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The LAP LUNA 3D system is used to support reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning. LAP LUNA 3D may also be used to guide patients through breath-holds. The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and radiosurgery treatments and CT simulation for radiation therapy planning.

The LUNA 3D optical camera system captures the current 3D patient skin surface with one or multiple camera pods. The software calculates the spacial deviations between the captured live surface and a reference surface within a selected region of interest using a registration algorithm. Reference surfaces may be generated with the optical camera system or may be imported using data received from Treatment Planning Systems (TPS). Based on the registration results the user can adjust the patient position for reproducible patient positioning relative to the treatment isocenter. During the imaging (simulation) and treatment delivery process, the system continuously calculates the deviations between live- and reference surface for patient motion monitoring to ensure that the patient position remains within pre-defined tolerances.

Here's an analysis of the acceptance criteria and study information for the LUNA 3D device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provides limited detailed acceptance criteria and mostly focuses on comparison to a predicate device. The performance claims primarily relate to accuracy.

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

The provided summary does not specify a sample size for any clinical test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is "non-clinical performance testing" which typically refers to bench testing rather than studies involving human subjects or clinical data.

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

The provided summary does not mention any test set requiring expert ground truth or the involvement of experts for this purpose. The performance testing relies on a "calibration phantom."

4. Adjudication Method for the Test Set

As no expert-derived ground truth or clinical test set is described, no adjudication method is mentioned or applicable in the provided document.

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

A MRMC comparative effectiveness study was not performed or described in the provided summary. The summary focuses on the device's standalone performance and comparison of technical characteristics to a predicate device, not on human reader improvement with or without AI assistance.

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

Yes, a standalone performance assessment was conducted. The "non-clinical performance testing in terms of warm-up drift, latency, and multi-camera accuracies of the camera pods" and the reported "positioning accuracy" and "respiratory tracking" metrics (using a calibration phantom) reflect the algorithm's performance without direct human interaction during the measurement process. The device's function is to provide information for humans to use, but the core measurements are automated.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance testing was established using a calibration phantom. This is a physical object with known dimensions and properties used to assess the accuracy of the imaging system.

8. Sample Size for the Training Set

The provided summary does not specify a sample size for any training set. Given that this is a 510(k) for a medical charged-particle radiation therapy system accessory and not a purely AI/ML enabled diagnostic device, details on training data are often less emphasized in the summary unless substantial AI model development is a primary feature. The LUNA 3D is described as an "optical camera system" with "software calculates the spacial deviations... using a registration algorithm," which implies algorithms but not necessarily deep learning that would require a large training set in the typical sense.

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

As no training set is described, no information on how its ground truth was established is provided.

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The Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic 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. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D GEN2 Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D GEN2 Implant. The Luna 3D GEN2 Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D GEN2 Implant and associated accessories set of disposable and re-usable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D GEN2 Interbody Fusion System are identical to the primary predicate device. The Luna 3D GEN2 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 3D GEN2 Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space. Once the implant is in the desired position, the device is expanded into its ultimate height and forming a bone graft pocket. Teeth on the outer surfaces of the top and bottom components engage the implant into the adjacent endplates.

The Luna 3D GEN2Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (VESTAKEEP i4R, conforming to ASTM F2026), nitinol wire (superelastic alloy SE508, conforming to ASTM F2063) and tantalum rod conforming to ASTM F560. This 510(k) was submitted in support of the Generation 2 device.

This FDA 510(k) summary does not describe an AI medical device. It pertains to the Luna 3D GEN2 Interbody Fusion System, which is a physical intervertebral body fusion device used in spinal fusion procedures. The document focuses on mechanical and material testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI algorithm based on data.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI device is not applicable and cannot be extracted from this document.

The "Performance Testing" section (page 5) describes the mechanical testing performed on the device:

• Acceptance Criteria & Reported Performance: Not explicitly stated as acceptance criteria with numerical targets. However, the document states, "The results demonstrate that the Luna 3D GEN2 Interbody Fusion System device is substantially equivalent to the predicate devices." This implies that the performance in these tests met a level comparable to the predicate devices.

