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The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The RIGEL™ 3DR Anterior Cervical Corpectomy System is a vertebral body replacement device intended to provide structural stability and mechanical support to the cervical spine following corpectomy.

The RIGEL™ 3DR Anterior Cervical Corpectomy System consists of implants additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001 and instrumentation manufactured from Stainless Steel per ASTM F899. The RIGEL™ 3DR Anterior Cervical Corpectomy System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements. The implants are provided sterile packed and are intended for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding the RIGEL™ 3DR Anterior Cervical Corpectomy System. It primarily focuses on the substantial equivalence of this medical device to previously cleared predicate devices.

It is crucial to understand that this document describes a medical device (an implant), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested points related to AI/SaMD performance criteria, expert adjudication, MRMC studies, and ground truth for training sets are not applicable.

Here's an analysis based on the provided text, highlighting the non-applicability of SaMD-specific questions:

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

The document does not explicitly state acceptance criteria in a quantitative table format as one would expect for an AI/SaMD. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance data presented are mechanical tests designed to show that the device meets established standards for spinal implants and performs comparably to its predicates.

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

This information is not applicable as the document describes mechanical testing of a physical implant, not a software device evaluated on a dataset. The "test set" in this context refers to the physical samples of the implant tested as per ASTM standards. The specific number of physical samples for each test (e.g., how many implants underwent compression testing) is not detailed. Data provenance such as country of origin or retrospective/prospective is not relevant for mechanical device 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 is not applicable. Ground truth, in the context of SaMD, refers to establishing the correct diagnosis or outcome from medical images/data, often by expert consensus. For a physical implant, "ground truth" is established by adherence to engineering specifications and performance against recognized ASTM standards. There are no medical experts establishing ground truth for the performance of the implant itself in this context, although clinical expertise guides the design and intended use.

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

This is not applicable for a physical device. Adjudication methods are used in SaMD studies to resolve discrepancies between expert readers on a test set to establish a definitive ground truth. For mechanical testing, the "adjudication" is inherent in the standardized test procedures and their objective measurements.

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 is not applicable. MRMC studies are specifically designed to evaluate the impact of AI on human reader performance. This document concerns a physical device, not an AI.

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

This is not applicable. A standalone performance evaluation refers to an AI algorithm making decisions without human intervention. This document is about a physical spinal implant.

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

As mentioned, the concept of "ground truth" as it applies to SaMD is not applicable here. For this physical device, the "truth" of its performance is derived from standardized mechanical testing (ASTM F2077-18 for static and dynamic compression/torsion, ASTM F2267-04 for subsidence). These tests provide objective, measurable data points against established industry standards for material strength, durability, and biocompatibility rather than a clinical ground truth.

8. The sample size for the training set

This is not applicable. Training sets are used to train AI algorithms. This document describes a physical medical device. While there's a design and development process for the implant, it doesn't involve "training" in the AI sense.

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

This is not applicable for the same reasons as above.

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When used as a single-level partial vertebral body replacement device, the Galileo™ devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patients for the partial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors. or trauma/fracture, or osteomvelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galleo ™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.

The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti- 6A1-4V) device and is available in various widths and heights. It has openings of various sizes to allow for the placement of bone graft and for the free flow of cells between the bone graft and the bone of the patient. It is intended for partial vertebral body replacement in a single vertebra and to hold bone graft material.

The provided text is a 510(k) premarket notification for the "Galileo Vertebral Body Replacement Device". This document primarily focuses on establishing substantial equivalence to a predicate device based on mechanical performance, rather than evaluating an AI/ML powered device. As such, many of the requested criteria for AI/ML device studies (such as sample sizes for test/training sets, expert ground truth development, MRMC studies, standalone performance, etc.) are not applicable or detailed in this type of submission.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets those criteria, specifically for its mechanical performance.

Acceptance Criteria and Device Performance (Mechanical)

Study Details (Mechanical Performance):

• Sample size used for the test set and the data provenance: Not specified in the document. The testing would involve physical samples of the device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically defined by established engineering standards (ASTM F2077 in this case) and measured by testing equipment.
• Adjudication method: Not applicable for mechanical tests.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is a mechanical device, not an AI/ML diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
• The type of ground truth used: Mechanical performance standards defined by ASTM F2077.
• The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Additional Information from the Document:

• Device: Galileo Vertebral Body Replacement Device
• Predicate Device: Galileo Vertebral Body Replacement Device (K192145)
• Reason for new submission (K221542): The Galileo VBR has additional sizes (7mm, 8mm, 9mm, 10mm widths and heights, all 12mm depth) compared to the predicate.
• Changes: No changes were made to the device design, materials, or manufacturing method, only additional sizes were introduced.
• Conclusion: The device is substantially equivalent to the predicate device, and the new device sizes do not raise new questions of safety and effectiveness, based on the required design verification and validation activities (mechanical performance tests). No clinical tests were required or performed for this submission.

