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The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF, SPIRA® Open Matrix LLIF and SPIRA®-O Open Matrix Lateral Anterior Lumbar interbody fusion devices indicated for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative discase (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis). spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The SPIRA® Anterior Lumbar Spacers are intended to be used with additional FDAcleared supplemental fixation systems. The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers system must be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

The Camber Spine Technologies SPIRA-A Integrated Fixation System is indicated for use at one or more levels from L1-S1 as an adjunct to fusion in skeletally mature patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy) spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The Camber Spine Technologies SPIRA-A Integrated Fixation System spacers must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These devices are intended to be used with or without three screws and/or anchors which accompany these implants. These spacers are intended for use with additional FDA-cleared supplemental fixation. In addition, these spacers are intended for stand-alone use in patients with DDD at one or two contiguous levels only when ≤20° lordotic implants are used with three screws per implant. Other configurations of this system are not intended for stand-alone use and must be used with additional FDA-cleared supplemental fixation.

The Camber Spine Technologies SPIRA® Anterior Lumbar interbody fusion devices that have an open matrix design to permit packing with autogenous graft material to facilitate fusion. The subject submission seeks to expand the indications of the existing SPIRA® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF and SPIRA® Open Matrix LLIF). Additionally, this submission seeks to expand the anterior lumbar spacer options by adding the subject SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers components to the SPIRA® Anterior Lumbar Spacers as well as add the SPIRA®-A Integrated Fixation System.

The Camber Spine Technologies SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers are interbody fusion devices with an open matrix design consisting primarily of spiral support members to permit bone growth (i.e., interbody fusion) throughout the implants may be inserted from an anterior oblique lateral approach. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The implants are available in a variety of sizes to accommodate varies patient anatomies.

The Camber Spine Technologies SPIRA®-A Integrated Fixation System is an anterior lumbar interbody fusion device that has an open matrix design to permit packing with autogenous and/or allogenous graft material to facilitate fusion as well as additional fixation options to secure the idsc space. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place, and structural arched to help distribute load across the joint space. The device contains three holes to insert bone screws or anchors for integrated fixation, as well as blocking screws to prevent fixation back-out. Patients with previous non-fusion spinal surgery at the treated level may be treated.

Camber Spine Technologies SPIRA® Anterior Lumbar Spacers, SPIRA®-A Integrated Fixation System blocker screws, and bone anchors are additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001. The SPIRA®-A Integrated Fixation System bone screws are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.

The provided text is a 510(k) summary for the Camber SPIRA® Anterior Lumbar Spacers. It details the device, its indications for use, and a comparison to predicate devices, but it does not contain information related to software, AI, or diagnostic performance criteria as typically found in studies for such devices. Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I populate the other requested fields related to AI/software performance studies.

The document focuses solely on the substantial equivalence of the SPIRA® Anterior Lumbar Spacers, SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers, and SPIRA®-A Integrated Fixation System to previously cleared predicate devices based on design, indications for use, materials, and mechanical performance testing.

Here's what I can extract from the provided text regarding performance testing, even though it doesn't align with the requested AI/software performance criteria:

Performance Testing Details (Mechanical, not AI/Software):

The document mentions mechanical testing performed on the SPIRA®-A Integrated Fixation System, and Finite Element Analysis and geometric comparisons for the SPIRA®-O devices.

• Mechanical Testing for SPIRA®-A Integrated Fixation System:

  • Static and dynamic compression shear per ASTM F2077
  • Static and dynamic axial compression per ASTM F2077
  • Subsidence per ASTM F2267
  • Expulsion
  • Static and dynamic bending per ASTM F2193
  • Anchor impaction testing

• Analysis for SPIRA®-O devices:

  • Finite Element Analysis
  • Geometric comparisons to the predicate

Results of Performance Testing:

"The results all tests and analysis have shown the subject devices to be substantially equivalent to the predicate interbody devices."

"testing shows that the subject SPIRA®-A Integrated meets or exceeds the values of previously cleared devices."

