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The HAnano InterFuse® Modular Interbody is intended to be used for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. 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 I spondylolisthesis or retrolisthesis at the involved level(s). The HAnano InterFuse® device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous nonfusion surgery at the involved spinal level(s). The HAnano InterFuse® device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

The HA™" InterFuse® Modular Interbody is a modular lumbar intervertebral body fusion device with an implantable portion composed of polyetheretherketone (PEEK), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. This device is designed to be implanted via a PLIF approach utilizing a minimally invasive surgical technique to restore collapsed/afflicted disc space. The device construct consists of an initial A module, any number of middle B modules to appropriately fill the interbody space, and a final C module in which each module interlocks with the adjacent module(s). These modules are inserted via a rail system in which a PEEK and stainless steel tail attached to each module extends beyond the disc space and allows the modules to be inserted in a sequential fashion. The PEEK portion of the tail can be detaches the entire rail and allows the modules to be progressed laterally in the disc space and repeated to construct the implant in an in situ fashion. The modules will be manufactured in several different size/lordotic options to appropriately accommodate patient pathologies.

I am sorry, but the provided text does not contain the information required to fulfill your request. The document describes a 510(k) submission for a medical device (Intervertebral Body Fusion Device) and focuses on demonstrating substantial equivalence to a predicate device. It discusses the device's description, indications for use, modifications, and a summary of technological characteristics.

Crucially, it explicitly states:

• "Performance Testing - Clinical: Clinical testing was not applicable to support a substantial equivalence determination for the subject device."

This indicates that no clinical study (which would typically involve defining acceptance criteria, using a test set, establishing ground truth, and potentially MRMC studies) was conducted or presented in this submission. Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily relies on non-clinical performance testing related to material strength and surface coating (adhesion testing) to support the substantial equivalence claim.

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The NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pediatic patients, the NEX-D2 Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft to facilitate fusion.

The Next Orthosurgical NEX-D2 Posterior Fixation System is a non-cervical pedicle screw system that consists of pedicle screws, rods, connectors, and set screws. All components are available in a variety of sizes to match patient anatomy. All components are manufactured from Ti-6AI-4V ELI per ASTM F136, commercially pure titanium per ASTM F67, and cobalt chrome allov per ASTM F1537, These components are supplied either sterile or non-sterile.

The provided document is a 510(k) summary for the NEX-D2 Posterior Fixation System, which is a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through novel acceptance criteria and studies.

Therefore, the information typically requested in your prompt regarding acceptance criteria, device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for a novel AI/medical device with new performance claims is not applicable to this document.

Instead, the document focuses on non-clinical mechanical testing to demonstrate that the new device components are substantially equivalent to existing, cleared devices.

Here's how to interpret the available information in the context of your request:

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

• Acceptance Criteria: The document states, "The subject devices met the pre-determined acceptance criteria." It implies these criteria are derived from the performance of the predicate devices according to the listed ASTM standards. However, the specific numerical acceptance criteria (e.g., minimum bending strength, maximum deflection) are not detailed in this summary. They would typically be found in the full 510(k) submission, referencing the specific ASTM standard requirements for such devices.
• Reported Device Performance: The document generally states, "Testing results demonstrate that the NEX-D2 Posterior Fixation System is substantially equivalent to the predicate devices." It does not provide specific numerical performance results for the NEX-D2 system (e.g., exact values for static compression bending strength, fatigue life cycles). This level of detail is also usually present in the full submission, comparing the subject device's performance directly to the predicate or to the ASTM standard's requirements.

2. Sample sized used for the test set and the data provenance

• For the non-clinical mechanical tests, the sample sizes are not specified in this summary. These quantities would be defined by the relevant ASTM standards for the specific tests performed (e.g., a certain number of constructs for fatigue testing).
• Data Provenance: The tests were conducted internally by Next OrthoSurgical or a contracted lab to support the 510(k) submission.

