(242 days)
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- Inflammatory joint disease including rheumatoid arthritis
- Correction of functional deformity including congenital hip dysplasia
- Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Components of the Signature Orthopaedics hip replacement range are intended for cementless fixation only.
The system is modular and consists of the Signature Orthopaedics Origin™ and NEO-T Hip Stem, Femoral Heads, and PX-Series and G-Series Acetabular Cups.
The Signature Orthopaedics Origin™ Hip Stem is manufactured from titanium alloy per ASTM F136 and below the resection line is coated with HA per ISO 13779-2. The stem is straight and tapered with a lateral chamfer to aid insertion. The stem has both vertical and horizontal grooves to resist axial and torsional loading.
The Signature Orthopaedics NEO-TTM Hip Stem is a porous coated femoral stem manufactured from titanium alloy per ASTM F136. The proximal stem below the resection line is porous coated with titanium powder per ASTM F1580. The stem is straight and tapered with a rectangular cross-section. The stem has a distal slot and lateral chamfer to ease insertion.
Both stems are available in standard and high offset neck geometries. Each stem's neck has a 12/14 morse taper for connection of a Cobalt Chrome or Ceramic (BIOLOX forte or BIOLOX Delta) femoral head.
The Logical™ PX-Series and G-Series Acetabular Cups are metal backed cementless acetabular cups with highly cross-linked polyethylene liners. Both series of acetabular cup consist of a porous coated shell manufactured from titanium alloy per ASTM F136, and a modular liner manufactured from cross-linked UHMWPE per ASTM F648. The PX-Series and G-Series shells differ in their shell's porous coating. The PX-Series is coated with titanium beads while the G-series is coated with a combination of titanium beads and particles. Both series of cups are available with either no holes or three holes to allow the use of bone screws to supplement fixation.
The provided text describes a 510(k) summary for the "Origin™ Total Hip System," a medical device, which typically focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not describe a study that uses human subjects, expert review, AI, or statistical measures like sensitivity, specificity, or AUC, which are common for AI/ML device evaluations. Therefore, many of the requested categories (2-9) are not applicable to this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" with specific thresholds that the device had to meet, nor does it provide detailed quantitative "reported device performance" against such criteria in a granular manner. Instead, it lists various non-clinical tests performed to verify the device's performance is "adequate for anticipated in-vivo use" and to support substantial equivalence.
| Performance Test | Reported Device Performance (Summary) |
|---|---|
| Range of motion analysis | Performed; adequate for anticipated in-vivo use |
| Articular surface wear simulation | Performed; adequate for anticipated in-vivo use |
| Modular component connection strength testing | Performed; adequate for anticipated in-vivo use |
| Ceramic head burst testing | Performed; adequate for anticipated in-vivo use |
| Femoral stem fatigue testing | Performed; adequate for anticipated in-vivo use |
| Liner impingement testing | Performed; adequate for anticipated in-vivo use |
| Cup Liner Push, Lever Out and Torque Testing | Performed; adequate for anticipated in-vivo use |
| Bone screw torsion testing | Performed; adequate for anticipated in-vivo use |
| Various coating characterization, abrasion, and adhesion strength testing | Performed; adequate for anticipated in-vivo use |
| Various crosslinked UHMWPE characterization, chemical, and mechanical testing | Performed; adequate for anticipated in-vivo use |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A): This document describes non-clinical, in-vitro/mechanical testing, not a study involving human subjects or data that would have a "test set" in the context of an AI/ML device. The "sample size" would refer to the number of physical components tested (e.g., number of femoral stems for fatigue testing, number of ceramic heads for burst testing), but these specific numbers are not provided in this summary. The data provenance is laboratory testing conducted by the manufacturer, Signature Orthopaedics Pty Ltd, in Australia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A): This is a non-clinical device that does not involve expert adjudication or ground truth establishment in the way an AI/ML diagnostic device would. Performance is measured using established engineering standards and methodologies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable (N/A): See #3.
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 (N/A): This document is about a mechanical implant, not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A): This document is about a mechanical implant, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable (N/A): As this is non-clinical testing for a mechanical implant, the "ground truth" is typically defined by engineering standards, physical measurements, and established biomechanical principles rather than expert consensus, pathology, or clinical outcomes data. For example, the ground truth for "femoral stem fatigue testing" would be the point of failure or the ability to withstand a specified number of cycles at a given load according to an ASTM or ISO standard.
8. The sample size for the training set
Not Applicable (N/A): This is a mechanical device, not an AI/ML system that uses a "training set."
9. How the ground truth for the training set was established
Not Applicable (N/A): See #8.
§ 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.