Search Results

1. Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previous failed total hip arthroplasty.

The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

The Parallel-Sided Extensively Coated Femoral Stem is designed to replace the patural femoral hip component due to disease or accident. The femoral hip prosthesis is made from wrought titanium alloy (Ti-6AI-4V) (ASTM F136) and has a porous coat, designed to be used in uncemented applications. The stem diameters and lengths are within the range of the previously cleared predicates. In addition to the cylindrical stem design, the Parallel-Sided Extensively Coated Femoral Stem offers a lateralized offset for optimal patient fit.

The provided document describes a 510(k) premarket notification for the "Parallel-Sided Extensively Coated Femoral Stem" device. Upon review of the document, the following observations can be made regarding acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance:

   The document does not explicitly define specific quantitative acceptance criteria for the device's performance. Instead, it states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This approach is typical for 510(k) submissions, where the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device rather than meeting pre-defined quantitative performance thresholds.

   Acceptance Criteria	Reported Device Performance
   Demonstration of "substantial equivalence" to predicate devices (Reach® Revision System- K982367, AML® Hip Stem- K012364, XR-Series Bi-Metric® Femoral Stems- K052089)	"The technological characteristics (materials, design, sizing, and indications) of the Parallel-Sided Extensively Coated Femoral Stem are similar or identical to the predicate devices or to other previously cleared devices."
   "Functional within its intended use" based on non-clinical testing. (Intended use: femoral hip component replacement due to disease or accident, uncemented applications).	"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." (However, specific performance metrics or thresholds are not detailed in this summary).
   Material composition (wrought titanium alloy (Ti-6AI-4V) (ASTM F136)) and porous coating for uncemented applications.	The device is made from "wrought titanium alloy (Ti-6AI-4V) (ASTM F136)" and "has a porous coat, designed to be used in uncemented applications."
   Stem diameters and lengths within the range of previously cleared predicates.	"The stem diameters and lengths are within the range of the previously cleared predicates."
   Presence of a lateralized offset (as an additional feature).	"In addition to the cylindrical stem design, the Parallel-Sided Extensively Coated Femoral Stem offers a lateralized offset for optimal patient fit." (This is a design feature, not a performance metric per se, but supports "optimal patient fit" as an intended functional outcome).

2. Sample size used for the test set and the data provenance:

   The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means there was no human-patient-based test set with associated data provenance for this specific 510(k) submission. The evaluation relied solely on non-clinical (laboratory) testing and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Not applicable, as no clinical test set was used, and therefore, no expert-established ground truth for a test set was required for this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   Not applicable, as no clinical test set was used.

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:

   Not applicable. This device is a physical orthopedic implant, not an AI or imaging diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its evaluation.

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

   Not applicable. This device is a physical orthopedic implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   For the "non-clinical laboratory testing," the ground truth would be established by engineering standards, material specifications, mechanical testing protocols (e.g., fatigue, static strength, wear), and performance benchmarks derived from the predicate devices. This would involve objective measurements and comparisons against established industry and regulatory standards for orthopedic implants.

8. The sample size for the training set:

   Not applicable in the context of clinical data for AI/ML. For the non-clinical testing, the "sample size" would refer to the number of devices tested in laboratory experiments (e.g., how many stems were subjected to fatigue testing). This information is not provided in the summary.

9. How the ground truth for the training set was established:

   Not applicable in the context of clinical data for AI/ML. For the non-clinical testing, the "ground truth" or validation data would be established through adherence to national and international standards for medical device testing (e.g., ASTM, ISO standards for hip implants), recognized testing methodologies, and comparison to the known performance characteristics of the predicate devices.

Ask a specific question about this device