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The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.

The provided text is a 510(k) summary for the Cavetto®-SA Cervical Cage System, which is an intervertebral fusion device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets acceptance criteria for a new AI/ML-driven medical device.

Therefore, many of the requested categories for acceptance criteria and study details (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set) are not applicable to this submission as it describes a traditional medical device (implantable cage and screws) that typically undergoes mechanical testing rather than AI/ML performance evaluation.

Based on the provided text, here's what can be extracted and what information is not available due to the nature of the device:

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

The document mentions "Performance Data" but specifies that it was a "comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing." This suggests that the acceptance criteria would be related to material properties and substantial equivalence to the predicate device's materials, rather than a clinical performance metric. Specific quantitative acceptance criteria and reported performance metrics in a table format are not provided in this document. The conclusion states "The overall technology and material characteristics lead to the conclusion that the Cavetto®-SA Cervical Cage System is substantially equivalent to the predicate device." This "substantial equivalence" is the primary performance claim rather than a separate set of performance criteria.

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

• Not Applicable. The document describes a traditional implantable medical device, not a diagnostic or AI/ML device that would use test sets of patient data in this manner. The performance data mentioned refers to material comparison, not clinical trial data with patient samples.

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

• Not Applicable. This is not relevant for the type of device described. Ground truth for an AI/ML diagnosis is established by expert consensus or other definitive methods, which is not what is being evaluated here.

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

• Not Applicable. See point 3.

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

• Not Applicable. An MRMC study is relevant for AI-assisted diagnostic devices. This is a physical implantable device.

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

• Not Applicable. This device does not involve an algorithm.

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

• Not Applicable. The "performance data" mentioned focuses on material comparison to a predicate device, not establishing clinical ground truth for diagnosis/prognosis.

8. The sample size for the training set:

• Not Applicable. This device does not utilize a training set in the context of machine learning.

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

• Not Applicable. See point 8.

In summary, the provided document is a 510(k) summary for a physical medical implant (intervertebral fusion device). It asserts substantial equivalence to a predicate device based on technological characteristics and material comparisons, rather than providing the detailed performance study information typically associated with AI/ML-driven diagnostic or prognostic devices as requested in your prompt.

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The Cavetto® MAXI Cervical Cage 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. These patients should have had six weeks of non-operative treatment. The Cavetto® MAXI Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Cavetto® MAXI Cervical Cage System is intended to be used with supplemental fixation.

The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® MAXI Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.

This 510(k) is submitted only for the purposes of changing the name of the Cavetto® Cervical Cage System (K172320) to the Cavetto® MAX) Cervical Cage System. The two devices are otherwise identical, and no changes whatsoever have been made to the Cavetto® Cervical Cage System (K172320).

The provided text describes a 510(k) premarket notification for the Cavetto® [MAX] Cervical Cage System. This submission is for changing the name of an already cleared device (Cavetto® Cervical Cage System, K172320). No changes were made to the device itself. Therefore, the information regarding acceptance criteria and performance data primarily refers to mechanical testing performed on the predicate device, which is identical to the subject device.

Here's an breakdown of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in numerical terms for the mechanical tests. Instead, it states that the performance data for the predicate device, also known as the Cavetto® Cervical Cage System (K172320), was leveraged. The conclusion drawn is that the strength of the Cavetto® [MAX] Cervical Cage System (which is identical to the predicate) is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

• Static axial compression per ASTM F2077
• Static torsion per ASTM F2077
• Dynamic axial compression per ASTM F2077
• Dynamic torsion per ASTM F2077
• Static subsidence per ASTM F2267
• Static expulsion
  The results of this non-clinical testing show that the strength is sufficient for its intended use and substantially equivalent to legally marketed predicate devices. |

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

The document does not specify the sample size for the mechanical tests. It also does not provide information on the provenance of the data (e.g., country of origin, retrospective/prospective), as these are typical considerations for clinical studies, not mechanical bench 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 question is not applicable. The study described is mechanical bench testing, not a clinical study involving human readers or expert consensus to establish ground truth for diagnostic accuracy.

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

This question is not applicable. Adjudication methods are relevant for clinical studies where multiple experts interpret data. This submission focuses on mechanical performance 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.

This question is not applicable. The device described is a cervical cage system, an implantable medical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

This question is not applicable. This is not an AI algorithm.

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

For mechanical testing, the "ground truth" is defined by the physical properties and performance characteristics measured according to established ASTM standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth for this type of evaluation.

