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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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The Crystal Vision Smoke Evacuator System with Accessories is intended to remove smoke created in surgical procedures.

The Crystal Vision Smoke Evacuator System with Accessories is designed to remove smoke created in surgical procedures. The Crystal Vision Smoke Evacuator System with Accessories can be used to remove smoke produced by lasers, electrosurgical devices, argon beam coagulators, LEEP devices, and other devices that create smoke during surgical procedures.

During internal surgical procedures such as laparoscopy. it helps to maintain the desired internal pressure (pneumoperitoneum). The Crystal Vision Smoke Evacuator System with Accessories removes up to 20 litersper-minute of smoke produced.

The Crystal Vision Smoke Evacuator System with Accessories automatically activates when active (smoke producing) devices that are coupled to the smoke evacuator, with special sensors, are turned on.

The Crystal Vision Smoke Evacuator System with Accessories automatically turns off, at a time predetermined by the operator, after the active device turns off and automatically activates when the high pressure limit is exceeded in the pneumoperitoneum and it remains running to remove smoke, vapors, and gases until the internal pressure returns to levels below the preset maximum.

The Crystal Vision Smoke Evacuator System with Accessories can be used to evacuate CO2 gas from the pneumoperitoneum at the end of laparoscopic procedures.

The Crystal Vision Smoke Evacuator System with Accessories is intended to be used by trained professionals.

The subject device (Crystal Vision Smoke Evacuator System with Accessories) operates under same technologies, same mechanism of actions as the predicate (Crystal Vision (Model 470) and Accessories) and will use same accessories as the predicate device.

The modifications are: increase dimension of the product chassis to partially enclose the Input ULPA filter and the Output Charcoal filter; replace mechanical controls with push buttons; eliminate Stand By switch; replace flow set display, from bargraph display to 3 digits display; expand flow reading from 2 to 3 digits.

Accessories description:

The ULPA Filter & Water Trap:

The ULPA Filter & Water Trap for the Crystal Vision Smoke Evacuator System with Accessories, like the filters for the predicate device, is a replaceable filter that is completely enclosed to protect health care personnel from potential contamination during filter change. The ULPA Filter & Water Trap has a ULPA (Ultra Low Penetration Air) media.

Charcoal Output Filter:

The Charcoal Output Filter for the Crystal Vision Smoke Evacuator System with Accessories, like the one for the predicate device, is a replaceable filter that is completely enclosed and installed on the back of the Crystal Vision Smoke Evacuator System. The filter contains Granular Activated Charcoal from coconut shell and its life is based on the ability of the charcoal to absorb odors.

Sensor:

The Sensor for the Crystal Vision Smoke Evacuator System with Accessories, like the sensor for the predicate device, is an accessory which activates the Crystal Vision Smoke Evacuator automatically, when a cutting, smoke producing device will activate.

Foot Pedal:

The foot pedal is used for end user convenience as to activate the smoke evacuator when needed. The foot pedal shall be connected through same input connector used by sensor(s).

Intra-Abdominal Tubing Set, Sterile and Non-Sterile:

The I/A tubing is used during laparoscopic procedures, to evacuate the smoke produced. It connects to the trocar at one end and to the smoke evacuator to the other end.

Smoke Tubing, Sterile and Non-Sterile:

The smoke tubing may be used during any surgical procedure where there are smoke producing devices that needs smoke evacuation.

Smoke Tubing with In-Line Filter, Non-Sterile:

The smoke tubing may be used during any surgical procedure where there is smoke producing devices that needs smoke evacuation. In addition, the smoke tubing has a HEPA filter

Wand, Sterile and Non-Sterile:

The wand is a hand held device that may be used during any surgical procedure where there is smoke producing devices that needs smoke evacuation.

The provided document is a 510(k) premarket notification for a medical device (Crystal Vision Smoke Evacuator System with Accessories), not a study proving the device meets specific acceptance criteria based on diagnostic performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through modifications to the form and controls of an existing smoke evacuator system.

Therefore, the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert involvement, MRMC studies, standalone performance, and ground truth establishment for a diagnostic AI/device cannot be extracted from this document, as it is not relevant to the type of device and submission described.

