(113 days)
Balance® Hip System Standard Femoral stems:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Correction of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
The Balance® Hip System Standard Femoral stems are intended for uncemented use only.
Balance® Hip System Microplasty® stems:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed femoral head resurfacing components.
The Balance® Hip System Microplasty® Stems are intended for uncemented use only.
The Balance® Hip System Femoral stems are collarless, porous coated stems available in 10mm increments of length. The proximal geometry of the Balance® Hip System Standard and Microplasty® stems provide immediate three point (anterior-proximal, inferior-medial, and distal-lateral) fixation. The top of the stems have a threaded hole to accommodate the inserter / extractor tool.
This is a 510(k) premarket notification for the Balance® Hip System and as such describes demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance as one might see for a novel device. The document repeatedly states that the new device, the Balance® Hip System, is "substantially equivalent" to predicate devices. There is no independent study with acceptance criteria and a reported device performance. The only performance data mentioned is for "non-clinical testing," which "demonstrates that the Balance® Hip System is technically equivalent to the predicate femoral hip stems."
Therefore, for this particular document, I cannot fulfill all sections of your request as it pertains to a new device performance study with acceptance criteria.
However, I can extract the following information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no formal table of "acceptance criteria" or "reported device performance" against such criteria in the context of a new efficacy study. The submission asserts substantial equivalence to predicate devices. The "performance" is implicitly that the device performs equivalently to the listed predicates in a non-clinical setting.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices (Mallory-Head® Total Hip System, Mayo Conservative Hip Prosthesis, Bi-Metric® Total Hip System) in terms of materials, design, and indications for use. | Non-clinical testing determined that the stems are substantially equivalent to the predicate stems and technically equivalent to predicate femoral hip stems. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document refers to "non-clinical testing" rather than a clinical trial with a defined test set of patients. The testing details (e.g., number of components tested) are not provided.
- Data Provenance: The testing is "non-clinical" and likely conducted in a laboratory setting. No country of origin for such data is specified, but the applicant is based in Warsaw, Indiana, USA. The testing is not described as retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study involving expert assessment of clinical outcomes or images where ground truth would be established by experts. The "ground truth" for substantial equivalence would be based on engineering principles and comparisons to existing devices.
4. Adjudication method for the test set:
Not applicable, as there is no clinical test set requiring adjudication in the context of this submission.
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 submission is for an orthopedic implant (hip stem), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this submission is for an orthopedic implant, not an algorithm or software device.
7. The type of ground truth used:
The "ground truth" for this 510(k) submission is the established performance and safety of the predicate devices (Mallory-Head® Total Hip System, Mayo Conservative Hip Prosthesis, Bi-Metric® Total Hip System). The new device is deemed "substantially equivalent" based on comparison to these known devices, using material properties, design specifications, and non-clinical performance data (e.g., mechanical testing).
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" in this 510(k) submission for an orthopedic implant.
9. How the ground truth for the training set was established:
Not applicable.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.