Search Results

The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0,°6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy.

The purpose of this Traditional510(k) submission is to gain clearance for modifications made to the subject device.

This document is a 510(k) premarket notification for a medical device called the "Stable-C Interbody System" by Nexus Spine, LLC. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study proving the device meets those criteria, such as:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

Instead, the document focuses on:

• Device Description: The Stable-C Interbody System is an anterior cervical interbody device made of titanium alloy, with lordotic angles of 0°, 6°, and 12°. It includes two fixation anchors.
• Indications for Use: Indicated for skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1, defined as discogenic back pain with degeneration confirmed by history and radiographic studies. It is a standalone system to be used with bone anchors and autogenous or allogenic bone graft, after six weeks of non-operative treatment.
• Substantial Equivalence: The primary predicate is Nexus Spine, LLC Stable-C Interbody System (K231763; K232530), with an additional predicate being Nexus Spine, LLC Tranquil-C Interbody System (K240416). The subject device's indications, sizing, geometry, technological characteristics, materials, manufacturing, sterilization, and packaging are stated to be similar or identical to the predicate devices.
• Performance Testing: The submission states that "The subject changes to the Stable-C Interbody System do not introduce a new worst case, as confirmed by bench top usability testing of the device and instrumentation in a simulated implantation. Additional performance testing is not required to establish substantial equivalence." This indicates that no new clinical or significant performance studies were conducted to prove specific acceptance criteria for the current submission beyond bench-top usability testing to confirm the changes did not worsen performance compared to the already cleared predicate device.

In summary, this document is a 510(k) submission and does not describe a study to prove a device meets acceptance criteria in the manner you've requested. It argues for substantial equivalence based on similarities to predicate devices and limited bench testing for modifications.

Ask a specific question about this device

The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.

The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-L Interbody System is a stand-alone lumbar interbody system including an interbody cage additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and associated bone screws manufactured from titanium alloy per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. Stable-L Interbody devices are provided nonsterile and are expected to be sterilized by the end-user prior to use.

The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0 , 6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy.

The purpose of this Special 510(k) submission is to gain clearance for the subject devices to be provided sterile via gamma radiation.

The provided text is a 510(k) summary for the Nexus Spine Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System. It states that the purpose of the Special 510(k) submission is to gain clearance for these devices to be provided sterile via gamma radiation, whereas the predicate devices were provided non-sterile. The document explicitly states:

"The subject components are identical in indications, sizing and geometry, technological characteristics, and materials to the predicates. The only difference between the subject device and predicate device is that the subject device is provided sterile via gamma radiation and the predicate device is provided nonsterile. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness."

And under "Performance Testing":

"There is no change to the intended use, indication for use, materials, geometry, or dimensions to the Stable-L Standalone Lumbar Interbody System or Stable-C Interbody System. There is no mechanical performance testing included in this submission. Sterilization validation, packaging validations, and shelf life validation have all been performed to support the gamma radiation sterilization change."

Based on this, the acceptance criteria and study proving the device meets the acceptance criteria are not related to the clinical performance or diagnostic accuracy of an AI/ML-driven device, but rather to the sterility and packaging integrity of a medical implant after a change in sterilization method.

Therefore, I cannot provide the information requested in points 1-9 of your prompt, as it pertains to AI/ML device validation (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.). This document describes a medical device, but its 510(k) submission focuses on a sterilization method change, not an AI/ML component.

If you are looking for an example of an AI/ML device clearance document, this specific text will not provide the details you're seeking regarding AI/ML acceptance criteria and performance studies.

Ask a specific question about this device

The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in sketally mature patients with cervical disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0, °6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation may be needed. When used without the supplied fixation, the Stable-C is intended for use with supplemental fixation (e.g., anterior plate, posterior pedicle screws). The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The subject system seeks to gain clearance for updated indications for use and design changes to the previously cleared device.

The provided document is a 510(k) premarket notification for a medical device called the "Stable-C Interbody System," which is an anterior cervical interbody fusion system. It is important to note that this document is for a physical medical implant (an intervertebral fusion device), not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) product.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of AI/SaMD (e.g., test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets) is not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a traditional medical device like the Stable-C Interbody System are based on:

1. Substantial Equivalence: The primary method for clearance is demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing:
   • Indications for Use
   • Technological Characteristics (e.g., materials, design, operating principles)
   • Performance Data (bench testing, and in some cases, animal or clinical data if differences in technological characteristics raise new questions of safety or effectiveness).
2. Performance Testing: Bench testing (e.g., mechanical, durability, material properties) to ensure the device performs as intended and is safe.
3. Biocompatibility: Ensuring the materials used are biocompatible.
4. Sterilization: Validation of sterilization methods.

