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Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage.

Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction. The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles. Microcurrent to target facial stimulation. Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software. Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons. Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.

Here's an analysis of the acceptance criteria and supporting study for the Luna 4 plus device, based on the provided FDA 510(k) summary:

The document provided primarily focuses on establishing "substantial equivalence" of the Luna 4 plus to existing predicate devices, rather than defining explicit acceptance criteria and then presenting a study to prove meeting those criteria in the traditional sense of a clinical trial for a novel device. The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate devices through conformance to recognized standards and comparative testing.

The "study" that proves the device meets "acceptance criteria" (i.e., is substantially equivalent to predicates) is a combination of:

• Non-clinical testing: Electrical safety, EMC, and biocompatibility, as per applicable standards.
• Lab bench performance testing: Characterization of electrical stimulation output, including Anti-Shock System performance and overload conditions.
• Usability studies: To demonstrate substantial equivalence given new indications.

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

Since explicit "acceptance criteria" in the format of specific numerical thresholds tied to a single study result are not provided, I will construct a table reflecting the key equivalency demonstrations and comparisons made against the predicate devices. The "reported device performance" will be the "Subject Device" values from the Substantial Equivalence Comparison Table, along with notes on safety and efficacy from the "Conclusion" and "Comparison in details" sections.

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

The document does not specify a distinct "test set" in terms of a clinical or image dataset. The testing primarily involved non-clinical lab-based evaluations:

• Electrical safety, EMC, and biocompatibility: Tested against applicable standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993 series). This typically involves a single or small number of device units.
• Lab bench performance testing: Characterization of electrical stimulation, Anti-Shock System, and overload conditions. This would also involve a small number of physical devices.
• Usability studies: These are mentioned, but no specifics on sample size (number of users) or study design (e.g., prospective, retrospective, country of origin) are provided.

Therefore, there isn't a "sample size for the test set" in the context of an AI/algorithm performance study using patient data.

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

This information is not applicable/provided in the document as it does not describe a study involving expert-derived ground truth for a test set of patient data, which is typical for AI/algorithm performance evaluations. The evaluations performed are engineering-based and comparative.

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

This information is not applicable/provided as there is no described test set requiring expert adjudication for ground truth.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device (Luna 4 plus) is a physical device for topical aesthetic treatment and does not involve "human readers" interpreting medical cases or AI assistance in diagnostic tasks.

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

The device is a physical, user-operated aesthetic device. While it contains integrated software ("integral software" to control microcurrent and the "Anti-Shock system"), this is part of the device's functional control, not a standalone diagnostic or interpretative algorithm. Therefore, a "standalone algorithm-only performance study" as typically understood for AI/ML devices is not applicable/provided.

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

The concept of "ground truth" as typically used for AI/ML models is not directly applicable here. The "truth" for this device's evaluation is primarily based on:

• Reference standards: Adherence to national and international engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series).
• Benchmarking against predicate devices: Demonstrating similar or improved safety and functionality compared to legally marketed devices.
• Physical measurements: E.g., optical power density, electrical output characteristics.

For the usability studies mentioned, the "ground truth" would likely be user feedback or successful completion of tasks, but details are not provided.

8. The sample size for the training set

This information is not applicable/provided as the document does not describe the development of an AI/ML model that would require a "training set." The integral software is likely rule-based or control-loop driven rather than a machine learning algorithm.

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

This information is not applicable/provided for the reasons stated in point 8.

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The indications for use for the TL-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the TL-S20S-755A include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a 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 regimen. Use on all skin types (Fitzpatrick L-VI), including tanned skin. (HR. SHR Modes) The indications for use for the TL-S20S-810B include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re- growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, and SHR Modes).

Not Found

This document is an FDA 510(k) clearance letter for the Luna Diode Laser System. It does not contain any information about the acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML medical device.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and manufacturing practices, but not the technical validation of an AI algorithm.

Therefore, I cannot provide the requested information based on the provided text.

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.

The Luna Dental Implant System is a device of pure titanium (ASTM F67) and titanium alloy (ASTM F1136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. This 510k is intended to add the new models of the following abutments to the Luna Dental Implant System: Healing Abutment I, Duo Abutment, Duo Plus Abutment, Temporary Abutment.

The document provided does not contain information about the performance of an AI/ML powered device, but rather pertains to the 510(k) clearance of the Luna Dental Implant System, which is a traditional medical device (dental implants and their components).

