunction with other titanium and titanium alloy implants. |
| Technological Characteristics: Substantial equivalence to predicate devices, with no new safety/efficacy issues. | "All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." Specific details on the "modified plate designs" are not provided beyond them being "a variety of plate configurations for different anatomical applications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission doesn't describe a clinical or performance "test set" in the traditional sense for evaluating a new device's performance against specific metrics. It's a comparison to existing predicate devices.
- Data Provenance: Not applicable. No new efficacy data from human subjects or retrospective/prospective studies are presented for the modified designs. The data "provenance" here relates to the established safety and efficacy of the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. No "ground truth" for a test set was established by experts for this submission. The determination of "substantial equivalence" is made by the FDA based on the comparison provided by the manufacturer.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was conducted or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is not mentioned as it is irrelevant for a submission focused on demonstrating substantial equivalence of minor design modifications to existing hardware. There is no AI component or human-in-the-loop performance being evaluated.
- Effect Size of Human Readers with/without AI: Not applicable. No AI component is described.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Not applicable. This device is a physical bone plating system, not an algorithm or software.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and efficacy profile of the legally marketed predicate devices. The submission argues that the modified device is equally safe and effective due to its substantial equivalence. There is no new "ground truth" derived from pathology, outcomes data, or expert consensus specifically for these modified plates beyond the assertion that they are functionally similar to the predicates.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. No training set for an algorithm was used.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.