The document discusses performance bench testing against electrical safety and electromagnetic compatibility standards (ANSI/AAMI/ES 60601-1 and IEC 60601-1-2), stating that the device met "Acceptance criteria on all applicable clauses of above mention standards." However, it does not provide a table of these specific acceptance criteria or the reported performance in measurable terms like sensitivity, specificity, or AUC, as these are not relevant for a smoke evacuator's function. No clinical testing (which would involve human or real-world performance data typically associated with diagnostic or AI devices) was performed or required for this submission.

Summary of what can be inferred for this specific device/submission based on the provided text:

• Acceptance Criteria & Reported Performance: The document states the device met acceptance criteria for electrical safety and electromagnetic compatibility standards (ANSI/AAMI/ES 60601-1 and IEC 60601-1-2). No specific numerical thresholds or results beyond "met" are provided. This is typical for predicate device submissions focused on substantial equivalence for physical devices, not diagnostic software.
• Sample Size for Test Set & Data Provenance: Not applicable, as no diagnostic "test set" in the AI sense was used. Performance was assessed via bench testing on the device itself.
• Number of Experts & Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No. The device is a physical smoke evacuator, not an AI or diagnostic tool where MRMC studies would be relevant.
• Standalone Performance: Not applicable.
• Type of Ground Truth: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

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Crystal®:
The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.

The Crystal® device is intended to be used with supplemental spinal 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 non-operative treatment prior to being treated with these devices.

Mosaic®:
The Mosaic® device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in sketally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

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, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant.

Vertu®:
The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level ( C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.

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. Two screws should be used to ensure adequate fixation of the implant.

Crystal:
Crystal is an intervertebral body fusion device for use in cervical spinal surgery. The device is generally box-shaped with various holes throughout its geometry 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.

Mosaic:
The Mosaic Spinal Implant System is composed of a device body and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry for the placement of graft material. Additionally, it has teeth on its superior and inferior external surfaces to keep the device from migrating once placed in its desired location. The box-shaped body has projections (or flanges) that encompass screw holes. Screws pass through screw holes and affix to bone to help prevent implant migration.

Vertu:
The Vertu Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally 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. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration.

Here's a breakdown of the acceptance criteria and study information for the Crystal®, Mosaic®, and Vertu® intervertebral body fusion devices, based on the provided FDA 510(k) summary:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the same way a de novo or PMA application might. Therefore, the "acceptance criteria" here are essentially the performance metrics of the legally marketed predicate devices, and the "study" is the non-clinical testing performed to show equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are implied to be the performance of the predicate devices. The "reported device performance" demonstrates that the subject devices perform comparably to these predicates.

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

The document does not explicitly state the sample sizes (e.g., number of units tested) for each mechanical test. The data provenance is derived from non-clinical bench testing conducted to support the substantial equivalence claim. There is no mention of country of origin for this testing, but it is typically conducted by the manufacturer or a contract research organization.

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

Not applicable. This submission relies on non-clinical bench testing and comparison to predicate device performance, not on expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

Not applicable for non-clinical bench testing focused on mechanical properties.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Studies No clinical studies were performed."

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

This is not applicable as the device (intervertebral body fusion device) is a physical implant, not a software algorithm. The document explicitly states: "Software Verification and Validation Testing The device does not contain software. Therefore no software verification and validation testing were performed."

7. The Type of Ground Truth Used

The ground truth used is based on the established performance characteristics and safety profile of the predicate devices and recognized consensus standards (e.g., ASTM, ISO) for material and mechanical testing. For the wear debris, the ground truth for comparison was specifically the predicate Calix PC (K112036).

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set.

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Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays, veneers, crowns, and bridges.
For use by or on the order of a dental professional.

The Crystal® Ultra CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.

The provided text describes a 510(k) submission for a dental CAD/CAM material called "Crystal® Ultra." This device is a material, not an AI-powered diagnostic tool, and therefore most of the requested information about acceptance criteria, study design, and ground truth establishment for AI performance metrics are not applicable.

However, I can extract the relevant information regarding the non-clinical performance data and how the device's equivalence was established.

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

The submission states that bench testing was performed in accordance with FDA recognized standards and compared to predicate devices. The "acceptance criteria" here are implicitly the satisfactory performance against these standards and demonstrating substantial equivalence to the predicate devices. The reported device performance is that it met these criteria.

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

The document does not specify the sample sizes for the bench tests. The tests were performed in accordance with FDA recognized standards (ISO 6872, ISO 10477, ISO 7405, ISO 4049, ISO 10993). These are likely laboratory bench tests, not clinical studies involving human patients or specific geographical data provenance. Therefore, terms like "retrospective or prospective" are not applicable.

