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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 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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