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The APERTO Lucent System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The APERTO Lucent is a modification of the AIRIS Elite MRI System. The APERTO Lucent has been revised to increase the clinical utility as compared to the AIRIS Elite Magnetic Resonance imaging system. Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

The provided text describes the FUJIFILM Healthcare Corporation's APERTO Lucent MRI System (K233629) and its substantial equivalence to a predicate device, the AIRIS Elite V4.9 MRI system (K032232).

The document does not describe specific acceptance criteria in terms of numerical thresholds for device performance (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance evaluations.

Here's the information extracted from the document:

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

As mentioned, explicit numerical acceptance criteria for performance metrics are not provided. The performance evaluation focuses on demonstrating that the new features and coils perform as intended and produce acceptable image quality for clinical use.

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

• Test set sample size: Not explicitly stated. The document refers to "clinical image examples" for new features and coils.
• Data provenance: Not explicitly stated (e.g., country of origin). The study involved "clinical image examples" and validation by a radiologist. It is likely prospective, as it involves evaluating new features and coils.

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

• Number of experts: One radiologist.
• Qualifications of experts: "A radiologist." No further details on years of experience or sub-specialty are provided.

4. Adjudication method for the test set

• Adjudication method: Not applicable/None mentioned. The document states a single radiologist validated the clinical images for acceptable image quality. There is no indication of multiple reviewers or an adjudication process.

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

• MRMC study: No. This submission is for an MRI system, not an AI-assisted diagnostic device. The document does not describe any AI component or human-in-the-loop performance evaluation.

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

• Standalone performance: Not applicable. This is for an MRI system, not an algorithm.

7. The type of ground truth used

• Ground truth: Clinical images were validated for "acceptable image quality for clinical use" by a radiologist. This can be considered a form of expert assessment/consensus (from a single expert in this case) on image quality rather than a definitive "ground truth" for specific diagnoses, as the purpose was to evaluate system functionality and image quality.

8. The sample size for the training set

• Training set sample size: Not applicable. This document describes an MRI system, not an algorithm that undergoes a "training" phase with a dataset. The software development likely involved internal testing and verification, but not in the context of machine learning training data.

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

• Ground truth for training set: Not applicable (see point 8).

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The DORO LUCENT® Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging.

The DORO LUCENT® Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.

The DORO LUCENT® Skull Clamp ensures an adequate positioning of a patient's head and provides rigid fixation for neurosurgery. The device is suitable for intra-operative X-ray and CT based imaging procedures.

The DORO LUCENT® Skull Clamp consists of a fixed arm, an adjustable arm and modular pin holders. Thus, using the DORO LUCENT® Skull Clamp Pediatric Set, the skull clamp can be configured as three-pin or four-pin pediatric set up.

The provided text describes the 510(k) clearance for the DORO LUCENT® Skull Clamp and DORO LUCENT® Skull Clamp Pediatric Set. However, it does not contain information about a study based on AI/ML or any performance testing related to software or AI. The tests mentioned are for mechanical performance, usability, and reprocessing of the physical device.

Therefore, for aspects related to AI/ML device performance, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, the information is not available in the provided document.

Here's a breakdown of what is available based on the mechanical device performance testing:

Device: DORO LUCENT® Skull Clamp (1101.001) and DORO LUCENT® Skull Clamp Pediatric Set (1101.040)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. For mechanical/physical performance tests, the "sample size" typically refers to the number of units tested. The document indicates "Tests were performed and the results are shown in the table below," implying a sufficient number of tests were conducted to confirm performance.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these physical device tests. These are likely internal laboratory tests conducted by the manufacturer.

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

• Not applicable. This device is a mechanical skull clamp, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these tests is the physical measurement and observation of the device's performance against defined engineering and safety standards.

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

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

• No. This type of study is relevant for AI/ML diagnostic tools being compared to human performance, which is not the case for this mechanical device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. There is no algorithm or software for standalone performance in this mechanical device.

7. Type of Ground Truth Used:

• Engineering and Safety Standards/Specifications: The ground truth for these tests is established by the device's design specifications and compliance with relevant industry standards (e.g., for mechanical strength, CT compatibility, and reprocessing).

8. Sample Size for the Training Set:

• Not applicable. This is a mechanical device, not an AI/ML product developed through a training process with a data set.

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

• Not applicable. See point 8.

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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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Crystal® devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.

Vertu® devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/ C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach and packed 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) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws should be used to ensure adequate fixation of the implant.

Lucent® are 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 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 Zeus® Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one level 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 1 spondylolisthesis at the involved level. The Zeus® Lumbar Interbody Fusion Devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Ceres®-C Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ceres@-C Stand-Alone Cervical implant is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted with an anterior approach.

The Omega XP device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with 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. Omega XP device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fration. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Spinal Elements' Crystal Cervical Interbody System is an intervertebral body fusion device for use in cervical spine surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of bone graft material. 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.

Spinal Elements' Vertu Cervical Interbody System is composed of an implant body and fixation screws. The implant body is generally a box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Each screw hole is lined in its internal surface with a titanium ring insert. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.

The Lucent device is an interbody fusion device for use in lumbar spine surgery. Because PEEK is translucent, tantalum pins are placed in various locations of the PEEK device to serve as markers for radiographic visualization of the device orientation. The Lucent devices are of various shapes, heights, width, length and lordosis to suit patient anatomy.

The Zeus Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The Ceres-C Stand-Alone Cervical System includes a PEEK spacer with Tantalum markers, and a titanium interbody plate and screws. The spacer component is assembled to the interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

The Omega XP System devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion in the lumbar spine. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various sizes and are designed to expand in height intraoperatively to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

This document is a 510(k) Premarket Notification from the FDA regarding several spinal intervertebral body fusion devices manufactured by Spinal Elements, Inc. The document states that the devices are substantially equivalent to previously marketed predicate devices and therefore do not require a premarket approval application.

Critically, this document is a regulatory approval notice based on the substantial equivalence principle, not a study evaluating the performance of an AI/ML powered medical device. It explicitly states under "Performance Data" that: "No changes were made to the existing devices nor were any new components were added to the systems. Therefore, no additional testing was required or performed."

As such, this document does not contain the information required to answer the prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI/ML powered medical device. The device described (intervertebral body fusion devices) is a physical implant, not a software-based AI/ML product.

Therefore, I cannot provide the requested information based on this document.

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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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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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