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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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Lucent® 3D 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 and/or corticocancellous 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 subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. They include a lid which further facilitates installation of bone graft and which is shut prior to implantation. The exterior of the devices has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.

The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.

The provided text is a 510(k) summary for the Lucent® 3D Spinal System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the performance of an AI/ML-based device against specific acceptance criteria derived from a clinical study.

Therefore, the information required to answer your request (acceptance criteria for an AI/ML device, details of a study proving it meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) is not present in the provided text.

The document discusses:

• Device Description: Intervertebral body fusion devices, box-shaped with "teeth", made from titanium alloy.
• Indications for Use: Spinal fusion for degenerative disc disease (DDD) at L2-S1, with or without Grade 1 spondylolisthesis/retrolisthesis, requiring supplemental spinal fixation and bone graft.
• Substantial Equivalence: Comparison to predicate devices (Lucent® K150061, OmegaLIF K150395) based on indications, surgical technique, design, manufacturing, and materials.
• Performance Data: Lists various mechanical tests (Static Compression, Static Compression Shear, Dynamic Compression, Dynamic Compression Shear, Subsidence) performed according to ASTM standards, concluding that "All data indicates that the device will perform as intended."

In summary, the provided document does not contain the information requested about a study for an AI/ML device's acceptance criteria.

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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 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 subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as an interbody device or interbody cage. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. The exterior of the devices have "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are surgically positioned.

The devices submitted herein may be manufactured from polyetheretherketone (PEEK) materials and titanium alloy (Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472) or PEEK material conforming to ASTM F 2026 with a plasma sprayed coating of commercially pure titanium (per ASTM F 1580) on their superior and inferior surfaces and titanium alloy (Ti-6Al-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472). Because PEEK is radiolucent, tantalum (per ASTM F 560) pins are placed in various locations of the PEEK devices to serve as markers for radiographic visualization of device orientation.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called Lucent® XP Curved, an intervertebral body fusion device.

Based on the provided text, the device does not involve an AI/ML component or complex diagnostic performance. Therefore, a study demonstrating the device meets acceptance criteria related to AI/ML performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop improvement, ground truth methodology) is NOT applicable here.

The acceptance criteria and supporting "study" are primarily focused on mechanical performance and material characteristics to demonstrate substantial equivalence to a previously cleared predicate device.

Here's a breakdown of the relevant information provided:

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

The document states: "All data indicates that the device will perform as intended." The "acceptance criteria" are implied by adherence to the referenced ASTM standards and the demonstration of "substantial equivalence" to the predicate. No numerical performance metrics are provided in a table format in this document, as the focus is on similarity to an already cleared device, not novel performance claims.

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

• Test Set Sample Size: Not explicitly stated as a number of 'cases' or 'patients'. The testing is mechanical (on the device itself) rather than clinical. The "sample" would refer to the number of devices or test coupons subjected to the specified ASTM mechanical tests. This information is typically detailed in the full test reports, not usually summarized in this 510(k) format.
• Data Provenance: The document does not specify country of origin for the mechanical testing data. It is inherently "retrospective" in the sense that the justification relies on the established performance of the predicate device.

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

• Not Applicable. This is a mechanical device, not one requiring expert human interpretation of medical images or data for ground truth establishment. The "ground truth" for this device's performance is objective mechanical testing per engineering standards (ASTM F 2077-18).

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

• Not Applicable. As no expert review or human interpretation is involved in establishing performance, no adjudication method is necessary.

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 does not involve AI or human readers for diagnostic assistance.

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

• Not Applicable. This device does not have a software algorithm component.

7. The type of ground truth used:

• For mechanical performance: Objective engineering standards and test results from the ASTM F 2077-18 standards.
• For biocompatibility: Identity to previously cleared materials and manufacturing processes from predicate device K182584.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this device does not utilize machine learning or AI.

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

• Not Applicable. As there is no training set.

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The Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.

