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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous bone graft.

The standard Rampart One device may be used with or without supplemental fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.

The oblique Rampart One device must be used with supplemental fixation systems cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

Regarding the Rampart™ One Lumbar Interbody Fusion Device and its K180002 submission for expanded indications of use, the document states that no new performance or clinical testing was performed or required. Therefore, there are no specific new acceptance criteria or studies associated with this particular submission that prove new performance.

The document instead refers to previously conducted performance testing for the Rampart One device and a review of published clinical data for similar stand-alone devices.

Here's a breakdown based on the provided text, focusing on what is mentioned or not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Since new performance testing was not conducted for this specific submission, there isn't a table of new acceptance criteria and device performance. The document states that the initial performance testing for the Rampart One device remains valid. That initial testing established conformance to the following standards:

Note: The specific quantitative performance metrics (e.g., specific load values, displacement limits) for "conformed" are not provided in this summary but would have been part of the original K163670 submission's testing report.

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

• For Performance Testing: The sample sizes used for the initial performance testing (referenced but not detailed here) are not specified in this document. These would have been documented in the original K163670 submission.
• For Clinical Data (Review): The document mentions a "review of published clinical data," which implies data collected retrospectively or prospectively from various studies. No specific sample size or data provenance (e.g., country of origin) is given for this review, as it refers to a compilation of existing literature rather than a new, specific clinical study associated with this submission.

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

This information is not applicable to this submission, as no new clinical test set was created or evaluated in a way that required an independent expert panel for ground truth establishment. The clinical evaluation relied on a review of existing published literature.

4. Adjudication Method for the Test Set

This information is not applicable, as no new clinical test set requiring adjudication was performed for this submission.

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

No MRMC comparative effectiveness study was done for this submission. The submission states that "clinical testing was not required or performed to support substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable as the device is a physical medical implant, not an algorithm or AI software, and therefore "standalone performance" in that context does not apply.

7. Type of Ground Truth Used

• For Performance Testing: The ground truth for the engineering performance tests (e.g., compression, pullout) is the physical properties and mechanical behavior of the device under specified testing conditions, as measured against the limits set by the ASTM standards.
• For Clinical Data Review: The "ground truth" for the clinical evaluation was derived from published clinical outcomes related to similar stand-alone anterior lumbar intervertebral body fusion devices with integrated fixation. This essentially means the consensus findings and results reported in established medical literature.

8. Sample Size for the Training Set

This is not applicable as the device is a physical implant and does not involve a "training set" in the context of an algorithm or AI model.

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

This is not applicable as the device is a physical implant and does not involve a "training set" in the context of an algorithm or AI model.

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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment.

The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixations systems cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium allov screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided text is a 510(k) premarket notification for a medical device called the "Rampart One Lumbar Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic performance. Therefore, the information typically requested in your prompt (such as a table of acceptance criteria, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not part of this document.

The document primarily addresses the device's design, materials, indications for use, and non-clinical mechanical testing to show that it is as safe and effective as existing predicate devices.

Here's a breakdown of the available information in relation to your request, with an emphasis on what is not present because it's not a required component of a 510(k) for this type of device:

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

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion for a 510(k) is the demonstration of "substantial equivalence" to a predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance (Non-Clinical): Mechanical testing was conducted. The document states:
  • ASTM F2077: Static and Dynamic Compression, Static and Dynamic Compression Shear tests were performed.
  • ASTM F2267: Subsidence test was performed.
  • ASTM F543-13: Axial Pullout test was performed.
  • Anti-Screw Backout Expulsion: A test was performed.
  • Bacterial endotoxin testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011.
  • Specific performance metrics (e.g., precise load limits, displacement values, or pass/fail thresholds) are NOT detailed in this summary. The FDA review process would have evaluated the raw data and compared it against established standards or predicate device performance, but these specific numbers are not public in this summary document. The "Conclusion" states: "Spineology has demonstrated that the Rampart One Lumbar Interbody Fusion Device is substantially equivalent to the predicate devices."

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

• Not Applicable in the traditional sense for this type of device: For a mechanical device like an interbody fusion device, "test set" typically refers to the samples of the device itself (e.g., a certain number of devices tested for mechanical properties). The document does not specify the number of devices tested for each mechanical test.
• Data Provenance: The tests were conducted according to ASTM and ANSI/AAMI standards, likely in a laboratory setting. Country of origin for data is not specified, but the submitter is Spineology Inc. in Saint Paul, Minnesota, USA. The testing is prospective in the sense that the manufacturer specifically conducted these tests for this submission.

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: This is not a diagnostic device or an AI/ML algorithm that requires expert ground truth labeling. Mechanical properties are measured objectively by instrumentation in a laboratory, not by expert opinion.

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

• Not applicable: No expert adjudication is involved in evaluating the primary performance of this mechanical device.

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 is a mechanical implantable device, not a diagnostic imaging or AI-assisted device. No human reader studies (with or without AI assistance) are relevant or mentioned.

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):

• Mechanical Standards: The "ground truth" for the mechanical testing is adherence to established industry standards (ASTM, ANSI/AAMI) for biocompatibility, sterility, and mechanical strength, often compared against performance data from predicate devices. Clinical "outcomes data" is generally part of a PMA (Premarket Approval) process, not a 510(k), unless specific new safety/effectiveness questions arise.

8. The sample size for the training set:

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

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

• Not applicable: As above, no training set is involved.

Summary of what the document does provide:

• Device Name: Rampart One Lumbar Interbody Fusion Device
• Intended Use: Intervertebral body fusion at one or two contiguous levels in the lumbar spine (L2-S1) for patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, who are skeletally mature and have had six months of non-operative treatment.
• Materials: PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), tantalum (radiopaque markers).
• Mechanisms of Action: Integrated fixation with titanium alloy screws, hollow core for bone graft.
• Non-Clinical Testing Conducted: Mechanical tests (Static/Dynamic Compression/Shear, Subsidence, Axial Pullout, Anti-Screw Backout Expulsion) and Bacterial Endotoxin Testing, all performed according to recognized standards.
• Predicate Devices: Several predicate devices are listed, including other Spineology Rampart devices and devices from Cutting Edge Spine, Synthes Spine, and Biomet Spine. The new device is compared to these predicates to demonstrate substantial equivalence in intended use, indications for use, fundamental scientific technology, principle of operation, biological safety, base materials, and size offering.

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