(155 days)
The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.
The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.
This document is a 510(k) premarket notification for the MEDPOR® Fixation System - Cranial. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove device performance against those criteria. In the context of a 510(k) submission for a device like plates and screws, the "acceptance criteria" are generally related to demonstrating that the new device is as safe and effective as existing legally marketed devices (predicate devices) and that any differences do not raise new questions of safety or effectiveness.
Therefore, the requested information elements (1-9) which typically relate to performance studies for novel or significantly modified devices, are not explicitly provided in this 510(k) summary. A 510(k) does not usually include a formal "study" with stated acceptance criteria and device performance results in the same way a PMA or de novo submission might. Instead, it relies on comparisons to predicate devices and adherence to established material standards and manufacturing practices.
Here's a breakdown of what can be extracted and what is not applicable or stated:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific performance study in this 510(k) summary. The acceptance criteria for a 510(k) is generally the demonstration of "substantial equivalence" to predicate devices, meaning the new device has "similar technological characteristics" and "same intended use."
- Reported Device Performance: No specific performance metrics (e.g., tensile strength, fatigue life, etc.) are reported with numerical values in this summary. The submission implies that the material and design choices (titanium, specific alloys) meet established standards (ASTM F67, ASTM F136), which are themselves forms of performance criteria.
2. Sample size used for the test set and the data provenance
- Not applicable as no specific device performance testing study with a "test set" and "data provenance" is detailed in this 510(k) summary. The comparison is primarily against the characteristics of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as there is no "test set" ground truth established by experts in the context of this 510(k) summary. Substantial equivalence is assessed by regulatory reviewers based on design, materials, and intended use.
4. Adjudication method for the test set
- Not applicable for the same reasons as #3.
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 medical device for surgical fixation, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device for surgical fixation, not an algorithm.
7. The type of ground truth used
- The "ground truth" for a 510(k) submission for this type of device is the evidence that the device's technological characteristics (materials, design, sterilization) and intended use are substantially equivalent to legally marketed predicate devices, which are themselves considered safe and effective. The reference to conformity with ASTM standards (F67 and F136) serves as a form of "ground truth" for material properties.
8. The sample size for the training set
- Not applicable as there is no "training set" in the context of this 510(k) submission. Design and manufacturing are based on established engineering principles and material standards.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as #8.
Summary based on the provided document:
The provided document is a 510(k) Summary. For devices like the MEDPOR® Fixation System - Cranial, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to predicate devices already on the market. The "study" proving this largely involves a comparison of technological characteristics (materials, design, indications for use, sterilization) and adherence to recognized standards.
Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Features:
| Criteria Category (Implied) | Acceptance Criteria (How substantial equivalence is demonstrated) | Reported Device Features / Performance |
|---|---|---|
| Intended Use | Must be substantially equivalent to predicate devices. | "Intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton." (Compared to predicate intended uses which include cranial, craniofacial, and reconstructive procedures of the craniofacial skeleton). |
| Device Classification | Must align with predicate devices or existing classifications. | Class II, Code HBW, Reg. No. 882.5360 - Cranioplasty plate fastener (Matches or is consistent with classifications of predicate devices). |
| Materials | Must be substantially equivalent to predicate devices, preferably with a history of safe use, and adhere to recognized standards. | Plates: CP Grade 4 Titanium (Adheres to ASTM F67 Standard). Screws: 6-4 ELI Titanium Alloy (Meets ASTM F136 standard). (Comparable to titanium/titanium alloy used in multiple predicate devices, though one predicate uses bioabsorbable material). |
| Design | Must be substantially equivalent in form and function (e.g., plates and screws for fixation). | Plate and screw system. (Exhibited by all predicate devices). Includes color anodization for ease of use. |
| Sterilization | Must use appropriate and validated sterilization methods. | Ethylene Oxide & Steam sterilization. (Comparable to predicate devices which use steam, or are supplied sterile/non-sterile with instructions for steam sterilization). |
| Instrumentation | Presence of dedicated instrumentation. | Yes. (Comparable to most predicate devices). |
Explanation of Study (Substantial Equivalence Demonstration):
The "study" in this context is the detailed comparison provided in the "Substantial Equivalence" section and the comparative table on page 2 of the document. This comparison directly addresses how the MEDPOR Fixation System - Cranial aligns with the identified predicate devices:
- Comparison of Intended Use: The document argues that the intended use of the MEDPOR system (fixating cranial implants to the cranial skeleton) is comparable to the broad craniofacial, cranial, and reconstructive procedures of the predicate devices.
- Comparison of Materials: The use of specific titanium grades (CP 4 Titanium for plates, 6-4 ELI Titanium Alloy for screws) is stated to meet ASTM standards F67 and F136, respectively. The document highlights that titanium has a "long history of use in surgical implantable products" and that these materials are consistent with most predicate devices (Predicate Device #1 is an exception, being bioabsorbable).
- Comparison of Technological Characteristics: The document states that the "technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences do not raise new issues of safety and effectiveness." This includes design as a plate and screw system, dedicated instrumentation, and sterilization methods.
Missing/Not Applicable Information:
- Sample Size for Test Set/Training Set: Not applicable for a 510(k) based on substantial equivalence comparison of device characteristics.
- Data Provenance: Not applicable.
- Experts/Ground Truth for Test/Training set: Not applicable in the sense of clinical study experts. The "ground truth" hinges on the established safety and effectiveness of the predicate devices and conformity to recognized standards.
- Adjudication Method: Not applicable.
- MRMC or Standalone AI Study: Not applicable as this is not an AI/diagnostic device.
§ 882.5360 Cranioplasty plate fastener.
(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).