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The NEST-C Interbody System is indicated for use in cervical interbody fusion procedures with autogenous bone graff and/or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or multiple contiguous levels from the C2 to T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have six weeks of non-operative treatment.

The NEST-C Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

The NEST-C Interbody System is intervertebral body fusion device with solid and porous structures that both are simultaneously built using additive manufacturing method, from titanium alloy (Ti6Al4V ELI) powder per ASTM F3001. Offered in a number of footprints heights and lordotic angles to adapt to a variety of patient anatomies. The implant consists of a hollow window for bone graft packing and serrations on the superior/inferior surfaces of the cage for enhanced fixation. The internal porous structure provides additional space for bone graft packing. NEST-C cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

The provided document is a 510(k) summary for a medical device called the NEST-C Interbody System. This type of regulatory submission in the US does not typically include information about clinical studies with human participants comparing the device's performance against detailed acceptance criteria in the way a clinical trial for a drug or an AI diagnostic algorithm would, especially for an intervertebral body fusion device.

Instead, the acceptance criteria for this type of device are primarily based on non-clinical mechanical testing and biocompatibility evaluations to demonstrate substantial equivalence to legally marketed predicate devices. The "device performance" reported is how well the device met these engineering and safety standards.

Here's a breakdown based on the information provided:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NEST-C Interbody System are derived from recognized consensus standards for intervertebral body fusion devices, specifically ASTM F2077-22 (Static and Dynamic Evaluation of Flexible Spinal Intervertebral Body Fusion Devices) and F2267-04 (Mechanical Test for Spinal Artificial Discs). Biocompatibility is evaluated against ISO 10993-1.

While the specific numerical acceptance limits (e.g., minimum load to failure, maximum displacement) are not detailed in this summary, the document states that the device was subjected to these tests and that the "results demonstrate that the devices are substantially equivalent to the identified predicate devices." This implies that the NEST-C Interbody System met or exceeded the performance of the predicate devices in these mechanical and biological tests.

Study Details (Non-Clinical)

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set (for mechanical tests): The document refers to "worst case devices" being subjected to mechanical testing. The exact number of samples for each test (e.g., how many devices were tested for static compression, how many for dynamic torsion) is not specified in this summary.
   • Data Provenance: The tests are explicitly stated as "mechanical testing" and "biocompatibility evaluation," indicating laboratory-based, non-clinical studies performed by the manufacturer or a contracted lab. The country of origin for this testing is not specified but would likely be Taiwan (where Paonan Biotech Co. is located) or a certified lab it contracted. This is retrospective in the sense that the testing is performed on manufactured devices, not in a live patient setting.

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

   • This question is not applicable in the context of this 510(k) summary. For mechanical and biocompatibility testing, "ground truth" is established by the accepted scientific and engineering principles codified in the ASTM and ISO standards, and the performance is measured by instrumentation, not human experts. There are no "experts establishing ground truth" in the diagnostic sense for these non-clinical tests.

3. Adjudication Method:

   • This is not applicable as there is no human interpretation of results requiring adjudication in the context of mechanical or biocompatibility testing. The tests yield objective, quantifiable data measured by laboratory equipment.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation of medical images or data is involved and the AI's impact on reader performance is being assessed. The NEST-C Interbody System is an implantable surgical device, and its safety and effectiveness are primarily demonstrated through non-clinical mechanical testing, biocompatibility, and substantial equivalence to predicate devices.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No, a standalone performance study was not done. This concept applies to AI algorithms. The NEST-C Interbody System is a physical medical implant.

6. Type of Ground Truth Used:

   • For mechanical testing, the "ground truth" is defined by the objective performance criteria outlined in the ASTM standards (e.g., load capacity, resistance to fatigue, acceptable deformation). The reported performance is compared directly to these objective, quantifiable standards, often against the performance of predicate devices.
   • For biocompatibility, the "ground truth" is compliance with ISO 10993-1, which involves various in-vitro and/or in-vivo tests to assess biological responses to the device materials.

7. Sample Size for the Training Set:

   • This question is not applicable. There is no "training set" in the context of mechanical or biocompatibility testing for a physical implant device like the NEST-C Interbody System. These are not AI algorithms that learn from data.

8. How the Ground Truth for the Training Set Was Established:

   • This question is not applicable for the same reason as above. There is no training set for this device's non-clinical evaluations.

In summary, the provided document details a 510(k) submission for a physical medical implant. The "acceptance criteria" and "study" described are focused on engineering performance (mechanical testing) and biological safety (biocompatibility) to demonstrate substantial equivalence to existing legally marketed devices, rather than clinical efficacy studies involving human patient data, expert interpretations, or AI algorithm performance.