Indication for Use for the 430-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
· For use on Fitzpatrick skin types (I-V)

Indication for use for the 515-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles). and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
· For use on Fitzpatrick skin types (I-V)

Indication for use for the 560-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction
· For use on Fitzpatrick skin types (I-V)

Indication for use for the 585-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction
· For use on Fitzpatrick skin types (I-V)

Indication for use for the 640-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.

• · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
• · The removal of unwanted hair to effect stable long-term or permanent hair reduction
• · For use on Fitzpatrick skin types (I-V)

Indication for use for the 700-980nm wavelength
• The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime
· For use on Fitzpatrick skin types (I-V)

The LUVO Medical Technologies, Inc. Lucent : IPL is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using multiple filters reflecting a wavelength range of 430nm to 980nm. The Lucent : IPL system consists of a system console, electronics and software, cooling system, and handpiece with six filters

The provided text is a 510(k) premarket notification summary for the Lucent : IPL device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are explicitly stated as not applicable or not required in this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance for Lucent : IPL

The device, Lucent : IPL, did not undergo a de novo clinical study with specific acceptance criteria in the typical sense for this 510(k) submission. Instead, its performance and safety are established by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" here are implicitly linked to showing that its technical specifications and indications for use fall within the established range or scope of the predicates, and that any differences do not raise new questions of safety or effectiveness.

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

Since no specific performance metrics with predefined acceptance criteria from a de novo study are presented, the "acceptance criteria" are the ranges and types of indications provided by the predicate devices. The "reported device performance" is the Lucent : IPL's own specifications.

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

• Sample Size: Not applicable. A human clinical study (test set) was explicitly not required for this 510(k) submission, as stated in the document ("Results of Clinical Study: A human clinical study was not required as the device is substantially equivalent to the predicate devices.").
• Data Provenance: Not applicable, as no clinical study was performed.

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

• Not applicable, as no clinical study was performed and no "ground truth" for a test set was established.

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

• Not applicable, as no clinical study was performed and no "ground truth" for a test set was established.

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 IPL system, 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 medical device for treatment, not an AI algorithm.

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

• Not applicable. The basis for clearance is substantial equivalence to existing legally marketed predicate devices, meaning that the device's technical specifications and indications for use are similar enough not to raise new safety or effectiveness concerns. The "ground truth" in this context is the FDA's prior clearance of the predicate devices based on their established safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This refers to AI/ML development, which is not relevant to this type of device and submission.

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

• Not applicable. This refers to AI/ML development, which is not relevant to this type of device and submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" proving the Lucent : IPL meets acceptance criteria is the 510(k) premarket notification review process, which involved:

• Comparison to Predicate Devices: The submission meticulously compares the Lucent : IPL's technical specifications (wavelength, intended use, indications for use, pulse width, energy density, spot size) to two predicate devices:
  • Alma Harmony XL Multi-Application Platform (K072564)
  • Lumenis M22 System (K142860)
• Performance Testing (Non-Clinical): The document states that the following performance data was provided:
  • ES60601-1:2005/(R)2012 and A1:2012 Test for Medical Electrical equipment (General Requirements for basic safety and essential performance)
  • IEC 60601-1-2 Edition 4.0 2014-02 Test for Medical Equipment (General Requirements for basic safety and essential performance: electromagnetic compatibility)
  • IEC 60601-2-57 Edition 1.0 2011-01 (Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)

The conclusion, explicitly stated in the document, is: "The Lucent : IPL's intended use, indications for use and technical specifications are substantially equivalent to the Harmony XL Multi-Application Platform and the M22 System." This "substantial equivalence" is the "proof" accepted by the FDA for clearance in this case, rather than a de novo clinical study with specific performance metrics.

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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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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 autogenous 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® XP 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 Lucent® XP device is comprised of two PEEK endplates with teeth for engaging the vertebral body endplates on the outside of the device and an internal titanium mechanism for expanding the PEEK endplates of the device. 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. The device is made from PEEK-Optima® grade LT1 conforming to ASTM F2026 with or without a coating of commercially pure titanium conforming to ASTM F1580. The internal mechanism is made from titanium alloy conforming to ASTM F136.

