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Lucent® XP intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of corticancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

Lucent® XP intervertebral body fusion device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

This document is a 510(k) premarket notification acceptance letter from the FDA for a medical device called Lucent® XP, an intervertebral body fusion device. The document states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

However, the provided text does not contain any information about acceptance criteria for a study, nor does it describe a study that proves the device meets specific acceptance criteria related to its performance.

The document primarily focuses on:

• Regulatory Clearance: Announcing the FDA's decision that the Lucent® XP device is substantially equivalent to predicate devices.
• Device Description: Briefly outlining the device's design and intended use.
• Indications for Use: Specifying the conditions and patient population for which the device is intended.
• Technological Characteristics: Stating similarities to predicate devices.
• Performance Data (Mechanical Testing): Mentioning that non-clinical mechanical testing was performed in accordance with FDA guidance and ASTM standards, demonstrating substantial equivalence to predicate devices. It does not provide the results of this testing, nor does it define acceptance criteria for these tests or compare results against them.
• Substantial Equivalence: Listing the predicate devices to which Lucent® XP was deemed substantially equivalent.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your prompt, I would need a document that describes:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity for an AI device; or specific mechanical thresholds for a physical device).
• Quantitative acceptance criteria for these metrics.
• The results of a study (clinical or non-clinical) that explicitly reports these metrics and compares them against the established acceptance criteria.
• Details about the study's methodology, such as sample size, data provenance, ground truth establishment, etc.

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The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.

The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.

The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.

The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed.

The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board.

Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System.

These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets:

• . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems
• 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ●
• . 4003.500 DORO LUCENT® iXI Headrest System

By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.

The provided FDA 510(k) summary describes a medical device, the DORO LUCENT® iXI and iMRI Headrest System. This document focuses on the substantial equivalence of the new device to a predicate device rather than presenting a clinical study to evaluate diagnostic performance with a human-in-the-loop or standalone algorithm. Therefore, many of the requested criteria related to AI/algorithm performance and clinical study details are not applicable or not present in this submission.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated through "Pass" results in various performance tests.

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

This is a physical medical device (headrest system), not an AI/software device. The "test set" here refers to the physical units of the device and its components undergoing engineering and materials testing. The document does not specify the exact number of units or components tested for each criterion. The provenance of the data is from pro med instruments GmbH, the manufacturer, and the tests were likely conducted internally or by accredited third-party labs. The study is a prospective testing of manufactured devices against pre-defined engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a physical device's performance often relates to instrumented measurements (e.g., force, torque, imaging artifacts) and material properties, not expert consensus as would be used for diagnostic imaging algorithms.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies for diagnostic accuracy, where expert opinions need to be reconciled. For device performance testing, results are quantitative or pass/fail based on pre-defined specifications.

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 device is not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

The ground truth for this device's performance is based on engineering specifications, material science, sterility standards, and regulatory requirements (e.g., MRI compatibility standards). For example, "MR-Compatibility" is verified against established standards for how metallic or non-metallic objects interact with MRI fields. "Static load" is verified against a specified weight with a safety factor.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI/machine learning training sets.

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

Not applicable. As there is no training set for an AI algorithm, no ground truth needs to be established for it.

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Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The Lucent® device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

The provided text is a 510(k) summary for the Lucent® XP intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through technical comparisons and non-clinical testing. It explicitly states that no acceptance criteria or studies proving device performance against such criteria are presented in this document.

The document details the following about the device's evaluation:

1. Acceptance Criteria and Reported Device Performance:

   • No specific acceptance criteria (e.g., in terms of clinical outcomes, accuracy, or specific performance metrics) are mentioned in this 510(k) summary.
   • The document states: "All data indicates that the device will perform as intended." This is a general statement and not a specific performance metric against a defined acceptance criterion.

2. Sample Size used for the test set and the data provenance:

   • No clinical or standalone performance test sets are mentioned. The "non-clinical testing" refers to mechanical tests of the device itself (hardware). The sample sizes for these mechanical tests are not provided.
   • Data provenance is not applicable as no clinical or image-based studies are referenced.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable, as no expert-reviewed test sets (e.g., for image interpretation or diagnosis) were used. The evaluation was based on mechanical testing of the physical device.

4. Adjudication method for the test set:

   • Not applicable, as no expert-reviewed test sets were used.

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 MRMC or human-in-the-loop studies were performed. The device is a physical intervertebral body fusion device, not an AI or imaging diagnostic tool.

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

   • Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

   • For the mechanical testing, the "ground truth" would be the engineering specifications and recognized industry standards (ASTM F 2077-14) against which the device performance was measured.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable.

Summary of Device Evaluation (based on the provided text):

The evaluation for the Lucent® XP intervertebral body fusion device primarily relied on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies or performance against specific acceptance criteria.

• Mechanical Testing:

  • Performed in accordance with the FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device."
  • Included:
    • Static and Dynamic Compression Testing per ASTM F 2077-14
    • Static and Dynamic Compression Shear Testing per ASTM F 2077-14
  • The document states: "All data indicates that the device will perform as intended."

• Biocompatibility Testing: The materials and manufacturing processes were stated to be identical to previously cleared devices (K152011), thus no new biocompatibility testing was reported.

• No Electrical Safety, Software Verification, Animal Studies, or Clinical Studies were performed.

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Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The Lucent® device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

This document is a 510(k) summary for a medical device called Lucent®, an intervertebral body fusion device.

Here's an analysis of the provided text in the context of your request:

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

The document does not provide acceptance criteria or reported device performance in the typical sense of quantitative metrics for a study. This 510(k) pertains to line additions to an already cleared device, and the submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data against specific acceptance criteria.

The "Performance Data" section explicitly states: "No clinical testing was found to be necessary. Given the type of changes made to the Lucent device, no additional non-clinical testing was required or performed."

Therefore, I cannot generate a table of acceptance criteria and reported device performance from this document.

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

As stated above, no new performance data or clinical testing was conducted for this 510(k) submission. The device's substantial equivalence is based on its similarity to previously cleared devices. Therefore, there is no test set sample size or data provenance to report from this document.

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):

Since no new performance data or clinical testing was performed, there was no test set for which ground truth needed to be established by experts.

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

Not applicable, as no test set was used for new performance evaluation.

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 device is an intervertebral body fusion device (a physical implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable, as no new performance validation using a specific ground truth was conducted. The ground for substantial equivalence relies on comparison of design, materials, and indications for use with predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of Device Acceptance and Study proving criteria:

The document describes the device, Lucent®, as an intervertebral body fusion device. This 510(k) submission is for line additions to an already cleared device. The primary method of demonstrating acceptance and meeting criteria is through substantial equivalence to legally marketed predicate devices.

The study that "proves" the device meets acceptance criteria, in this context, is the comparison to predicate devices. The submission argues that:

• The subject device is identical in indications for use, manufacturing method, raw material and operating principles to the predicate devices cleared in K122967 and K150061.
• It has equivalent technological characteristics to its predicates in areas including labeling/indications for use, general design features, function, material, manufacturing process, and instrumentation.

Therefore, the "proof" is based on the argument that because the device is sufficiently similar to devices already found safe and effective, no new performance studies are required.

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