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

• Not Applicable. This is a mechanical device, and "ground truth" in this context refers to the specified performance requirements of industry standards (ASTM) rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

• Not Applicable. Mechanical testing results are objective measurements against established standards, not subject to expert adjudication of subjective assessments.

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 device is a surgical implant (pedicle screw system), not an AI-powered diagnostic or assistive tool. No human reader studies were performed.

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

• Not Applicable. This is a mechanical surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance acceptance is based on adherence to recognized industry standards (ASTM F1717, ASTM F1798, ASTM F543, ANSI/AAMI ST72) and demonstrating performance comparable to previously cleared predicate devices.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not Applicable.

In summary, for the NEX-D2 Posterior Fixation System, the primary "study" is a series of non-clinical mechanical tests demonstrating compliance with recognized ASTM standards and substantial equivalence to predicate devices, rather than a clinical trial or AI performance study with human-in-the-loop assessments.

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The InterForm Cervical Interbody Cage System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The device is intended to be implanted via an open, anterior approach and used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Cervical Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the cervical spine. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device.

Not Found

I am sorry, but the provided text from the FDA 510(k) K161608 document does not contain information about the acceptance criteria or a study that proves the device meets those criteria. The document is primarily an FDA clearance letter and an "Indications for Use" statement for the InterForm Cervical Interbody Cage System.

It states that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance, rather than a detailed report of a new study to establish acceptance criteria for the device's performance.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for a test set
3. Number and qualifications of experts for ground truth establishment
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. Ground truth establishment for the training set

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The VertiForm Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the VertiForm Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft to facilitate fusion.

The VertiForm Posterior Fixation System is a non-cervical spinal fixation system consisting of pedicle screws, set screws, rods and cross connectors. The pedicle screws are offered in a Polyaxial. Fixed or Uniplanar pedicle screw configuration and are available in a variety of geometries and sizes to accommodate patient anatomy. They are offered non-sterile and sterile. The VertiForm Posterior Fixation System is manufactured from titanium alloy (ASTM F136), medical-grade commercially pure titanium (ASTM F67) and medical-grade cobalt chrome (ASTM F1537). This Special 510(k) Premarket Notification seeks clearance to add variable cross connectors to the currently marketed VertiForm Posterior Fixation System.

The provided document is a 510(k) summary for a medical device called the "VertiForm Posterior Fixation System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study or detailed acceptance criteria for an AI/algorithm.

Therefore, the information required to fill out the table and answer the study-related questions (points 1-9) about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies is not present in this document.

Here's why and what information is available:

• Device Type: This is a physical spinal implant system (pedicle screws, rods, cross connectors), not an AI/algorithm-based diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This is often achieved through comparison of indications for use, technological characteristics, and sometimes non-clinical performance testing (e.g., mechanical tests for implants).
• Focus of the Document: The document explicitly states that it seeks clearance to add "variable cross connectors" to an already marketed VertiForm Posterior Fixation System. The main comparison is between the modified device and the predicate device (the previous version of the VertiForm system, K141291).

What is present in the document is a summary of non-clinical (mechanical) testing performed to demonstrate equivalence, not AI performance metrics:

• Non-Clinical Test Summary (Section 5):
  • Dynamic compression testing: Performed in accordance with ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, 2004."
  • Bacterial endotoxin testing: Performed in accordance with ANSI/AAMI ST72.
  • Results: "Testing results demonstrated that the VertiForm Posterior Fixation System with variable cross connectors performs comparable with the predicate device."

In summary, the request pertains to information typically found in submissions for AI/algorithm-enabled medical devices, which is not applicable to this 510(k) for a spinal implant system.

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The VertiForm Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the Vertiform Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and or allograft to facilitate fusion.

The VertiForm Posterior Fixation System consists of pedicle screw assemblies, set screw, rod and crosslink. The pedicle screw assemblies consist of Polyaxial Pedicle Screw, Fixed Pedicle Screw, and Uniplanar Pedicle Screw and are in a variety of geometries and sizes to accommodate patient anatomy. They will be provided non-sterile. The VertiForm Posterior Fixation System is manufactured from Titanium allov in accordance with ASTM F136, medical-grade commercially pure titanium per ASTM F67 and medical grade cobalt chrome per ASTM F-1537.