This document describes the Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®). However, it does not contain detailed acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-based medical devices.

Instead, this is a 510(k) Premarket Notification for a spinal implant, which relies on demonstrating substantial equivalence to a predicate device. The "performance data" section focuses on mechanical and physical testing rather than clinical performance or comparisons of human readers with and without AI assistance.

Therefore, I cannot provide all the requested information, specifically regarding AI-related aspects (like MRMC studies, standalone algorithm performance, AI training/test sets, expert qualifications for ground truth in an AI context).

Here's an breakdown of the available information based on your request, explicitly noting what is not applicable (N/A) or not provided (N/P) in this document for the requested AI-centric details:

Device Name: Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®)

Device Type: Intervertebral Body Fusion Device (Spinal Implant)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For this type of device (spinal implant), acceptance criteria are primarily based on meeting the performance specifications outlined in relevant ASTM standards for mechanical integrity, rather than clinical efficacy metrics like sensitivity/specificity for an AI algorithm. The document states that "All data indicates that the device will perform as intended," implying successful adherence to these standards, but does not provide quantitative results or detailed pass/fail thresholds within this summary.

Regarding AI/ML-specific Study Information:

This document is for a physical medical device (spinal implant), not an AI/ML algorithm. Therefore, the following points are not applicable (N/A) or not provided (N/P) as they pertain to AI/ML device evaluations.

2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device)
4. Adjudication method for the test set: N/A (Not an AI/ML 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: N/A (Not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Not an AI/ML device; for spinal implants, "ground truth" would be related to physical properties and functionality confirmed by engineering tests and potentially predicate device history / clinical literature)
8. The sample size for the training set: N/A (Not an AI/ML device)
9. How the ground truth for the training set was established: N/A (Not an AI/ML device)

Summary of this Document's Approach:

This 510(k) submission leverages the concept of substantial equivalence. The manufacturer demonstrates that the Lucent® XP and Lucent XP Ti-Bond® device has the same indications for use, manufacturing method, raw materials, and operating principles as several legally marketed predicate devices. The "Performance Data" section confirms that the device has undergone standard mechanical tests (Static Compression, Dynamic Compression, Subsidence, Compression Shear) according to specific ASTM standards, and the results indicate it performs as intended. This type of testing is standard for implantable devices to ensure structural integrity and biocompatibility, rather than diagnostic accuracy as would be required for an AI/ML system.

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Lucent® and Lucent Ti-Bond® are intervertebral body fusion devices 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).

These devices are intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with these devices.

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.

The provided text is a 510(k) Premarket Notification for the LUCENT® and LUCENT Ti-BOND® intervertebral body fusion devices. It is a submission to the FDA seeking clearance to market a medical device, demonstrating its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria in terms of performance metrics (e.g., a specific strength value that must be met). Instead, it relies on demonstrating that the device performs comparably to predicate devices under a set of established tests.

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

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical tests (Static Compression and Dynamic Compression). It simply states that "Non-clinical testing were used," and lists the types of tests.
• Data Provenance: The document does not provide details about the country of origin for the data or whether it was retrospective or prospective. Given that no animal or clinical studies were performed, the "data" primarily refers to the results of the benchtop mechanical, biocompatibility, and material characterization tests.

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

This information is not applicable in the context of this 510(k) submission for these types of mechanical and biocompatibility tests. "Ground truth" for mechanical testing is established by engineering standards and validated testing protocols. For biocompatibility, it's established by recognized standards (e.g., ISO 10993-1) and material master files. There's no mention of experts establishing ground truth in the way it would be for, say, a diagnostic imaging study.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human readers or evaluators make subjective assessments that need to be reconciled, such as in clinical trials or AI performance evaluations involving expert consensus. This document describes benchtop mechanical and material tests, which rely on objective measurements and adherence to standards rather than expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. The device is a physical intervertebral body fusion device, not a software algorithm. The document explicitly states: "The device does not contain software. Therefore no software verification and validation testing were performed."

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" is adherence to established engineering standards and regulatory guidance. The document states that testing was performed "in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." This guidance document would define acceptable ranges or performance attributes that the device must meet to demonstrate safety and effectiveness comparable to predicate devices.

