(29 days)
The MaxLock Extreme System is indicated for the following:
• The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
• The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
• The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
• The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.
The MaxLock Extreme™ System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium allov or PEEK.
The provided text describes the 510(k) summary for the MaxLock Extreme™ System, a medical device consisting of plates and screws for bone fixation. The submission focuses on establishing substantial equivalence to a previously cleared device (K123203).
Based on the provided information, no clinical study or performance data demonstrating specific acceptance criteria with reported device performance is available for an AI/ML powered device. The submission relies on non-clinical testing for substantial equivalence.
Here's an analysis of the provided text in relation to your questions, highlighting why most are not applicable in this context:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The submission for the MaxLock Extreme™ System is for a physical medical device (plates and screws) and primarily relies on demonstrating substantial equivalence to a predicate device through non-clinical means. It does not involve an AI/ML component with associated acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc.
- The text states: "Finite element analysis was performed on the subject device to determine the worst case Benchtop mechanical testing comparing the strength of the implant. subject and predicate devices was performed and the results support substantial equivalence." This refers to mechanical performance, not AI/ML performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. As there are no AI/ML performance studies described, there is no "test set" of data in the context of an AI/ML model for this submission. The "test set" would refer to the mechanical testing described above, but the size and provenance of that data (e.g., number of implants tested, where the testing was performed) are not specified.
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 by human experts for an AI/ML model's performance is mentioned or relevant to this submission. Mechanical testing does not typically involve expert "ground truth" in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no AI/ML performance study with a test set requiring adjudication.
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 physical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or software component for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the mechanical testing mentioned, the "ground truth" would be the measured physical properties and performance against engineering standards or predicate device performance, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
- Not Applicable. No AI/ML model is being trained.
9. How the ground truth for the training set was established
- Not Applicable. No AI/ML model is being trained.
Summary of what is described (non-AI/ML):
The submission for the MaxLock Extreme™ System is a 510(k) premarket notification for a physical medical device. The primary method for proving substantial equivalence to the predicate device (K123203) involves:
- Finite element analysis: Used to determine the "worst case" strength of the implant.
- Benchtop mechanical testing: Performed to compare the strength of the subject device to the predicate device.
The premise for substantial equivalence is based on "similarities in indications, design, and materials." This is a typical approach for non-AI/ML device submissions where physical and material properties are key.
§ 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.