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The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disease (DDD) at one level or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.

The Deploy™ Expandable Interbody System is comprised of the interbody implant cages, surgical instruments which include trial instruments to aid in the selection of the appropriate implant size for the patient's anatomy, and sterilization trays. The implants are manufactured from titanium alloy Ti-6AI-4V (ASTM F136, ASTM F3001) and are offered with various heights and shapes for different patient anatomy. Each implant is designed to be inserted and then rotate in-situ, providing immediate fixation and the arm deployed for the graft containment area. Ridges on the superior and inferior surfaces of the titanium implants contact the endplates to resist expulsion forces. The implants are designed to be used in conjunction with supplemental spinal fixation instrumentation. The surgical instruments are manufactured from stainless steel (ASTM F899. ISO 7153-1). The implants and surgical instruments are provided non-sterile and require sterilization prior to use within sterilization trays following validated sterilization parameters as provided within the Instructions for Use.

The provided text is a 510(k) summary for the Deploy™ Expandable Interbody System, which is a medical device. This document focuses on the regulatory clearance for the device and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of AI/software performance.

Therefore, the requested information regarding acceptance criteria, reported device performance in a clinical study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it is not a clinical study report for an AI/Software as a Medical Device (SaMD).

The document discusses:

• Device Description: The Deploy™ Expandable Interbody System is comprised of interbody implant cages and surgical instruments, manufactured from titanium alloy.
• Indications for Use: Intervertebral body fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1), and for patients diagnosed with degenerative scoliosis, used with autograft and/or allogenic bone graft and supplemental spinal fixation systems.
• Technological Characteristics: Similar to predicate devices in principle of operation, design, intended use, material composition, and function.
• Summary of Testing: Biocompatibility risk assessment (ISO 10993-1, Part 5) and mechanical testing including static axial compression (ASTM F2077), static compressive shear (ASTM F2077), dynamic axial compression (ASTM F2077), dynamic compressive shear (ASTM F2077), static subsidence (ASTM F2267), and wear debris testing (ASTM F1877). These are engineering performance tests, not clinical performance for diagnostic accuracy.
• Substantial Equivalence Conclusions: The device was shown to be substantially equivalent to predicate systems based on indications for use, design, function, material composition, sizes, and mechanical performance.

This document is a regulatory submission demonstrating the safety and effectiveness of a physical medical implant, not an AI/software product, and thus does not contain the information requested about acceptance criteria and studies for AI/software performance.

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Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

The Cambria System device is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The cervical spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers, and are generally box-shaped with a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.

The Cambria System device is offered in a variety of heights and footprints to accommodate variations in patient anatomy. The cervical spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).

The Cambria NanoMetalene cervical spacers are provided in gamma sterilized packaging; the Cambria PEEK implants are provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with the Cambria System facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The provided 510(k) summary for the SeaSpine Cambria System does not include acceptance criteria or a study demonstrating the device meets such criteria in the way typically found for AI/software-as-a-medical-device (SaMD) products. This document describes a medical device (an intervertebral fusion device) and its substantial equivalence to a predicate device, focusing on mechanical performance, materials, and sterility, rather than diagnostic accuracy or algorithmic performance.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this regulatory submission for a physical implantable device.

However, I can extract the relevant information regarding the non-clinical and clinical testing performed to support the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (intervertebral fusion device), the "acceptance criteria" and "device performance" are primarily related to its mechanical properties, material safety, and sterility, rather than diagnostic metrics like sensitivity or specificity. No explicit acceptance criteria values (e.g., "must withstand X force") are provided in this summary, but the types of tests performed imply compliance with relevant standards.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Non-Clinical): Not explicitly stated, but mechanical testing typically uses a specific number of samples per test type as proscribed by the ASTM standards (e.g., ASTM F2077, F2267). The summary indicates "engineering analysis" and states that "conclusions from previously performed" tests remained valid, suggesting that a formal re-testing of a full set of samples might not have been performed if the modifications were deemed minor structurally.
• Data Provenance (Clinical Literature): The summary mentions an "assessment of clinical literature data." This implies retrospective data collection from existing studies, but the specific country of origin or the nature of these studies is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes a physical medical device, not an AI/SaMD product requiring expert-derived ground truth for diagnostic or interpretative tasks. The "ground truth" for mechanical testing is compliance with physical standards. For clinical equivalence, it relies on literature established via clinical trials for similar predicate devices.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above.

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 section is not applicable as the device is not an AI product.

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

This section is not applicable as the device is not an AI product.

7. The Type of Ground Truth Used

• Non-Clinical (Mechanical): Ground truth is based on established engineering and materials science principles, and adherence to recognized standards such as ASTM F2077, ASTM F2267, and ANSI/AAMI ST-72:2011.
• Clinical: For supporting the expanded indications, the ground truth was derived from "clinical literature data," implying established clinical outcomes and efficacy data for similar devices from published studies or historical clinical trials.

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI product and therefore does not have a "training set" in the machine learning sense. Its design and manufacturing are based on established engineering principles and materials.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the reasons stated above.

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The Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the lumbar spine (L2 to S1), and are intended to be used with autogenous bone graft and supplemental fixation systems that have been cleared by the FDA for use in the lumbar spine.

The proposed devices within the Coalesce™ Lumbar Interbody Fusion System are sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the lumbar spinal column in lumbar intervertebral body fusion procedures. Each device within the Coalesce™ System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more tantalum markers, depending on footprint, to enable visibility under x-ray in vivo.

The provided text describes a medical device, the Coalesce™ Lumbar Interbody Fusion System, and its clearance process with the FDA. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. The "testing" mentioned is primarily performance testing against engineering standards for intervertebral body fusion devices, not clinical studies with human participants or evaluation of algorithm performance in an AI context.

Therefore, I cannot provide the requested information. The text does not report:

1. A table of acceptance criteria and reported device performance related to diagnostic or evaluative metrics.
2. Sample sizes for test sets, data provenance, or details about training sets.
3. Number or qualifications of experts to establish ground truth.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used in a clinical or AI context.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Non-Clinical Testing" section (I) describes:

• Functional performance testing: static and dynamic compression, compression shear, subsidence, and expulsion.
• Standards referenced: (ASTM) F2077-14, (ASTM) F2267-04, and (ASTM) F1877-16.
• Conclusion: "Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices."

This indicates that the device met the requirements of these engineering standards, which likely have their own defined acceptance criteria (e.g., maximum deformation under load, minimum load to failure). However, these specific criteria and the detailed results showing compliance are not included in the summary.

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