(86 days)
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
The 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. Each of the plate styles utilizes the same screw types and screw instruments for insertion. All of the plates and screws are manufactured from titanium and are provided non-sterile. The screws were cleared for marketing and distribution under K942340 and K942341.
The provided text describes a 510(k) premarket notification for the Acumed Congruent Bone Plate System. This is a submission demonstrating equivalence to existing devices, not a study presenting novel performance data or acceptance criteria that would typically be associated with a new device development and validation.
Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable to this type of regulatory submission.
Here's an explanation of what can be gleaned from the document in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting new performance acceptance criteria through a specific study for a novel device. The "performance" is implicitly deemed acceptable if it is substantially equivalent to legally marketed predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: The submission does not describe a clinical or performance study with a test set of data. It relies on the established safety and effectiveness of predicate devices.
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)
- Not Applicable: No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No test set or adjudication method 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 is a bone plate system, not an AI or imaging diagnostic device. Therefore, an MRMC 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 is a medical device (bone plate), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth is established for device performance in this document. The "ground truth" for regulatory approval in a 510(k) is the demonstrated safety and effectiveness of the identified predicate devices.
8. The sample size for the training set
- Not Applicable: There is no "training set" in the context of this 510(k) submission for a bone plate system.
9. How the ground truth for the training set was established
- Not Applicable: As above, no training set or ground truth for a training set is relevant here.
Summary of Relevant Information from the Document:
While the document does not fit the typical structure for a performance study with detailed acceptance criteria, it does address the regulatory acceptance of a medical device based on substantial equivalence.
Device Description and Justification for Substantial Equivalence:
The Acumed Congruent Bone Plate System consists of bone plates and screws made from titanium, provided non-sterile. The plates are pre-bent. The screws were previously cleared under K942340 and K942341.
The justification for substantial equivalence is based on:
- Indication, Intended Use, Material, Design, and Size: The Acumed system is stated to be similar to several predicate devices.
- Predicate Devices:
Acceptance Information (as interpreted for a 510(k) submission):
- Device Status: The device was determined to be "substantially equivalent" to legally marketed predicate devices.
- Performance Data (Limited): The document mentions that "On file at Acumed is data which shows that the instrumentation and implants can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 10-6." This is a specific performance aspect relating to sterility. However, no specific "acceptance criteria" (e.g., tensile strength, fatigue life thresholds) are explicitly stated in this public summary for the plates themselves, as these would typically be compared to predicate device performance or established standards during the engineering and testing phases, which are then summarized for the 510(k) reviewer.
In essence, the "acceptance criteria" for a 510(k) is whether the new device is as safe and effective as a legally marketed predicate device. The "study" proving this is the detailed comparison provided in the full 510(k) submission (not fully provided here, only the summary).
§ 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.