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The uCerv Flux ™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

The provided FDA document is a 510(k) clearance letter for a medical device, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI algorithms is not present in this document.

The document describes the uCerv Flux™-C 3D Porous Titanium Cervical Interbody, an intervertebral body fusion device. The acceptance criteria and "study" described relate to the mechanical performance of this physical device, not a digital diagnostic or AI-driven system.

Here's the relevant information based on the provided text:

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

Explanation: The document states that "Mechanical testing of the worst case Flux-C devices was relied upon in support of the original uCerv Flux™-C 3D Porous Titanium Cervical Interbody clearance. The testing included static and dynamic axial compression and static torsion according to ASTM F2077 and subsidence according to ASTM F2267. An engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case." It further mentions, "Mechanical testing of the worst case subject uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants included dynamic torsion according to ASTM F2077 and expulsion tests. The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices." The acceptance criteria are implicit in meeting the standards (ASTM F2077, ASTM F2267) and demonstrating substantial equivalence to predicate devices. Specific numerical thresholds for acceptance are not provided in this summary.

Regarding the remaining points (2-9), the provided document does not contain information about an AI algorithm or a study involving human readers, so these points cannot be addressed. The document is for a physical orthopedic implant.

Here's why the other points are not applicable:

• 2. Sample size used for the test set and the data provenance: Not applicable. This document is about a physical device's mechanical performance, not an AI test set with data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI test set is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.
• 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 AI assistance or human reader study is discussed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device is its mechanical integrity and performance as per ASTM standards, compared to predicate devices.
• 8. The sample size for the training set: Not applicable. No AI training set is mentioned.
• 9. How the ground truth for the training set was established: Not applicable. No AI training set is mentioned.

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The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine.

The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can't be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.

The DOLOMITE Anterior Cervical Stabilization System are implants developed for the stabilization of the cervical column. The spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a locking mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights in PEEK OPTIMA LT120HA or machined Titanium alloy. The plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient in machined Titanium alloy. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates to allow bone growth.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding the Astura Medical, LLC's "DOLOMITE Anterior Cervical Stabilization System." This document is a regulatory notice of substantial equivalence for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML powered medical device, which is what the prompt is asking for.

The document explicitly states under "Clinical Test Summary" that "No clinical studies were performed." and under "Non-clinical Test Summary" that "The following analyses were conducted: Dynamic Compression Static Compression Dynamic Torsion Static Torsion. The results of these evaluations indicate that the Dolomite implants are equivalent to predicate devices."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, specifically in the context of an AI/ML powered medical device, based on the provided text. The text describes a conventional medical device (an intervertebral body fusion device) and its regulatory clearance process, which relies on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than performance against specific acceptance criteria in a clinical study of an AI/ML product.

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The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Aries® Lumbar Interbodies are interbody fusion devices used to provide structural stability in skeletally mature patients. The implants were developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients and multiple surgical approaches. Each interbody has an axial hole to allow grafting material to be placed inside of the interbody. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

This document describes Aries® Lumbar Interbodies, an intervertebral body fusion device, and its acceptance criteria for FDA clearance.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not include information on sample size for a test set or data provenance for any clinical studies. It explicitly states, "No clinical studies were performed." The testing conducted was non-clinical (mechanical and pyrogenicity).

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

This information is not applicable as no clinical studies were performed, and thus no expert-established ground truth for a test set was required in this submission. The "ground truth" for the non-clinical tests was established through adherence to recognized ASTM standards.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies requiring human adjudication were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical studies were performed."

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

This information is not applicable. The device is an intervertebral body fusion device, which is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was based on established industry standards and specifications (ASTM F2077, ASTM F2267, ASTM F3001, and pyrogenicity limits). The goal was to demonstrate equivalence to predicate devices, meaning the device performed within the acceptable parameters defined by these standards, similar to already cleared devices.

8. The Sample Size for the Training Set

This information is not applicable as there was no algorithm or AI component requiring a training set. The device is a physical medical implant.

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

This information is not applicable as there was no algorithm or AI component requiring a training set or its associated ground truth.

