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The Integrity Spine Lumbar Interbody Fusion is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) may be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach:
• as a single device via a transforaminal (TLIF) approach; or
• as as a single device via an anterior or anterolateral (ALIF) approach.
  The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
  The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

This document is a 510(k) premarket notification for the Integrity Spine Lumbar Interbody Fusion System. It is an FDA clearance letter and a 510(k) summary, not a study report proving a device meets acceptance criteria. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, ground truth, or expert involvement for evaluating device performance in the context of AI or diagnostic accuracy studies.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical mechanical testing for safety and performance in a physical device context (interbody fusion).

Therefore, I cannot extract the requested information from this document. The document discusses:

• Device Name: Integrity Spine Lumbar Interbody Fusion System (Page 2)
• Intended Use: Intervertebral body fusion of the lumbar spine, from L2 to S1, for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, for skeletally mature patients who have had six months of non-operative treatment. (Page 2)
• Testing: Non-clinical mechanical testing including static and dynamic compression, static and dynamic torsion, subsidence, and expulsion testing. These tests were conducted according to ASTM standards (F2077-11, F2267-04, and a Draft Standard F-04.25.02.02). (Page 5)
• Conclusion: The device is substantially equivalent to predicate devices based on shared intended use, implant design, material, and non-clinical mechanical test results. (Page 5)

The prompt asks for acceptance criteria and study details that are typically found in studies evaluating diagnostic devices, AI algorithms, or clinical performance. This document pertains to a surgical implant and its mechanical properties.

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The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body 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 DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK were developed as implants for the stabilization of the cervical and lumbar spinal column. The implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery.

Here's an analysis of the provided text regarding acceptance criteria and study information for the Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK devices.

Based on the provided FDA 510(k) summary, these devices are intervertebral body fusion devices, and the submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria from a clinical study for a novel AI/software function.

Therefore, most of the requested fields related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this particular device submission. The "acceptance criteria" here refer to the regulatory standards and testing required for this type of medical implant to demonstrate safety and effectiveness equivalent to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The testing described is non-clinical mechanical testing of the physical implant, not a study involving patient data or a "test set" in the context of AI/software performance.
• Data Provenance: Not applicable. The data comes from benchtop mechanical testing, not human subjects.

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)

• Not applicable. Ground truth as typically defined for AI/software (e.g., diagnostic labels) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles.

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

• Not applicable. There was no clinical or expert-based adjudication in the context of this submission. The "adjudication" for mechanical testing is based on whether the device passed the specified ASTM standards.

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. No MRMC study was performed as these are physical medical implants, not AI/software for interpretation.

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

• Not applicable. No algorithm-only performance study was conducted.

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

• Not applicable. The "ground truth" for this submission are the established ASTM standards for mechanical testing of intervertebral body fusion devices.

8. The sample size for the training set

• Not applicable. There was no "training set" in the context of an AI/software algorithm.

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

• Not applicable. There was no "training set" or corresponding ground truth to establish.

Summary of the Study:

The provided document describes a 510(k) premarket notification for three intervertebral body fusion devices: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK.

The study relied on non-clinical mechanical testing to demonstrate "substantial equivalence" to previously marketed predicate devices, as is common for Class II medical devices in the 510(k) pathway.

Specifically, the following analyses were conducted:

• Static and dynamic compression per ASTM F2077
• Static and dynamic torsion per ASTM F2077
• Subsidence per ASTM F2267

The manufacturer, Osteomed Implantes, LTDA, concluded that the DICOM PEEK, DIMEI PEEK, and TLIF PEEK devices are equivalent to the predicate devices based on similarities in principles of operation, technology, materials, and indications for use, supported by the results of these non-clinical evaluations.

No clinical studies were performed. The submission explicitly states this.

Ground Truth for Non-clinical Testing: The ground truth for this type of testing is adherence to the specified ASTM international standards (ASTM F2077 for compression/torsion and ASTM F2267 for subsidence), which are recognized benchmarks for evaluating the mechanical properties of intervertebral body fusion devices. The devices are expected to meet or exceed the performance of the predicate devices under these test conditions.

