(28 days)
The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including, but not limited to cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System includes a variety of plate confiqurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue.
The bone plates will be manufactured of unalloved, commercially pure titanium and titanium 6AI-4V ELI allov. The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards and The American Society for Testing and materials (A.S.T.M.) F136 Standard. The screws will be manufactured of a titanium 6Al-4V ELI alloy that meets The American Society for Testing and materials (A.S.T.M.) F136 Standard.
The plate and screw kit confiqurations are sterilized using gamma radiation sterilization methods. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the devices has been achieved and can be maintained.
This submission K022033 does not contain a study that describes acceptance criteria for device performance in the manner typically seen for software or AI/ML devices. This is a 510(k) premarket notification for a Class II medical device, specifically Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System.
For devices like bone plates and screws, the "acceptance criteria" and "study" proving they meet those criteria are typically focused on substantial equivalence to predicate devices and adherence to established material and sterilization standards, rather than performance metrics like sensitivity, specificity, or accuracy.
Here's a breakdown based on the provided document, addressing the requested points where applicable, and noting where the information is not present or not relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Material Composition Standards: |
- Plates: Unalloyed, commercially pure titanium and titanium 6Al-4V ELI alloy, adhering to ASTM F67 and ASTM F136 Standards.
- Screws: Titanium 6Al-4V ELI alloy, meeting ASTM F136 Standard. |
| Sterilization Efficacy: | - Successfully completed sterilization validation studies proving sterility has been achieved.
- Successfully completed packaging validation studies proving sterility can be maintained. |
| Intended Use Equivalence: | - Intended for use in non-load bearing fixation, cranial bone fixation, brow fixation, and treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton.
- Matches the indications for use of predicate devices: Bioplate, Inc., Wurzburg, Synthes, TiMesh, and KLS-Martin.
- Intended for single use only. |
| Technological Characteristics Equivalence: | - Same indications for use as predicate devices.
- All technical characteristics are "substantially equivalent" to predicate devices.
- "Minor differences raise no new issues of safety and efficacy." |
| Manufacturing Quality System: | - Implicitly meets Good Manufacturing Practice (GMP) requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), as mandated by FDA for all medical devices. (Mentioned in FDA letter as a general requirement, not a specific claim from the submitter). |
| Safety and Efficacy (Overall Substantial Equivalence): | - Found substantially equivalent by FDA to legally marketed predicate devices, allowing it to proceed to market. The FDA letter states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document. This type of device (bone plates and screws) does not typically involve a "test set" in the context of diagnostic or AI/ML performance evaluation studies. The "testing" refers to material and sterilization validation, which are engineering and manufacturing tests, not clinical performance tests with patient data.
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)
This information is not applicable and not provided. "Ground truth" for this device is established by adherence to engineering standards (ASTM), manufacturing specifications, and successful physical/chemical testing for material properties and sterility. It doesn't involve expert medical interpretation in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for disputes in expert-labeled datasets, which is not the case here.
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
This information is not applicable and not provided. MRMC studies are used for evaluating diagnostic performance, often involving human readers and AI/ML systems. This is not a diagnostic device; it's a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is effectively established by:
- Adherence to Material Standards: ASTM F67 and ASTM F136 specifications define the "truth" for material composition and properties.
- Validation of Manufacturing Processes: Successful completion of sterilization validation and packaging validation studies (likely per ISO standards or similar) serves as "ground truth" for sterility.
- Substantial Equivalence: The ultimate "ground truth" for marketing approval is that the device is substantially equivalent to predicate devices already on the market, meaning it performs as intended and introduces no new safety or efficacy concerns.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of an AI/ML algorithm for this device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" or "ground truth" establishment in the AI/ML sense for this device.
§ 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.