Reasoning for not fulfilling the request completely:

The request is primarily focused on AI/software device performance criteria and studies, which would typically include metrics like sensitivity, specificity, AUC, human reader performance, ground truth establishment, training set details, etc. The provided 510(k) summary is for a physical medical device (intervertebral body fusion device) and focuses on demonstrating substantial equivalence through mechanical testing and design comparisons, not AI or software performance. There is no mention of an algorithm or AI assistance in the provided text.

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The Camber Spine Alcantara Thoracolumbar Plate System 2, 3 and 4-screw plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by patient history and radioaraphic studies): Pseudoarthrosis: Spondylolisthesis: Spinal stenosis: Tumors; Trauma (i.e. Fractures including dislocation and subluxation) Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion.

The Camber Spine Alcantara Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Camber Spine Alcantara Thoracolumbar Plate System is an anterior/ anterolateral/ lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Camber Spine Alcantara Thoracolumbar Plate System consists of plates that include bone screw holes and blocking mechanisms to prevent screw back-out, and bone screws, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies. All Alcantara Thoracolumbar plates and screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text does not describe an AI/ML powered device, but rather a thoracolumbar plate system. Therefore, an analysis of acceptance criteria and study details related to AI/ML device performance is not applicable. The text focuses on the mechanical performance and substantial equivalence of the Alcantara Thoracolumbar Plate System to predicate devices.

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The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroliac joint disruptions and degenerative sacroiliitis.

The Camber SI Fixation System is comprised of a single-use implant and reusable instruments. The Camber SI Fixation System implant is intended to be implanted in the undeployed state via a posterior approach into the sacroiliac joint. Once implanted, the anchors are deployed to stabilize the sacroiliac joint. The Camber SI Fixation System implant includes multiple openings to allow surgeons to fill them with autogenous bone graft.

The provided text describes a Camber Sacroiliac (SI) Fixation System, a medical device for sacroiliac joint fusion. It details the regulatory clearance (K233972) and includes a "Performance Testing Summary."

However, this document does not contain any information about a study involving an AI/software device that requires acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance.

The performance testing listed here relates to the mechanical and biological aspects of a physical implantable device (e.g., static vertical shear, dynamic vertical shear, expulsion, pin retaining, anchor strength, cadaver testing), not to the performance of an AI algorithm or a diagnostic software.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, specifically regarding AI performance, based on the provided text. The questions you've asked (about sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, and ground truth for training/test sets) are all relevant to the validation of AI/software as a medical device, which is not the subject of this document.

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SPIRA® Posterior Lumbar Spacers (SPIRA®-P Posterior Lumbar Spacer, SPIRA®-T Oblique Posterior Lumbar Spacer, and SPIRA®-TA Posterior Lumbar Spacers) are lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis), and failed previous fusion (pseudoarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. SPIRA® Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems. SPIRA® Posterior Lumbar Spacers are intended for use with an autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The Camber Spine Technologies SPIRA® Posterior Lumbar Spacers are lumbar interbody fusion devices that have an open matrix design to permit packing with autogenous graft material to facilitate fusion. The subject submission seeks to expand the indications of the existing SPIRA® Posterior Lumbar Spacers (SPIRA®-P and SPIRA®-T) as well as add the subject SPIRA®-TA components to the Camber Spine Technologies SPIRA®-TA Posterior Lumbar Spacer allows the interbody fusion device to be inserted from a transforaminal approach. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The device contains a rotating pin that allows for articulation to accommodate the surgical approach. Patients with previous non-fusion spinal surgery at the treated level may be treated.

Camber Spine Technologies SPIRA®-TA device body is additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001-14. The internal device components (locking cap and pivot pin) are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.

I am sorry, but the provided text is a 510(k) summary for a medical device (SPIRA® Posterior Lumbar Spacers), which is a regulatory document addressing the substantial equivalence of the device to existing predicate devices.

This document focuses on:

• Device Description and Indications for Use: What the device is and what it's used for.
• Substantial Equivalence: How it compares to already cleared devices.
• Performance Testing (Mechanical): Mechanical tests performed to ensure the device's physical properties are comparable.

Crucially, this document does NOT contain information about:

• AI/Algorithm Performance: There is no mention of any AI or algorithm being part of this medical device. The device is a physical interbody fusion spacer.
• Ground Truth Establishment: This would be relevant for evaluating an AI, not a physical implant.
• Human Reader Studies (MRMC): These are performed to assess the impact of AI on human interpretation, which is not applicable here.
• Standalone Algorithm Performance: No algorithm is discussed.
• Training Set/Test Set Details: These are relevant for AI model development and validation, not for physical implants.

