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The UNiTi ACDF Implant System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.

Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.

The UNiTi ACDF Implant System is limited to one level fusion. A single UNiTi Implant must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.

Warning: This device is not approved for attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The UNiTi ACDF Implant System consists of plate-like staple implants offered in various sizes to match the various patient anatomies. To accommodate different patient anatomies, the implant sizes are offered in bridge length from 14mm to 20mm and with a leg lengths of 12mm and 14mm. The UNiTi ACDF Implant is manufactured from pseudo-elastic (super-elastic) Nitinol with superelastic properties at room temperature and at in vivo temperatures. The implant is retained in an active open position with its legs held parallel by the insertion device. Upon release from the insertion device, the active compression from the implant is transferred to the bones at the fusion site. In its implant position, the UNiTi ACDF Implant is intended to provide active compression and maintain stability across the fusion site at the desired cervical level (C3-C7).

This document describes the UNiTi ACDF Implant System, a spinal intervertebral body fixation orthosis. However, it does not contain the information required to answer your questions about acceptance criteria and study details as it primarily focuses on the device description, indications for use, technological characteristics, and a broad statement about performance and substantial equivalence to predicate devices.

Specifically, the document does NOT provide:

• A table of acceptance criteria and reported device performance. While it lists types of performance tests (Static compression bending, Static torsion, Dynamic compression bending, Corrosion, Cadaveric implantation and range of motion, Pullout), it does not present specific criteria (e.g., maximum deflection, number of cycles survived, corrosion rate limits) or the actual results obtained from these tests.
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document concludes with a general statement that "The results of this non-clinical testing show that the strength of the UNiTi ACDF Implant System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This is a summary statement that doesn't provide the detailed data requested.

Therefore, for this particular device, the provided text does not allow for a detailed response to your specific questions regarding acceptance criteria and study data.

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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 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 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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