(82 days)
The INTERSEAL® Acetabular Cup is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The INTERSEAL® Acetabular Screw Hole Plug provides an optional filler for INTERSEAL® acetabular shell screw holes to prevent a pathway for wear debris through unused screw holes holes during placement of the acetabular shell without screws. The INTERSEAL® Acetabular Screw Hole Plug is machined from ultra high molecular weight polyethylene (UHMWPE) conforming to ASTM F 648. The one-piece, snap-in design will be offered sterile in a pack of up to four plugs for insertion into the screw holes of the INTERSEAL® Acetabular Cup by the surgeon during implantation.
The provided text focuses on the 510(k) summary for a medical device called the INTERSEAL® Acetabular Screw Hole Plug. It describes the device, its indications for use, and a brief summary of a single test. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a comprehensive study proving the device meets those criteria.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Properties: Met or exceeded minimum requirements of ASTM F 648. | EtO-sterilized components and control unsterilized UHMWPE bar stock meet or exceed the minimum requirements of ASTM F 648. |
Missing Information: The specific quantitative "minimum requirements" of ASTM F 648 are not detailed in this document. Only a qualitative statement of compliance is given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not specify the sample size used for the tensile properties testing, nor does it provide any information on data provenance (country of origin, retrospective/prospective).
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)
This question is not applicable to the type of testing described. The "ground truth" for tensile properties is established by the ASTM F 648 standard, which defines the physical and mechanical properties of UHMWPE. It doesn't involve expert interpretation in the way, for example, a diagnostic imaging study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication is typically used in studies involving subjective assessment or multiple expert opinions to establish a ground truth. For materials testing like tensile properties, the results are objectively measured against a standard.
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 question is not applicable. The device is a physical implant (an acetabular screw hole plug), not an AI-assisted diagnostic tool or an imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as the device is a physical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance in terms of tensile properties is defined by the ASTM F 648 standard for Ultra-High-Molecular-Weight Polyethylene (UHMWPE) for surgical implants.
8. The sample size for the training set
This question is not applicable. The device is a physical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for a physical implant.
In summary:
The provided text details the regulatory submission for a physical medical device. The "acceptance criteria" discussed are related to the material properties of the device, specifically its tensile properties, which are shown to meet an existing industry standard (ASTM F 648). The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive, detailed study report with all the specifics of experimental design, sample sizes, and expert panel configurations that would be present in a clinical trial or AI performance study.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.