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The nvª, nvº, and nv are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.

The nv4, nv9, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.

The nv4 and nv2 devices have multiple footprints to adapt to the general shape of the vertebral endplates. The nv , nv , and nv are available in multiple heights to accommodate patient variability and have a hollow centre to accommodate bone graft. The devices are implanted via a variety of surgical approaches which include anterior, and transforaminal. There are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

This document is a 510(k) summary for medical devices (nvª, nvP, and nv*) from Nvision Biomedical Technologies, LLC. It outlines the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner requested (i.e., performance metrics like sensitivity, specificity, accuracy, etc., typically associated with AI/ML devices).

The document focuses on:

• Device Description: Intervertebral body fusion devices made from PEEK Optima® LT1 with tantalum markers.
• Intended Use: Lumbar spinal fusion for degenerative disc disease (DDD) in conjunction with supplemental fixation and autograft.
• Substantial Equivalence: Claims substantial equivalence to listed predicate devices (Genesys Spine ApacheTM System and SeaSpine Spacer System – PacificaTM) in terms of intended use, materials, design, technological characteristics, mechanical safety, and performance.
• Mechanical Testing: Mentions performance testing was conducted according to standardized tests (Static and Dynamic Axial Compression per ASTM F2077, Subsidence per ASTM F2267, Expulsion) and that these results "demonstrate substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving device performance against those criteria, as this document does not contain that type of data. The information provided is primarily for regulatory clearance based on substantial equivalence to existing devices, focusing on design, materials, and mechanical safety, rather than a clinical performance study with specific acceptance criteria that would be relevant for devices like AI/ML products.

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The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic 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 DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 System is to be used with supplemental fixation.

The Benvenue Luna 360 System consists of the Luna 360 Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 360 System are identical to predicate interbody lumbar cages. The Luna 360 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 360 Implant is available in heights ranging from 8mm to 13mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates.

The Luna 360 Implant is manufactured from polyetheretherketone (PEEK Optima LT-1), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

The provided text describes a 510(k) premarket notification for the "Luna 360 Interbody Fusion System." This document is primarily concerned with establishing substantial equivalence to legally marketed predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in AI/ML medical device submissions.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, and adjudication methods is not available in the provided text, as this type of information is generally not required for this specific device type and approval pathway.

The device is an intervertebral body fusion device, not an AI/ML algorithm, and thus the concepts of "acceptance criteria" for algorithm performance, "test set," "training set," "ground truth," "MRMC studies," or "standalone performance" as they relate to AI/ML devices do not apply here.

However, the document does contain information about performance testing relevant to a medical device's physical and mechanical properties.

Here's a breakdown of the relevant information provided:

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

• Acceptance Criteria (Implicit): The implicit acceptance criterion is that the device demonstrates mechanical properties that are "substantially equivalent" to legally marketed predicate devices, particularly regarding static/dynamic compression, shear-compression, torsion, subsidence, and expulsion. The specific numerical thresholds for "acceptance" are not explicitly stated as they would be in an AI/ML performance summary, but rather implied by meeting the standards of similar devices.
• Reported Device Performance:
  • Mechanical Testing: The tests demonstrated that the Luna Interbody System is "substantially equivalent" to legally marketed predicate devices in static/dynamic compression, static/dynamic shear-compression, static/dynamic torsion testing (per ASTM F2077), static subsidence (ASTM F2267), and expulsion testing (ASTM Draft Standard F-04.25.02.02).
  • Cadaveric Testing: Performed to validate the surgical technique.
  • MR Compatibility Testing: Performed to demonstrate MR safety.

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

• Not applicable for this type of device and testing. The "test set" in this context refers to the physical devices undergoing mechanical and material testing, not a dataset of patient images or clinical outcomes.

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)

• Not applicable. "Ground truth" in this context would likely refer to engineering specifications or validated test methods, rather than expert diagnostic opinions.

