(79 days)
EXPRT™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.
The provided document is a 510(k) premarket notification for a medical device called the EXPRT™ Revision Hip System. This type of notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not include extensive clinical study data with acceptance criteria for device performance as would be found in a PMA (Premarket Approval) application or a more comprehensive clinical trial report for AI/software devices.
Instead, the document focuses on demonstrating substantial equivalence based on indications for use, material, design features, dimensions, surgical implantation technique, intended use, packaging, sterilization, and non-clinical testing.
Therefore, many of the requested items regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or not provided in this specific FDA 510(k) document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics often associated with AI/diagnostic devices. Instead, the "performance" here refers to the device's ability to meet non-clinical testing standards and be substantially equivalent to predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrates substantial equivalence to predicate devices in Indications, Material, Design, Dimensions, Surgical Technique, Intended Use, Packaging, Sterilization | "All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified." |
| Fatigue testing standards | "Fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices." |
| Bacterial endotoxin levels | "Bacterial endotoxin testing is equivalent to the previously cleared system." |
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 as a formal clinical test set with specific sample sizes. The "testing" mentioned refers to non-clinical fatigue and endotoxin testing, not a clinical study on human subjects with a test set.
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 as there was no clinical study or test set requiring expert-established ground truth for performance evaluation of a diagnostic or AI algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as there was no clinical study or test set requiring adjudication.
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
An MRMC study is not applicable as this is a physical medical device (hip replacement system), not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable for the purpose of this 510(k). The "ground truth" for the device's safety and effectiveness is largely based on its similarity to legally marketed predicate devices and its ability to pass non-clinical engineering and material tests.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device.
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”