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)

This is not applicable as the device is a material, and the "ground truth" for its performance is established through standardized physical and chemical testing, not expert interpretation of cases.

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

This is not applicable for a material test. The "adjudication" is based on the results of standardized laboratory tests against predefined 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

This is not applicable. This device is a material, not an AI or diagnostic tool that would involve human readers.

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

This is not applicable as the device is a material, not an algorithm.

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

The "ground truth" for this device's performance is derived from standardized physical and chemical measurements obtained through bench testing according to ISO standards (e.g., flexural strength, solubility, density). The comparison is made to the established performance characteristics of legally marketed predicate dental materials.

8. The sample size for the training set

This is not applicable as the device is a dental material, not an AI algorithm requiring a training set.

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

This is not applicable as there is no training set for this type of device.

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The Crystal Monitor® Model 16 is intended for wireless monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.

The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

The Crystal Monitor Model 16 is an eight-channel, programmable, wireless data acquisition system intended to monitor and record physiological signals. Any channel can be programmed to monitor any physiological signal. Harnesses connect electrodes or sensors from the patient to the patient unit. The patient unit, worn by the patient, acquires, amplifies, and digitizes physiological signals. These signals are then transmitted by radio frequency to a computer unit connected via a serial port to a personal computer (PC). The data is then displayed in real-time and can be stored on the PC.

The Crystal Monitor Model 16 incorporates state-of-the-art wireless technology for viewing and recording physiological signals such as EEG, EKG, EMG, and EOG. This 8channel monitor is the most unobtrusive, flexible, and convenient way of measuring and transmitting physiological signals. Subjects can now be untethered during studies while real time data is collected and displayed. The Crystal Monitor Model 16 wireless physiological signal monitor consists of a Transmitter (also called the Patient Unit), a Receiver Assembly (a Receiver [also called the Computer Unit], receiver cable, and power supply), accessories (Universal Differential Harness, mounting band, electrolyte gel, screwdriver, batteries, and Test Pack), and a PC Operator Interface Software program.

The Patient Unit collects signals from electrodes attached to the subject, performs analogto-digital conversion, encoding, formatting, and transmitting of all signals. The signals are transmitted via a radio transmitter. The Computer Unit receives the transmitted data packets, performs extensive error detection and correction, and then sends the data through a Receiver cable to the PC Operator interface where the data can be stored, monitored in real time, or analyzed at a later time.

The Crystal Capture program consists of several software components that allow the user to acquire, store, and view physiological data as acquired by the Crystal Monitor Transmitter. The software provides a simple graphical interface for setting up and managing data acquisition. The Crystal Configuration Wizard allows customization of the number of input channels (1-8), ranges (micro- to millivolts), and sampling rate. Configurations can be saved allowing the user to program the Crystal Monitor for numerous applications.

The provided text describes a 510(k) premarket notification for the Crystal Monitor Model 16, an 8-channel wireless data acquisition system for physiological signals. It details the device's technical characteristics, intended use, and substantial equivalence to existing devices. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or accuracy of physiological signal measurement against a ground truth.

Instead, the document focuses on regulatory compliance and technical specifications. The "acceptance criteria" discussed are primarily related to safety, electromagnetic compatibility, and adherence to voluntary standards.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• FCC Part 15.109, Class B digital device
• FCC Part 15.249, Intentional radiator, FCC ID#N9Y0007
• IEC 60601-1-2 Medical Electrical Equipment, Part 1 General requirements for safety
• EN 61000-4-2: 1995 Electrostatic discharge immunity test
• EN 61000-4-3: 1995 Radiated, radio-frequency, electromagnetic field immunity test
• EN 61000-4-4: 1995 Electrical fast transient/burst immunity tests
• EN 61000-4-6: 1996 Immunity to conducted disturbances induced by radio-frequency fields
• EN-55011 Electromagnetic Emissions
• IEC 601-2-26 (environmental conditions: 10° to 50° C, 25-95% humidity) |
  | Functional Equivalence to Predicate Devices: | "The Crystal Monitor Model 16 is technically the same as the Crystal-EEG Model 15 with the exception of software, labeling, and production company." It states they have "the same hardware, board designs, drawings, and all available accessories." |
  | Wireless Signal Transmission (Implicit Functionality): | Acquires, amplifies, and digitizes physiological signals, then transmits them by radio frequency to a computer for display and storage. Performs "extensive error detection and correction" upon reception. |
  | Programmability (Implicit Functionality): | 8-channel, programmable (number of channels 1-8, ranges micro- to millivolts, sampling rate). |
  | Real-time Display and Storage (Implicit Functionality): | Data is "displayed in real-time and can be stored on the PC." |

