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Signature Orthopaedics' Fusion Taper System is 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, hemi-arthroplasty, surface replacement, or total replacement
  Signature Orthopaedics' Fusion Taper System is intended for cementless fixation only.

The Fusion Taper System consists of modular femoral heads and taper sleeves. The Fusion Taper Sleeve is manufactured from Ti6Al4V as per ISO 5832-3. The Fusion Ceramic Head is manufactured from an alumina matrix as per ISO 6474-2. All Fusion Heads are intended for total hip arthroplasty. The Fusion Heads connect to the femoral stem via a Fusion Taper Sleeve which has a 12/14 inner taper and 16/18 outer taper. Signature Orthopaedics Fusion Taper System is indicated for use with Signature Ti6A14V femoral stems: TSI Stem (K102172), Origin Stem (K121297. K161155), Aria Stem (K121297), Remedy Stem (K133370), Spartan Stem (K192883), World Stem (K201278), and acetabular components: Logical Cup (K121297, K153131), Logical Liners (K121297), Logical 20deg Hooded Liners including lateralised variants (K153131), World Cup (K201278), and World Liner (K201278).

This document is a 510(k) summary for the Signature Orthopaedics Fusion Taper System, a hip replacement prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not describe an AI/ML device or a study proving that such a device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies related to an AI/ML device from this document. The document describes a physical medical device (hip implant components) and its non-clinical testing for regulatory clearance.

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The Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities and deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; and failed previous fusion (pseudarthrosis). In addition, the C-Zero Pedicle Screw and Freedom Pedicle Systems are intended for skeletally mature patients in the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra and degenerative spondylolisthesis with objective evidence of neurologic impairment.

All of the Signature Orthopaedics' C-Zero and Freedom Pedicle Screw Systems' components (except for CoCr longitudinal rods) are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136. The subject systems' CoCr longitudinal rods are manufactured from wrought Cobal-Chromium as per ASTM-F1537.

The Signature Orthopaedics' C-Zero and Freedom Pedicle Screw Systems are used to provide immobilization and stabilization of spinal segments in the treatment of acute and chronic instabilities or deformities of the lumbar, thoracic and sacral spine. These pedicel rod and screw systems surgically implanted from a posterior approach. The device subject to this file include polyaxial pedicle screws, rods, connectors and hooks.

The provided text describes a 510(k) premarket notification for a medical device, the Signature Orthopaedics C-Zero Pedicle Screw System and Freedom Pedicle Screw System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and detailed study results for a novel AI/software device.

Therefore, much of the requested information (acceptance criteria, device performance tables, sample sizes for AI training/test sets, expert adjudication details, MRMC studies, standalone performance for AI, and ground truth for AI) is not applicable to this type of submission. This document describes the mechanical testing of a physical implantable device, not the performance of an AI or software algorithm.

However, I can extract the relevant information regarding the performance testing that was conducted to support the substantial equivalence claim.

Device Description and Purpose:
The Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are pedicle rod and screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. They are used for various acute and chronic instabilities and deformities of the thoracic, lumbar, and sacral spine, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, and failed previous fusion. They are also intended for severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra and degenerative spondylolisthesis with objective evidence of neurologic impairment.

Performance Testing to Establish Substantial Equivalence (Not Acceptance Criteria for an AI Device):

The submission states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are adequate for anticipated in-vivo use." This testing specifically targeted the "worst case sizes" of the pedicle screws.

Here's the closest information available to your requested format, reinterpreted for a mechanical device submission seeking substantial equivalence:

Table of Performance Testing and Reported Device Performance

Testing Standard Compliance:
The testing was carried out according to the following standards:

• ASTM-F1717 Standard Test Methods for Spinal Implant Construct in a Vertebrectomy Model
• ASTM-F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• ASTM-F543 Standard Specification and Test Method for Metallic Medical Bone Screw

Information Not Applicable or Not Provided for This Type of Submission:

1. Sample size used for the test set and the data provenance: Not applicable. This refers to physical components, not a data-driven AI test set. The testing was conducted on "worst case sizes" of the pedicle screws.
2. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for an AI algorithm is not relevant here. The "ground truth" for a mechanical device is its physical performance characteristics against established engineering standards and predicate device performance.
3. Adjudication method: Not applicable.
4. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted diagnostic or interpretation tasks.
5. Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This is a physical device, not an algorithm.
6. The type of ground truth used: For a mechanical device, the ground truth is established mechanical properties and performance deemed adequate by engineering standards and comparison to legally marketed predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

Conclusion stated in the document:
"Based upon the predicate comparison, the intended use, similar technological characteristics and the results of the various mechanical testing, the proposed devices are substantially equivalent to the predicate devices."