8. The sample size for the training set

This question is not applicable. There is no training set as this is not an AI/machine learning device.

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

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

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The Transept™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Transept™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Transept™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Transept™ Cervical Plate System implant components are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

I am sorry, but the provided text is a 510(k) summary for a medical device (Transept™ Cervical Plate System), which is a spinal intervertebral body fixation orthosis.

This type of device is a physical orthopedic implant and instrumentation, not an AI or software-as-a-medical-device (SaMD). The document details mechanical performance testing, materials, and indications for use, but does not contain information related to AI/ML device performance, acceptance criteria for an AI/ML algorithm, or details about clinical studies involving human readers or ground truth establishment for an AI/ML model.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details, as these are not relevant to the described medical device and are not present in the provided text.

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

The Cortina™ [MAX] Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with tantalum markers manufactured from EVONIK PEEK as described in MAF-1922 with the submissions of the predicate Cortina [MAX] (K171914 and K180431) or medical grade titanium per ASTM F136 with a TECOTEX® surface coating. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies. This submission is intended to add the titanium implants and expand the size offering to include larger footprints.

1. Acceptance criteria and reported device performance

The document does not explicitly state numerical acceptance criteria for device performance. Instead, it argues that the new device, the Cortina™ [MAX] Lumbar Cage System made from titanium, requires no additional testing because it is identical in form, shape, and function to previously cleared PEEK devices (K171914/K180431). The rationale given is that titanium material produces implants with a higher yield load and stiffness when the shape is identical.

Similarly, for the PEEK devices, the document states that the addition of longer PLIF implants (36-42 mm) does not create a new mechanical worst-case compared to the previously tested 20x9x7mm PLIF (K171914/K180431), thus no additional testing is required for the additional length in the line extension.

The DLIF implants also do not need to be tested as a new worst-case because their design and footprint do not represent a new worst-case for either static or dynamic mechanical testing, and the smallest DLIF is significantly larger than what was previously tested.

Therefore, the reported "device performance" in this context is that the new iterations of the device (titanium material and expanded PEEK sizes) are expected to perform equivalently or better than the previously cleared predicate devices for which performance was established, without the need for new mechanical testing to demonstrate this equivalence.

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

No new test set was used for this submission. The device's substantial equivalence is based on comparisons to previously cleared predicate devices. Therefore, there is no new data provenance to report beyond what would have been established for the predicate devices.

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

Not applicable. As no new test set was directly used for this submission, no new ground truth was established by experts for this specific 510(k). The equivalence is based on technical characteristics and previous clearances.

4. Adjudication method for the test set

Not applicable. No new test set requiring adjudication was performed for this 510(k) submission.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No MRMC comparative effectiveness study was done. This submission focuses on substantial equivalence based on material and size modifications to an existing device, rather than a comparative effectiveness study involving human readers and AI.

6. Standalone (algorithm only without human-in-the-loop performance) study

Not applicable. This device is an intervertebral body fusion device (physical implant), not a software algorithm or AI device.

7. Type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" relies on the established performance and safety of the predicate devices (Cortina™ [MAX] Lumbar Cage System - PEEK version, K171914/K180431, and other referenced devices). This would have been established through a combination of mechanical testing, material characterization, and potentially clinical data (if required for the predicates) to demonstrate their safety and effectiveness.

8. Sample size for the training set

Not applicable. This device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.

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

Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

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The Arco™-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) on the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental fixation system cleared by the FDA. The Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

The Arco™-SA ALIF System is an intervertebral fusion device made from titanium per ASTM F136 with TECOTEX® surface from TECOMET, Inc. or medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device implant cages are offered in a variety of footprints and sizes to accommodate various patient anatomies. The Arco™-SA ALIF System is offered in heights of 12-22mm, widths of 28-43mm, and lengths of 24-32mm. The subject device implant screws are offered in Ø5.0-6.0mm diameters and lengths ranging 20-35mm. The subject device implant is offered with a lordosis of 7- 30°. The purpose of this submission is to add larger footprint options and add the titanium implants to the previously cleared system

The provided text is a 510(k) summary for the Arco™-SA Lumbar Cage System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.

Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from the provided text. This device falls under the category of an "Intervertebral Body Fusion Device," which typically relies on mechanical testing, material biocompatibility, and intended use comparison for FDA clearance, rather than studies involving performance characteristics like those seen in diagnostic or AI-driven devices.

