(811 days)
The Cross Medical Bone Plate System is intended for non-spinal applications only in the treatment of internal fixation of pelvic fractures.
3.5 mm x 8 mm Bone Screw through 3.5 mm x 30 mm Bone Screw in 2 mm increments
4.0 mm x 8 mm Bone Screw through 4.0 mm x 30 mm Bone Screw in 2 mm increments
C-Plates Assorted Sizes
Device specific instrumentation is necessary for the insertion and anchoring of the CM Bone Plate System. System instrumentation includes: Plate Holder, Plate Cutter, Plate Bender, Plate Shaper, Plate Template, Drill Guide, Drill Bits, Driver Handle, Screw Taps, Screwdriver, Screw Holder, Sterilizer Case.
The implants of the new system are made from titanium alloy (6A1, 4V, ELI) and CP titanium or from 22-23-5 Stainless Steel.
The titanium bone plates are made from commercially pure titanium meeting ASTM F67-89. This material is also known as Commercially Pure Titanium (CP Ti, Grade 2). The stainless steel bone plates are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The titanium bone screws are made from the industry standard alloy Ti 6A1-4V ELI, ASTM F-136-92. The stainless steel bone screws are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The surface of both the titanium screws and titanium plates are anodized and/or matte finished. The surface of both the stainless steel screws and stainless steel plates are matte finished.
The CP titanium plates are offered for their ease of contouring and their mechanical performance.
This document is primarily a premarket notification (510(k)) for the Cross Medical Bone Plate System, seeking to establish substantial equivalence to previously marketed devices. It is not a study that proves a device meets specific acceptance criteria in the way a clinical trial or performance study for a novel device would. Instead, the "acceptance criteria" here are the regulatory requirements for showing substantial equivalence.
Therefore, many of the requested fields regarding detailed study design, sample sizes, expert qualifications, and comparison with AI performance are not applicable to this type of regulatory submission. The document focuses on demonstrating that the device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use.
Here's an attempt to answer the questions based on the provided text, with clarifications on applicability where necessary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k)) | Reported Device Performance (Summary of how it meets criteria) |
|---|---|
| Material Composition Equivalence | Titanium plates: Commercially Pure Titanium (CP Ti, Grade 2), ASTM F67-89. |
| Stainless steel plates: ASTM F-1314 (22-23-5 Stainless Steel). | |
| Titanium screws: Ti 6A1-4V ELI, ASTM F-136-92. | |
| Stainless steel screws: ASTM F-1314 (22-23-5 Stainless Steel). | |
| These materials are stated as "industry standard alloy" and conform to recognized ASTM standards, implying equivalence to predicate devices. | |
| Device Design/Specifications Equivalence | Bone Screws: 3.5 mm x 8 mm to 3.5 mm x 30 mm (2 mm increments), and 4.0 mm x 8 mm to 4.0 mm x 30 mm (2 mm increments). |
| C-Plates: Assorted Sizes. | |
| Design descriptions are provided, and substantial equivalence is claimed against Ace and Synthes brand bone plates and screws, suggesting comparable designs. | |
| Intended Use Equivalence | Non-spinal applications only, specifically for internal fixation of pelvic fractures. This matches the intended use of legally marketed predicate devices for which substantial equivalence is being claimed. |
| Sterilization Protocol Validity | Recommended sterilization cycle: Steam, Gravity, 250° F (121° C) for 30 minutes, "laboratory validated." This aligns with HIMA/AORN protocols and provides a validated method. The device is supplied non-sterile. |
| Instrumentation Compatibility/Safety | System includes Plate Holder, Cutter, Bender, Shaper, Template, Drill Guide, Drill Bits, Driver Handle, Screw Taps, Screwdriver, Screw Holder, Sterilizer Case. Instruments made from stainless steel (ASTM F-899-84 and/or A276-91 standards). These are described as "standard manual orthopaedic surgical instruments ordinarily exempt from 510(k)" and are included for completeness, implying they are well-established and safe. |
| Overall Safety and Effectiveness (Substantial Equivalence) | "Based on the basic design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, surgical approach, preproduction quality assurance planning and engineering analysis, Cross Medical Products, Inc. believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to existing legally marketed bone plate and screw systems." The FDA's letter (K961320) confirmed this finding of substantial equivalence based on the submitted information. |
| Performance Standards Adherence (where applicable) | "Food and Drug Administration developed performance standards applicable to the Cross Medical Bone Plate System do not exist." Voluntary standards (vendor/materials certifications, in-house SOP’s, ASTM, ISO) are utilized as appropriate. |
2. Sample Size Used for the Test Set and the Data Provenance
- Not Applicable. This document is a 510(k) premarket notification. It does not describe a clinical study with a "test set" in the sense of patient data. The basis for substantial equivalence relies on material properties, design comparisons, and mechanical testing (mentioned but not detailed). The "data provenance" would refer to the standards and engineering analyses performed.
- The document states: "mechanical testing" was included in the reasoning for substantial equivalence. However, no specific details like sample size, methodology, or results of these tests are provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. As this is not a clinical study involving diagnosis or interpretation, there is no "ground truth" established by experts in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information and comparison to predicate devices. The expertise involved would be in engineering, materials science, and orthopedics for the design and manufacturing, and regulatory affairs for the submission.
4. Adjudication Method for the Test Set
- Not Applicable. No test set or expert adjudication in the context of clinical data interpretation is 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
- Not Applicable. This device is a passive implant (bone plate and screw system) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical, surgical implant and does not involve an algorithm.
7. The Type of Ground Truth Used
- For the purpose of this 510(k) submission, the "ground truth" is effectively the established safety and effectiveness of the identified predicate devices (Ace Brand Bone Plates and Screws, Synthes Brand Bone Plates and Screws). The manufacturer demonstrates that their device is sufficiently similar to these legally marketed devices that it raises no new questions of safety or effectiveness.
- The document also implies reliance on engineering standards (ASTM F67-89, ASTM F-1314, ASTM F-136-92, ASTM F-899-84, A276-91) for material composition and HIMA/AORN protocols for sterilization, which serve as benchmarks for performance and safety.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an algorithm or AI-driven device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.