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI/ML powered device from this document. The document describes the mechanical and material characteristics of dental implants and their substantial equivalence to previously cleared predicate devices, not AI/ML model performance.

To answer your request, I would need a document describing the study and acceptance criteria for an AI/ML powered medical device.

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The Luna® G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/ institutional environment on adult patients. It is to be used on patients > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.

The Luna® G3 BPAP system is a microprocessor controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. Its hardware design is identical to the previously cleared Luna® G3 BPAP 25A (K201620). The subject device includes two models, with different pressure ranges. They both have four therapy modes, which are CPAP, Spontaneous (S), Timed (T) and Spontaneous/Timed (S/T).

This 510(k) summary (K212263) describes a device modification to an existing Bi-level PAP system (Luna G3 BPAP System). The core of the submission revolves around demonstrating substantive equivalence to a predicate device (Luna G3 BPAP 25A, K201620) and referencing a device (Juno VPAP ST-A, K153061) for new functionalities.

It is crucial to understand that this document describes a device intended for treatment of Obstructive Sleep Apnea (OSA), providing positive airway pressure. It is not an AI/ML powered diagnostic device that would typically involve a multi-reader multi-case (MRMC) study or complex ground truth establishment from expert consensus or pathology, as might be seen for an imaging AI.

Therefore, many of the typical "acceptance criteria" and "study types" for AI/ML-powered devices, such as those related to standalone performance (e.g., sensitivity, specificity, AUC), MRMC studies, and expert ground truth establishment for a diagnostic output, are not applicable to this type of medical device submission.

Instead, the acceptance criteria and supporting studies are focused on engineering and performance characteristics of the medical device itself, ensuring it functions safely and effectively as intended and is equivalent to previously cleared devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a single aggregated table of "acceptance criteria" versus "reported performance" for a diagnostic output as would be seen for AI/ML diagnostic tools. Instead, it details specific performance tests and standards met, comparing the subject device's characteristics to its predicate and reference devices. The "acceptance criteria" are implied by adherence to recognized standards and demonstrated equivalence to the cleared predicate.

Here's an interpretation of relevant performance characteristics that serve as de facto acceptance criteria and their reported performance:

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The Luna® G3 BPAP 25A is a Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/ institutional environment on adult patients. If is to be used on patients >66lbs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.

The Luna® G3 BPAP 25A is a microprocessor controlled, blower-based system that generates bi-level positive airway pressure (IPAP/EPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 25 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway.

This document, primarily a 510(k) Pre-market Notification to the FDA, describes a medical device called the Luna® G3 BPAP 25A, a Bi-level Positive Airway Pressure (BPAP) device for treating Obstructive Sleep Apnea (OSA). The document outlines its intended use, technological characteristics, and compares it to predicate devices to prove substantial equivalence.

Acceptance Criteria and Device Performance:

The acceptance criteria for the Luna® G3 BPAP 25A are not explicitly stated as quantitative performance metrics (e.g., accuracy, sensitivity, specificity) but are derived from comparing its technological characteristics and performance against legally marketed predicate and reference devices, as well as adherence to recognized regulatory standards. The "reported device performance" refers to the demonstrated compliance with these standards and the equivalence of its characteristics to established devices.

Here's a table summarizing the implicit acceptance criteria (based on predicate device characteristics and regulatory standards) and the reported performance of the subject device:

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The Luna XD Ti Interbody Fusion System consists of the Luna XD Ti Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna XD Ti Interbody Fusion is to be used with autogenous bone graft and/or allogence bone graft composed of cancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna XD Ti Implant. The Luna XD Ti Interbody Fusion System is to be used with supplemental fixation.

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

The Luna XD Ti Implant is an assembly of three (3) PEEK components referred to as the Top, Middle and Bottom, similar to the Luna 3D Gen2. Additionally, a Nitinol Spine is inserted into the middle component to retain its normally closed shape configuration. And finally, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder. The final components have radiopaque tantalum markers for fluoroscopic visibility.

The outer surfaces of the Top and Bottom components have teeth in addition to the already rough surface created by the Ti coating, which are designed to enhance the implant's resistance to expulsion. Upon insertion of the outer components, the middle component is inserted to expanded into its ultimate height. The central cavity of the implant accommodates placement of autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft through a graft window.

The Luna XD Ti Implant is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580).

The Luna XD Ti Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates. In addition, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder conforming to ASTM F1580 with a specified grain size and morphology. This additional titanium coating offers initial stability due to increased surface roughness and possibly also long-term stability due to bony ingrowth created from osteoconductive microenvironment on the device surface.