Missing Information: It's crucial to understand that this document does not present clinical performance acceptance criteria such as accuracy of EEG readings, signal-to-noise ratio, or agreement with a gold standard for physiological signal interpretation. The "reported device performance" above is a summary of capabilities and compliance with safety/EMC standards, not clinical efficacy.

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

• None provided. The document describes regulatory compliance testing (e.g., EMC, electrical safety) but does not detail human subject testing or clinical performance evaluation with a "test set" of patient data.

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)

• Not applicable. No clinical test set or ground truth established by experts is described for clinical performance.

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

• Not applicable. No clinical test set or adjudication method is described.

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

• No such study was done or described. This device is a physiological signal monitor, not an AI-based diagnostic tool that assists human readers.

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

• Not applicable in the context of an "algorithm" as typically referred to in AI/diagnostic studies. The device's primary function is data acquisition and display, not automated interpretation or standalone diagnostic decision-making beyond what an electroencephalograph intrinsically does (i.e., record signals). The "software components" described are for acquiring, storing, and viewing, not for AI-driven standalone analysis.

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

• For the safety and EMC standards, the "ground truth" is compliance with the specifications of those standards (e.g., does it emit below a certain level, does it withstand a certain electrostatic discharge).
• For functional equivalence, the "ground truth" is the established performance and design of the predicate device (Crystal EEG Model 15).
• No clinical ground truth (expert consensus on EEG readings, etc.) is mentioned.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" in the conventional sense.

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

• Not applicable/Not provided. As there is no described training set, there is no discussion of how its ground truth was established.

Conclusion:

The provided 510(k) summary for the Crystal Monitor Model 16 focuses on technical specifications, regulatory compliance with safety and EMC standards, and substantial equivalence to a predicate device. It does not present a clinical study with acceptance criteria related to physiological signal accuracy, diagnostic performance, or a "ground truth" derived from patient data interpreted by experts. The "study" referenced in the prompt's question is essentially the device's submission to and compliance with various engineering and safety standards, and its comparison to a previously cleared predicate device.

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The Crystal 5000 Phased Array TMJ Coil is a receive-only phased array RF coil used for obtaining diagnostic images of the temporo-mandibular joint, condyle, and mandible in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Proview™ (0.23Tesla) MRI scanner manufactured by Marconi Medical Systems Finland.

The Crystal 5000 Phased Array TMJ Coil is designed to provide Magnetic Resonance Images of the temporo-mandibular joint. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Marconi Medical Systems' Proview 0.23Tesla scanner.

The indications for use are the same as for standard imaging:

The Marconi Medical Systems Proview 0.23Tesla system is indicated for use as a diagnostic imaging device that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Crystal 5000 Phased Array TMJ Coil is a phased array receive only coil. The elements and associated circuitry are enclosed in housing made of plastic materials, which are fire rated and have high impact and tensile strength.

The provided document is a 510(k) premarket notification for a medical device cleared in 2001. This type of regulatory submission, particularly for
a device developed at this time, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in efficacy studies for newer, more complex devices
or AI/ML-driven technologies.

Therefore, many of the requested items (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies,
standalone performance) are not applicable to this type of submission. The safety and effectiveness are established through comparison to a predicate device.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

The "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to existing predicate devices. The
performance is described by comparing the features of the Crystal 5000 Phased Array TMJ Coil to these predicates.

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on substantial equivalence to predicate devices, not on a new clinical study with a test set of patient data to evaluate performance. The comparison is feature-based against existing cleared devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There was no specific "test set" in the context of diagnostic performance evaluation for which ground truth needed to be established by experts.

3. Adjudication method for the test set: Not applicable. No test set was used in this manner.

4. 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 a passive MRI accessory (a coil), not an AI-driven image analysis tool. It does not involve human readers interpreting images with or without AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an MRI coil, not an algorithm.

