(60 days)
The ORTHOLOC™ 2 Lapidus with Rotation System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include: Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion).
The ORTHOLOC™ 2 Lapidus with Rotation System is designed to facilitate arthrodesis of the first metatarsal-cuneiform joint, or Lapidus fusion. The system achieves its intended effect through the use of plates of various designs and both locking and non-locking screw configurations.
The provided text is a 510(k) summary for the ORTHOLOC™ 2 Lapidus with Rotation System, a bone fixation device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where the device meets acceptance criteria defined by performance metrics like sensitivity or specificity.
Therefore, this document does not contain the requested information regarding acceptance criteria, reported device performance (in terms of clinical metrics), sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML device.
Instead, the submission relies on non-clinical evidence to demonstrate substantial equivalence to a legally marketed predicate device.
Here's what can be extracted from the document regarding the "study" that proves the device meets acceptance criteria (in the context of a 510(k) for a traditional medical device):
Acceptance Criteria and Device Performance (in the context of a traditional device):
The "acceptance criteria" here are implicitly related to the performance of the predicate device and established standards for metallic bone fixation appliances. The device is deemed to meet these criteria if its performance is comparable and safe.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength as per ASTM F382 (Static Four-Point Bend) | Testing conducted; results indicate performance comparable to predicate. |
| Absence of pyrogens (Pyrogenicity Analysis per ANSI/AAMI ST72:2011) | Testing conducted; results indicate the device is non-pyrogenic. |
| Material composition (Titanium Alloy) | Identical materials as the legally marketed predicate device. |
| Sterilization methods | Identical sterilization methods as the legally marketed predicate device. |
Detailed breakdown of your requested information based on the provided text:
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A table of acceptance criteria and the reported device performance
See the table above. The "acceptance criteria" for a 510(k) are typically that the new device performs at least as well as the predicate and meets relevant safety standards and performance specifications from recognized standards. Specific numerical performance metrics (like sensitivity/specificity for AI) are not provided for this type of device. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a traditional medical device (bone plate) and the "testing" refers to benchtop engineering tests, not a clinical study with patient data in the way an AI/ML device would. No patient data or clinical test sets are mentioned. -
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. Ground truth for clinical data is not relevant here as no clinical data studies are presented. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical data test set. -
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 an AI-assisted device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" would be the established physical and chemical properties of the materials and the performance standards defined by ASTM and ANSI/AAMI. -
The sample size for the training set
Not applicable. No training set for an AI/ML algorithm is mentioned. -
How the ground truth for the training set was established
Not applicable. No training set for an AI/ML algorithm.
In summary, the provided document is a 510(k) submission for a non-AI bone fixation device. The "studies" conducted are non-clinical engineering tests (static four-point bend, pyrogenicity analysis) to demonstrate its physical performance and safety characteristics are substantially equivalent to a predicate device and meet established standards. It does not contain the type of AI/ML-specific performance metrics or study details you requested.
§ 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.