The Luna XD Ti Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580). This 510(k) is submitted in support of the additional surface coating to an existing Device cleared under K183560.

The extract provided describes the Luna XD Ti Interbody Fusion System, which is an intervertebral body fusion device. The document is an FDA 510(k) premarket notification summary.

Based on the provided text, the device is not an AI/ML powered device. The information focuses on mechanical testing, material properties, and sterilization, comparing the device to a predicate device. Therefore, several of the requested categories related to AI/ML device performance, such as 'number of experts used to establish ground truth', 'adjudication method', 'MRMC study' and 'standalone algorithm performance' are not applicable to this submission.

Here is the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document primarily describes mechanical and material testing based on ASTM standards. It does not mention human subject studies or a "test set" in the context of clinical data for AI/ML performance. The "testing" refers to bench testing of the device and its materials.
• No information on "data provenance" (country of origin, retrospective/prospective) is provided as it's not a clinical study.

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 medical device (interbody fusion system) of the mechanical type, not an AI/ML diagnostic or prognostic tool. Therefore, "ground truth" as related to expert interpretation of data is not relevant here.

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

• Not Applicable. See point 3.

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. This is not an AI-assisted device.

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

• Not Applicable. This is not an algorithm.

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

• For mechanical and material performance, the "ground truth" is established by adherence to recognized ASTM and other relevant standards for material properties, mechanical integrity, and biocompatibility, as well as comparison to the performance of a legally marketed predicate device. The ultimate "ground truth" for substantial equivalence lies in demonstrating that the modified device performs similarly or better than the predicate device in relevant bench tests.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. See point 8.

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The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The Luna Dental Implant System - Healing Abutment is to be connected to the implant and is to heal gingiva before setting abutment on the implant in the oral cavity. It is made of commercially pure titanium alloy Gr4. It offers narrow and regular platform types, and the narrow type has anodizing surface treatment in purple to be distinguished from the regular type.

The provided text is a 510(k) summary for the Luna Dental Implant System - Healing Abutment, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or non-clinical study designed to prove the device meets specific performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to proving device performance against specific criteria.

The 510(k) summary explicitly states its basis for substantial equivalence:
"The Luna Dental Implant System - Healing Abutment is substantially equivalent to its predicate device (K123155) in terms of indications for use, raw material, and design. The differences are in body design and size range. The design change does not raise a question in substantial equivalence since the change is not significant. We have identified a reference device that encompass the size range of the subject device. Based on the information submitted here in we conclude that the subject device is substantially equivalent to the predicate devices."

The "Non-Clinical Testing" section merely states: "Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification. The risk assessment did not show that the device changes affected biocompatibility, sterilization, and shelf life such that the testing in the prior (predicate) file is still applicable." This indicates that no new performance testing was conducted or deemed necessary to demonstrate the modified device meets specific acceptance criteria, as its equivalence to the predicate implies it meets the same criteria the predicate device did.

In summary, this 510(k) document is a declaration of substantial equivalence, not a report of a study designed to establish acceptance criteria for a novel device and prove its performance against those criteria.

Since the requested information (acceptance criteria, performance data, sample sizes, expert details, etc.) is not present in the provided text, I cannot complete the table or answer the specific questions about the study from this document.

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The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.

The LunaGuard™ Nighttime Dental Protector is an over-the-counter, flexible and moldable one-piece dental guard consisting of a lightweight polycaprolactone (PCL) plastic material can diffuse and absorb grinding forces, along with the microperforations in the mouthguard, to protect the teeth from the grinding and clenching associated with bruxism.

When in place over the upper teeth, the guard maintains separation between upper and lower teeth, reducing noise and damage associated with teeth grinding. It is designed to fit around the teeth with no or minimal space in order to form a barrier between the upper and lower teeth. The lightweight, thin design allows for comfort while sleeping, and does not impede speaking, drinking, or breathing.

The LunaGuard™ material is self-fit by the user using the "boil and bite" method. Once submerged in hot but not boiling water, the dental guard turns clear when it reaches 160 degrees Fahrenheit (71.1 degrees Celsius), indicating readiness to mold. At this point, the user shapes the dental guard around their upper teeth for a snug and user-specific fit.

The provided text is a 510(k) Premarket Notification from the FDA for a device called "LunaGuard Nighttime Dental Protector". This document primarily focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/ML-based medical device.

