(15 days)
The Acumed Scapula Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the scapula.
The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.
This submission, K051083, is for the Acumed Scapula Congruent Bone Plate System. This device is a metallic bone fixation appliance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Substantially equivalent to predicate devices based on similarities in materials and intended use. |
| Effectiveness | Substantially equivalent to predicate devices based on similarities in materials and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This indicates that no dedicated test set or study was performed to prove the device meets acceptance criteria. The claim of safety and effectiveness relies on substantial equivalence to predicate devices. Therefore, there is no sample size and no data provenance in the traditional sense of a study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Since no test set or study was conducted, no experts were used to establish ground truth for this device in isolation. The evaluation relies on the known safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
As no test set was used, there was no adjudication method employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed. The document explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." Therefore, there is no effect size of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study was done as this is a physical medical device (bone plate system), not an algorithm or AI.
7. Type of Ground Truth Used
The ground truth implicitly used for this submission is the established safety and effectiveness of the legally marketed predicate devices. The new device is deemed "substantially equivalent" based on its characteristics (materials, intended use) aligning with those predicates.
8. Sample Size for the Training Set
No training set was used for this type of device submission. The submission relies on demonstrating substantial equivalence to existing devices, not on training a model.
9. How the Ground Truth for the Training Set Was Established
Since no training set was used, there was no ground truth established for a training set. The basis for approval is the comparison to predicate devices, which have already been established as safe and effective through their own regulatory processes (which would have involved various forms of testing and clinical data).
§ 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.