6. The type of ground truth used: The "ground truth" for this type of submission is implicitly the established safety and effectiveness of the predicate devices. The new device is shown to be substantially equivalent in its design and function to these already-cleared devices, implying a similar safety and performance profile.

7. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."

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

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The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color.

Except for decreased light transmittance due to the tint intensity, the pretinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only.

The CRYSTAL TINTED SOFT CONTACT LENSES are available in Aqua, Amber, Roval Blue, Sky Blue, Sapphire Blue, Emerald Green, Mint Green, Green, Light Yellow, Dark Yellow, Light Red, Dark Red, Brown, Black and Orange. They are available with or without tinted centers (pupillary area). The practitioner may also choose tint intensity and custom mix colors (via consultation with CRII).

CRYSTAL TINTED SOFT CONTACT LENSES are color enhanced soft contact lenses that have been previously prescribed for a specific patient. They have been supplied to CRII by a certified supplier to be modified by a tinting process. This process uses color additives that have been supplied by a certified supplier and listed as safe for contact lenses containing hydroxyl groups in accordance with FDA color additive regulations. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris.

CRYSTAL TINTED SOFT CONTACT LENSES are tinted using certified Reactive dyes listed by the FDA as approved for use with contact lenses. The lens material is modified by permanently fixing tints to the polymer using the following color additives, either alone or in combination: Reactive Blue 19, Reactive Blue 21, Reactive Yellow 86, Reactive Black 5, Reactive Red 11, Reactive Blue 163, Reactive Orange 78, Reactive Yellow 15, and Reactive Red 180.

The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

Based on the provided 510(k) notification summary for the "Crystal Tinted Soft Contact Lenses," here's a breakdown of the acceptance criteria and the supporting study information:

This device (Crystal Tinted Soft Contact Lenses) is a medical device, but not one that typically relies on AI or complex algorithms requiring extensive performance studies as seen in imaging or diagnostic AI. Instead, the "study" for this type of device focuses on demonstrating safety and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• ISO Ocular Irritation Study in the Rabbit: Negative
• ISO Acute Systemic Toxicity Study in the Mouse: Negative
• Cytotoxicity Using the ISO Elution Method: Negative (Section 2) |
  | c. Color additives used are safe and within regulatory limits. | Color additives are FDA-listed Reactive Dyes, used in amounts "not to exceed the minimum reasonably required to accomplish the intended coloring effect." Lenses are thoroughly washed to remove unbound reactive color additives. (Section 1 & 5) |
  | Effectiveness/Substantial Equivalence: | |
  | a. Indications for Use consistency with predicate | "Daily wear to enhance and/or alter the apparent eye color." (Same as predicate) (Section 3 & 5) |
  | b. Intended Use consistency with predicate | "Daily wear to enhance and/or alter the apparent eye color." (Same as predicate) (Section 3 & 5) |
  | c. Lens Function consistency with predicate | "Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error." (Same as predicate) (Section 5) |
  | d. Material (Polymer, Additives) consistency with predicate | Polymer: Hydrophilic (Same as predicate)
  Additives: FDA Listed Reactive Dyes (Same as predicate) (Section 5) |
  | e. Manufacturing process results in similar characteristics after tinting | Reactive Dye molecules permanently fixed to the polymer. "The color additives are not removed by lens handling and cleaning/disinfecting procedures. The optical performance characteristics are not altered by the lens tinting process." (Section 1 & 5) |
  | f. Compatibility with disinfection methods (chemical disinfection) | "The lens may be disinfected using a chemical disinfection system only." (This implies compatibility was confirmed, though specific data isn't detailed in the provided text beyond this statement.) (Section 3 & 8) |
  | g. Optical parameters remain the same as originally prescribed (except for decreased light transmittance due to tint intensity). | "Except for decreased light transmittance due to the tint intensity, the pretinted lens optical parameters remain the same as originally prescribed for the user prior to tinting." (This is a claim supporting equivalence, implying testing or analysis confirmed this property.) (Section 3 & 8) |