Therefore, I cannot provide the detailed information requested in your prompt as it pertains to the acceptance criteria and study proving an AI device meets those criteria. The provided text describes a physical Class II medical device (lumbar spacer) and its mechanical performance testing for FDA clearance, not an AI-powered diagnostic or assistive technology.

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The Camber Spine ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is indicated for use 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 radios. Patients should have received 6 months of non-operative treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is intended to be used with additional FDAcleared supplementary fixation systems. The Camber Spine ENZA®- O Titanium Lateral Anterbody Fusion (ALIF) must be used with autogenous graft material or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

The Camber Spine Technologies ENZA®-O Titanium ALIF is a lumbar interbody fusion device that has a hollow chamber to permit packing with autogenous graft material or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. Additionally, the device has integrated fixation through superior anchoring plates. These implants may be implanted via an anterior oblique lateral approach. Patients with previous non-fusion spinal surgery at the treated level may be treated.

Camber Spine ENZA®-O device body is additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001-14. The internal device components (anchor plates, deployment ram, assembly pin and retention blocking screw) are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136. The internal sheer pin component is manufactured from PEEK per ASTM F2026.

This FDA 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML device performance. It focuses on the substantial equivalence of a physical medical device (an intervertebral body fusion device) to previously cleared predicate devices through mechanical testing.

Therefore, I cannot provide the requested information, as it is not present in the provided text.

The document discusses:

• Device: ENZA®-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
• Purpose: A lumbar interbody fusion device for skeletal maturity patients with degenerative disc disease.
• Acceptance Criteria (for mechanical performance): Not explicitly stated with numerical values, but the text mentions "Mechanical testing, including static and dynamic compression shear, static and dynamic axial compression per ASTM F2077, as well as expulsion have been performed on the subject ENZA®-O interbody devices. The results have shown them to be substantially equivalent to the predicate interbody devices." This implies that the device's mechanical performance, when tested against these standards, was deemed comparable to the predicate devices.
• "Study" (Performance Testing): "Mechanical testing, including static and dynamic compression shear, static and dynamic axial compression per ASTM F2077, as well as expulsion have been performed on the subject ENZA®-O interbody devices."
• Reported Device Performance: "The results have shown them to be substantially equivalent to the predicate interbody devices."

The following information is NOT available in the provided text:

1. A table of acceptance criteria and the reported device performance: While mechanical testing is mentioned, specific numerical acceptance criteria and reported performance values are not provided.
2. Sample size used for the test set and the data provenance: No information on the number of devices tested or the origin of any test data.
3. Number of experts used to establish the ground truth... and qualifications: This is irrelevant as it's a physical device, not an AI/ML diagnostic.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance of the predicate device, not expert consensus, pathology, or outcomes data.
8. Sample size for the training set: Not applicable (not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable.

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The SPIRA®-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain with degeneration of the disc confirmed by patient history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), pseudarthrosis, and failed previous fusion. The device is intended for use with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

When used with screws, SPIRA®-C Integrated Fixation System are standalone interbody fusion devices intended for use at one or two contiguous levels in the cervical spine (C2-T1). When used with anchors, SPIRA®-C Integrated Fixation System is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

The SPIRA®-C Integrated Fixation System cages are interbody cages with integrated screws to provide additional fixation in interbody fusion procedures. The subject submission seeks to add anchors as an option for use for integrated fixation. The SPIRA-C® Integrated Fixation System cages are provided various heights and footprints to accommodate patient anatomy. The SPIRA®-C Integrated Fixation System has spiral supports to allow for a hollow chamber to permit packing with bone graft to facilitate fusion. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. When used with screws as integrated fixation, SPIRA-C Integrated Fixation is a stand-alone cervical fixation device. However, this submission seeks to add anchors as another option for integrated fixation. When used with anchors, the SPIRA-C Integrated Fixation System must be used with supplemental fixation.

