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Rampart™ O, Rampart™ T, and Rampart™ A implants are 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 1 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 of non-operative treatment.

Rampart™ O, Rampart™ T, and Rampart™ A implants are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart O, Rampart T, and Rampart A 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 made of PEEK-OPTIMA LT1 with titanium or tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft and/or allograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided document is a 510(k) premarket notification for intervertebral body fusion devices, seeking clearance to expand the indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about the performance of a device that relies on AI or algorithms, nor does it present acceptance criteria or a study proving that a device meets such criteria in the context of an AI/algorithmic medical device.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered based on the available text:

1. A table of acceptance criteria and the reported device performance:
   Not applicable. This document is a 510(k) submission for an intervertebral body fusion device, not an AI/algorithmic device. No performance metrics or acceptance criteria for an AI system are present.

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. No test set for an AI/algorithmic device is mentioned.

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. No ground truth establishment for an AI/algorithmic device is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. No test set adjudication for an AI/algorithmic device is mentioned.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. No standalone algorithm performance is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable. No ground truth for an AI/algorithmic device is mentioned. The document references "published clinical data for lumbar intervertebral body fusion devices" and a "clinical literature review," but this is for predicate device comparison and safety profile, not for establishing ground truth for an AI algorithm.

8. The sample size for the training set:
   Not applicable. No training set for an AI/algorithmic device is mentioned.

9. How the ground truth for the training set was established:
   Not applicable. No training set or ground truth for an AI/algorithmic device is mentioned.

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Rampart™-O: Rampart™-O is an intervertebral body fusion device 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 of non-operative treatment. Rampart™-O is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.

Rampart™-T: Rampart™-T is an intervertebral body fusion device 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 of non-operative treatment. Rampart™-T is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.

Rampart™-O and Rampart™-T devices are designed for use with autograft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine. The devices are available in a range of lengths and heights. The devices are provided sterile and non-sterile. The associated instruments are provided non-sterile.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, there are no specific acceptance criteria or performance metrics reported for the device, as no testing was performed. The 510(k) relies on substantial equivalence to predicate devices.

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

• Sample Size for Test Set: Not applicable. No testing was performed on a test set.
• Data Provenance: Not applicable. No new data was generated or used from a test set.

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

• Number of Experts: Not applicable. No test set was used, and thus no ground truth was established by experts for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "No testing was performed."
• Effect Size of Human Reader Improvement with AI vs. Without AI: Not applicable, as no MRMC study or AI component is mentioned.

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

• Standalone Performance: No, a standalone performance study was not done. The device is a physical intervertebral body fusion device, not a software algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No new empirical data requiring a ground truth was generated as "no testing was performed." The submission relies on substantial equivalence to previously cleared devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is a physical medical implant, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. The device is a physical medical implant, not an AI/ML algorithm requiring a training set or its associated ground truth establishment.

Summary of the K132053 510(k) Submission:

This 510(k) application for the Rampart™-O and Rampart™-T intervertebral body fusion devices is a submission to update the indications for use and the ability to provide the products as sterile. Crucially, the application states: "No testing was performed."

Therefore, the submission establishes substantial equivalence based on the intended use, materials, configuration, and performance characteristics of the predicate products (Rampart™ O (K131216) and Rampart™ T (K121129)), rather than through new performance studies or data collection. This means that all questions related to acceptance criteria, device performance studies, test sets, training sets, ground truth establishment, and expert involvement are not applicable to the information provided in this specific 510(k) summary.

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Rampart™ O is an intervertebral body fusion device 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 of non-operative treatment.

These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.

Rampart™ O is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart™ O devices are designed for use with autograft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.

The provided text describes a 510(k) premarket notification for the Rampart™ O intervertebral body fusion device. This type of submission is for medical devices, not AI/ML-driven diagnostic tools, therefore many of the requested categories are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The device under review is an intervertebral body fusion device, which is a physical implant. The acceptance criteria and "performance" in this context refer to the device's physical properties and its ability to function as intended within the human body, not diagnostic accuracy.

• Static Compression Strength
• Static Compression Shear Strength | Substantial Equivalence Demonstrated:
• Previous preclinical testing according to ASTM F2077 (static compression and static compression shear) was used to justify substantial equivalence.
• Testing demonstrated similar performance characteristics to the identified predicate devices. |
  | Material Biocompatibility: | Assumed to be met as it's an extension of existing cleared devices. |
  | Sterility: | Device and associated instruments are provided non-sterile (implies sterilization by user). |
  | Design/Configuration:
• Range of lengths and heights (for new sizes) | Extended range of sizes for lordotic and non-lordotic implants. Design is similar to predicate devices. |
  | Intended Use Safety & Efficacy: | Similar to predicate devices, for lumbar interbody fusion (L2-S1) in patients with DDD and up to Grade I spondylolisthesis, with autograft and supplemental fixation. |

Study Details (Applicability to AI/ML is explained)

This document is for a traditional medical device (implant), not an AI/ML diagnostic. Therefore, many of the questions related to AI/ML performance studies, ground truth, and expert evaluation are not directly applicable.

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

   • N/A (for AI/ML): This is not an AI/ML device. The "test set" in this context refers to the samples used for mechanical testing.
   • Mechanical Testing Samples: Not explicitly stated, but typically involves a sufficient number of devices to meet ASTM F2077 statistical requirements for each test type (static compression and static compression shear). The provenance for these physical devices would be their manufacturing origin, not patient data.

2. 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):

   • N/A (for AI/ML): This is not an AI/ML device. "Ground truth" in this context would implicitly refer to established standards for mechanical properties and material science, not clinical expert consensus. Testing is performed by engineers/technicians in a lab setting.

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

   • N/A (for AI/ML): This is not an AI/ML device. Adjudication methods like 2+1 are for clinical judgments or diagnostic accuracy, not mechanical testing.

4. 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: This is a physical implant, not an AI-assisted diagnostic tool. MRMC studies are not relevant.

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

   • No: This is a physical implant, not an algorithm.

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

   • N/A (for AI/ML): For this physical device, the "ground truth" for proving substantial equivalence relies on established preclinical mechanical testing standards (ASTM F2077) that define acceptable performance parameters for intervertebral body fusion devices. This is a material and mechanical engineering 'ground truth'.

7. The sample size for the training set:

   • N/A (for AI/ML): This is a physical implant. There is no concept of a "training set" for an AI/ML model.

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

   • N/A (for AI/ML): This is a physical implant. There is no "training set ground truth."

In summary, the provided document is a 510(k) summary for a physical medical implant (Rampart™ O). The study described is a preclinical mechanical testing study demonstrating substantial equivalence to predicate devices, as required for traditional device clearances, not an AI/ML performance study.

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Rampart™ P and Rampart™ O are 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 of non-operative treatment.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
Rampart™ P and Rampart™ O are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart™ P and Rampart™ O are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.

The provided text is a 510(k) summary for a medical device (Rampart™ P and Rampart™ O), specifically intervertebral body fusion devices. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

Based on the provided text, there is no information regarding acceptance criteria or a study proving the device meets acceptance criteria related to AI/algorithm performance for image analysis or other diagnostic purposes, as implied by the questions. The "testing" section explicitly states "Preclinical testing according to ASTM F2077, including static compression and static compression shear. This testing demonstrated similar performance characteristics to the identified predicate devices." This refers to biomechanical testing of the implant itself, not a study evaluating human reader performance with or without AI, or standalone algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria (including the table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, and ground truth information) because such information is not present in the provided 510(k) summary. These questions are typically relevant for AI/ML devices or diagnostic imaging devices, not for an intervertebral body fusion implant as described here.

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