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

• Bioburden Testing: Ten samples were tested for microorganisms. (Section 2)
• Toxicity Studies: "All dyes to be used in the custom tinting process were mixed together and applied to (hydrophilic) soft contact lenses. The contact lenses were then subjected to the following three Toxicity Studies..." While the exact number of lenses or animals used in each specific toxicity study (Ocular Irritation, Systemic Toxicity, Cytotoxicity) is not explicitly stated in the provided text, the standard ISO protocols for these tests would involve specific sample sizes (e.g., rabbits for ocular irritation, mice for systemic toxicity, in-vitro samples for cytotoxicity). However, the document doesn't provide the specifics beyond "the contact lenses were then subjected to..."
• Data Provenance: The Bioburden testing was performed at NAMSA in Northwood, Ohio. The Toxicity Studies were performed by North American Science Associates Incorporated. This indicates the testing was done by certified labs. The submission date (Oct 14, 1999) suggests the data is retrospective relative to the submission, but the tests themselves would have been conducted prospectively by the labs.

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

There were no human "experts" establishing ground truth in the conventional sense (e.g., radiologists interpreting images) for this device's performance assessment. The "ground truth" for contact lenses is established through standardized laboratory testing (bioburden, toxicity) and material characterization, guided by FDA regulations and ISO standards. The expertise comes from the certified laboratories (NAMSA, North American Science Associates) conducting these specific tests and interpreting the results against established pass/fail criteria.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The evaluation relied on objective laboratory test results against predefined standards (e.g., "

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This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.
This device 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 CRYSTAL Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. This CRYSTAL-SEAL system is most similar to the Crystal and Crystal Plus Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-954432. Like many commercial implants, the CRYSTAL devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). CRYSTAL Implants also are available in coated form, either hydroxyapatite or titanium plasma spray.

The provided text is a 510(k) summary for a dental implant system (CRYSTAL and CRYSTAL-SEAL Implants System). It does not contain information about acceptance criteria, device performance metrics, or a study design that would prove the device meets specific performance criteria. This document is focused on establishing substantial equivalence to pre-amendment devices and other already-cleared devices.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's what can be inferred and what is explicitly stated concerning the lack of a traditional performance study:

1. Table of acceptance criteria and the reported device performance:

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

• N/A. No formal test set or clinical study specific to the CRYSTAL and CRYSTAL-SEAL Implants System is described in this 510(k) summary. The submission relies on substantial equivalence to predicate devices and general literature on endosseous implants.

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

• N/A. No test set or ground truth establishment process for performance evaluation is described.

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

• N/A. No test set or adjudication method is described.

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

• N/A. This device is a dental implant, not an AI software or a diagnostic imaging device that would typically involve human readers or MRMC studies.

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

• N/A. This device is a physical medical device (dental implant), not an algorithm or AI system.

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

• N/A. Given the type of submission (510(k) based on substantial equivalence), the "ground truth" for proving safety and effectiveness relies on the long-standing history of similar pre-amendment devices and contemporary legally marketed predicate devices. The document cites literature reviews and a 10-year study (Toronto study by Zarb) on the Branemark implant technique as evidence of safety and effectiveness for endosseous implants in general, not specifically for the CRYSTAL system.

8. The sample size for the training set:

• N/A. No "training set" in the context of an algorithm or AI model is applicable here.

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

• N/A. Not applicable, as there is no training set for an algorithm.

Conclusion regarding the "study that proves the device meets the acceptance criteria":

The provided text does not describe a specific study for the CRYSTAL and CRYSTAL-SEAL Implants System that establishes acceptance criteria and directly proves the device meets them. Instead, the submission relies on the concept of Substantial Equivalence (SE).

The core argument for the device's safety and effectiveness is made by:

• Similarity to pre-amendment devices: Stating that it is "equivalent to devices manufactured and sold before 1976."
• Similarity to currently marketed predicate devices: Explicitly referencing K-954432 (Crystal and Crystal Plus Implants System) and other examples cleared by the FDA (e.g., Bofors Nobelpharma, Core-Vent Corp., etc.).
• General acceptance and literature review: The document includes a "Clinical Discussion and Brief Literature Review" which summarizes that "Endosseous implants...have been proved safe and effective through the years." It references a Medline search, a Consensus Development Conference on Dental Implants (NIH, 1988), and specifically the Toronto 10-year study by Zarb on the Branemark implant technique. This literature supports the general safety and effectiveness of the class of devices, implying that because the CRYSTAL system is substantially equivalent in design, materials, and intended use, it also shares this established safety and effectiveness.

In essence, the "proof" is through demonstrating that the device is fundamentally the same as other devices already proven safe and effective, rather than presenting a de novo study for this specific product.

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