This document is a 510(k) Summary for the SPIRA®-C Integrated Fixation System, a medical device. It does not describe a study involving an algorithm or AI. Therefore, it is impossible to extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth for AI model development.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on engineering rationale. It states that "Testing, through the use of Finite Element Analysis (FEA) simulations, shows that the anchors are equivalent to the screw-based construct and has less internal stress than the non-integrated SPIRA® -C Open Matrix cage." This is the extent of the "performance testing" described.

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The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Camber SI Fixation System is implanted, it must be used with a SICONUS SI Joint Fixation System screw implanted across the same sacroiliac joint.

The Camber SI Fixation System is a fusion device consisting primarily of an open architecture 3D generated titanium body to permit bone growth (fusion) throughout the implant. All internal surfaces have a roughened texture. The upper and lower faces have specifically designed surface approximately 0.5 mm thick to provide a trabecular support structure. In addition, the device utilizes a set of two sharpened anchor plates that translate from within the device in slightly angular opposing lateral directions which provide an anchoring system to fixate the implant between ilium and sacrum. The Camber SI Fixation System device has one footprint: 23x26 mm. Implant heights range from 9 to 13mm in 2 mm increments with 8° angulation.

This document is a 510(k) summary for a medical device (Camber Sacroiliac (SI) Fixation System), not a study analyzing AI performance. Therefore, most of the requested information about acceptance criteria, study design, and AI performance metrics is not applicable.

However, I can extract the relevant information regarding the performance testing of the device itself and how it meets acceptance criteria based on predicate devices.

1. A table of acceptance criteria and the 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)

This information is not provided in the given document. The document states "Testing performed indicate that the Camber SI Fixation System is as mechanically sound as the cleared devices," but does not detail the specific sample sizes for mechanical testing or cadaveric/usability testing.

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 this document describes mechanical and cadaveric testing for a physical implant, not an AI or diagnostic device that requires expert-established ground truth.

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

This information is not applicable for mechanical or cadaveric testing of a physical implant.

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 as this document describes a physical medical device (sacroiliac joint fixation system), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as this document describes a physical medical device, not an algorithm.

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

For the mechanical testing, the "ground truth" or benchmark was established by the performance of the predicate devices. For cadaveric and usability testing, the "ground truth" would be related to anatomical feasibility, surgical ease of use, and stabilization, which is typically assessed by surgeons or technical experts during the testing process. The document does not specify the exact methods or criteria for "ground truth" in these non-mechanical tests beyond indicating they were performed to establish substantial equivalence.

8. The sample size for the training set

This information is not applicable as this document describes a physical medical device and its mechanical testing, not a machine learning model that requires a training set.

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

This information is not applicable as this document describes a physical medical device and its mechanical testing, not a machine learning model.

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Camber Spine Navigation System instruments are intended to be used in the preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

Camber Spine Navigation System contains reusable instruments, provided non-sterile, including inserters, taps, probes, awls, and awl taps. These instruments are intended to be used with the Medtronic StealthStation® Navigation System and its associated NavLock arrays, to assist surgeons in precisely locating anatomical structures for preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery. The instrumentation is designed for use with the Medtronic StealthStation® Navigation System hardware and software. These instruments are made of medical grade stainless steel according to the ASTM F899 and many include a titanium nitride coating per SAE AMS 2444A.

This document does not contain information about acceptance criteria and a study proving the device meets the acceptance criteria. It is a 510(k) summary and FDA clearance letter for the Camber Spine Navigation System.

The document primarily focuses on:

• FDA Clearance: Announcing the 510(k) clearance for the Camber Spine Navigation System.
• Device Description: Describing the components and intended use of the Camber Spine Navigation System.
• Indications for Use: Specifying the medical conditions and procedures for which the device is intended.
• Substantial Equivalence: Explaining how the device is similar to legally marketed predicate devices.
• Performance Testing (General Statement): Briefly mentioning that performance testing was conducted to verify functionality, accuracy, and compatibility, and to demonstrate substantial equivalence, but does not provide details of the acceptance criteria, the specific study design, or the results of this testing.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
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.

This document indicates that performance testing was done ("Performance testing demonstrates that the Camber Spine Navigation System instruments are substantially equivalent to the predicate devices."), but it does not provide the details of this testing that would allow me to answer your specific questions about acceptance criteria, study methodology, or results.

