(325 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
- · Dislocation risks (when used with SignaSure range)
Signature Orthopaedics' Origin. Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at 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 hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar 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 SignaSure Dual Mobility System is available in two configurations, a Monobloc configuration and a Modular configuration. The Monobloc configuration is a Dual Mobility acetabular system consisting of a metallic shell, cemented, and a mobile polyethylene insert to articulate within the shell as a femoral head. The Modular configuration (subject device) is a dual mobility acetabular system consisting of 2 components; a mobile polyethylene component and a metallic insert which can be used with interfacing cemented or cementless cups.
The SignaSure Poly, used in both configurations, is manufactured from highly crosslinked polyethylene (as per ASTM F648) and is spherical in geometry with outer and inner spherical conforming articular surfaces. The inner articular surface mates and retains a femoral head. The outer articular surface articulates within the highly polished inner diameter of the SignaSure Cementless or Cemented Cup to be used, or the metallic insert. The SignaSure Poly components are available in size 37 to 41 mm (outer diameter) allowing use with 22 mm and 39 to 59 mm femoral heads.
The SignaSure Logical Insert is manufactured from Cobalt Chrome (CoCr) alloy (as per ASTM F1537 and ISO 5832-12) and mates with Signature Orthopaedics' Logical Shell to be implanted without bone cement and the SignaSure World Insert is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and mates with Signature Orthopaedic's World Cup to be implant without bone cement. The SignaSure Logical Insert is available in 34 to 48 mm sizes whereas the SignaSure World Insert is available in 38 to 46 mm (internal diameter) sizes.
The SignaSure Cementless Cup is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and is sequentially plasma sprayed with titanium coating (as per ASTM F1580) and hydroxyapatite (as per ISO 13779-1 and ISO 13779-2) to gain cementless fixation. The SignaSure Cemented Cup is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and is grit blasted and macro textured to aid in fixation via bone cement. These cups, as from K211742, underwent no changes and were included in this submission as they interact with the subject SignaSure Poly devices.
This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "SignaSure Dual Mobility System." It is a notification of the agency's substantial equivalence determination for the device, and it details the device description, indications for use, and a summary of performance testing to support the claim of substantial equivalence to predicate devices.
Acceptance Criteria and Study for the SignaSure Dual Mobility System
The provided document describes the "SignaSure Dual Mobility System" and demonstrates its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI or diagnostic device. The acceptance criteria in this context refer to the performance benchmarks used to determine that the new device is as safe and effective as existing legally marketed predicate devices.
The information provided does not relate to an AI or diagnostic device, therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set, and ground truth type) are not applicable.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" are typically related to meeting established standards and demonstrating performance comparable to predicate devices in terms of mechanical, material, and functional characteristics. The "reported device performance" in this context refers to the results of the non-clinical tests and engineering evaluations.