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The PK High Tibial Osteotomy Correction System is an external fixation device, which is intended for use in the treatment of the following indications in the tibia:

• Temporary fracture fixation
• Correction of deformity
• Osteotomy
• Bone union
• Bone reconstruction
• Fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality
• Leg lengthening

The PK High Tibial Osteotomy Correction System is a single-use external fixator which consisting of the following components: fixation plate, cortex pin and cancellous pin. Pins are available in various lengths and diameters according to practical requirements. These pins and other components are manufactured from 316L stainless steel (ASTM F138/ ISO 5832-1) and aluminum alloy. These devices are intended to be used in the tibia. Adjustment of the fixator is possible during the course of treatment. All components are provided sterile.

The provided document is a 510(k) premarket notification for a medical device called the "PK High Tibial Osteotomy Correction System." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing details of an AI/ML algorithm's performance.

Therefore, the information required to answer your questions regarding acceptance criteria, study data, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details for an AI/ML device is NOT present in this submission.

This 510(k) submission confirms that:

• The device is a medical device (external fixator), not an AI/ML algorithm.
• The approval is based on substantial equivalence to predicate devices, not on a clinical performance study of an AI/ML algorithm.
• Non-clinical performance data (mechanical testing) was conducted, referring to ASTM F1541, to demonstrate substantial equivalence, but this is physical device testing, not AI/ML algorithm performance.
• "Clinical testing was not required for this submission." This explicitly states that no clinical performance data was gathered or submitted for this device, which would be crucial for evaluating an AI/ML algorithm.

In summary, the provided document does not contain the information requested in your prompt because it is about a physical medical device clearance, not an AI/ML algorithm's regulatory approval.

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The NEST Interbody System is indicated for interbody fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should be skeletally mature and have six months of non-operative treatment. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).

The NEST Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The NEST Interbody System is an intervertebral body fusion cage which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow, rectangular implant consists of both solid and porous structures and serrations on the superior and inferior porous surfaces are for enhanced fixation.

The implant is designed to be used with supplemental fixation with cleared for use in the lumbosacral spine. The implant is offered in a variety of sizes to accommodate a variety of patients' anatomy. NEST is additively manufactured from Ti6Al4V alloy (ASTM F3001) and is provided sterile.

The provided text describes a medical device, the NEST Interbody System, and its 510(k) submission to the FDA. However, it does not contain specific acceptance criteria, reported device performance data, study details (like sample size, data provenance, expert qualifications, or adjudication methods), or information about AI assistance or standalone algorithm performance.

The document focuses on:

• Product Information: Device name, regulation number, regulatory class, product code, indications for use.
• Manufacturer Information: Company name, contact person, date prepared.
• Predicate Devices: Identifying legally marketed predicate devices for substantial equivalence.
• Device Description: General features, material (Ti6Al4V alloy), and intended use.
• Summary of Non-Clinical Testing: Mentioning compliance with FDA guidance and specific mechanical tests performed (Static Compression, Dynamic Compression, Static Compression Shear, Static Torsion, Subsidence per ASTM F2077 and F2267).
• Conclusion: Stating substantial equivalence based on design, materials, features, indications, and mechanical testing results.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details because it is not present in the provided text. The document pertains to a traditional 510(k) submission for a physical medical implant, not an AI/ML-driven device, so questions related to human reader improvement with AI assistance or standalone algorithm performance are not applicable based on the given information.

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The II-Type Intervertebral Spacer is intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment prior to treatment with an intervertebral cage. The II-Type Intervertebral Spacer is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

II-Type Intervertebral Spacer consists of PEEK cages of various widths and heights, which include Ta markers, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft.

The provided text is for a medical device called an "II-Type Intervertebral Spacer," which is a physical implant used in spinal fusion surgery. This type of device does not typically involve AI, thus the questions regarding AI performance, human-in-the-loop, and training sets are not applicable.

Here's an analysis of the provided information concerning acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for the "II-Type Intervertebral Spacer" to demonstrate its substantial equivalence to predicate devices. The acceptance criteria are implicitly defined by the chosen ASTM standards, and the reported performance indicates that the device met these standards.

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

• Sample size: The document states that testing was performed "using samples each of a worst case construct." It does not specify the exact number of samples for each test (e.g., 5 samples for axial compression, 3 for torsion, etc.), but it refers to "samples" in plural.
• Data provenance: The data is based on non-clinical (in vitro/mechanical) testing performed by Paonan Biotech Co., Ltd. The country of origin for the testing itself isn't explicitly stated, but the company is located in Taiwan, R.O.C. This is a prospective test specifically conducted for regulatory submission.

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

This question is not applicable as the device is a physical intervertebral spacer being evaluated through mechanical and materials testing against engineering standards, not through clinical trials or expert assessment of diagnostic images that would require "ground truth" established by human experts.

4. Adjudication method for the test set:

This question is not applicable for the same reasons as #3. Mechanical testing results are objective measurements against specified standard limits, not subjective interpretations requiring adjudication.

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 question is not applicable. The device is a physical implant for spinal fusion and does not involve AI or diagnostic imaging interpretation.

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

This question is not applicable. There is no algorithm associated with this device.

