(217 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
Signature Orthopaedics' Origin, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems are intended for cemented fixation only.
Signature Orthopaedics' constrained liner components are indicated particularly for 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.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemihip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- Acute femoral head or neck fracture
- Fracture dislocation of the hip
- Avascular necrosis of the femoral head
- Non-union of femoral neck fractures
- Certain high subcapital and femoral neck fractures in the elderly
- Degenerative arthritis involving only the femoral head
The Logical C-Series Acetabular Shell is a metal backed cementless acetabular cup that is compatible with a highly cross-linked polyethylene liner from the Origin Total Hip System predicate device (K121297), as well as the Logical Constrained Liner and Logical 20° Hooded Liner. The shell's substrate is manufactured from Ti6A14V alloy per ASTM F136. The outer surface of the shell is sequentially coated with commercially pure titanium (per ASTM F1580) and Hydroxylapatite (per ISO 13779-2). The shell is available in no-hole. 3-hole or multi-hole configurations to allow use of bone screws for supplemental fixation.
The Logical Constrained Liner and the Logical 20° Hooded Liner are line range extensions to the Logical Liner per K121297. The Logical Constrained Liner differs from the original range in that it provides greater than 180 degree head coverage to constrain the head within liner. The Logical 20° Hooded Liner differs from the original range in that it incorporates a 20° hood as opposed to the original 10° hood. The Logical Constrained Liner and Logical 20° Hooded Liner are manufactured from highly crosslinked polyethylene (XLPE) identical to the Logical Liner per K121297. The Logical Constrained Liner further incorporates a titanium alloy collar to support the liner's rim. Furthermore, the Logical Constrained Liner is assembled with the Logical Shell and Logical Constrained Liner Collar via titanium alloy snapring. The Logical Constrained and 20° Hooded Liners articulate with a femoral head of appropriate diameter.
The provided text is a 510(k) summary for the Logical C-series Acetabular Shell, Logical Constrained Liner, and Logical 20° Hooded Liner. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness through a traditional clinical study with acceptance criteria for device performance.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes for test/training sets, expert involvement, and ground truth establishment is not explicitly detailed in the provided document in the context of a new efficacy study.
However, I can extract information related to the non-clinical performance testing conducted to support substantial equivalence.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or quantitative performance results in a table format for the device itself against novel safety and effectiveness endpoints. Instead, it states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices are adequate for anticipated in-vivo use." The conclusion drawn is that "Non-clinical testing results support the substantial equivalence claim." This implies that the device's performance, as measured by the non-clinical tests, was comparable to or met the established performance of the predicate devices.
2. Sample size used for the test set and the data provenance
The document describes "non-clinical testing and engineering evaluations." This typically refers to laboratory-based tests on physical samples of the medical device components. It does not refer to clinical patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable here. The sample sizes for these engineering tests are also not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided as the document describes engineering and non-clinical performance testing of mechanical components, not a study evaluating diagnostic accuracy or a similar clinical outcome requiring expert ground truth establishment.
4. Adjudication method for the test set
This information is not applicable and not provided for the same reasons as point 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
This information is not applicable and not provided. The device in question is an orthopedic implant (hip replacement components), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is an orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided as it relates to non-clinical engineering tests on device components. The "ground truth" in this context would be the objective measurements and engineering standards applied to the device components during laboratory testing.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/machine learning study requiring training data.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as point 8.
Summary of available information related to performance testing:
The device's performance was evaluated through the following non-clinical tests:
- Range of motion analysis
- Shell stiffness testing
- Modular component connection strength testing
- Cup-Liner Push Out testing
- Head-Liner Assembly / Disassembly Testing
- Liner-Shell Assembly Testing
- Various coating characterization, abrasion and adhesion strength testing
These tests were conducted to demonstrate that the device performs "adequately for anticipated in-vivo use" and to support "substantial equivalence" to predicate devices. The specific quantitative results or direct acceptance criteria for each test against which the device's performance was measured are not detailed in this 510(k) summary. The implication is that the device met the performance benchmarks implicitly or explicitly established based on the predicate devices or relevant industry standards.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.