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The MediExpand Cervical Expandable VBR System is intended for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Use of the MediExpand Cervical Expandable VBR System is limited to single-level or two-level corpectomy and the device is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The MediExpand Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The MediExpand Cervical Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The devices can be adjusted to the required height after implantation. Once it is adjusted to the desired height the device is mechanically locked in place with fixation screws. The devices have a rectangular space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic anqles. The devices have threaded holes for anchor screws which can be inserted into the adjacent vertebral bodies. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.

The provided text describes the MediExpand Cervical Expandable VBR System, a device intended for use in the cervical spine. However, the document does not provide specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested. Instead, it offers a summary of premarket notification for FDA clearance, focusing on substantial equivalence to predicate devices.

The "Performance Testing" section mentions "Clinical data from Europe have shown the clinical performance and support the use of the MediExpand Cervical Expandable VBR System." It also references "Real World Data (RWD) ... from three sites in Germany" and states, "There were no instances of implant failure, and none of the patients suffered from implant associated damages/injuries." While this suggests positive outcomes, it does not present quantifiable acceptance criteria or a structured study for evaluating those criteria.

Therefore, many of the requested elements cannot be definitively extracted or are not present in the provided text.

Here's a breakdown of what can be a gathered from the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly list acceptance criteria in a quantitative or qualitative manner. It states "There were no instances of implant failure, and none of the patients suffered from implant associated damages/injuries" as a reported performance, but this is a broad statement rather than a specific measure against a predefined criterion.

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

• Sample size: 338 patients.
• Data provenance: Retrospective Real World Data from three sites in Germany (University Hospital of Ludwig-Maximilians-University (LMU) in Munich, Central Clinic in Bad Berka, Schoen Clinic Hamburg Eilbek, Hamburg).

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

This information is not provided in the text. The RWD mentions outcomes like "no instances of implant failure" or "no implant associated damages/injuries," which would likely be determined by medical professionals, but the number or qualifications of these experts are not detailed.

4. Adjudication method for the test set

This information is not provided in the text.

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 is not applicable as the device is a medical implant (Spinal Intervertebral Body Fixation Orthosis) and not an AI-assisted diagnostic tool or imaging system.

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

This is not applicable as the device is a medical implant and not an algorithm.

7. The type of ground truth used

The "ground truth" for the reported performance appears to be clinical outcomes and observations from the "Real World Data" provided by the three German sites, indicating "no instances of implant failure" and "none of the patients suffered from implant associated damages/injuries." This would implicitly involve expert clinical assessment by treating physicians.

8. The sample size for the training set

This is not provided in the text. The document refers to "Real World Data" used to support substantial equivalence, but it doesn't describe a separate "training set" in the context of machine learning or algorithm development.

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

This information is not provided as there is no mention of a "training set" or its ground truth establishment.

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CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths, and heights to match the patient's anatomy. Static (titanium) and expandable (titanium and cobalt chrome) cervical cages are available and are implanted via an anterior approach. The cervical implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt Chrome (per ASTM F1537). The purpose of this Traditional 510(k) submission is to introduce a new 12x14mm cervical expandable footprint size to the previously cleared CAPRI Corpectomy Cage System.

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

The provided text describes the 510(k) premarket notification for the K2M, Inc. CAPRI Corpectomy Cage System. This submission introduces a new 12x14mm cervical expandable footprint size to an already cleared system. As such, the study focuses on demonstrating the substantial equivalence of this new footprint to the predicate device, rather than proving a new device's performance against specific clinical acceptance criteria for effectiveness or safety in a clinical trial setting. The studies conducted are mechanical tests to ensure the new footprint maintains the same structural integrity and performance characteristics as the predicate.

Here's the information extracted from the provided text, addressing your points:

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

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for each test, but it lists the mechanical tests performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "met" if the device demonstrates substantial equivalence.

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

The document does not specify sample sizes (number of devices tested) for the mechanical tests. It also does not mention data provenance in terms of country of origin or whether a retrospective/prospective study was conducted, as these were benchtop mechanical tests, not clinical studies involving patient data.

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

This is not applicable to the type of study described. The study involves mechanical testing against ASTM standards and comparison to a predicate device, not expert-based ground truth establishment as would be seen in diagnostic imaging or clinical effectiveness studies.

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

This is not applicable as the study involves mechanical testing against defined standards, not human evaluation requiring adjudication.

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

This is not applicable. The device is a spinal implant, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a medical implant, not an algorithm.