Here's a breakdown based on the provided text, indicating where information is absent:

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

   This information is not provided in the document. The document's purpose is to show substantial equivalence to predicate devices, not to present performance data against predefined acceptance criteria for accuracy, sensitivity, etc.

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

   Not applicable. This is not a study involving a test set of data for performance evaluation. The "test" for this device involves comparing its characteristics (materials, dimensions, indications for use, technological characteristics) to legally marketed predicate 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)

   Not applicable. "Ground truth" in the context of diagnostic or AI performance studies is not relevant here. The evaluation is based on engineering and material characteristics, and comparison to predicate devices, which are assessed by regulatory bodies and engineering principles.

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

   Not applicable. There is no "test set" in the context of performance metrics 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 device is not an AI-assisted diagnostic tool or an imaging analysis system, so an MRMC study is not relevant.

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

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

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

   Not applicable in the context of performance measurement. The "ground truth" for the device's claims of safety and effectiveness is established through compliance with recognized standards for materials (e.g., ASTM F136 for titanium, ASTM F2026 for PEEK, ASTM F560 for tantalum), mechanical testing (though here a comparison to predicate material was done in lieu of new mechanical testing), and comparison of technological characteristics to already cleared devices.

8. The sample size for the training set

   Not applicable. This is a medical device, not a machine learning algorithm requiring a training set.

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

   Not applicable.

Summary of Relevant Information from the Document:

The document describes the Arco™-SA Lumbar Cage System, an intervertebral fusion device. The "study" referenced in the prompt's context is the 510(k) premarket notification process, which aims to demonstrate substantial equivalence to legally marketed predicate devices, not performance against specific clinical acceptance criteria.

Key Findings from the 510(k) Summary:

• Acceptance Criteria & Device Performance: The primary "acceptance criterion" for this submission is substantial equivalence to predicate devices. The "performance" is demonstrated by showing that the subject device shares "nearly identical technological characteristics" with predicate devices and that "the minor differences do not raise any new issues of safety and effectiveness."
  • Identical Characteristics to Predicates: Principles of Operation, Indications for Use, Implant Materials, Implant Sizes, Surgical Approach.
• Comparison of Materials: "A comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing." This suggests that the materials themselves (titanium per ASTM F136, PEEK per ASTM F2026, tantalum markers per ASTM F560) are the primary basis for demonstrating similar performance to predicate devices (which presumably underwent such testing or had equivalent material specifications).
• Conclusion: "The overall technology and material characteristics lead to the conclusion that the Arco™-SA Lumbar Cage System is substantially equivalent to the predicate device."

This document is a regulatory submission for a physical implant, not a study evaluating the performance of a diagnostic or AI-powered system against quantifiable accuracy metrics.

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The Neurostructures Cavetto® [MAX] Cervical Cage 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. These patients should have had six weeks of non-operative treatment. The Neurostructures Cavetto® [MAX] Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Neurostructures Cavetto® [MAX] Cervical Cage System is intended to be used with supplemental fixation.

The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® [MAX] Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.

This document (K181590) describes a 510(k) premarket notification for a medical device called the "Neurostructures Cavetto® [MAX] Cervical Cage System." The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about a study that proves the device meets acceptance criteria in the way typically associated with AI/ML device performance studies (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement).

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Technological characteristics: Similarities in indications for use, principles of operations, implant material, sterility, surgical approach, and structural support mechanism.
• Performance data: An engineering comparison of material showing mechanical equivalence to the primary predicate device, and bacterial endotoxin testing.

Therefore, it's not possible to fulfill the request for information on acceptance criteria and study details related to a device's performance in terms of diagnostic accuracy or comparative effectiveness with human readers, as this type of information is not present in the provided document.

To directly answer your specific points based only on the provided text:

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

   • Not applicable. The document does not describe performance criteria or results in terms of diagnostic accuracy, sensitivity, specificity, or other metrics typical for AI/ML devices. The "performance data" mentioned refers to mechanical equivalence and endotoxin testing, not clinical or diagnostic performance against a ground truth.

2. Sample sizes used for the test set and the data provenance:

   • Not applicable. No test set of clinical data is described. The "performance data" refers to engineering comparisons and lab testing.

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 establishment by experts is mentioned, as there is no test set for clinical performance.

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

   • Not applicable. No test set is described.

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 or AI assistance is mentioned. This device is an intervertebral fusion device, not a diagnostic AI tool.