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The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF systems are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The Brisbane and Gladstone ALIF systems may be used as stand-alone devices or in conjunction with supplemental fixation. When used as a stand-alone device the subject devices must be used with all three screws.

The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF cages are manufactured from PEEK-OPTIMA LT1 per ASTM-F2026. The Screws for Brisbane and Gladstone ALIF cages are manufactured from Ti6A14V alloy per ISO 5832-3 and ASTM-F136.

The Brisbane and Gladstone ALIF cages consist of a wedge-shaped geometry and intended for implantation by an anterior approach. The cages are hollow to allow loading of bone graft. The cages are wedge shaped to restore lordosis of the fused vertebral bodies. The superior and inferior surfaces have serrated teeth to resist expulsion. The cages have three holes each on their anterior faces to facilitate the use of titanium bone screws. The use of the bone screws make the subject cages stand-alone cages. The superior and inferior surfaces of Brisbane ALIF cage is Titanium Plasma Spray (TPS) coated per ASTM-F1580.

This document is a 510(k) premarket notification from the FDA for medical devices, specifically artificial intervertebral fusion devices (Brisbane ALIF Device, Gladstone ALIF Device). The information provided is for a physical medical device (an implantable cage for spinal fusion), not an AI/ML-based medical device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) is not applicable to this document.

The document discusses the mechanical and material performance testing of the device, which are the relevant acceptance criteria for this type of physical implant.

Here's a breakdown of the relevant information from the document regarding acceptance criteria and performance studies, adapted to the context of a physical device:

Acceptance Criteria and Device Performance for a Physical Implantable Device

Since this is a physical medical device (an intervertebral fusion device), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to its mechanical, material, and functional performance, not diagnostic accuracy or AI algorithm performance.

Here's how the information in the document aligns with your request, reinterpreted for a physical device:

1. A table of acceptance criteria and the reported device performance:

The document lists the types of non-clinical tests performed, implying that the device met the acceptance criteria for these tests as defined by the ASTM standards. Specific numerical results or pass/fail thresholds are not detailed in this summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each test. For mechanical testing, this typically refers to the number of devices or components tested according to the respective ASTM standards.
• Data Provenance: The tests were "Non-clinical testing and engineering evaluations" conducted by Signature Orthopaedics Pty Ltd (located in Australia). The data is retrospective in the sense that it was generated prior to submission for regulatory review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This concept is relevant for AI/ML diagnostic devices where human experts establish ground truth for image interpretation. For a physical device, the "ground truth" is established by the physical properties and mechanical performance measured against industry standards (ASTM). The experts involved would be engineers and material scientists.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus in human interpretation of data for AI/ML ground truth. For physical testing, adherence to a standard (e.g., ASTM) and internal quality control procedures guides the interpretation of results.

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. MRMC studies are for evaluating the performance of AI/ML diagnostic tools with human readers. This document describes a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This refers to AI algorithm performance. The "performance" here is the physical device's mechanical and material properties.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for this physical device's performance is established by recognized engineering and material standards, specifically ASTM (American Society for Testing and Materials) standards. The manufacturer demonstrated that the device adheres to these standards, which are internationally recognized benchmarks for material and mechanical properties relevant to medical implants.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of a physical medical device; this term is used for AI/ML model development.

9. How the ground truth for the training set was established:

• Not Applicable. As above, no training set for a physical device.

In summary, the provided document is a regulatory submission for a physical medical implant, not an AI/ML software device. Therefore, many of the requested criteria related to AI/ML performance evaluation are not applicable. The document confirms that non-clinical testing (mechanical, material, and coating properties) was conducted according to relevant ASTM standards to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices.

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