  • Tests performed:
    • Static compression
    • Static compression-shear
    • Static torsion
    • Static modified compression-shear
    • Dynamic compression
    • Dynamic compression-shear
    • Dynamic torsion
    • Expulsion
    • Subsidence
    • Corrosion testing (ASTM F2129)
    • Nickel leaching quantitative ICP/MS analysis
    • Surgical technique validation in cadaver specimens

• Sample size for the test set: Not specified in the provided text. The document mentions "worst-case devices" were subjected to mechanical testing, but the number of devices is not given.

• Data provenance: Not applicable in the context of an AI device. The tests are laboratory-based mechanical and material performance tests.

• Number of experts and qualifications for ground truth: Not applicable. The "ground truth" here is the physical performance of the device under specific mechanical loads and conditions, measured objectively according to ASTM standards.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable. This is a physical device, not an AI algorithm for diagnostic or prognostic purposes.

• Standalone (algorithm only) performance: Not applicable. This is a physical device.

• Type of ground truth used: Material and mechanical engineering standards (ASTM F2077-14, F2267-04, F2129, F2063, F560) and cadaveric testing for surgical technique validation.

• Sample size for the training set: Not applicable. There is no training set for a physical device.

• How the ground truth for the training set was established: Not applicable.

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The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomative 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. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D Interbody Fusion System are identical to predicate interbody lumbar cages. The Luna 3D Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 3D Implant is available in heights ranging from 8mm to 15mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates.

The Luna 3D Implant is manufactured from polyetheretherketone (PEEK Optima LT-1 or Evonik VESTAKEEP i4R), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a diagnostic algorithm or AI product would be evaluated (e.g., sensitivity, specificity, or reader studies). This document is a 510(k) premarket notification for a medical device called the "Luna 3D Interbody Fusion System," which is an implant for spinal fusion procedures.

The "Performance Testing" section describes bench testing conducted to evaluate the impact of design changes on product performance. This is typical for mechanical devices and focuses on physical and mechanical properties, not diagnostic accuracy or human-AI comparative effectiveness.

Here's an analysis of the information that is available in relation to your request, and where the requested information is missing:

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

• Missing. The document describes a medical implant, not an AI or diagnostic device that would have performance criteria like sensitivity or specificity. The "performance testing" referred to are mechanical bench tests.

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

• Missing. The "performance testing" involved mechanical bench tests (static/dynamic compression, shear-compression, torsion, and subsidence testing). These do not involve "test sets" in the context of patient data or AI evaluation.

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)

• Missing. This concept is not applicable to the type of device and testing described.

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

• Missing. This concept is not applicable to the type of device and testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Missing. This is not an AI or diagnostic imaging device.

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

• Missing. This is not an AI or algorithm-based device.

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

• Missing. For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical testing standards (e.g., ASTM F2077, ASTM F2267). The document states the results "confirmed that this design is substantially equivalent to legally marketed predicate devices," implying successful adherence to these standards and equivalence criteria.

8. The sample size for the training set

• Missing. This concept is not applicable to the type of device and testing described.

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

• Missing. This concept is not applicable to the type of device and testing described.

Summary of available information related to performance:

The document describes performance testing for the Luna 3D Interbody Fusion System, which is a physical implant. This testing was primarily bench testing (mechanical tests) to confirm the new design's equivalence to predicate devices and ensure its structural integrity and performance under various loads.

• Tests Conducted:
  • Static/dynamic compression
  • Static/dynamic shear-compression
  • Static/dynamic torsion tests (per ASTM F2077)
  • Subsidence testing (per ASTM F2267)
• Purpose: To evaluate the impact of minor design changes (e.g., addition of an 8-degree lordotic version, expansion of implant height, use of alternative PEEK material, alternative trial instrument) on product performance.
• Conclusion of Testing: The results "confirmed that this design is substantially equivalent to legally marketed predicate devices."

In essence, for this medical implant, the "acceptance criteria" were implied to be meeting the mechanical performance characteristics demonstrated by predicate devices, as assessed through standardized bench tests. This is a very different type of evaluation compared to the performance assessment of AI/diagnostic software.

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