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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 CONMED CrystalView™ Pro Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures.

The CONMED CrystalView™ Pro Irrigation System is designed to automatically provide and control distention and irrigation of the operative site during arthroscopic procedures. The system consists of a console with two peristaltic pumps and a control valve. It can be used as an inflow only pump or as an inflow and outflow / suction pump, utilizing currently marketed CONMED disposable tubing sets. The set pressure and measured pressure are displayed on the equipment. A USB port allows for easy import and export of Surgeon Presets and System settings to or from the console. The CONMED CrystalView™ Pro Irrigation console is sold non-sterile and must be located in a non-sterile area of the operating suite. The console gets connected to an autoclavable remote control which is a hand-held device, used in the sterile field with the cord connected to the console, that provides the same control functions as the console with the exception of Stand-by and Presets. The remote control gives the user the added advantage of controlling these functions from within the sterile field. Additionally, the system communicates with different existing, marketed accessories like power supply, tubing sets, cables, shaver sensor etc.

This document is a 510(k) Summary of Safety & Effectiveness for the CONMED CrystalView™ Pro Irrigation System, comparing it to a predicate device. This type of document is typically for medical devices that are substantially equivalent to an already legally marketed device, and therefore does not usually contain extensive clinical study data (such as MRMC studies, large training/test sets for AI, or detailed ground truth methodologies) as might be seen for novel devices or AI/ML-driven diagnostics. The focus here is on bench testing and demonstrating equivalence rather than proving clinical performance against a disease gold standard.

Based on the provided text, here is the information requested:

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

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

The document primarily discusses "extensive bench testing" and "design verification and validation testing." There is no mention of a clinical "test set" with patient data. The testing described appears to be laboratory-based engineering and quality assurance testing. Therefore, information on sample size for a test set based on patient data and data provenance is 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 information is not provided. The testing described is against engineering specifications and regulatory standards, not against "ground truth" established by experts for diagnostic performance. "User Validation" is mentioned, which might involve expert users, but no details are given about their number, qualifications, or how they established a ground truth.

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

Not applicable, as there is no traditional "test set" for diagnostic performance described in the document that would require an adjudication method.

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

An MRMC comparative effectiveness study was not done. The device is an irrigation system, not an AI-driven diagnostic tool or an assistive technology for human readers/clinicians in the way an AI algorithm might be.

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

This is not applicable. The CONMED CrystalView™ Pro Irrigation System is a physical medical device (a pump system), not an algorithm.

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

The "ground truth" in this context refers to the device meeting its own specifications and applicable industry/regulatory standards. This includes:

• Engineering specifications: For flow and pressure performance, reliability, electrical safety, EMC, software functionality, etc.
• Regulatory standards: Such as IEC 60601-1-2 for electrical safety and ISO 14971 for risk management.
• User requirements: Validated through "User Validation."

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the performance tests described.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The Crystalsert Delivery System is intented to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling.

The Crystalsert Delivery System is a device used for folding and delivering the Crystalens accommodating intraocular lens and other IOLs indicating use of the Crystalsert Delivery System in their approved labeling into the eye. The Crystalsert Delivery System consists of a syringe shaped body and tip with a plunger and drawer. The Crystalsert Delivery System is a sterile, disposable plastic device, with a small tubular pathway in which the lens can be placed into the eye with one continuous motion, designed for single use only.

The provided document is a 510(k) summary for the Bausch & Lomb Crystalsert Lens Delivery System (Model CI-26). It primarily focuses on demonstrating substantial equivalence to a predicate device (Model CI-28) through nonclinical bench and laboratory tests.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly "Pass" for all tests, indicating that the device met the established benchmarks for each test. The document emphasizes that the proposed device demonstrated equivalence to the predicate device.

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

The document states: "Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Crystalsert Lens Delivery System (Model Cl-26). No animal or clinical testing was required for this submission."

• Sample Size: The exact sample sizes for each nonclinical test are not specified in the provided text.
• Data Provenance: The data provenance is from nonclinical bench and laboratory testing. The country of origin of the data is not explicitly stated, but the submitter (Bausch + Lomb) is based in St. Louis, Missouri, USA, implying the testing likely occurred within the US or by US-affiliated labs. The nature of the testing is prospective as it was conducted for the purpose of this submission.

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

Since this submission relies solely on nonclinical bench and laboratory testing, the concept of "ground truth" established by human experts in the way it applies to diagnostic or prognostic devices is not directly applicable. The "ground truth" for these tests would be defined by the technical specifications, standards (e.g., ISO, AAMI), and predefined acceptance criteria for each test. The individuals performing and evaluating these tests would be laboratory technicians and engineers, whose qualifications are not detailed but are assumed to be appropriate for conducting such tests.

4. Adjudication Method for the Test Set

As the evaluation is based on objective nonclinical tests against predetermined acceptance criteria, there is no human adjudication method in the sense of a 2+1 or 3+1 design. The results are binary (Pass/Fail) based on direct measurement and comparison to specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical testing was required for this submission." This type of study is relevant for diagnostic imaging or AI devices involving human interpretation, which is not the case here.