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

For mechanical testing, the "ground truth" is typically defined by adherence to established engineering standards (e.g., ASTM F2077-18, ASTM F2267-04 R18) and meeting performance characteristics comparable to the predicate device. There is no expert consensus, pathology, or outcomes data used as ground truth for this type of submission.

8. The sample size for the training set

This is not applicable. There is no training set mentioned, as this is a submission for a medical implant, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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When used as a single-level partial vertebral body replacement devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors, or traumaffracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galileo™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.

The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti-6A1-4V) device and is available in various widths and heights. It has openings of various sizes to allow for the placement of bone graft and for the free flow of cells between the bone graft and the bone of the patient. It is intended for partial vertebral body replacement in a single vertebra and to hold bone graft material.

The provided document does not describe the acceptance criteria and study that proves a device (Galileo Vertebral Body Replacement Device) meets the acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical medical device: a vertebral body replacement. The studies described are non-clinical mechanical performance tests (ASTM F2077 and ASTM F2267) to demonstrate the device's structural integrity and resistance to subsidence and expulsion. These are standard engineering tests for implantable devices, not AI/ML performance evaluation studies.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria, performance, sample sizes, expert ground truth adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

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The NEXXT MATRIXX® corpectomy devices are indicated for use in the cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature patients to replace a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The NEXXT MATRIXX® corpectomy devices are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The NEXXT MATRIXX® corpectomy devices are intended for use with autograft or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft, as an adjunct to fusion and with FDA-cleared supplemental internal fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

This looks like a 510(k) summary for a medical device called the NEXXT MATRIXX® System, specifically for its corpectomy devices. Unfortunately, the provided document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI or algorithm performance.

The "Performance Data" section explicitly states: "The modified corpectomy device was evaluated via mechanical testing including included static and dynamic compression and static and dynamic torsion (ASTM F2077), subsidence (ASTM F2267) and expulsion. The results demonstrated the performance of the modified corpectomy is substantially equivalent to the predicate."

This describes physical and mechanical performance testing of the device itself (an implant used in spinal surgery), not the performance of an AI or algorithm. Therefore, I cannot extract the information requested regarding:

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

The document is about the physical testing and substantial equivalence of a spinal implant device.

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The Bengal® Stackable Cage System is indicated for use in the thoracolumbar spine (i.e. T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Bengal® Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Bengal® Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation.

The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon's bone graft material of choice. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.

The Bengal Stackable Cage System is a VBR Spinal System designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period, as well as for treating fractures of the thoracic and lumbar spine.

The structure of the polymer/carbon-fiber composite implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and medial-lateral directions, which resist rotation and migration. The polymer/carbon-fiber composite implants have cavities to accept packing of bone graft.

The provided text is a 510(k) summary for the Bengal® Stackable Cage System, primarily seeking to expand its indications for use to include the cervical spine. However, it does not contain specific acceptance criteria or performance data for an AI/CADe device.

Instead, it describes a medical device (a spinal implant) and relies on a "literature analysis of published clinical data" to support the modified indication for use. It explicitly states, "No additional testing was required as the technological characteristics are consistent and or similar with those of the primary predicate device and the additional predicate device."

Therefore, based solely on the provided text, I cannot provide the information requested about acceptance criteria and a study proving device performance for an AI/CADe device.

If you are looking for information about the Bengal® Stackable Cage System itself, I can elaborate on its description and intended use from the text. But for AI/CADe device performance, this document does not contain that information.

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The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement system manufactured from PEEK-OPTIMA LT120HA (HA PEEK) or titanium alloy (Ti6Al4VELI). The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy and graft windows to help facilitate bony integration. The HA PEEK spacers have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion and X-ray markers in the form of tantalum pins. The titanium alloy spacers have roughened superior and inferior surfaces to prevent migration/expulsion.

The provided text describes a 510(k) premarket notification for a medical device, the ALTA Anterior Cervical Corpectomy System. It is a submission for substantial equivalence to legally marketed predicate devices, not for a new AI/ML-based diagnostic or assistive technology requiring extensive clinical performance studies with human readers.

Therefore, many of the requested details, such as "acceptance criteria for device performance" in the context of an AI study, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details, are not applicable to this specific submission as it pertains to a physical orthopedic implant device.

The relevant information from the document pertains to the device's physical and mechanical performance, not its diagnostic or interpretative accuracy.

Here's a breakdown of the applicable information based on the provided document, addressing the relevant parts of your request and noting what is not applicable:

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

Since this is a physical implant, the "acceptance criteria" are related to mechanical and material properties, and the "reported device performance" refers to the results of non-clinical (bench) testing.