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SPIRA®-P Posterior Lumbar Spacers are lumbar interbody fusion devices indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-P Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

SPIRA®-T Oblique Posterior Lumbar interbody fusion devices indicated for use 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. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-T Oblique Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

SPIRA Posterior Lumbar Spacers (SPIRA-P Open Matrix PLIF, SPIRA-T Oblique Open Matrix TLIF) are lumbar interbody fusion devices used to provide structural stability following discectomy. SPIRA Posterior Lumbar Spacers have different shapes to accommodate posterior and transforaminal approaches.

The provided text describes a 510(k) premarket notification for SPIRA®-T Oblique Posterior Lumbar Spacers and SPIRA®-P Posterior Lumbar Spacers. This is a submission to demonstrate substantial equivalence to previously cleared devices, not a study evaluating an AI/ML-based device. Therefore, the detailed information typically requested for AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document discusses mechanical performance testing of intervertebral body fusion devices, not the diagnostic performance of an imaging AI.

Here's the information that can be extracted regarding the acceptance criteria and proof of mechanical performance for this physical device:

Acceptance Criteria and Device Performance (Mechanical Testing)

The study described in this document is a series of mechanical performance tests, not a clinical study involving human readers or an AI algorithm.

Therefore, most of the specific questions regarding AI/ML device performance metrics (sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not relevant or answerable from the provided text, as the device is a physical medical implant, not a software device.

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The Camber Spine Technologies SPIRA-C Integrated Fixation System consists of a stand-alone interbody device indicated for use at one or two contiguous levels in the cervical spine, from C2-C3 disc to the C7-T1 disc, in skeletally mature patients who have had six weeks of non-operative treatment for the cervical disk disease is defined as intractable radiculopathy and/or myelopathy with hermiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The SPIRA-C Integrated Fixation System must be used with internal screw fixation. The Camber Spine Technologies SPIRA-C Integrated Fixation System must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The SPIRA®-C Integrated Fixation System consists of a stand-alone interbody fusion device with internal screw fixation. The SPIRA®-C Integrated Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two levels from the C2-C3 disc to the C7-T1 disc. The system is comprised of a Titanium Alloy (Ti-6Al-AV ELI) interbody cage and screws. The SPIRA®-C Integrated Fixation System cages are provided in 7 degrees of lordosis, 6-12mm heights, 14-20mm widths and 13-16mm depths. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The SPIRA® C Integrated Fixation System is that has spiral supports to allow chamber to permit packing with autogenous and/ or allogenic bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The bone screws used with this device are provided in self-tapping options, along with variable angle and fixed angle trajectories, and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 12-18mm lengths.

This document describes the SPIRA-C Integrated Fixation System, an intervertebral body fusion device. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Performance Testing Summary" section.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Testing performed" and "The results demonstrate" but does not specify the sample size for the mechanical tests. The data provenance is not explicitly stated as retrospective or prospective, but given the nature of mechanical testing for a medical device, it would be prospective laboratory testing conducted specifically for this submission. The "country of origin of the data" is not stated, but the submission is to the U.S. FDA, implying the data would be generated in a manner acceptable for U.S. regulatory standards.

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

This is a mechanical device test, not an AI or diagnostic imaging study. Therefore, the concept of "ground truth established by experts" in the clinical sense (e.g., radiologists interpreting images) does not apply. The "ground truth" here is based on engineering standards (ASTM) and performance relative to predicate devices. The expertise would lie in the engineers and technicians conducting and interpreting the mechanical tests according to these standards. The document does not specify the number or qualifications of the personnel who performed these tests.

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

Not applicable. This is a mechanical device test, not a clinical study involving human interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document pertains to the mechanical safety and effectiveness of an intervertebral body fusion device, not an AI or diagnostic imaging system.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this mechanical device testing is based on:

• Established ASTM standards (F2077-18 and F2267-04): These standards define methodologies and criteria for evaluating spinal implant performance.
• Performance of legally marketed predicate devices: The device's performance is accepted if it is "as mechanically sound as predicate devices." This implies that the 'ground truth' for acceptable performance is benchmarked against the established performance of existing, cleared devices.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for a physical medical device.

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