(21 days)
The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The ORTHOLOC™ SPS Shoulder Plating System is designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking screws manufactured from stainless steel per ASTM F2229 and non-locking screws manufactured from stainless steel per ASTM F138 or ASTM F2229. The system is provided non-sterile and requires steam sterilization prior to use.
The provided text is a 510(k) premarket notification for a medical device called the ORTHOLOC™ SPS Shoulder Plating System. This type of document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than presenting a study proving a device meets specific clinical performance acceptance criteria.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance studies are not available within this document because clinical studies were not performed.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Screw Torsion (ASTM F543-17) | Passed all testing with the same acceptance criteria as the predicate device. |
| Driving Torque (ASTM F543-17) | Passed all testing with the same acceptance criteria as the predicate device. |
| Axial Pullout (ASTM F543-17) | Passed all testing with the same acceptance criteria as the predicate device. |
Note: The specific numerical acceptance criteria from ASTM F543-17 are not detailed in this document, only that the device met them and they were the same as the predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified for the bench testing. The document states "No clinical studies were performed."
- Data Provenance: The document refers to "non-clinical bench testing" performed to ASTM F543-17 standards. This implies laboratory-based testing, not human or animal data. No country of origin for the data is specified, but the applicant company is located in Bloomington, MN, USA. The testing is prospective for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information pertains to studies involving human interpretation or clinical outcomes. Since only non-clinical bench testing was performed, no experts were used to establish ground truth in this context. The "ground truth" for bench testing would be the physical measurements against engineering specifications.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions or diagnoses. For bench testing, results are typically determined by instrumental measurements and adherence to test 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:
- No. An MRMC comparative effectiveness study was not performed. This document is for a mechanical orthopedic implant, not an AI-assisted diagnostic device, and no clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. A standalone performance study was not performed. This device is a mechanical implant, not an algorithm or AI system.
7. The type of ground truth used:
- For the non-clinical bench testing, the "ground truth" would be engineering specifications and the established performance criteria within ASTM F543-17. There is no pathology or outcomes data mentioned.
8. The sample size for the training set:
- Not applicable. There is no training set mentioned as no clinical studies or AI/machine learning development were discussed. The device itself (the implant) does not have a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth for one.
§ 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.