7. The type of ground truth used:

The "ground truth" for this device's acceptance is based on:

• Engineering standards: Specifically, compliance with ASTM F2077-11 and ASTM F2267-04. These standards define the parameters and acceptable limits for mechanical performance.
• Material properties: The inherent biocompatibility and mechanical properties (e.g., modulus) of PEEK.
• Comparative data: Performance relative to "legally marketed lumbar interbody fusion" predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set:

This question is not applicable as there is no AI algorithm involved that would require a training set.

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

This question is not applicable as there is no AI algorithm involved.

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TREND II Spinal Fixation System - STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1-Sacrum/Ilium) for the following indications:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Degenerative Spondylolisthesis with objective evidence of neurologic impairment
• Fractures
• Dislocation
• Scoliosis
• Kyphosis
• Spinal tumor
• Failed previous fusion (pseudarthrosis)

TREND II Spinal Fixation System- STEP Series includes cannulated screw, non-cannulated screw, rod, set screw, hook, and transverse link. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.

This document is a 510(k) premarket notification from the FDA, focusing on the substantial equivalence of "TREND II Spinal Fixation System- STEP Series" to predicate devices. It does not describe an AI medical device or a study involving human-in-the-loop or standalone AI performance. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI device.

The document primarily discusses:

• Device Type: Thoracolumbosacral pedicle screw system (a traditional medical implant, not AI)
• Regulatory Class: Class II
• Product Code: NKB
• Indications for Use: Spinal immobilization and stabilization for various conditions (e.g., degenerative disc disease, fractures, scoliosis)
• Predicate Devices: Comparison to "Paonan" Armstrong Posterior Spinal Fixation System (K161225) and MYKRES Spinal System (K051704).
• Performance Data: Mechanical testing (static/dynamic axial compression bending, static torsion, pullout test) to demonstrate substantial equivalence, referring to ASTM F1717 and ASTM F543. These are engineering performance tests for physical implants, not AI algorithm performance.

Therefore, it is impossible to provide the requested information about acceptance criteria and an AI study from this document.

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"Paonan" Armstrong Posterior System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacraliliac spine (T1-Sacrum/Tium) for the following indications:

• Degenerative disc diseases (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) degeneration of the disc confirmed by history and radies)
• Degenerative Spondylolisthesis with objective evidence of neurologic impairment.
• Fractures
• Dislocation
• Scoliosis
• Kyphosis
• Spinal tumor
• Failed previous fusion (pseudarthrosis)

"Paonan" Armstrong Posterior Spinal Fixation System includes pedicle screws, rods, cross connectors, and associated instruments. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.

The document describes the "Paonan" Armstrong Posterior Spinal Fixation System, a medical device for spinal immobilization and stabilization. It outlines the acceptance criteria and the study performed to demonstrate its substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression Bending Test
• Dynamic Compression Bending Test
• Static Torsional Test (for spinal construct) | Performed, demonstrating "satisfactory mechanical performance" (implied as being equivalent to the predicate, though specific numerical results are not provided in this summary). The summary states, "The results demonstrate substantial equivalence of the 'Paonan' Armstrong Posterior Fixation System to the predicate device." |
  | Mechanical Testing per ASTM F1798:
• Axial Gripping Capacity Test
• Torsional Gripping Capacity Test (of Cross Link and Connecting Block interconnection mechanism) | Performed, demonstrating "satisfactory mechanical performance" (implied as being equivalent to the predicate). The summary states, "The results demonstrate substantial equivalence of the 'Paonan' Armstrong Posterior Fixation System to the predicate device." |

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

The document discusses mechanical testing of the device components, not clinical data from patients. Therefore, the concepts of "test set sample size" and "data provenance (country of origin, retrospective/prospective)" as they relate to human subjects or retrospective/prospective studies are not applicable in this context. The study performed involves laboratory-based mechanical tests of the physical device components.

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

This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717, ASTM F1798) and the performance of the predicate device, not by expert human interpretation of images or patient data. The evaluation is based on objective measurements and comparison to defined metrics derived from the standards and predicate.

4. Adjudication Method for the Test Set

This is not applicable. As the study involves mechanical testing against engineering standards, there is no human adjudication process involved in establishing test results or "ground truth." Results are determined by measurement and comparison to predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

This is not applicable. An MRMC study pertains to the evaluation of diagnostic devices that rely on human interpretation of images or data, often comparing AI performance with and without human assistance. This document describes mechanical testing of a spinal fixation system, not a diagnostic AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is not applicable. The device is a physical spinal fixation system, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's mechanical performance is defined by:

• Established engineering standards: Specifically ASTM F1717 (for static/dynamic compression bending and static torsion of spinal constructs) and ASTM F1798 (for axial and torsional gripping capacity).
• Predicate device performance: The "Paonan" Armstrong Posterior Spinal Fixation System's performance was compared to the predicate system (MYKRES Spinal System, K051704) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical implant, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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