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

• Not applicable.

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 not an AI-assisted diagnostic tool.

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

• Not applicable.

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

• For the mechanical testing, the "ground truth" would be the established ASTM standards (F2077, F2267, and ASTM Draft Standard F-04.25.02.02) and engineering principles for mechanical performance. For MR compatibility, the "ground truth" would be established MR safety protocols.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device.

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

• Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (intervertebral body fusion system) based on substantial equivalence to existing devices, supported by a series of mechanical and material performance tests. It does not involve a clinical study or AI/ML algorithm, and therefore the specific questions related to AI/ML validation are not addressed by the text.

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The Integra® Expandable Intervertebral Body Fusion Device (IBD) 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 history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASTM F2026), titanium (Ti-6Al-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiographic tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft. They are available in a range of sizes, and their heights can be intra-operatively expanded to the desired height to accommodate variations in surgical approach and patient anatomy. Non-expandable implants are manufactured from PEEK-OPTIMA® LT1 only with radiopaque markers. The system also includes instruments to assist with the surgical procedure/ implantation, as well as trays and caddies for organization.

This is a medical device application for an intervertebral body fusion device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, is not applicable in this context.

Here's a breakdown of why the requested information cannot be provided given the input:

• Device Type: The Integra Expandable IBD System is a physical medical implant (intervertebral body fusion device) made of PEEK, titanium, and cobalt chromium. It is not a software algorithm or an AI/ML diagnostic tool.
• Regulatory Pathway: This is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices. This pathway typically relies on non-clinical (bench) testing and comparison to existing devices, rather than large-scale clinical trials or AI/ML performance studies with specific acceptance criteria like sensitivity, specificity, etc.
• Non-Clinical Testing: The submission explicitly states "Non-clinical Testing: The Integra Expandable IBD System demonstrated equivalent performance to the predicate systems through static and dynamic axial compression shear testing per ASTM F2077, with wear evaluation per ASTM F1877, subsidence testing per ASTM F2267, and expulsion testing per ASTM Draft F04.25.0202. In addition, a cadaver implantation study was conducted to demonstrate usability and graft containment/volume of the subject device."
• Clinical Testing: The submission explicitly states "Clinical Testing: No clinical testing was required to demonstrate equivalence."

Therefore, I cannot populate the table or answer the questions as they pertain to AI/ML device validation. The provided document concerns a traditional medical device demonstrating substantial equivalence through non-clinical performance standards and a cadaver study, not through a study involving AI performance metrics, readers, or ground truth as defined in an AI context.

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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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The SynCage Evolution spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the SynCage Evolution spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Synthes SynCage Evolution spacer is a radiolucent device for use in interbody fusion. It is to be used in conjunction with supplemental fixation to provide structural stability in skeletaly mature individuals. The Synthes SynCage Evolution spacer is fabricated from Invibio® PEEK-OPTIMA® LT-1 (ASTM F2026-10) with four anterior and one posterior tantalum (ASTM F560-08) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant. Implantation is through an anterior or anterolateral approach. The Synthes SynCage Evolution spacer is provided sterile. The Synthes SynCage Evolution spacer is available in three footprints (Small: 32x25mm; Medium, 36x28mm; Large, 40x31mm), four lordotic angles (6°, 10°, 14°, 18°), and a range of heights (9-19mm) to suit individual pathology and anatomical conditions. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material (i.e., autograft).

The provided text describes a 510(k) summary for the Synthes SynCage Evolution Spacer, an intervertebral body fusion device. It details the device's description, intended use, and a comparison to predicate devices, focusing on non-clinical performance data.

Here's an analysis based on your request:

1. Acceptance Criteria and Reported Device Performance

The document does not specify explicit acceptance criteria in terms of numerical thresholds or performance targets for a device meeting clinical or diagnostic accuracy. Instead, it states that the device's performance was evaluated through non-clinical bench testing and compared to predicate devices for substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Clinical data and conclusions were not needed for this device."
Therefore, there was no test set of clinical data used to evaluate the device's performance in humans. The evaluation was based solely on non-clinical bench testing.

