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The Stable-L 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.

When used with the provided blades, supplemental fixation is required.

When used with the provided screws, 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 existing Stable-L Interbody System is a 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 either non-sterile to be sterilized by the end-user or sterile via gamma irradiation.

The subject submission seeks to add interbody cages with integrated blade fixation as well as expand the size offerings available. Additionally, this submissions seeks to gain clearance for a minor modification to the Stable L Cover Plate as well as extend the shelf life of devices provided sterile.

The provided FDA 510(k) clearance letter and summary for the "Stable-L Lumbar Interbody System" describe a spinal implant, not an AI/software medical device.

Therefore, the requested information regarding AI/software device acceptance criteria, performance studies (e.g., MRMC studies, ground truth establishment, training/test set details), and expert qualifications is not applicable to this document.

The document focuses on the physical characteristics and mechanical performance of the intervertebral body fusion device. The "Performance Testing" section mentions:

• Expulsion
• Blade compression/collapse
• Confirmatory Dynamic compression and dynamic shear per ASTM F2077
• Confirmatory insertion and screw pull out testing

These tests are standard for implantable mechanical devices and aim to demonstrate that the device performs equivalently to previously cleared predicate devices and does not raise new questions of safety or effectiveness. The criteria for these tests would typically involve specific force, displacement, or fatigue cycle thresholds, and the reported performance would be the successful completion of these predefined values.

In summary, this document does not contain the information needed to answer your request about AI/software device acceptance criteria and performance studies.

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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.

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The Tranquil-L™ Interbody System is intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 – S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.

The Tranquil-L Interbody System is a lumbar interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. Implants are provided sterile via gamma irradiation. Instruments are provided clean and non-sterilization at the user's facility.

The purpose of this special 510(k) is to gain clearance for modifications to existing lumbar implants and add implant footprints for the DLIF surgical approach.

This FDA 510(k) Premarket Notification is for the Tranquil-L Interbody System, a lumbar interbody fusion system. The document states that engineering analysis and confirmatory testing were conducted to demonstrate substantial equivalence to previously cleared devices. However, the provided text does not contain specific acceptance criteria or reported device performance metrics in a table format. It also lacks details regarding the sample size, data provenance, expert involvement for ground truth, adjudication methods, or specific standalone or MRMC study results.

Therefore, based solely on the provided text, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them, as this information is not present.

The document primarily focuses on establishing "substantial equivalence" of the modified Tranquil-L Interbody System to its predicate devices by indicating that:

• Materials are identical to the primary predicate (Titanium Alloy (Ti-6Al-4V ELI) per ASTM F3001).
• Geometry differences are slight, and analysis and testing have shown equivalent performance.
• Engineering analysis and confirmatory testing were conducted, including dynamic compression and dynamic compression shear per ASTM F2077.

Without specific performance metrics from these tests and the acceptance thresholds, a table of acceptance criteria and reported performance cannot be generated. Similarly, information regarding ground truth establishment, expert qualifications, and study design details (sample size for test/training, provenance, MRMC, standalone) are not available in this document.

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The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-CTM Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Tranquil-C™ Interbody System is a cervical interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the cervical spine. Implants are provided non-sterile or sterile via gamma irradiation. Instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The purpose of this special 510(k) is to gain clearance for modifications to existing cervical implants and the size range offered.

The provided document is a 510(k) summary for the Nexus Spine Tranquil-C Interbody System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on clinical studies or performance objectives with measurable outcomes.

Therefore, the document does not contain the acceptance criteria or the study that proves the device meets specific acceptance criteria in the way you've described for a typical diagnostic or AI-driven device.

Here's why and what information is available:

• Device Type: The Tranquil-C Interbody System is an implantable medical device (intervertebral body fusion device) for spinal fusion surgery. Its "performance" is primarily assessed through mechanical and biocompatibility testing, and its safety and effectiveness are established by demonstrating substantial equivalence to predicate devices that have already proven safe and effective.
• 510(k) Process: A 510(k) submission aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and materials. If significant differences exist, performance testing (e.g., mechanical, biocompatibility) is conducted to ensure the new device is as safe and effective as the predicate.
• Lack of Clinical Study with Acceptance Criteria: The document explicitly states: "Engineering analysis has determined that the subject changes do not create a new worst case condition. Therefore, previously conducted testing remains applicable and no additional performance testing is required." This means no new performance study (e.g., a clinical trial comparing outcomes or an AI-specific validation study) was conducted for this specific 510(k) submission. The safety and effectiveness are inferred from the predicate devices and existing testing.

Consequently, I cannot fill out your requested table and information points as they are designed for a different type of device evaluation (e.g., diagnostic accuracy, AI performance).

