(85 days)
Components of the Inter-Op™ HA Porous Acetabular System are intended to replace the acetabulum during total hip arthroplasty. The four metallic shell styles are porous coated and used in conjunction with a snap-in polyethylene liner. The acetabular components of this system are intended to achieve biological fixation to bone without the use of bone cement.
While three of the shell styles are hemispherical, the Protrusio HA Porous Shell is designed to compensate for protrusio defects where there has been thinning of the medial and superior walls of the acetabulum. The inner diameter is hemispherical while the outer shell has a 10mm build up, thus maintaining the anatomical hip center and avoiding the medialization of the femoral component.
Diagnostic indications for use of components of the Inter-Op HA Porous Acetabular System include:
- revision of a previously implanted acetabular prosthesis;
- patient conditions of noninflammatory degenerative joint disease; e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies; and,
- inflammatory joint disease; e.g., rheumatoid arthritis.
The Inter-Op™ HA Porous Acetabular System consists of a Ti-6Al-4V alloy (ASTM F136) shell which utilizes a polyethylene snap-in liner. Hydroxylapatite (HA) coated Cancellous Structured Titanium™ (CSTi™) porous coating provides biological fixation in a cementless application. The shells are available in a variety of sizes and designs to address different clinical situations in both primary and revision arthroplasties. Inter-Op HA Porous Acetabular Components are recommended for use with all Sulzer Orthopedics total hip replacement devices.
The system includes two primary designs: (1) a hemispherical shell with an offset outer radius in the rim region, which permits the loads to be transmitted to the periphery of the outer surface; and (2) a hemispherical shell with two plugged screwholes. The plugs may be removed intraoperatively for additional screw fixation, if desired. A dome hole plug is also provided.
Two multi-holed shells designed for screw application are provided for those clinical situations in which deficient bone stock exists in the acetabulum. Those screwholes that are not utilized may be plugged after implantation. This shell is available in two designs: (1) a standard hemispherical cup, and (2) a protrusio cup which adds 10mm of thickness of the medial wall over a standard hemispherical cup to address protrusio deficiencies in the acetabulum. A dome hole plug is also provided.
All the shell designs share identical internal geometry and locking mechanism thereby accepting any of the acetabular liners designed for this system. The acetabular liner is manufactured from Ultra-High Molecular Weight Polyethylene, or UHMWPE (ASTM F648) and is offered in various configurations in order to address different clinical situations. The liners are also available in a variety of sizes to accommodate available femoral head components.
The provided document is a 510(k) summary for a medical device (Inter-Op™ HA Porous Acetabular System), primarily focused on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or a detailed engineering validation might.
Instead, the document states that the device is "substantially equivalent" to existing marketed devices. This regulatory pathway means that extensive new clinical efficacy studies with predefined acceptance criteria are typically not required, as the safety and effectiveness are presumed to be similar to the established predicate devices.
Therefore, most of the information requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this type of regulatory submission. The focus is on demonstrating similar characteristics and intended use.
However, I can extract what limited relevant information is present:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state acceptance criteria in a quantitative table with specific metrics that were "met." It rather states:
| Feature/Performance Aspect | Reported Device Performance (vs. Predicate) |
|---|---|
| Locking Mechanism Integrity | The strength of the locking mechanism compares favorably to other currently marketed devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable/Not provided. The document does not describe a clinical "test set" in this context. The evaluation was likely based on engineering tests and comparison to predicate device specifications.
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/Not provided. Ground truth establishment for a diagnostic device or a comparative clinical study is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided.
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/Not provided. This is a medical device (hip prosthesis), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/Not provided in the context of a "test set" for performance evaluation. The "ground truth" for this device would be its ability to provide biological fixation and function as a hip replacement, which is inferred through its similarity to predicate devices and general knowledge of orthopedic implants.
8. The sample size for the training set:
Not applicable/Not provided. This type of device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable/Not provided.
Summary based on the provided text:
The submission for the Inter-Op™ HA Porous Acetabular System is a 510(k) premarket notification. The core of this submission is a demonstration of substantial equivalence to legally marketed predicate devices, rather than an independent demonstration of meeting new, specific acceptance criteria through a clinical study. The only performance aspect explicitly mentioned is the integrity of the locking mechanism, which "compares favorably to other currently marketed devices," implying a comparison against established industry standards or predicate device performance, rather than a novel, quantitative acceptance criterion. The FDA's letter explicitly states, "The data presented support equivalence with no additional claims over a conventional porous-coated uncemented hip prosthesis (i.e., biological fixation only)."
§ 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.