• Sample Size for Test Set: Not applicable (no clinical test set).
• Data Provenance: Not applicable (no clinical data).

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

As no clinical data was used for evaluation, there was no ground truth established by experts for a test set. The evaluation relied on engineering principles and bench testing standards.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method employed.

• Adjudication Method: Not applicable.

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

No MRMC study was conducted. The document states: "Clinical data and conclusions were not needed for this device."

• MRMC Study: No.
• Effect Size of Human Readers with vs. without AI: Not applicable.

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

This device is an intervertebral fusion spacer, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance was evaluated through bench testing.

• Standalone Study: Not applicable (device is not an algorithm).

7. The Type of Ground Truth Used

For the non-clinical performance evaluation, the "ground truth" was established by standardized engineering testing protocols as defined by ASTM F2077-11 and ASTM F2267-04. The performance was then compared to that of legally marketed predicate devices, implying that their established performance under these tests served as a reference for "substantial equivalence."

• Type of Ground Truth: Bench testing standards (ASTM F2077-11 and ASTM F2267-04) and performance of predicate devices.

8. The Sample Size for the Training Set

This document describes a physical medical device, not an AI or machine learning model. Therefore, the concept of a "training set" is not applicable.

• Sample Size for Training Set: Not applicable.

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

As there is no training set mentioned or implied for this physical device, this question is not applicable.

• How Ground Truth for Training Set Was Established: Not applicable.

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The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach: a
• as a single device via a transforaminal (TLIF) approach: or -
• as as a single device via an anterior or anterolateral (ALIF) approach.
  The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
  The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

Since the extracted text refers to a 510(k) summary for a medical device (Integrity Spine Lumbar Interbody Fusion System), the "acceptance criteria" and "device performance" would typically relate to comparisons to predicate devices based on non-clinical testing, rather than explicit numerical performance metrics like sensitivity or specificity often seen in AI/diagnostic device contexts. Also, there's no mention of a "study that proves the device meets the acceptance criteria" in terms of clinical trials or AI performance evaluations with ground truth. The summary focuses on substantiating substantial equivalence through non-clinical testing.

Here's an attempt to answer your questions based solely on the provided text, acknowledging that many of your points are not directly addressed due to the nature of this particular 510(k) summary:

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

Based on the provided text, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to predicate devices through non-clinical testing. The "reported device performance" is the successful completion of these tests with results deemed equivalent. There are no explicit numerical acceptance criteria for performance provided in the document in the way one might see for diagnostic AI (e.g., sensitivity > X%, specificity > Y%).

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

The document describes non-clinical mechanical testing rather than testing on patient data. Therefore, the concept of "test set" in terms of patient data, data provenance, or retrospective/prospective studies does not apply here. The "samples" used were physical devices subjected to the specified ASTM tests. The sample sizes for these specific mechanical tests are not detailed in this summary.

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 question is not applicable to the provided document. The ground truth for this device's evaluation (substantial equivalence) is established through adherence to recognized international standards for mechanical testing (ASTM standards) and comparison to legally marketed predicate devices, not through human expert interpretation of clinical data in a diagnostic context.

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

This question is not applicable to the provided document, as it pertains to clinical data interpretation and not mechanical device testing.

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

There is no mention of a multi-reader multi-case (MRMC) study. This document describes a medical device (spinal implant) and its substantial equivalence determination, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical spinal implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" is established by the specified ASTM (American Society for Testing and Materials) standards for mechanical performance (e.g., F2077-11 for static and dynamic testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion). The performance of the predicate devices under these same standards also serves as a comparative benchmark.

8. The sample size for the training set

This question is not applicable to the provided document. There is no concept of a "training set" for a physical medical device like a spinal implant in the context of this 510(k) summary.

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

This question is not applicable to the provided document for the same reasons as point 8.

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