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The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine AIS-C Cervical Anchored Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical (mechanical) testing. It does not contain information about a study involving human-in-the-loop performance, AI assistance, or the establishment of ground truth by medical experts for a diagnostic or AI-powered device. Therefore, many of the requested items (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone AI performance) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and the (mechanical) study that proves the device meets those criteria.

Here's a breakdown of the available information:

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

The acceptance criterion for the mechanical tests was set as follows:

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

• Sample Size: Not explicitly stated as a numerical sample size. The document mentions "all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing." This implies a selection of specific configurations for mechanical testing rather than a statistical sample size in the context of human data.
• Data Provenance: The data is from non-clinical mechanical testing, not human or patient data. Therefore, country of origin or retrospective/prospective classification is not applicable in the typical sense. The testing was conducted to U.S. standards (ASTM).

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. This document describes mechanical testing of a medical implant, not a diagnostic device or AI system that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance against established industry standards and predicate device performance.

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

• Not Applicable. Pertains to human review of data, not mechanical 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:

• No. This was not an MRMC study and did not involve human readers or AI assistance.

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

• No. This device is a physical 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 is objective mechanical testing per established ASTM standards (F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; F2267-04 for static subsidence; and ASTM draft standard F-04.25.02.02 for expulsion testing). The "truth" is whether the device meets or exceeds the mechanical performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning device.

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

• Not Applicable. This is not an AI or machine learning device.

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The ALTA Cervical Interbody Spacer is indicated for intervertebral body fusion procedures with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). 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 supplemental internal 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 cages.

The ALTA Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in two material choices: PEEK and titanium. The PEEK implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.

This document is a 510(k) premarket notification for the ALTA Cervical Interbody Spacer. This type of FDA submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and efficacy through clinical trials. Therefore, the information typically requested about acceptance criteria and detailed study designs for AI/medical imaging devices is not present here.

Specifically for your questions:

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

   • This document does not contain quantitative acceptance criteria and reported performance metrics in the way one would see for an AI/imaging device. The device's "performance" is demonstrated through non-clinical mechanical testing, showing equivalence to predicate devices, rather than clinical outcomes or diagnostic accuracy.

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

   • No clinical "test set" data in the context of an AI/imaging device is provided. The non-clinical tests (static/dynamic compression, torsion, subsidence, expulsion) involve mechanical samples of the device itself.
   • The document explicitly states: "No clinical studies were performed."

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. There is no clinical test set requiring expert-established ground truth.

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

   • Not applicable. No clinical test set.

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 is a medical implant, not an AI/imaging diagnostic device.

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

   • Not applicable. This is a medical implant, not an AI/imaging diagnostic device.

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

   • For the non-clinical tests, the "ground truth" is based on established ASTM standards for mechanical properties (e.g., F2077 for compression and torsion, F2267 for subsidence). The device's performance is compared against these standards or against the performance of predicate devices as per those standards.

8. The sample size for the training set

   • Not applicable. There is no AI model or "training set."

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

   • Not applicable. There is no AI model or "training set."

Summary of Device Performance (from the provided text, related to non-clinical testing):

Conclusion: The provided document describes a 510(k) submission for a cervical interbody spacer. The device received clearance based on demonstrating "substantial equivalence" to existing predicate devices, primarily through non-clinical mechanical testing and comparison of design, materials, and intended use. No clinical studies were performed, and thus, no data regarding acceptance criteria, test set, training set, expert consensus, or AI performance metrics are included.

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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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When used as a cervical intervertebral fusion device, the GPS™ Cervical Spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.
When used as a lumbar intervertebral fusion device, the GPS™ PLIF and TLIF Spacers are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). The device is to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

The basic shape of the Cervical and Lumbar GPS™ devices is a structural column having upper and lower implant openings and a central cavity for autograft bone. The cervical devices have a "B" shaped cross-section. The PLIF devices are rectangular having a pyramidal anterior surface. The TLIF device cross-section is curved having a wedged leading face. For all devices, surface teeth assist in the seating the implant between the vertebral bodies. Each device type is available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.

