(29 days)
The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.
The OsteoMed ExtremiLOCK Foot Plating System consists of plates of various shapes and sizes featuring compression, locking, elongated or compression elongated holes, angulated locking, non-locking and cannulated screws, implantable K-Wires, washers, and appropriate instrumentation. Modifications to plates of the subject system include increasing the thickness of the plates, material changes, and addition of features.
The implants of the OsteoMed ExtremiLOCK Foot Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
The provided text describes a medical device submission (K131445) for the OsteoMed ExtremiLOCK Foot Plating System. It's a 510(k) submission, which focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical efficacy studies.
Here's an analysis of the acceptance criteria and study information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantified acceptance criteria in terms of performance metrics (e.g., specific thresholds for strength, accuracy, or clinical outcomes). Instead, the acceptance criteria are implicitly met by demonstrating performance equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength | "ExtremiLOCK implants underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." Performance equivalence was shown through "verification comparison to the predicate devices." |
| Material Biocompatibility | "ExtremiLOCK implants are manufactured from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), the same materials used in the manufacture of the predicate devices. These materials are biocompatible." |
| Design & Functionality | "A design, dimensional, and performance comparison was performed to establish substantial equivalence to the legally marketed predicate devices... The basis of substantial equivalence for this device is based on similarities in intended use, material, function, performance, design, technology and operational principles..." |
| Intended Use | "The intended use of the OsteoMed ExtremiLOCK implants is the same as the OsteoMed Foot Plating System and the OsteoMed Calcaneal Foot and Screw Fixation System." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for specific mechanical tests or their provenance. The device's clearance is based on non-clinical tests (mechanical verification and comparisons) rather than human clinical trials.
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)
This information is not applicable as the clearance is based on non-clinical, mechanical testing and comparisons to predicate devices, not on expert clinical evaluation of cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the clearance is based on non-clinical, mechanical testing and comparisons to predicate devices, not on expert clinical evaluation of cases.
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
This information is not applicable. The device is a surgical fixation system, not an AI or diagnostic imaging tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering specifications and established mechanical testing standards for bone fixation devices, aiming to demonstrate equivalence to predicate devices that have prior regulatory clearance.
8. The sample size for the training set
This information is not applicable as there is no mention of a training set; the evaluations are based on mechanical verification and comparative analysis.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved in this regulatory submission for a physical medical device.
§ 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.