(21 days)
The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC° bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
PERI-LOC° Locking Bone Plates and Locking Bone Screws for the Upper Extremity are line additions to the PERI-LOC* Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking bone screws made from stainless steel. PERI-LOC* locking bone plates and locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
The provided text is a 510(k) summary for the PERI-LOC® Locking Bone Plates and Locking Bone Screws for the Upper Extremity. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device would.
Therefore, much of the requested information cannot be extracted from this particular document, as it describes a mechanical implant device and not a diagnostic algorithm. Specifically, there is no mention of a "study that proves the device meets acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or accuracy for diagnosis.
However, I can extract the general intent behind the acceptance criteria for a medical device seeking 510(k) clearance, which is substantial equivalence to legally marketed predicate devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criterion for a 510(k) submission like this is Substantial Equivalence to legally marketed predicate devices. The "reported device performance" is that it is substantially equivalent.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition." The FDA's letter states: "we have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your became o ready fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to togethy the enactment date of the Medical Device Amendments, or to conninered print to may 20, 1978, in ecordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a mechanical implant like this, the "test set" would typically refer to mechanical bench testing or sometimes limited animal or cadaveric studies, not clinical data in the sense of patient-derived data for diagnostic performance.
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/relevant for this type of device and submission. Expert consensus for ground truth is typically for diagnostic classification tasks, which this device does not perform.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/relevant for this type of device and submission. Adjudication methods are used to establish ground truth in diagnostic studies.
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/relevant. This is a mechanical implant device, not an AI diagnostic system that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/relevant. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/relevant in the context of diagnostic ground truth. For a mechanical device, performance is typically evaluated through mechanical testing (e.g., strength, fatigue, torsional stability) and comparison to the predicate, potentially with some in vivo or in vitro biomechanical studies. The document does not detail these specific tests, but infers their comparison to predicate devices.
8. The sample size for the training set
This information is not applicable/relevant. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/relevant. This is not an AI/ML 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.