However, I can extract what is relevant from the document regarding the device's assessment:

1. Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Implied): The implied acceptance criterion for a 510(k) is "substantial equivalence" to the predicate devices in terms of safety and effectiveness. This is typically met by demonstrating that the new device has similar technological characteristics, materials, and intended use as the predicate, and any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance:
  • Mechanical/Biocompatibility (Inferred from Predicate): The device is manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, indicating compliance with recognized standards for implantable materials. The document states "previously conducted testing remains applicable" from the predicate devices (Nexus Spine, LLC Tranquil Interbody System – K181483, K170297, Spinal Elements, Ventana™ C - K222833, Nexus Spine, LLC – Stable L and Stable C Interbody System – K232530). This implies the device, through its substantial equivalence, meets the mechanical and biocompatibility performance standards established by these predicate devices. The "performance" here refers to attributes like strength, fatigue resistance, and biological inertness, which are typically assessed through lab-based mechanical testing, not through diagnostic accuracy metrics of an AI.

2. Sample Size for Test Set and Data Provenance:

• Not applicable. This is not an AI/diagnostic device and no "test set" in that context was used for this submission. The evaluation relies on engineering analysis and comparison to predicate devices, not patient data from a test set.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. Ground truth, in the context of expert consensus for diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for the device's safety and effectiveness is established through the regulatory clearance of its predicate devices and the robust engineering principles applied to its design and materials.

4. Adjudication Method:

• Not applicable. No adjudication of expert opinions on a test set occurred.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is not a diagnostic device or product involving human readers interpreting images with or without AI assistance.

6. Standalone Performance:

• Not applicable. This is not an algorithm whose standalone performance would be evaluated.

7. Type of Ground Truth Used:

• Regulatory/Engineering Equivalence: The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, supported by engineering analysis that demonstrates the new device is as safe and effective despite minor modifications.

8. Sample Size for Training Set:

• Not applicable. As this is not an AI/machine learning device, there is no "training set."

9. How Ground Truth for Training Set was Established:

• Not applicable.

In summary: The provided FDA letter and 510(k) summary are for a traditional medical device (interbody fusion system) seeking market clearance via the substantial equivalence pathway, not a software-as-a-medical-device (SaMD) or AI-driven diagnostic. Therefore, the details about acceptance criteria and studies you've requested are not present because they are not typically required or relevant for this type of submission.

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The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The PressON Spinal Fixation System is composed of pedicle screws, cortical screws, couplers, and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6Al-4V ELI (ASTM F136).

This document is a 510(k) premarket notification for the "PressON Spinal Fixation System." It is a regulatory document from the FDA, and as such, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document describes a spinal fixation system, which is a physical implant used in spinal surgery, not a software or AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, ground truth establishment, MRMC studies, or standalone performance, are not applicable to this submission.

The "Performance Testing" section explicitly states: "Mechanical testing was not performed as the additional parts for the PressON system did not create a new worst case scenario. All previously submitted testing for the PressON system (K223529) is applicable to the subject device." This indicates that the device's performance is established through mechanical testing (which is standard for spinal implants), but that testing was already performed and submitted under a previous 510(k) (K223529) for a very similar device.

Therefore, I cannot provide the requested information for an AI/ML device based on this document.

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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 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 Stable-L Standalone Lumbar 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 subject submission seeks to gain clearance for design changes to the previously cleared devices, as well as expand the screw offerings of the system.

The provided text is a 510(k) summary for the Stable-L Standalone Lumbar Interbody System. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about studies involving AI or human readers, or detailed clinical performance criteria typically found in studies for diagnostic devices. Therefore, I cannot provide all the requested information.

Based on the provided text, here is what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) that would be relevant for an AI-powered diagnostic device. Instead, it refers to substantial equivalence to a predicate device based on design, indications for use, materials, and mechanical performance testing.

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 describes bench performance testing for a medical implant (lumbar interbody system), not a diagnostic AI device using a "test set" of clinical data. Therefore, this information is not applicable and not provided. The testing involves physical devices.

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

This information is relevant for studies validating diagnostic devices. As this document describes testing for a spinal implant, there is no mention of "experts" establishing a "ground truth" for a test set in the context of clinical interpretation or diagnosis.

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

This information is relevant for studies validating diagnostic devices, particularly when there are discrepancies in expert interpretations. As this document describes testing for a spinal implant, there is no mention of adjudication methods.

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 such study was conducted or is mentioned in the document. This type of study is for evaluating AI-assisted diagnostic tools, not for medical implants.

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

This refers to the performance of an AI algorithm without human involvement. As described, this device is a physical medical implant, not an AI algorithm. Therefore, this is not applicable.

