(14 days)
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The ORTHOLOC™ Bone Screws subject to this premarket notification include the nonlocking 3.5mm low profile cortical bone screws and non-locking 3.5 and 4.0 cortical bone screws.
These screws are manufactured from titanium alloy and have a solid core. The implants are single use only devices.
This document is a 510(k) Pre-market Notification for the ORTHOLOC™ Bone Screws. It describes mechanical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study on algorithm performance or clinical utility in the context of medical imaging or AI.
Therefore, many of the requested elements for describing acceptance criteria and a study to prove a device meets acceptance criteria (especially those related to AI, ground truth, experts, and reader studies) are not applicable to this submission.
However, I can extract the relevant information regarding the non-clinical evidence provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Perform at least as well as legally marketed predicate devices in terms of mechanical strength (specifically pull-out force) | "The results show that the subject ORTHQLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOCTM Bone Screws and Wright Compression Screws." (Specifically from worst-case pull out testing) |
| Be manufactured from biocompatible material (Titanium alloy) | Device is manufactured from titanium alloy. |
| Maintain the same indications for use, diameter, and size range as predicates | "The subject screws are identical in indication for use, diameter, size range and material to the predicates..." |
| No new types of safety and effectiveness questions | "...differ only in screw neck radii. No new types of safety and effectiveness questions can be expected." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a number of screws. The term "worst-case pull out testing" implies a representative sample was tested, but the exact count is not provided.
- Data Provenance: Not applicable. This is not clinical data but mechanical testing performed by the manufacturer. The location of the testing laboratory is not specified but would typically be internal to the manufacturer or a third-party testing facility. It is a prospective test in the sense that the new device was manufactured and then tested.
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. This submission does not involve clinical data or medical images requiring expert interpretation or ground truth establishment in that context. The "ground truth" here is the physical mechanical strength measured in a laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication method is relevant for mechanical pull-out testing. The "adjudication" is based on comparing measured force values against predicate device performance or established standards.
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 not a study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing is the measured mechanical strength (specifically pull-out force) of the screws, as determined through standardized laboratory testing procedures. The comparison is made against the measured mechanical performance of legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device requiring a training set.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.