The provided document is a 510(k) summary for the GPS™ Spacers, an intervertebral body fusion device. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and performance data.

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The "Performance Data" section specifically states: "Mechanical testing of the worst case GPS™ Spacers was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. Expulsion testing was performed. The mechanical test results demonstrate that the GPS™ Spacer performance is substantially equivalent to the predicate devices."

This indicates that the performance data presented is related to mechanical and material properties of the physical intervertebral fusion device, not the performance of an AI/ML algorithm. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, ground truth establishment, or sample sizes relevant to an AI/ML device study, as that information is not present in the provided text.

Based on the nature of the device (intervertebral body fusion device), it is a physical implant and not an AI/ML-driven diagnostic or therapeutic device. The typical metrics, study designs, and ground truth methodologies for AI/ML devices (like sensitivity, specificity, MRMC studies, expert adjudication for image analysis) are not applicable here.

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The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). 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 supplemental internal 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 INTESS™ Cervical Cage was developed as implants for the stabilization of the cervical column. The INTESS™ implants have graft windows which help facilitate bony integration. The INTESS™ implants have ridges on both their inferior and superior surfaces. X-ray markers are integrated for visualization of the implants during and after surgery.

Materials:
Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:
Maintain adequate disc space until fusion occurs.

The provided document is a 510(k) Summary for the INTESS™ Cervical Cage. This type of document is a premarket notification to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device.

It's important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics like a typical AI/software device. For a traditional medical device like the INTESS™ Cervical Cage, "acceptance criteria" are usually met by demonstrating that the device's functional and safety characteristics are comparable (substantially equivalent) to already approved devices.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device (with details like sample sizes, expert ground truth, MRMC studies, etc.) does not directly apply to this 510(k) submission for a physical implant.

However, I can extract the information relevant to the equivalence demonstration for the INTESS™ Cervical Cage:

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

Since this is a 510(k) to demonstrate substantial equivalence, "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" is a demonstration that the INTESS™ Cervical Cage performs comparably to these predicates in non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of human data. For mechanical testing, the "sample size" refers to the number of physical devices tested. This information is typically detailed in the test reports referenced by the ASTM standards, but not usually in the 510(k) summary itself. The document states "The following tests were conducted," implying a sufficient number of devices were tested to meet the ASTM standards.
• Data Provenance: Not applicable for a non-clinical mechanical test 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):

Not applicable. Ground truth from human experts is not used for mechanical testing of a physical implant. The "ground truth" for mechanical performance is established through adherence to recognized ASTM standards and the associated testing methodologies.

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

Not applicable. This device's evaluation did not involve human adjudication of test results in the way an AI/software device would. The mechanical tests have pass/fail criteria based on engineering specifications.

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. This is a physical implant, not an AI/software device. No MRMC study was performed.

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

No. This is a physical implant.

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

The "ground truth" for the non-clinical tests is based on established engineering and materials standards (ASTM F2077, ASTM F2267, ASTM F2026, ASTM F560) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. There is no training set for a physical implant.

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

Not applicable. There is no training set for a physical implant.

Summary of the Study (Equivalence Demonstration):

The study conducted to support the INTESS™ Cervical Cage was a series of non-clinical bench tests designed to demonstrate the device's mechanical integrity and material properties.

• Tests Performed:
  • Static and dynamic compression per ASTM F2077
  • Static and dynamic torsion per ASTM F2077
  • Subsidence per ASTM F2267
• Materials Conformance: Zeniva ZA500 PEEK conforming to ASTM F2026 and Unalloyed tantalum conforming to ASTM F560.
• Conclusion: The results of this testing indicated that the INTESS™ Cervical Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.
• Clinical Studies: No clinical studies were performed.

In essence, for this device, "acceptance criteria" are met by demonstrating that its physical and mechanical properties, as measured by standard engineering tests, are comparable to those of already approved predicate devices.