| Acceptance Criteria (General for Hip Implants) | Reported Device Performance (SignaSure Dual Mobility System) |
|---|---|
| Mechanical Performance: | |
| - Liner-Shell Offset Pull-Out Strength per ASTM F1820 requirements. | - Non-clinical testing conducted per ASTM F1820. (Implied: Meets or exceeds requirements, demonstrating substantial equivalence). |
| - Liner-Shell Rotational Stability (torque-out) per ASTM F1820 requirements. | - Non-clinical testing conducted per ASTM F1820. (Implied: Meets or exceeds requirements, demonstrating substantial equivalence). |
| - Liner-Shell Push-Out Strength per ASTM F1820 requirements. | - Non-clinical testing conducted per ASTM F1820. (Implied: Meets or exceeds requirements, demonstrating substantial equivalence). |
| - Fretting Corrosion characteristics per ASTM F1875 standards. | - Non-clinical testing conducted as per ASTM F1875 and Engineering Evaluation. (Implied: Acceptable levels of fretting corrosion, demonstrating substantial equivalence). |
| - Impingement characteristics per ASTM F2582-14 standards. | - Non-clinical testing conducted per ASTM F2582-14. (Implied: Acceptable impingement range, demonstrating substantial equivalence). |
| - Range of Motion per ISO 21535:2007 requirements. | - Non-clinical testing conducted per ISO 21535:2007. (Implied: Acceptable range of motion, demonstrating substantial equivalence). |
| - Head Poly Assembly, Pull-Out, and Lever Out Strength. | - Head Poly Assembly Testing, Head Poly Pull-Out Testing, Head Lever Out Testing, Post Impingement Lever-Out Testing per ASTM F1820 were conducted. (Implied: Results demonstrate adequate strength and stability, demonstrating substantial equivalence). |
| Material Compatibility and Biocompatibility: | |
| - Polyethylene (highly crosslinked) per ASTM F648 standard. | - SignaSure Poly manufactured from highly crosslinked polyethylene (as per ASTM F648). (Implied: Meets material standard). |
| - Cobalt Chrome (CoCr) Alloy per ASTM F1537 and ISO 5832-12 standards. | - SignaSure Logical Insert, SignaSure World Insert, SignaSure Cementless Cup, SignaSure Cemented Cup manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12). (Implied: Meets material standards). |
| - Titanium Coating per ASTM F1580 standard (for cementless fixation). | - SignaSure Cementless Cup sequentially plasma sprayed with titanium coating (as per ASTM F1580). (Implied: Meets coating standard for cementless fixation). |
| - Hydroxyapatite per ISO 13779-1 and ISO 13779-2 standards (for cementless fixation). | - SignaSure Cementless Cup sequentially plasma sprayed with hydroxyapatite (as per ISO 13779-1 and ISO 13779-2). (Implied: Meets coating standard for cementless fixation). |
| Design and Indications for Use: | |
| - Same intended use and indications for use as predicate devices. | - The SignaSure Dual Mobility System has the same intended use, indications for use, materials, and similar design features to the predicate devices. Specifically, the SignaSure Modular Insert Dual Mobility System shares the same intended use and indications for use as Stryker's MDM Insert (K103233, K112556). (Explicitly stated to be comparable). |
| - Similar design features to predicate devices. | - The SignaSure Cup's geometry is similar to the Serf Novae Dual Mobility Acetabular Cup (K111572). The SignaSure Cementless Cup's coating is identical to the Logical C-Series Cup (K121297). The SignaSure Cemented Cup's outer surface is similar to the Serf Novae Stick Dual Mobility Acetabular Cup (K111572). The Monobloc Configuration is unchanged from K211742. (Explicitly stated to be comparable or identical). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as this is a non-clinical, engineering testing summary, not a human clinical trial. The "test set" would refer to the number of physical device units or components subjected to each specific test. This information is typically detailed in the full test reports, not in the 510(k) summary.
- Data Provenance: Not applicable in the context of human data. The tests are non-clinical, conducted in a laboratory setting to evaluate material and mechanical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in this context would refer to established engineering standards (ASTM, ISO), and the experts would be the engineers and technicians performing and verifying the tests, who are qualified in biomechanics, materials science, and medical device testing. Their qualifications are not specified in this summary.
4. Adjudication method for the test set
- Not applicable. Performance against engineering standards is typically determined by measurements and comparison to defined limits, not through a human adjudication process.
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. This is a hip replacement prosthesis, not an AI or diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hip replacement prosthesis, not an AI or algorithm.
7. The type of ground truth used
- Ground Truth: Established international and national standards for medical device materials and mechanical performance (e.g., ASTM F648, F1537, F1580, F1820, F1875, F2582-14, ISO 5832-12, ISO 13779-1, ISO 13779-2, ISO 21535:2007). These standards define the acceptable performance characteristics. The predicate devices also serve as a comparative "ground truth" for substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of a physical hip implant seeking 510(k) clearance based on non-clinical testing.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.