(314 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 & fracture non-union or mal-union
- 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, hemiarthroplasty, surface replacement, or total hip replacement
- Dislocation risks (when used with SignaSure Dual Mobility System)
Signature Orthopaedics' Longboard Revision Stem is intended for individuals undergoing revision surgery of the hip only.
Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World, Everglade and Longboard Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
The Longboard Revision Stem is a femoral stem and a partially threaded distal locking screw intended for single use and cementless fixation for revision hip arthroplasties. The components are manufactured from titanium alloy as per ISO 5832-3 and ASTM F136 and the stem has a titanium alloy grit blast along the body. The Longboard Revision Stem is a symmetrical with a neck angle of 135°. The stem body is tapered and finned, while the distal tip is finless to allow for initial version adjustments. The stem neck features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components.
This FDA 510(k) Clearance Letter for the Longboard Revision Hip Stem describes a medical device (an orthopedic implant), not a software or AI/ML-based device. Therefore, the questions regarding acceptance criteria and study design for performance evaluation of algorithms and AI/ML systems (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing for mechanical properties and material characteristics, as is standard for orthopedic implants.
Here's an analysis of the provided information relevant to the device's acceptance criteria and the study that proves it meets them, framed within the context of a physical medical device:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
For physical medical devices like the Longboard Revision Hip Stem, acceptance criteria primarily revolve around:
- Safety and Effectiveness: Ensuring the device is safe for its intended use and performs as expected.
- Biocompatibility: Materials used must be compatible with the human body.
- Mechanical Performance: The device must withstand anticipated physiological loads and stresses without failure for its expected lifespan.
- Conformity to Standards: Compliance with established industry and regulatory standards.
- Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.
The study described to prove the device meets these criteria is the non-clinical performance testing and engineering evaluations.
1. Table of Acceptance Criteria and the Reported Device Performance
The document doesn't provide a precise "table" of numerical acceptance criteria in the format typically seen for AI/ML performance (e.g., "Sensitivity >= X%"). Instead, acceptance is inferred from the successful completion of specified engineering tests and adherence to industry standards, followed by a conclusion of substantial equivalence.
| Acceptance Criterion (Inferred from Regulatory Requirements for Orthopedic Implants) | Reported Device Performance Summary (from document) |
|---|---|
| Mechanical Strength & Endurance: Withstand anticipated physiological loads and stresses without fracture or fatigue failure. | Non-clinical testing and engineering evaluations (FEA and physical testing) conducted on worst-case sizes. Results show that "the strength of the Signature Orthopaedics Longboard Revision Hip Stem is sufficient for their intended use and substantially equivalent to the legally marketed predicate device." Specifically, "Stem and Neck Fatigue FEA" and "Stem and Neck Fatigue Testing" were performed. |
| Range of Motion: Allow for functional hip joint movement. | "Range of Motion" testing was performed to verify adequate performance. |
| Material Biocompatibility: Materials are safe for implantation. | Manufactured from titanium alloy as per ISO 5832-3 and ASTM F136. These are standard, biocompatible implant-grade materials. |
| Conformity to Standards: Adherence to relevant international and national testing standards. | Testing conducted in accordance with: |
- ISO 21535 (Hip Joint Replacement Implants)
- ASTM F2996 (FEA for Hip Femoral Stems)
- ISO 7206-4 (Endurance of Stemmed Femoral Components)
- ISO 7206-6 (Endurance of Neck Region)
- ASTM F543 (Metallic Medical Bone Screws) |
| Substantial Equivalence: The device is as safe and effective as existing legally marketed predicate devices. | "The Longboard Revision Hip Stem have the same intended use and same indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design, and are manufactured using the same materials as the predicate devices. Any differences do not raise new questions of safety and effectiveness as established with performance testing. The subject devices are at least as safe and effective as the legally marketed predicate devices." |
Information Not Applicable/Provided for a Physical Device:
The following points are primarily relevant to software, AI/ML, or diagnostic devices, and therefore are not applicable to this 510(k) for a physical orthopedic implant:
- Sample size used for the test set and the data provenance: Not applicable. Testing is primarily mechanical/physical on device samples, not on patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is its physical behavior under load, measured by engineering methods, not expert consensus on images.
- 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. This is for diagnostic interpretation, not an implant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm here.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of image interpretation. Ground truth for this device is mechanical integrity, material properties, and functionality under specified conditions, verified by laboratory testing.
- The sample size for the training set: Not applicable as there is no training set for a mechanical device.
- How the ground truth for the training set was established: Not applicable.
In summary: The clearance of the Longboard Revision Hip Stem relies on non-clinical, laboratory-based mechanical and materials testing of physical device samples against established industry standards and comparison to predicate devices, to demonstrate its safety and effectiveness for its intended use, rather than on clinical data or AI/ML performance metrics.
§ 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.