(89 days)
· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
· Dislocation risks
When used with Constrained Liner:
· The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration® Anatomic Shell is indicated for cementless use only.
The Restoration Anatomic Shell is a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The subject device substrate is manufactured from Ti-6Al-4V ELI alloy and has a porous CP-Ti coating. The materials, design features and screw hole locations of the Restoration Anatomic Shell are identical to the primary predicate device cleared in K142462. The purpose of this submission is to add compatibility of Trident Polyethylene Liners and clarify the indications for use for specific compatible liners.
This document is a 510(k) premarket notification for a medical device and therefore describes a device that is substantially equivalent to a predicate device. Information regarding acceptance criteria and detailed study results as requested in the prompt are generally not included in 510(k) summaries to the same extent as they would be for a PMA application or a clinical trial publication.
Based on the provided text, the device is the Restoration Anatomic Shell, which is a hip joint prosthesis component. The submission is for adding compatibility with Trident Polyethylene Liners and clarifying indications for use.
Here's an analysis of the provided information, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the form of numerical thresholds or performance targets for a device that uses AI/algorithm. Instead, it refers to non-clinical testing performed to establish substantial equivalence to predicate devices. This type of regulatory submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The non-clinical tests performed are:
| Test Type | Reported Device Performance |
|---|---|
| Lever-out Test of a Trident Polyethylene Liner in a Trident Shell | Not detailed in the provided text, presumably met internal criteria for substantial equivalence. |
| Push-out Test of a Trident Polyethylene Liner in a Trident Shell | Not detailed in the provided text, presumably met internal criteria for substantial equivalence. |
| Lever-out Test of a Trident Constrained Polyethylene Liner in a Trident Shell | Not detailed in the provided text, presumably met internal criteria for substantial equivalence. |
| Range of Motion for the Trident 0° Constrained Acetabular Liner | Not detailed in the provided text, presumably met internal criteria for substantial equivalence. |
Important Note: This document does not describe the acceptance criteria or performance of an AI/algorithm-based device. It pertains to a physical medical device (a hip prosthesis component).
Regarding AI/Algorithm-specific questions (which are not applicable to this document):
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device, not an AI algorithm.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Additional Information from the Document:
- Study Type: Non-clinical laboratory testing.
- Clinical Testing: The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.
- Basis for Equivalence: The submission claims substantial equivalence to predicate devices (Restoration Anatomic Shell K142462 and Trident Porous Titanium Acetabular Shell K010170) in terms of intended use, indications, design, materials, performance characteristics, and operational principles.
- Device Description: The device is a sterile, single-use, cementless acetabular shell made from Ti-6Al-4V ELI alloy with a porous CP-Ti coating. Its design features and screw hole locations are identical to its primary predicate. The submission focuses on adding compatibility with different liners.
§ 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.