(106 days)
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The R3 HA Coated Acetabular Shells are line additions to the existing R3 Acetabular System. The R3 HA Coated Acetabular Shells have the same design as the existing R3 Shells. The difference is the addition of HA coating. The R3 Ha Coated Acetabular Shells will be offered in No-Hole, 3-Hole and Multi-Hole design options. The R3 HA Coated Acetabular Shells will be used with existing R3 Acetabular Liners and accessories and existing Smith & Nephew femoral heads and femoral stems.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
Based on the provided FDA 510(k) summary for the "R3 HA Coated Acetabular Shells," there is no specific information on acceptance criteria for a device performance study or any human-in-the-loop or standalone AI performance studies.
This document is a 510(k) clearance for a hip implant, which typically focuses on demonstrating substantial equivalence to a predicate device rather than complex AI performance metrics. The clearance is for a medical device (hip implant), not a software or AI-driven diagnostic/treatment device.
Therefore, many of the requested categories for AI-related studies (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training set details) are not applicable to this document.
Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI-specific performance criteria:
Acceptance Criteria and Study for R3 HA Coated Acetabular Shells
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | The locking mechanism should perform as intended and meet applicable requirements to ensure safety and effectiveness when used with existing R3 Acetabular Liners and accessories. The overall mechanical characteristics should be substantially equivalent to predicate devices. | The document states: "The locking mechanism is the same as for the predicate R3 acetabular shell. Therefore, all testing previously conducted confirmed that the device should perform as intended." This implies that the device did perform as intended, meeting established mechanical performance benchmarks derived from the predicate device's prior successful testing. |
| Coating Performance | StikTite coating and hydroxyapatite (HA) coating must meet applicable FDA guidance requirements. This would include aspects like adhesion, biocompatibility, and perhaps dissolution rates for HA. | The document states: "Testing conducted on the StikTite coating and hydroxyapatite according to FDA guidance confirmed that the coatings met applicable requirements." This directly confirms that the coating performance met the specified regulatory standards and guidance, indicating successful testing outcomes. |
| Biocompatibility | Materials used (including coatings) must be biocompatible and raise no new questions of safety or effectiveness compared to predicate devices. | The document states: "The R3 HA Coated Acetabular Shells are manufactured from the same materials as the listed predicates." and "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness." This implicitly confirms biocompatibility through comparison to already cleared predicate devices using the same materials, suggesting the materials meet established biocompatibility norms. |
| Indications for Use | The device's intended use should align with the predicate devices and be appropriate for primary and revision surgery in cases of trauma, NIDJD, inflammatory degenerative joint disease, and various fracture/deformity corrections. | The Indications for Use section is identical to general indications for hip components, and the comparison section explicitly states, "The R3 HA Coated Acetabular Shells are technologically substantially equivalent to predicate devices in terms of intended use..." This confirms that the device is deemed appropriate for the stated indications, having met the implicit criteria of comparable intended use and safety/effectiveness for those indications. |
| "No New Questions" | The materials, design, mechanical performance, and safety of the R3 HA Coated Acetabular Shells should not raise any new questions of safety or effectiveness compared to the predicate devices. | The conclusion states: "The R3 HA Coated Acetabular Shells are technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety." and "any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device." This is the ultimate acceptance criterion for 510(k) clearance and was met. |
Summary of the Study Proving Acceptance Criteria were Met:
The study proving the device met the acceptance criteria was a non-clinical performance testing effort, specifically focusing on mechanical testing of the locking mechanism and coating evaluation for both StikTite and hydroxyapatite. This testing was conducted according to FDA guidance. The central argument for substantial equivalence relies on the fact that the R3 HA Coated Acetabular Shells share the same design (other than the HA coating), materials (with the addition of HA), and locking mechanism as already cleared predicate devices.
Regarding AI-Specific Information (Not Applicable to this Document):
The following points are not addressed in the provided 510(k) summary because this document pertains to a physical medical implant, not an AI software component or an AI-assisted diagnostic/treatment system.
- Sample size used for the test set and the data provenance: Not applicable. (No AI test set described)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No AI ground truth described)
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. (No AI test set described)
- 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. (No AI component to evaluate)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (No AI component to evaluate)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. (No AI ground truth described)
- The sample size for the training set: Not applicable. (No AI training set described)
- How the ground truth for the training set was established: Not applicable. (No AI ground truth described)
In conclusion, this document demonstrates that the R3 HA Coated Acetabular Shells met the acceptance criteria for a 510(k) clearance by proving substantial equivalence to predicate devices through non-clinical mechanical and coating performance testing, consistent with FDA guidance. It does not involve any AI components or related performance studies.
§ 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.