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):

   • Not applicable. No ground truth for clinical performance is described. The "ground truth" for the mechanical comparison would be the established properties of the primary predicate device.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

   • Not applicable. This device is not an AI/ML algorithm.

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The Arco™-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA. The Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

The Arco™-SA Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F136, and tantalum markers per ASTM F560. The subject device implant cages are offered in a variety of footprints and sizes to accommodate various patient anatomies. The Arco™-SA Lumbar Cage System is offered in heights of 12-22mm, widths of 28- 38mm, and lengths of 24-29mm. The subject device implant screws are offered in Ø5.0-6.0mm diameters and lengths ranging 20-35mm. The subject device implant is offered with a lordosis of 7- 30°.

The provided text describes the 510(k) premarket notification for the Arco™-SA Lumbar Cage System, which is an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data.

However, the information requested in your prompt regarding acceptance criteria and a study proving a device meets acceptance criteria in a clinical or AI-related performance context is largely absent. The document focuses on non-clinical mechanical testing rather than clinical performance metrics of an AI model or a device's diagnostic accuracy.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

• Acceptance Criteria (for mechanical testing): The document references specific ASTM standards (ASTM F2077-11, ASTM F2267-04, ASTM DRAFT F-04.25.02.02) which implicitly contain acceptance criteria for the mechanical tests. However, the exact numerical acceptance values are not explicitly stated in this summary.
• Reported Device Performance (for mechanical testing): The document states: "The results of this non-clinical testing show that the strength of the Arco™-SA Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical performance results are not provided.

The following points cannot be answered from the provided text because the 510(k) summary focuses on substantial equivalence for a physical medical device (lumbar cage) based on mechanical testing and technological characteristics, not on the performance of an AI/software device or a clinical study that would involve ground truth or human readers.

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • Not applicable/Not provided. The "test set" here refers to the physical devices undergoing mechanical stress tests, not a dataset for an AI model.
• 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/Not provided. Ground truth is not relevant for the mechanical testing described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable/Not provided. Adjudication is not relevant for the mechanical testing described.
• 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 device, not an AI software/diagnostic tool requiring MRMC studies.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable/Not provided. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • Not applicable/Not provided. Ground truth is not relevant for the mechanical testing described.
• 8. The sample size for the training set
  • Not applicable/Not provided. There is no AI training set mentioned.
• 9. How the ground truth for the training set was established
  • Not applicable/Not provided. There is no AI training set mentioned.

In summary: The provided document is a 510(k) summary for a physical medical device (Arco™-SA Lumbar Cage System) demonstrating substantial equivalence through non-clinical mechanical testing against ASTM standards. It does not contain information about clinical studies, AI performance, ground truth establishment, or human reader effectiveness studies as it is not a diagnostic AI/software device.

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The Cortina™ [MAX] Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 lo S 1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ [MAX] Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confim1ed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Cortina™ [MAX] Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with titanium markers. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only provides a general statement that the device's strength is sufficient and substantially equivalent to predicate devices, rather than specific numerical performance metrics against pre-defined acceptance criteria. The acceptance criteria are referenced implicitly by stating adherence to ASTM standards.

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

The document describes non-clinical performance testing of mechanical properties. It does not refer to a "test set" in the context of patient data or clinical studies. Therefore, information regarding sample size for a test set, country of origin, or retrospective/prospective nature is not applicable to this submission, as it focuses on device characteristics, not clinical performance.

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

This information is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical mechanical performance.

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

This information is not applicable as the device is a physical medical implant (lumbar cage system), not an algorithm or an AI-powered system.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this document is established through physical testing against recognized mechanical engineering standards (ASTM standards). The document states that the testing validates the "strength" of the device.

8. The Sample Size for the Training Set

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

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

This information is not applicable for the same reasons as above.

Summary of the Study:

The provided document (K180431) describes a 510(k) premarket notification for the Cortina™ [MAX] Lumbar Cage System. The submission is primarily for a name change from the Cortina™ (K171914) to Cortina™ [MAX], with no changes to the device itself.

The "study" referenced in the document is a series of non-clinical performance tests designed to assess the mechanical strength and stability of the lumbar cage system. These tests were conducted according to established ASTM standards:

• Static axial compression per ASTM F2077-11
• Dynamic axial compression per ASTM F2077-11
• Static subsidence per ASTM F2267-04
• Static expulsion per ASTM DRAFT F-04.25.02.02

The acceptance criteria for these tests are implicitly the requirements of the respective ASTM standards for intervertebral body fusion devices. The reported device performance is a qualitative statement that "the strength of the Cortina™ (MAX) Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This document does not describe a clinical study, an AI/algorithm-based device, or a study involving human readers or patient data for performance evaluation. It is solely focused on demonstrating the physical and mechanical equivalence of the device to its predicate through engineering testing.

