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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.

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The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from 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 text describes mechanical testing conducted for the CONQUEST FN device to demonstrate its substantial equivalence to predicate devices. However, it does not contain information about a study involving human readers or AI assistance. Therefore, questions related to MRMC studies, human reader improvement with AI, and standalone AI performance cannot be answered from the provided text.

Here's the information extracted from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance:

The document describes pre-clinical mechanical testing. Typically, for such tests, "sample size" refers to the number of devices or constructs tested. The specific number of samples for each test (e.g., how many screws for pullout strength, how many constructs for fatigue) is not provided in the given text.

The data provenance is from pre-clinical mechanical testing conducted by Smith & Nephew, Inc. The country of origin is not explicitly stated for the testing, but Smith & Nephew is based in Memphis, Tennessee, USA. The data is prospective as it was generated specifically for the 510(k) submission to compare the new device against predicates.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This question is not applicable to this type of mechanical testing. Ground truth in this context is established by the physical testing methods and the measured mechanical properties, not by expert consensus on images or pathology.

4. Adjudication Method for the Test Set:

This question is not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert reviews, typically in image interpretation or clinical trials, not for direct physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

No, an MRMC comparative effectiveness study was not done. The provided text focuses exclusively on pre-clinical mechanical testing of a bone fixation device, not on AI-assisted diagnostic or interpretative tasks. Therefore, there is no information on human reader improvement with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. The device being described is a physical medical implant (bone fixation system), not a software algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these tests is mechanical performance metrics derived from standardized or accepted pre-clinical testing methods (e.g., axial pullout strength, insertion torque, torsional strength, fatigue life). The comparison is against established predicate device performance as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. The CONQUEST FN is a physical implant, not an AI model requiring a "training set."

9. How the Ground Truth for the Training Set was Established:

This question is not applicable as there is no training set for a physical implant device.

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