2. Sample sizes 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: This is not applicable in the context of an AI/ML test set. For physical device testing, "samples" refer to the number of devices or test coupons subjected to mechanical testing. The document states "The following analyses were conducted," implying standard mechanical testing as per the ASTM standards. The exact number of test samples (e.g., number of implants tested per condition for compression, torsion, subsidence) is not explicitly provided in this summary but would be detailed in the full test reports referenced by the ASTM standards.
• Data Provenance: Not applicable in the context of clinical patient data as no clinical studies were performed. The "data" comes from bench testing of the physical devices.

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. The "ground truth" for a physical orthopedic implant is established by engineering specifications, material standards, and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). It does not involve human expert consensus on medical images or diagnoses.

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth by reconciling discrepancies among human readers/experts. For a physical device's mechanical testing, there is no such adjudication process.

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

• This question is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human interpretation. This submission is for a physical implant, not a diagnostic or AI-assisted system.

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

• This question is not applicable. This refers to the performance of an AI algorithm in isolation. The product is a physical implant.

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

• For the non-clinical testing of this physical device, the "ground truth" is defined by engineering specifications, material properties, and relevant ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077 for compression/torsion and ASTM F2267 for subsidence) which dictate acceptable performance characteristics for spinal implants.

8. The sample size for the training set

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There is no "training set."

Summary of Device Performance Study:

The study proving the device meets its acceptance criteria is a non-clinical bench testing program.

• Tests Conducted: Static and dynamic compression per ASTM F2077, Static and dynamic torsion per ASTM F2077, and Subsidence per ASTM F2267.
• Results: The results of these evaluations indicated that the ALTA Corpectomy implants are equivalent to predicate devices.
• Clinical Studies: No clinical studies were performed as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

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The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Omnia Medical, LLC, regarding their VBR (Vertebral Body Replacement) system. This document is a clearance letter, not a study report, and therefore does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI/ML powered device. The document focuses on establishing substantial equivalence to existing predicate devices based on design, materials, and mechanical testing for a physical medical implant, not a diagnostic or prognostic algorithm that would require human-in-the-loop or standalone performance studies against acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not relevant to the approval of this type of device (a spinal implant) based on the provided text.

The closest relevant information is about "Mechanical Testing," which supports the device's substantial equivalence.

Mechanical Testing Information (as described in the document, which serves as the "study" for this type of device):

• Study Purpose: To demonstrate substantial equivalence to predicate devices.
• Tests Conducted:
  • Static and dynamic compression per ASTM F2077
  • Static and dynamic torsion per ASTM F2077
  • Subsidence per ASTM F2267
  • Expulsion testing
• Data Provenance: The data for these tests was "presented in the reference predicate submission (K172323)." This implies the data was collected previously for another submission and reused, rather than newly generated for this specific K191778 submission.
• Device Status: "No new device designs or worst-case sizes are being introduced."
• Conclusion: The previously submitted data supports the expanded indications for use.

Summary of absent information (and why, given the document type):

1. A table of acceptance criteria and the reported device performance, sample size, data provenance: Not applicable in the context of an FDA 510(k) clearance letter for a physical implant, where performance is demonstrated through mechanical testing against standards, not clinical accuracy metrics.
2. Number of experts, qualifications, adjudication method: Not applicable for mechanical testing of a physical implant. These relate to human interpretation of data, typically for AI/ML or diagnostic devices.
3. MRMC comparative effectiveness study: Not applicable. This is for assessing the impact of AI assistance on human readers, relevant for diagnostic AI.
4. Standalone (algorithm only) performance: Not applicable. This identifies if a device is a standalone AI algorithm.
5. Type of ground truth: Not applicable in the traditional sense. The "ground truth" for a physical implant's mechanical properties is adherence to established ASTM standards under specific testing conditions.
6. Sample size for training set & how ground truth for training set was established: Not applicable. These pertain to the development of AI/ML algorithms.

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The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

The provided text describes a medical device, the Normandy VBR System, and its substantial equivalence determination by the FDA. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning an AI/algorithm's performance.

The document is a 510(k) premarket notification approval letter and summary for a spinal implant. It focuses on demonstrating that the Normandy VBR System is substantially equivalent to existing predicate devices based on design, intended use, material composition, function, and mechanical performance.

Therefore, I cannot fulfill your request for information regarding AI device acceptance criteria and a study proving an AI device meets them. The provided text does not describe an AI medical device or its performance evaluation in the context you've outlined.

Here's what the document does provide the closest to your request, but is entirely in the context of a physical medical device (spinal implant) and its mechanical testing, not AI:

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

Important Note: The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate devices through mechanical testing. The document doesn't provide specific quantitative thresholds for these tests but rather states that the "mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices."

The following points cannot be addressed as the provided text pertains to a physical spinal implant, not an AI/algorithmic device:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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