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The Neurostructures Cavetto® Cervical Cage 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. These patients should have had six weeks of non-operative treatment. The Neurostructures Cavetto® Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous bone graft and placed via an open, anterior approach. The Neurostructures Cavetto® Cervical Cage System is intended to be used with supplemental fixation.

The Cavetto® Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.

This document is a 510(k) premarket notification for a medical device called the Neurostructures Cavetto® Cervical Cage System. It's an intervertebral fusion device to be used in the cervical spine.

Here's the breakdown of the information you requested based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum strength values). Instead, it lists the types of performance tests conducted and concludes that the strength of the device is sufficient for its intended use and substantially equivalent to legally marketed predicate devices.

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

The document does not specify the sample size (number of devices or tests performed) for each mechanical test. It mentions that the tests were "non-clinical testing," which typically means laboratory-based mechanical testing, not human or animal data. There is no information regarding country of origin or whether it's retrospective or prospective, as these are typically 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

This information is not applicable. The Neurostructures Cavetto® Cervical Cage System is a physical medical device, not an AI/software device that requires expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance is its mechanical properties as measured by standardized tests.

4. Adjudication method for the test set

This information is not applicable for mechanical testing of a physical device. Adjudication methods (like 2+1, 3+1) are typically used for medical image interpretation or clinical outcome assessment where subjective human judgment is involved.

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 type of study is relevant for AI-powered diagnostic or assistive tools, not for a physical intervertebral cage. The document focuses on the mechanical performance of the implant itself.

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

This question is not applicable. The device is a physical cervical cage, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is based on the results of standardized mechanical testing as described in ASTM F2077, ASTM F2267, and ASTM F04.25.02.02. The comparison is made against the performance of legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable. The device is a physical product, 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 there is no "training set" for this physical device.

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The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F560, and tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.

The provided document is a 510(k) premarket notification for the Cavetto®-SA Cervical Cage System, an intervertebral body fusion device. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold format for each test. Instead, it states that the "results of this non-clinical testing show that the strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This implies that the acceptance criterion for each test was to meet or exceed the performance of the legally marketed predicate devices. The specific performance values for the predicate devices are not provided in this summary.

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

• Sample Size: The document does not specify the number of samples or units tested for each non-clinical performance test (e.g., how many cages were subjected to static axial compression).
• Data Provenance: The data is from non-clinical testing (mechanical testing), not human or animal studies. Therefore, concepts like country of origin for human data or retrospective/prospective don't apply in the same way. The testing was conducted to established ASTM standards.

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

• Not applicable. This submission relies on non-clinical, mechanical performance data, not expert-derived ground truth based on interpreting medical images or clinical outcomes. The "ground truth" here is the physical measurement of the device's mechanical properties according to established engineering standards (ASTM).

4. Adjudication Method for the Test Set:

• Not applicable. As the data is purely mechanical testing against engineering standards, there's no "adjudication" in the sense of reconciling differing expert opinions. The tests are performed and measured objectively.

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

• No. This document describes a 510(k) submission based on non-clinical bench testing for a physical implantable device (a cervical cage). MRMC studies evaluate the performance of diagnostic algorithms or imaging techniques, often involving human readers. This type of study is not relevant to the evaluation of the Cavetto®-SA Cervical Cage System as presented here.

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

• Not applicable. This device is a physical medical implant, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. The Type of Ground Truth Used:

• For the non-clinical performance tests, the "ground truth" is established by adherence to published ASTM standards and the expected mechanical properties for devices of this type for their intended use. The comparison is made to predicate devices which have already demonstrated safety and effectiveness through their regulatory clearance based on similar mechanical and material properties.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this 510(k) submission. This is a physical medical device, not a machine learning model that requires training data.

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

• Not applicable. As there is no training set, this question is not relevant.

In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical implant (intervertebral cage) through non-clinical mechanical testing, rather than evaluating the performance of a diagnostic algorithm or AI system. Therefore, many of the requested categories (expert ground truth, MRMC studies, training sets) are not applicable to this type of regulatory submission. The core of the "proof" is that the device's mechanical properties, tested against recognized ASTM standards, are sufficient for its intended use and comparable to already cleared predicate devices.

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