This document is a 510(k) summary for the VertiForm Posterior Fixation System, which is a pedicle screw spinal system. It describes the device, its intended use, and substantial equivalence to predicate devices. The document does not contain specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/ML medical device.

Based on the provided text, here's what can be extracted and what is missing:

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

The document provides the following information regarding performance testing:

Note: The acceptance criteria are implicitly stated as "equivalent to the predicate devices" rather than specific numerical thresholds. The reported performance is a general statement of equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document states "Performance testing has been conducted for the subject devices in accordance with the following guidance documents: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, ASTM F1717". This refers to non-clinical (mechanical) testing of the device hardware, not a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The study described is a non-clinical, mechanical performance test of a physical device, not an AI/ML algorithm requiring expert-established ground truth from medical images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided for the same reasons as point 3.

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 information is not applicable/provided. No MRMC study or AI assistance is mentioned. The device is a physical spinal fixation system.

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

This information is not applicable/provided. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/provided. The "ground truth" for the mechanical performance tests would be the measured physical properties (e.g., strength, stiffness, fatigue resistance) according to the ASTM standard, and comparison to predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no training set for a physical implant device.

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

This information is not applicable/provided. There is no training set for a physical implant device.

In summary:

The provided document describes a traditional medical device (a spinal implant). The "study" mentioned is non-clinical performance testing of the device's mechanical properties, not a clinical trial or an evaluation of an AI/ML algorithm. Therefore, many of the requested details, especially those related to AI/ML device evaluation, are not present or applicable to this document. The key information provided is that mechanical tests (Static Compression, Dynamic Compression, Static Torsion) were performed according to ASTM F1717, and the device was found to be "equivalent to the predicate devices" in terms of mechanical safety and performance.

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When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.

The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.

The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.

All implants are packaged non-sterile to be sterilized at the hospital.

Materials:

PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:

Maintain adequate disc space until fusion occurs.

The InterForm Interbody Cage System is intended for spinal fusion procedures.
Here's a breakdown of the acceptance criteria and the study done:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states that the device is considered "substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances." The acceptance criteria, while not explicitly numerical, are therefore met by demonstrating performance comparable to the already legally marketed predicate devices. The study concludes that the results indicate the InterForm Interbody Cage System is equivalent.

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

This information is not provided in the document. The studies listed are non-clinical tests (mechanical testing), not studies involving human or animal subjects that would generate a "test set" of data in the typical sense of evaluating AI or clinical outcomes. The provenance of the samples (e.g., specific batches of PEEK and tantalum used in testing) is not detailed, nor is it relevant given the mechanical nature of the tests.

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

This information is not applicable as the studies are non-clinical mechanical tests, not clinical evaluations requiring expert interpretation or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical mechanical tests.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This device is a physical medical implant, not an AI or imaging device that would typically involve human reader studies.

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

This information is not applicable as the device is a physical medical implant and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established mechanical properties and performance standards outlined in the ASTM F2077 and ASTM F2267 standards, and the performance characteristics of the predicate devices. For mechanical tests, the ground truth is objectively measured physical properties and behaviors of the material and device under specific conditions.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant and would not have a "training set" in the context of machine learning or AI. For mechanical testing, the "samples" would be the manufactured devices or materials subjected to the tests. The exact number of units tested for each non-clinical test (static compression, dynamic compression, subsidence, expulsion) is not specified, but it would typically be a statistically significant number of physical samples to ensure reliability and reproducibility of the results according to the ASTM standards.

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

This information is not applicable for the same reasons as #8. The "ground truth" for material and device properties in mechanical testing is established through standardized testing procedures and validated measurement techniques, as defined by organizations like ASTM.

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