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A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuseTM system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

The A-CIFT™ SoloFuse™ consists of a PEEK OPTIMA LT1 spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The lordotic and nonlordotic PEEK-OPTIMA® LT1 spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm. The titanium bone screws traverse the PEEK-OPTIMA® LTI interbody device either through the body or a posterior/inferior flange to anchor into the patient's vertebral body, thereby securing the interbody into the final placement location. The cage has endplate teeth for additional fixation, ports for bone graft and an anti-screw backout.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

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)

The provided text describes non-clinical testing on the device itself (mechanical and material tests), not clinical studies involving human patients or data derived from them. Therefore, there is no "test set" in the sense of clinical data or patient samples.

For the mechanical tests, the sample size is not explicitly stated, but it refers to the A-CIFT™ SoloFuse™ device itself undergoing various mechanical tests. The provenance is not explicitly stated as a country of origin for data; however, the testing standards (e.g., ASTM) are international standards often adopted globally. This was not a retrospective or prospective human data study.

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 as the studies described are non-clinical mechanical and material tests of the device, not studies requiring expert interpretation of diagnostic images or clinical outcomes to establish ground truth.

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

This information is not applicable as the studies described are non-clinical mechanical and material tests, which do not involve subjective interpretation or adjudication by multiple experts in the context of clinical ground truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (intervertebral fusion device), not an AI-assisted diagnostic or treatment planning tool. Therefore, there is no mention of human readers or AI assistance effect size.

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

No, a standalone algorithm-only performance study was not done. This submission is for a physical medical device, not an algorithm.

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

For the mechanical tests, the "ground truth" is established by the specified ASTM standards and material specifications. The device's performance is compared against the requirements and benchmarks set by these established engineering and material standards, rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

This information is not applicable as the studies described are non-clinical mechanical and material tests of a physical device, and not machine learning or AI models that require training sets.

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

This information is not applicable since there is no training set for an AI model.

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When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Integrity Spine Core System is a cervical intervertebral body fusion system comprised of parallel and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The Integrity Spine Core System 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.

The Integrity Spine Core 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 provided text describes a 510(k) Premarket Notification for the Integrity Spine Core System, an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing, rather than a clinical study evaluating device performance in humans.

Therefore, many of the requested items related to clinical study design, such as acceptance criteria based on human performance, sample size for test sets (in a clinical context), expert ground truth establishment for diagnostic performance, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable to this 510(k) submission.

This submission primarily relies on bench testing to show mechanical equivalence.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of acceptance criteria and the reported device performance

Explanation of Acceptance Criteria: The acceptance criteria for this 510(k) submission are implicitly defined as demonstrating "substantially equivalent results" in non-clinical mechanical testing compared to the identified predicate devices. This means the Integrity Spine Core System's mechanical performance in these standardized tests must fall within expected ranges relative to the predicates, indicating no new questions of safety or effectiveness are raised.

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

• Sample Size for Test Set: Not applicable in the context of human data. For the mechanical tests, the sample sizes would be determined by the ASTM standards (e.g., number of constructs tested for compression, torsion, subsidence, and expulsion). The document does not specify these exact numbers, but it states the tests were "conducted in accordance with" the respective ASTM standards.
• Data Provenance: Not applicable as this submission is based on non-clinical (bench) testing, not human data. The tests were performed in a lab setting to assess the device's physical properties.

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

• Not Applicable. Ground truth, in the sense of expert diagnosis or outcome labeling from human data, is not established for this type of non-clinical mechanical testing. The "ground truth" here is the adherence to mechanical performance standards and comparison to predicate devices.

4. Adjudication method for the test set

• Not Applicable. This is relevant for studies involving human data where there might be disagreements in interpretation (e.g., reading medical images). For mechanical testing, outcomes are typically measured objectively based on physical properties.

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 an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

• Not Applicable. This is a physical medical implant, not an algorithm or AI system.

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

• Not Applicable / Bench Test Standards. The "ground truth" for this submission are the established ASTM standards for mechanical testing of spinal implants (F2077-11 for static and dynamic mechanical testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion) and the performance characteristics of the predicate devices. The aim is to demonstrate that the new device performs equivalently in these controlled mechanical environments.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical implant device. This concept applies to machine learning algorithms.

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

• Not Applicable. As there is no training set, there is no corresponding ground truth to establish.

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