(98 days)
The Smith & Nephew Conquest FN is indicated for displaced intracapsular femoral neck fractures.
The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional lengths of the proximal locking compression screws to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.
The provided document is a 510(k) premarket notification for a medical device called CONQUEST FN, which is an internal fracture fixation device. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing (axial pullout strength).
It does not contain information related to a study proving the device meets acceptance criteria based on its performance in interpreting medical images or diagnosing conditions. The acceptance criteria described are for mechanical properties of the device (e.g., pullout strength), not for AI/ML performance metrics like sensitivity, specificity, or AUC which would be relevant to an imaging-based AI device.
Therefore, I cannot provide a response that includes the requested information regarding:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy.
- Sample size used for the test set and data provenance (as no such test set is described for diagnostic performance).
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study.
- Standalone performance.
- Type of ground truth used (clinical outcomes, pathology, expert consensus).
- Sample size for the training set.
- How ground truth for the training set was established.
The document is primarily a regulatory submission for a physical orthopedic implant, not an AI/ML-driven diagnostic imaging device. The "acceptance criteria" mentioned in the document refer to engineering/biomechanical performance standards for the implant itself, such as axial pullout strength, and bacterial endotoxin limits for sterility.
Summary of relevant information from the document (limited to what is present):
Acceptance Criteria and Performance (related to the physical device):
- Acceptance Criteria for Axial Pullout Strength: Not explicitly quantified in the provided text, but stated as "met the acceptance criteria" for two different tests. These criteria likely refer to specific biomechanical standards or comparisons to predicate devices.
- Reported Device Performance for Axial Pullout Strength:
- OR-17-111: "Result concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior axial pullout strength compared to the predicate device [Targon FN Titanium System]."
- OR-17-164: "Results of the test concluded that the CONQUEST FN proximal locking screws met the acceptance criteria and exhibited similar or superior axial pullout strength as compared to the predicate device [cannulated screws]."
- Acceptance Criteria for Sterility: "Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance, 'Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile,' 'Pyrogen and Endotoxin Testing: Questions and Answers,' and ANSI/AAMI ST72."
- Reported Device Performance for Sterility: "met the acceptable endotoxin limits."
Other information:
- Sample size for testing pullout strength: Not specified.
- Nature of data: Pre-clinical (mechanical testing in a lab setting), not human patient data.
- Ground truth: For mechanical tests, the "ground truth" is the measured physical property (axial pullout strength) compared against a defined standard or predicate performance. For sterility, it is the endotoxin level measurement compared to the standard. This is not "ground truth" in the diagnostic sense.
- No information on AI/ML components or studies for diagnostic performance is present in this document.
§ 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.