(87 days)
General Indications for the Segmental System:
- This device is indicated for: .
- Moderate to severe knee instability
- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle
- Valgus, varus or flexion deformities
- The salvage of previously failed surgical attempts
Indications specific to the Variable Stiffness Stem extensions:
- Variable Stiffness stem extensions require the t use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone, but the remainder of the stem must be used uncemented.
The Variable Stiffness Stem extensions are intended to be used in the proximal and mid-shaft portion of the femur. They are available in either straight or bowed geometry and are made from Zimaloy™ Cobalt-Chromium-Molybdenum Alloy.
The Intercalary Segments are intended for the replacement of the mid-shaft portion of the femur or for use as a segment connected to other Zimmer® Segmental System components. They are made from Tivanium™ Ti-6Al-4V Alloy.
The provided text describes the Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments, a total hip prosthesis. The information focuses on its regulatory clearance (K081860) and comparison to predicate devices. However, it explicitly states:
"Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This indicates that the acceptance criteria were based on non-clinical (lab) performance testing, and no clinical study was conducted or required for this 510(k) clearance. Therefore, a direct answer to some of the requested points, particularly those related to a clinical study, cannot be provided from the given document.
Here's the breakdown of the available information:
Acceptance Criteria and Device Performance
Since clinical data was not required, the acceptance criteria and performance are based on non-clinical (lab) testing comparing the device to its predicate devices. The document implies that the device met these non-clinical criteria by stating: "Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety | Demonstrated as safe through non-clinical (lab) performance testing. |
| Effectiveness | Demonstrated as effective through non-clinical (lab) performance testing. |
| Manufacturing/Sterilization | Manufactured, packaged, and sterilized using the same materials and processes as the predicate devices. |
| Intended Use | Has the same intended use as the predicate devices. |
| Fixation Methods | Has the same fixation methods as the predicate devices. |
| Material Composition | Stem extensions: Zimaloy™ Cobalt-Chromium-Molybdenum Alloy. |
| Intercalary Segments: Tivanium™ Ti-6Al-4V Alloy. (These materials are implicitly accepted as safe and effective, likely based on predicate device history and material biocompatibility standards). |
Detailed Information Regarding the Study (where applicable from provided text)
-
Sample size used for the test set and the data provenance: Not applicable, as clinical studies with patient test sets were not performed or required. The testing referred to as "non-clinical (lab) performance testing" would involve mechanical or material samples, not human subjects.
-
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 requiring human expert ground truth was used.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication was used.
-
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 medical implant, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical implant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical (lab) performance testing, the ground truth would likely be based on established engineering benchmarks, material science standards, and performance characteristics of the predicate devices, rather than clinical outcomes or expert consensus on patient data.
-
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set in that context.
-
How the ground truth for the training set was established: Not applicable, as per point 7.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.