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

For the mechanical performance testing conducted, the "ground truth" would be established by engineering standards and measurements. The document does not explicitly state the specific "ground truth" criteria (e.g., specific torque values, force limits) but implies adherence to established mechanical testing methodologies to ensure equivalence to the predicate device.

8. The sample size for the training set

The document does not describe the development of an AI algorithm, and therefore there is no "training set."

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

As there is no AI algorithm or training set, this information is not applicable.

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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.

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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.

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The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The PressON Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. The system is composed of pedicle screws, cortical screws, and a variety of couplers. All components of the PressON Spinal Fixation System are made from Ti-6Al-4V ELI (ASTM F-136).

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria. The document is an FDA 510(k) clearance letter for the "PressON Spinal Fixation System," stating it is substantially equivalent to a previously cleared predicate device.

The information primarily concerns:

• The device's name and classification.
• Its intended use (indications for use).
• Details about the manufacturer and regulatory contacts.
• A list of mechanical performance tests performed (ASTM F1717 and ASTM F1798), but without reporting any specific results, acceptance criteria, or details of a study setup (like sample size, ground truth establishment, expert qualifications, etc.). The document only states that "Performance testing was performed, and results demonstrated that the subject device is substantially equivalent to the predicate device."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC study details or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This document pertains to the regulatory clearance of a physical medical device (spinal fixation system), not a software or AI/ML device that would typically involve the type of performance studies you are asking about (e.g., studies involving "human readers improve with AI vs without AI assistance").

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The PreView-III™ Anterior Cervical Plate System is intended for the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1). PreView-III™ Anterior Cervical Plate System is intended for use under the following indications degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture), tumor, deformity (i.e., kyphosis, and scoliosis), spinal stenosis, pseudoarthrosis, and failed previous fusion.

The PreView III™ Anterior Cervical Plate System is composed of the following components: Plates with preassembled locking rings. Bone screws. These components can be assembled by associated instruments to provide immobilization of the cervical spine. All components made from Ti-6Al-4V ELI (ASTM F-136).

The provided text is a 510(k) summary for the Nexus Spine, LLC's PreView-III™ Anterior Cervical Plate System. This summary describes a medical device, specifically an orthopedic implant for spine fixation, and assesses its substantial equivalence to a predicate device based on mechanical performance testing.

The questions you've asked are typically relevant to the performance validation of AI/ML-driven medical devices, particularly those that might use imaging data to assist in diagnosis or treatment planning.

Based on the provided text, the questions regarding acceptance criteria and study proving an AI device meets those criteria cannot be fully answered because this submission is NOT for an AI/ML device.

The PreView-III™ Anterior Cervical Plate System is a physical implant, not a software device or an AI application that processes images or data. The "performance testing" described in the document refers to mechanical tests (Static Compression Bending, Static Torsion, Dynamic Compression Bending) performed on the physical plate system to demonstrate its structural integrity and safety/effectiveness compared to a predicate device, as per ASTM F1717.

Therefore, many of the specific points you've requested (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details, etc.) do not apply to this type of device submission.

Here's what can be extracted and inferred from the text, reframing it in the context of a traditional medical device submission:

• Device Type: Physical Spinal Intervertebral Body Fixation Orthosis (implant).
• Purpose of "Study": To demonstrate mechanical substantial equivalence to a legally marketed predicate device (Alphaspine, Inc, PreView Anterior Cervical Plate System (K062371)).
• "Acceptance Criteria" (Mechanical Performance): While not explicitly stated as numerical criteria in a table, the implied acceptance criterion is that the PreView-III™ Anterior Cervical Plate System's mechanical performance (in terms of Static Compression Bending, Static Torsion, and Dynamic Compression Bending) must be substantially equivalent to the predicate device per ASTM F1717 standards.
• "Reported Device Performance": "The results demonstrated that the subject device has substantially equivalent mechanical performance to predicate device."
• Sample Size: For mechanical testing of physical implants, a "sample size" refers to the number of physical devices or components tested. This is not specified in the summary but would be detailed in the full test report submitted to the FDA. It's not "data samples" in the way AI models use them.
• Data Provenance: Not applicable in the context of patient data. The "data" comes from laboratory mechanical tests.
• Experts/Ground Truth/Adjudication/MRMC/Standalone Performance/Training Set: None of these are applicable because the device is a physical implant, not an AI/software device that interprets data or images. Its "performance" is determined by physical stress tests, not by human interpretation of its outputs or by learning from data.

In summary, the provided document does not contain the information needed to answer your questions because it describes a mechanical implant, not an AI/ML-driven medical device.

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