Based on the provided document, here's what can be extracted regarding the "acceptance criteria" and "study" for this physical device:

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

Since this is a physical implant, the "acceptance criteria" are not quantitative thresholds like sensitivity/specificity for an AI model. Instead, they are met through equivalence and performance testing.

• Primary Predicate: Nexus Spine, LLC, Stable-C Interbody System (K181621)
• Secondary Predicates: Aesculap ArcadiusXP C Spinal System (K153629), Genesys Spine AIS-C Cervical Stand-Alone System (K181295)
• Justification: "Insignificant differences" between subject device and primary predicate; Indications for Use expanded similar to Genesys Spine predicate; Materials identical to primary predicate. "Slight geometry differences" were addressed by testing. Conclusion: "does not raise new questions about safety and effectiveness." |
  | Mechanical Performance | Confirmatory bench performance testing performed:
• Dynamic axial compression per ASTM F2077-18
• Dynamic axial compression shear per ASTM F2077-18
• Reported Outcome: "Testing has confirmed that the proposed design changes and change in indications do not raise new issues of safety and effectiveness." (Implying the device met relevant performance specifications for these tests, although specific numerical results/acceptance limits are not detailed in this summary for confidentiality reasons). |
  | Biological Performance | Additional cadaveric testing conducted:
• Reported Outcome: "Cadaveric validation have shown that the subject Stable-C Interbody devices perform equivalent to the predicate devices." (This is likely to demonstrate the functional biomechanical performance in a more realistic anatomical setting, implicitly meeting "acceptance" by demonstrating equivalence to the established predicate). |
  | Materials | - Interbody cage: titanium alloy (Ti-6Al-4V) per ASTM F3001
• Fixation anchors: titanium alloy (Ti-6-Al-4V ELI) per ASTM F136
• Reported Outcome: "The Materials of the subject device are identical to those of the primary predicate." (This implies biocompatibility and material strength are accepted based on the predicate). |
  | Device Configuration | - Varied sizes available to accommodate patient anatomy.
• Provided clean and non-sterile for steam sterilization at user's facility (implies sterilization validation was performed, a standard requirement).
• Integrated fixation anchors, but supplemental fixation advisable if anchors don't provide adequate stability (addressing a potential use-case limitation). |

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

• Sample Size for Test Set: This concept doesn't apply to this type of device in the same way it would for AI where a distinct "test set" of images/data is used. For physical devices, "test samples" refer to the number of physical devices produced and subjected to mechanical/biological testing. The document states "confirmatory bench performance testing was performed on the subject Stable-C interbody devices" but does not specify the number of devices or "samples" tested in the summary. For cadaveric testing, it "was conducted on the subject IBDs," again without specifying the number of cadaveric specimens.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable for physical device bench testing. Cadaveric testing would typically be performed in a lab setting.

3. Number of experts used to establish the ground truth... and qualifications:

• Not applicable. Ground truth for a physical implant is established by engineering specifications, material standards, and biomechanical principles, not by expert interpretation of images for disease.

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

• Not applicable. Adjudication methods are for human reader performance assessments in image interpretation, which is not relevant here.

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. MRMC studies are for AI/SaMD products used to assist human interpretation of medical images.

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

• Not applicable. This device is a physical implant; there is no "algorithm" to be evaluated for standalone performance.

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

• For physical implants, "ground truth" is typically defined by:
  • Engineering Specifications: Device dimensions, material properties, tolerance limits.
  • Validated Test Methods: Adherence to recognized standards (e.g., ASTM F2077-18 for spinal implants) which define how performance is measured and acceptable ranges.
  • Biomechanical Equivalence: Demonstrating that the new device performs similarly to a predicate device in relevant biomechanical tests.

8. The sample size for the training set:

• Not applicable. There is no AI model requiring a training set for this physical device.

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

• Not applicable. Also related to AI model training.

In summary, the provided document is a regulatory submission for a traditional Class II medical device (a spinal implant) and its clearance pathways rely on demonstrating substantial equivalence and meeting specified physical and mechanical performance characteristics, not on methodologies typically associated with the evaluation of AI or SaMD products.

Ask a specific question about this device

The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles of 0 , 6°, and 12°) made from Ti-6Al-4V per ASTM F3001 and two fixation anchors made from Ti-6-Al-4V ELI per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text is a 510(k) premarket notification FDA letter for a medical device called the "Stable-C Interbody System." This document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices.

It does NOT describe a study involving an AI/Medical Device that uses machine learning, nor does it provide details about acceptance criteria and performance data in the context of an algorithm's accuracy or effectiveness.

The "Performance Data" section in the document refers to mechanical testing of the physical implant device to prove its structural integrity and safety, not the performance of an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, details of a study proving algorithm performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it is not relevant to an AI/ML medical device.

To answer your request, I would need a document describing the validation and performance of an AI/ML-based medical device.

Ask a specific question about this device