For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1) and material master files (e.g., Invibio device master file MAF 1209, ASTM F 1580 for titanium).

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device (intervertebral body fusion device) without software or AI components, there is no "training set" in the context of machine learning or algorithms.

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

This is not applicable for the reasons stated above (no training set for a physical device).

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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, anterior plate systems, and anterior screw and rod systems).

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

This product 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. The devices may be manufactured from titanium (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3, polyetheretherketone materials conforming to ASTM F 2026 or polyetheretherketone with a plasma sprayed coating of commercially pure titanium (per ASTM F 1580) on their superior and inferior surfaces.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance in relation to acceptance criteria, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or the ground truth establishment for a medical device.

The document is a 510(k) summary for a medical device called Lucent®, which is an intervertebral body fusion device. The purpose of this specific 510(k) is for a modification (larger sizes - line addition) to previously cleared devices. The document focuses on:

• Manufacturer and Contact Information
• Device Description: Describes the physical characteristics and materials of the Lucent device.
• Intended Use: Specifies the medical conditions, anatomical locations, and concomitant uses for the device.
• Performance Data: States that "Static torsion, ASTM F 2077" testing was performed. However, it does not provide the results of this testing or any acceptance criteria.
• Substantial Equivalence: Asserts that the device is substantially equivalent to predicate devices in stated aspects.
• FDA Correspondence: Official FDA letter granting clearance.
• Indications for Use (reiterated).

The document does not contain the kind of detailed study information you are asking for, which is typically found in full study reports or more comprehensive regulatory submissions.

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Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) 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, anterior plate systems, and anterior screw and rod systems).

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

This product is an intervertebral body fusion device, manufactured from titanium (Ti-6Al-4V) or PEEK-Optima®, 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 modification seeks clearance for the addition of PEEK devices coated with a plasma-sprayed titanium coating.

The provided text describes a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment, which are typical for studies validating AI/ML models or novel devices requiring extensive clinical data, is not directly applicable in the context of this 510(k) submission.

Here's an explanation based on the provided document and why most of your requested fields cannot be filled:

1. Nature of the Device: The Lucent® and Lucent Magnum® are physical intervertebral body fusion devices, not AI/ML systems or diagnostic tools. Their performance is assessed through mechanical testing against established ASTM standards and comparison to predicate devices, not through clinical studies with "test sets," "ground truth experts," or "AI assistance effect sizes."

2. 510(k) Process: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predecessor. The primary method for proving this "substantial equivalence" is through comparison of material specifications, design features, intended use, and performance data (often mechanical testing for implants) against predicate devices. Clinical efficacy studies as you've described for AI models are generally not required for 510(k)s unless the device raises new safety or effectiveness questions not addressed by predicates.

Therefore, many of your specific questions are not addressed in this type of regulatory document. I will fill in what can be inferred or directly stated from the text.

Acceptance Criteria and Device Performance (for a physical medical device)

The "acceptance criteria" for this device are implicitly tied to demonstrating performance at least as good as the predicate devices, as measured by standard mechanical tests. The "reported device performance" is a statement that the device did meet these criteria.

Study Details and Ground Truth Establishment

Given the nature of a 510(k) for a physical implant, the following information is not applicable or not provided in the document as it would be for an AI/ML diagnostic device study:

• Sample size for the test set: Not applicable. Performance was assessed through mechanical testing of the device itself and components, not a "test set" of clinical cases.
• Data provenance: Not applicable. Mechanical test results do not have "provenance" in the sense of clinical data (country or retrospective/prospective).
• Number of experts used to establish the ground truth for the test set & qualifications: Not applicable. There is no "ground truth" to be established by experts for a mechanical device in this context.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is not an AI algorithm assisting human readers.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology). The "ground truth" for mechanical performance is defined by the ASTM standards and the performance of the predicate device.
• Sample size for the training set: Not applicable. This is a physical device, not an AI model.
• How the ground truth for the training set was established: Not applicable.

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