(45 days)
The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint.
Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.
The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, F2229, F138 and F139. All implants are for single use only.
Here's an analysis of the provided FDA 510(k) summary regarding the ANTHEM™ Fracture System, focusing on acceptance criteria and supporting studies.
General Observation: The provided document is for a medical device (bone fixation system), not a diagnostic algorithm or AI product. Therefore, the typical "acceptance criteria" related to diagnostic performance (sensitivity, specificity, AUC) and associated studies (MRMC, standalone) are not applicable in this context. The acceptance criteria here would be related to mechanical performance, material properties, and biological safety, demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ASTM F543 (Standard Specification for Metallic Medical Bone Screws) | Performance of ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F543. |
| Mechanical Performance | ASTM F382 (Standard Specification for Metallic Bone Plates) | Performance of ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F382. |
| Material Composition | ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications) | Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136. |
| Material Composition | ASTM F1295 (Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications) | Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F1295. |
| Material Composition | ASTM F1472 (Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications) | Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F1472. |
| Material Composition | ASTM F1537 (Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)) | Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F1537. |
| Material Composition | ASTM F2229 (Standard Specification for Wrought, Nitrogen Strengthened 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel Bar, Billet, and Wire for Surgical Implants (UNS S21727)) | Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F2229. |
| Material Composition | ASTM F138 (Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)) | Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F138. |
| Material Composition | ASTM F139 (Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet, Strip, and Plate for Surgical Implants (UNS S31673)) | Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F139. |
| Manufacturing/Usage | Single Use Only | All implants are for single use only. |
| Substantial Equivalence | Technological characteristics (design, intended use, material composition, size range) | ANTHEM™ implants have the same technological characteristics as the predicate devices. |
| Substantial Equivalence | Performance | Performance demonstrated through engineering analysis and compliance with standards. |
| Substantial Equivalence | Intended Use | (Implied by overall claim of substantial equivalence and stated Indications for Use) |
Study Proving Device Meets Acceptance Criteria:
The primary study type used to demonstrate that the device meets acceptance criteria and is substantially equivalent is non-clinical performance testing and engineering analysis.
- Performance Data: "Performance of the ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F543 and ASTM F382. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices." (Page 4)
This indicates that mechanical tests were performed according to specified ASTM standards for bone screws and plates. The "engineering analysis" would involve comparing the design, materials, and expected performance of the new device to the predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state a "sample size" in terms of number of devices tested. For mechanical testing, this typically refers to a specified number of samples (e.g., 5, 10, or more) of each device configuration required by the ASTM standard to be tested to demonstrate compliance. This information is usually detailed in the full test report, not summarized in the 510(k) statement.
- Data Provenance: Not applicable in the context of this type of medical device submission. The tests are laboratory-based mechanical and material property evaluations, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable: This submission is for a physical medical device (bone fixation system), not a diagnostic algorithm. Therefore, "ground truth" established by human experts in the diagnostic sense (e.g., radiologists interpreting images) is not relevant here. Ground truth in this context would be defined by the physical dimensions, material properties, and mechanical performance test results as measured by calibrated equipment according to standard protocols.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not Applicable: Adjudication methods like 2+1 are used in clinical studies where human interpretation of data (e.g., imaging) needs to be reconciled to establish a consensus ground truth. This is not relevant for the mechanical testing of a bone fixation device.
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: The device is a physical bone fixation system, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: The device is a physical bone fixation system, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Technical Ground Truth: For this device, the "ground truth" and acceptance criteria are derived from:
- Mechanical Standards: Adherence to established ASTM standards (F543 for screws, F382 for plates) for mechanical properties (e.g., strength, fatigue resistance).
- Material Standards: Adherence to established ASTM standards for medical-grade materials (e.g., F136 for titanium alloy, F1537 for cobalt chromium molybdenum alloy, F138/F139/F2229 for stainless steel).
- Dimensional Specifications: Compliance with design specifications and tolerances that match predicate devices.
The "truth" is objective, measurable, and defined by engineering and material science principles, not clinical outcomes or expert interpretation of patient data.
8. The Sample Size for the Training Set
- Not Applicable: This is not a machine learning or AI device. There is no "training set" in the context of establishing substantial equivalence for a physical medical device. Device design and manufacturing processes are developed based on engineering principles and predicate device characteristics, not through data training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no "training set," this question is not relevant.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.