(150 days)
Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
- · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
- · Correction of functional deformity
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks
Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
Restoration Modular 115mm Conical Distal Stem Indications for Use:
- · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
· Rheumatoid arthritis; - · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and,
· Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
· Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.
The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty.
The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics' femoral heads, sleeves and acetabular components.
The Insignia Hip Stem is manufactured from Ti6Al4V ELI alloy and the device features hydroxyapatite coating over a commercially pure titanium plasma sprayed surface for cementless fixation.
The subject Restoration Modular 115mm Conical Distal Stem is a part of the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.
The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.
The provided text is a 510(k) summary for the Insignia Hip Stem and Restoration Modular 115mm Conical Distal Stem. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing related to Magnetic Resonance (MR) conditional safety. It does not describe a study involving device performance for its primary function (hip replacement) or human reader performance.
Therefore, many of the requested categories (e.g., effect size of human readers with AI, training set size, ground truth for training set) are not applicable to this document.
Here's a breakdown of the information that is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MR safety testing are implicitly the standards themselves (e.g., ASTM F2052-15). The document states that the components were "evaluated per the following standards" and that "The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned in the MR environment." This implies that the devices met the requirements of these standards to be considered MR Conditional. Specific numerical performance results are not provided in this summary.
| Acceptance Criteria (Measured against ASTM Standards for MR Safety) | Reported Device Performance |
|---|---|
| Magnetically Induced Displacement Force (ASTM F2052-15) | Evaluated per standard; devices are MR Conditional. (Specific numerical data not provided) |
| Magnetically Induced Torque (ASTM F2213-17) | Evaluated per standard; devices are MR Conditional. (Specific numerical data not provided) |
| Image Artifact (ASTM F2119-07 (Reapproved 2013)) | Evaluated per standard; devices are MR Conditional. (Specific numerical data not provided) |
| Heating by RF Fields (ASTM F2182-19) | Evaluated per standard; devices are MR Conditional. (Specific numerical data not provided) |
2. Sample size used for the test set and the data provenance
The study involved testing of the Insignia Hip Stem components and the Restoration Modular 115mm Conical Distal Stem. The sample size refers to the number of device components tested for MR compatibility. This information is not explicitly stated in the summary. The tests are non-clinical (laboratory-based), so data provenance like country of origin or retrospective/prospective is not applicable in the human data sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This category is not applicable. The ground truth for MR safety testing is established by the specifications of the ASTM standards, not by human experts adjudicating medical images or conditions.
4. Adjudication method for the test set
This category is not applicable. The evaluation is based on meeting parameters defined by engineered standards, not on human 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
This category is not applicable. The device is a hip implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This category is not applicable. The device is a hip implant, not an algorithm. The MR safety testing is inherently "standalone" in the sense that it evaluates the physical properties of the device itself.
7. The type of ground truth used
The ground truth for the MR safety testing is defined by the ASTM standards referenced (ASTM F2052-15, ASTM F2213-17, ASTM F2119-07 (Reapproved 2013), ASTM F2182-19). These standards establish protocols and acceptance criteria for classifying medical devices as MR Conditional.
8. The sample size for the training set
This category is not applicable. This is a physical medical device undergoing non-clinical safety testing, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This category is not applicable. As mentioned above, there is no training set.
§ 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.