Therefore, much of the requested information about acceptance criteria, specific performance metrics (like sensitivity, specificity, or AUC), sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and training set details, is not present in the provided document. This type of information is typically required for AI/ML device submissions where the algorithm's performance is the primary focus of review.

Here's a breakdown of what can be extracted and what is explicitly unobtainable from the provided text:

Unobtainable Information (due to the nature of this 510(k) for a physical device, not an AI/ML algorithm):

• A table of acceptance criteria and the reported device performance: This document doesn't define AI-specific acceptance criteria or report performance metrics like sensitivity, specificity, or AUC. The performance data discussed is related to physical properties and biocompatibility.
• Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The "test set" here refers to physical samples for material testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device would involve expert labeling of medical images/data. Here, "ground truth" for the physical properties would be lab measurements.
• Adjudication method for the test set: Not applicable.
• 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, as this is not an AI-assisted device.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical testing, ground truth refers to validated laboratory measurements and standards (e.g., ISO 10993 for biocompatibility).
• The sample size for the training set: Not applicable (no AI/ML training set).
• How the ground truth for the training set was established: Not applicable.

Information that can be extracted or inferred from the document:

The document describes the acceptance criteria and supporting study in terms of substantial equivalence for a physical device, not an AI/ML algorithm.

• Device Name: LunaGuard™ Nighttime Dental Protector
• Predicate Device: Pro Tech Dent (K121272), manufactured by Akervall Technologies Inc.
• Indications for Use: The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding. (Identical to the predicate device).

Summary of "Acceptance Criteria" and "Device Performance" (in the context of a physical device's 510(k) ):

The "acceptance criteria" here are implicitly tied to demonstrating that the LunaGuard™ is substantially equivalent to the predicate device in terms of:

1. Intended Use and Indications for Use: Identical.
2. Design and Materials: Similar (both polycaprolactone (PCL) plastic, 1.6 mm thickness).
3. Method of Action and Principles of Operation: Similar (over-the-counter re-moldable dental guards, non-sterile, single user, boil-and-bite).
4. Physical Properties: Equivalent as demonstrated by comparative testing.
5. Biocompatibility: Device found biocompatible for its intended use.

Study Proving Device Meets "Acceptance Criteria" (i.e., Substantial Equivalence):

The studies conducted were non-clinical performance testing and biocompatibility testing.

• Type of Study: Comparative performance testing and biocompatibility assessment.
• Sample Size Used for Testing: The document does not specify the exact number of units or material samples used for the physical and biocompatibility tests. It broadly states "The physical properties of the LunaGuard™ device were tested against those of the predicate."
• Data Provenance: The tests were performed in a laboratory setting for the purpose of this submission. The origin of the raw materials would be global, but the testing itself would be controlled by the manufacturer/testing labs. The document doesn't specify if this was retrospective or prospective testing, but for a 510(k), it's typically prospective testing of the manufactured product.
• Ground Truth for Physical Testing: The "ground truth" for these tests would be the established scientific methods and standards (e.g., ISO 10993 for biocompatibility, and material characterization techniques like density, hot stage optical microscopy, hardness, melt flow rate, and tensile testing). The "truth" is the measured value compared against acceptable ranges or values of the predicate.
• Qualifications of Experts for Testing: Not explicitly stated, but assumed to be qualified laboratory personnel following standard operating procedures for material and biocompatibility testing.
• Adjudication Method: Not applicable for material testing; results are quantitative measurements.

Biocompatibility Testing Details:

• Standard: ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
• Device Categorization: Surface device, contacts intraoral (mucosal, gingival, palatal) surfaces for limited contact.
• Result: Results show that the device is biocompatible for its intended use.

Non-Clinical Comparative Testing Details:

• Comparison: LunaGuard™ vs. ProTech Dent (predicate).
• Tests Performed: Density, hot stage optical microscopy, hardness, melt flow rate, and tensile testing.
• Result: Found to be equivalent with respect to these properties.

Conclusion:

The provided document describes the regulatory submission for a physical medical device. The "acceptance criteria" and "study" refer to demonstrating substantial equivalence to a predicate device through material characterization and biocompatibility testing, not an AI/ML algorithm's diagnostic performance. Therefore, most of the detailed questions regarding AI/ML device testing are not applicable to this specific submission type.

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The Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D GEN2 Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D GEN2 Implant. The Luna 3D GEN2 Interbody Fusion System is to be used with supplemental fixation.

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

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

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

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

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

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

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

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

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

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

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

• Adjudication method: Not applicable.

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

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

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

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

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

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