(67 days)
The subject femoral head is a single-use device intended for use in total hip replacement. It is intended for use with any currently available Howmedica Osteonics acetabular component. It is intended for use with any currently available Howmedica Osteonics hip stem featuring the V40™ trunnion and manufactured from a titanium alloy or Orthinox™ Stainless Steel. It is not intended for use with any stem manufactured from cobalt chromium alloy.
Indications:
- Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative . arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable uing other techniques;
- Revision procedures where other treatments or devices have failed. .
The subject Alumina V40™ Femoral Heads and the predicate Alumina V40™ Femoral Heads (#K003413) are manufactured from the same materials using the same manufacturing processes. They share the same indications for use and are of nearly identical design. The subject Alumina V40™ Femoral Heads differ from the predicate Alumina V40™ Femoral Heads as follows:
-
- An improved taper grinding technique provides a smoother taper surface finish. This smoother taper surface finish yields stronger ball heads that can now be used with Orthinox™ stainless steel stems (in addition to the titanium alloy stems previously cleared for use with the predicate femoral heads).
This document is an FDA 510(k) premarket notification for a medical device: Alumina V40™ Femoral Heads. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics as might be seen for novel high-risk devices.
Therefore, the information requested regarding acceptance criteria, study data, sample sizes, expert involvement, and reader studies is largely not applicable or not present in this type of regulatory document.
Here's an explanation based on the provided text:
-
This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is typically done by showing similar indications for use, technological characteristics, and performance. It does not generally require new clinical studies proving safety and efficacy against predefined acceptance criteria in the same way a PMA (Premarket Approval) submission would.
-
Focus on Technological Comparison: The document explicitly states the basis of the submission: "The subject Alumina V40™ Femoral Heads and the predicate Alumina V40™ Femoral Heads (#K003413) are manufactured from the same materials using the same manufacturing processes. They share the same indications for use and are of nearly identical design." The key difference is "an improved taper grinding technique provides a smoother taper surface finish," leading to "stronger ball heads that can now be used with Orthinox™ stainless steel stems."
Therefore, many of the specific questions about acceptance criteria, study design, and performance metrics are not addressed in this document because the regulatory pathway (510(k)) does not typically require them in this format.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in this context. This 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device through material and manufacturing process similarity, and an improved mechanical aspect. No specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy for a diagnostic device) or device performance against a predefined threshold are stated. The "performance" mentioned is an improved taper surface finish leading to "stronger ball heads" and expanded compatibility.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| None explicitly outlined as quantitative acceptance criteria for clinical or specific device performance beyond equivalence. | Improved taper grinding technique yields a smoother taper surface finish, resulting in stronger ball heads. |
| Expanded compatibility with Orthinox™ stainless steel stems (in addition to previously cleared titanium alloy stems). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. No clinical or performance test set data, sample sizes, or data provenance are mentioned in this 510(k) summary. The "test" here refers to the comparison against the predicate and the mechanical improvement, which would typically involve engineering testing rather than patient data.
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)
- Not Applicable. This type of information is generally relevant for diagnostic devices or those requiring expert review of outcomes. For a femoral head component with a technological improvement, this is not a consideration in a 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no clinical or expert-reviewed test set is described, there's no adjudication method.
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 an artificial hip component, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable in the traditional sense of clinical "ground truth." The "ground truth" for this submission is based on the technological characteristics and performance of the predicate device, against which the new device is compared to establish substantial equivalence, and mechanical testing results to support the "stronger ball heads" claim.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm or a clinical trial is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. As no training set is mentioned, this question is not relevant.
§ 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.