(30 days)
The WishBone Medical Plate and Screw System is indicated for pediatric and adult patients of the clavice, scapula, humerus, ulna, radius, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus, and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis.
The system includes Femoral Locking Plates and Screws, which are in infant, child, and adolescent pediatric subgroups and small stature adult patients.
The WishBone Medical Femoral Locking Plate System was designed to address deformity correction in the proximal and distal femur where plating is an option for correction. It is intended to be used for temporary stable internal fixation of femoral osteotomies and fractures in pediatric patients. The system consists of two plate sizes, 3.5mm and 4.5mm, which align with the corresponding screw sizes, and are offered in varying lengths based on the quantity of screw holes needed. Plates have three screw holes in the "head" of each plate, plus 3, 4, 6, 8, or 10 screw holes in the shaft of the plates, based on plate configuration. Plates are also offered in varying angles ranging from 85° to 140°, with differing offsets and flares. These variations allow surgeons to best match the presenting patient's anatomy. New 3.5mm and 4.5mm locking and non-locking cortical screws are being added to the system for use with these new plates.
The subject Femoral Locking Plate System implants are composed of 316- Stainless Steel material (ASTM F138-19) and are supplied in one of two single-use sterile packaging configurations based on plate size: sterile packed Tyvek-covered trays or Nylon pouches, each with a double sterile barrier.
The Femoral Locking Plate System is a line extension of the WishBone Medical Plate and Screw System (K180736 & K213498).
The provided regulatory submission for the WishBone Medical Plate and Screw System (K230527) does not include acceptance criteria or the study data that typically demonstrates medical device performance against such criteria in the context of diagnostic or AI-driven devices.
This submission is for a mechanical orthopedic implant (plates and screws), and the "acceptance criteria" discussed are primarily related to ensuring the new device (Femoral Locking Plate System) is substantially equivalent to previously cleared predicate devices based on design, materials, manufacturing processes, and mechanical performance.
Here's why the requested information regarding acceptance criteria and performance studies in the context of an AI/diagnostic device is not present:
- Device Type: This is a Class II orthopedic implant (metallic bone fixation appliances). The clearance process for such devices heavily relies on demonstrating mechanical equivalence, biocompatibility, and sterilization validation compared to existing, legally marketed predicate devices. It is not an AI/diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC based on analyzing clinical data.
- "Acceptance Criteria" for this device: For this type of device, "acceptance criteria" are implied through the non-clinical performance testing. These are typically engineering specifications and thresholds (e.g., specific torque values for screw torsion, load limits for bend tests) that the device must meet to ensure its mechanical integrity and safety. These are not explicitly laid out in a table in the provided public summary.
- "Study that proves the device meets the acceptance criteria": This refers to the non-clinical performance testing mentioned.
Therefore, many of the specific questions (like sample size for test set, data provenance, ground truth, MRMC studies, AI performance, etc.) are not applicable to this type of medical device submission.
However, I can extract the relevant information that is present in the document regarding the justification for substantial equivalence.
Summary of Acceptance Criteria and Performance (Based on Device Type and Available Information)
Given that this is a mechanical orthopedic implant, "acceptance criteria" are implied by successful performance in biomechanical and material tests. The document states that engineering analyses and testing were conducted to reaffirm substantial equivalence, meaning the device met the established performance standards of the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Performance comparable to predicate in Screw Torsion | "Engineering analyses and testing were conducted on the subject Femoral Locking Plate System to reaffirm substantial equivalence with the predicate devices, addressing: Screw Torsion." (Implies successful completion and comparable results) |
| Performance comparable to predicate in Screw Pull-out | "Engineering analyses and testing were conducted... addressing: Screw Pull-out." (Implies successful completion and comparable results) |
| Performance comparable to predicate in Screw Insertion and Removal | "Engineering analyses and testing were conducted... addressing: Screw Insertion and Removal." (Implies successful completion and comparable results) |
| Performance comparable to predicate in Four Point Dynamic Bend Test of Femoral Plates | "Engineering analyses and testing were conducted... addressing: Four Point Dynamic Bend Test of Femoral Plates." (Implies successful completion and comparable results) |
| Material/Design Integrity: | |
| Appropriate Laser Etch Location | "Engineering analyses and testing were conducted... addressing: Laser Etch Location Assessment." (Implies meeting design specifications) |
| Biocompatibility | "Engineering analyses and testing were conducted... addressing: Biocompatibility Risk Assessment." (Implies meeting established standards for medical device materials, confirmed by using 316-Stainless Steel, ASTM F138-19) |
| Sterilization Efficacy (SAL) | "Engineering analyses and testing were conducted... addressing: Sterilization Validation." (Implies achieving specified Sterility Assurance Level [SAL] and using the same method/dose as predicate.) |
| Functional Equivalence: | |
| Equivalent Intended Use, Indications for Use, Design Features | "The subject system and predicate systems have the same intended use. No new or increased risks have been identified. The subject system and predicate systems have similar intended use. No new or increased risks have been identified. The subject device design is comparable to the predicate system. No new or increased risks have been identified." |
Detailed Breakdown for AI/Diagnostic Device Questions (Not Applicable or Information Not Provided Herein):
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not Applicable. This is a mechanical device, not a diagnostic or AI device that uses clinical data for performance evaluation in this context. The "test set" here refers to the physical devices subjected to mechanical and material testing, not a dataset of patient images or readings.
- 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. Ground truth, in the context of clinical data interpretation, is not relevant for this mechanical device. The "ground truth" for mechanical testing would be the accepted engineering standards and specifications.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not Applicable. Adjudication methods are used for resolving disagreements in expert interpretations of clinical data, which is not part of this submission type.
- 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 not an AI-assisted diagnostic or interpretation device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not Applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Applicable. For mechanical performance, the "ground truth" is adherence to established ASTM standards and comparable performance to predicate devices.
- The sample size for the training set: Not Applicable. There is no "training set" in the AI sense for this device.
- How the ground truth for the training set was established: Not Applicable.
Conclusion:
The provided document details a 510(k) submission for a mechanical bone plate and screw system. The "acceptance criteria" and "studies" are related to mechanical engineering tests, material science, and sterilization validation to demonstrate substantial equivalence to predicate devices, rather than the performance metrics typically associated with AI or diagnostic clinical performance studies.
§ 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.