(28 days)
EVOLVE® EPS ORTHOLOC™ System: Intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, and ulna
The ORTHOLOCM 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters. These screws are manufactured from stainless steel conforming to ASTM F2229. The design features of the ORTHOLOC™ 3DSi Locking Screws are identical to the design features of the predicate devices EVOLVE® EPS ORTHOLOC™ System Locking Screws.
Here's an analysis of the provided text regarding the Ortholoc™ 3DSi Locking Screws, focusing on acceptance criteria and study information.
It's important to note that this document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification for a medical device. In the context of 510(k) submissions, the primary "study" is often a demonstration of substantial equivalence to a previously cleared predicate device, rather than a de novo clinical trial with traditional acceptance criteria for performance metrics like sensitivity, specificity, and accuracy.
Acceptance Criteria and Device Performance
The core "acceptance criteria" in a 510(k) for devices like this are the demonstration of substantial equivalence to a predicate device. This is primarily assessed by comparing indications for use, technological characteristics, and material properties.
| Acceptance Criteria (for Substantial Equivalence to Predicate K102352) | Reported Device Performance (ORTHOLOC™ 3DSi Locking Screws) |
|---|---|
| Indication for Use: Should be identical to the predicate. | Identical: "System indications for both subject ORTHOLOC™ 3DSi Locking Screws and predicate EVOLVE® EPS ORTHOLOC™ (K102352) are identical." |
| Technological Characteristics: Should be identical or minor changes only. | Identical with minor change: "The subject ORTHOLOC™ 3DSi Locking screws are identical to the previously cleared EVOLVE® EPS ORTHOLOC™ Locking screws (K102352) with only minor change to feature call-outs on the engineering drawing." |
| Material: Identical to the predicate. | Identical: "manufactured from stainless steel conforming to ASTM F2229," same as predicate (implied by "materials information" and "composition of design characteristics" leading to conclusion of no new safety/effectiveness questions). |
| Diameter and Size Range: Identical to the predicate. | Identical: "identical in indication for use, diameter, size range and material to the predicate." |
| Safety and Effectiveness: No new types of safety and effectiveness questions. | Conclusion: "No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices." |
Study Proving Acceptance Criteria:
The "study" in this context is the comparison report submitted in the Premarket Notification (510(k)). This report directly addresses the substantial equivalence criteria listed above.
Detailed Breakdown of Study Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A: This type of device (locking screws) typically does not involve a "test set" in the sense of patient data or clinical images for performance evaluation (e.g., diagnostic accuracy). The "testing" refers to material and mechanical property comparisons to a predicate device, as well as verification of design specifications. The document states "Substantial Equivalence - Non-Clinical Evidence" and "Substantial Equivalence - Clinical Evidence N/A". This indicates that no clinical "test set" of patient data was used or required for this 510(k) submission.
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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):
- N/A: As there was no clinical "test set" requiring ground truth establishment (e.g., for diagnostic accuracy), no experts were used for this purpose in this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A: No clinical test set.
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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:
- No: This device is a mechanical implant (locking screws) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A: For this type of 510(k) submission, the "ground truth" for substantial equivalence is primarily established by engineering specifications, material standards (ASTM F2229), and documented design features of both the new device and the predicate. The "truth" is whether the new device meets the same specifications and characteristics as the predicate.
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The sample size for the training set:
- N/A: This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
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How the ground truth for the training set was established:
- N/A: No training set.
§ 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.