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

No, this is not an algorithm or AI device. It's a medical device for delivering intraocular lenses. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests is based on engineering specifications, established industry standards (ISO, AAMI), and predefined acceptance criteria for each test (e.g., IOL surface homogeneity, lens power, dimensions, sterility, biocompatibility). It is objective and measurable, rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic efficacy studies in clinical settings.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI or machine learning algorithm, so there is no "training set" in the conventional sense. The device itself is manufactured, and its performance is evaluated against engineering and safety standards.

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

Not Applicable. (See point 8).

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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 Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lens identifying the Crystalsert Delivery System in their approved labeling.

The Crystalsert Delivery System is a device used for folding and delivering the Crystalens accommodating intraocular lens (AT-52SE, AT-50SE, HD520, HD500, AT50AO, AT52AO), Trulign™ Toric, and other IOLs indicating use of the Crystalsert Delivery System in their approved labeling into the eye. The Crystalsert Delivery System consists of a syringe shaped body and tip with a plunger and drawer. The Crystalsert Delivery System is a sterile, disposable plastic device, with a small tubular pathway in which the lens can be placed into the eye with one continuous motion, designed for single use only.

The provided document describes the Bausch & Lomb Crystalsert Delivery System, an intraocular lens guide. It outlines the device's description, indications for use, and a comparison to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria in the format typically expected for clinical or performance studies with quantitative results.

Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (K123736, Crystalsert Delivery System) based on similar indications for use, contraindications, materials, single-use nature, sterility, sterilization method, sterility assurance level, and shelf life.

The "Brief Summary of Nonclinical Test and Results" section states: "The Crystalsert Delivery System has successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards." However, it does not provide specific acceptance criteria or the reported device performance from these tests. The details of these tests (e.g., sample sizes, methodology, and quantitative results) are not included in this summary document.

Therefore, most of the requested information regarding acceptance criteria and a study demonstrating the device meets these criteria cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the information available in the provided text, with explicit notes where information is missing:

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

The document does not provide a table of explicit, quantified acceptance criteria with corresponding performance data from a specific study. Instead, it relies on demonstrating equivalence to a predicate device by matching various characteristics.

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary. The summary only states that "functional and biocompatibility testing" was performed.

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 and not provided. The document describes a medical device (an IOL delivery system), and the testing mentioned (functional, biocompatibility) typically involves engineering and laboratory assessments against standards, rather than expert-derived ground truth as might be seen in diagnostic AI.

4. Adjudication method for the test set

Not applicable and not provided, as the tests mentioned are functional and biocompatibility, not expert-based assessment requiring adjudication.

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 a delivery system, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is a physical delivery system, not an algorithm.

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

For the functional and biocompatibility testing, the "ground truth" would be adherence to established industry standards or internal specifications for mechanical performance and biological safety. The specific standards or specifications are not detailed in this summary.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable. This device is a physical product, not an AI algorithm.

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The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling.

The Crystalsert Delivery System is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

The provided document describes the Bausch & Lomb Crystalsert Delivery System, a device for inserting intraocular lenses. However, it does not contain a study to prove the device meets acceptance criteria in the context of an AI/ML algorithm or a typical clinical trial with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device through comparative analysis and functional testing against an international standard.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will address the parts that are relevant to this type of device submission.

Here's the breakdown of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or reported performance in the typical format of a study for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, safety and effectiveness are established through demonstrating equivalence to a predicate device and conformance to an international standard.

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

Not applicable for this type of device submission. This is a medical device for IOL insertion, not an AI/ML algorithm evaluated on a data set. The "test set" would be the functional testing of the device itself (e.g., number of units tested during engineering verification), which is not explicitly stated but implied by the "successful functional testing" claim. Data provenance like country of origin or retrospective/prospective is not relevant here.

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 an AI/ML algorithm is not relevant. The "ground truth" for this device would be its ability to correctly fold and insert an IOL, which is assessed via engineering and performance testing against a standard. Experts would be engineers and quality control personnel.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1) are for human interpretation of data for AI/ML algorithm training/testing. This device relies on objective functional testing against a standard.

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 is not an AI-assisted diagnostic or prognostic device for human readers.

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

Not applicable. This device is a manual tool, not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" is established by conformance to an international standard (ISO 11979-3, section 5) and successful functional performance specifications for its intended use (folding and inserting an IOL without damage). This is validated through engineering and performance testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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The Crystalsert™ Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.

The Crystalsert consists of a plunger, body, drawer and inserter tip. All of the components are manufactured with medical grade polypropylene. There is also a stainless steel spring for the plunger return. The plunger tip is 2.8 mm that requires the lens to be folded when delivered. The body has a loading dock area for placement of the lens with forceps with an additional notch to allow for correct haptic placement. Once the lens is placed in the loading dock, the drawer is pressed closed and then the plunger can be depressed to deliver the lens. Finger flanges are also built onto the body to assist in the deliver.

The provided document describes the Crystalsert™ Crystalens® Delivery System, an intraocular lens inserter. It is a 510(k) submission, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials.

Therefore, the study information requested (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) is not applicable or not provided in this type of submission. 510(k) clearances typically rely on performance testing that demonstrates the device meets its design specifications and functions as intended, aligning with the predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics with specific thresholds that would be used in a clinical study to quantify device efficacy (e.g., sensitivity, specificity for a diagnostic device). Instead, it focuses on demonstrating substantial equivalence to a predicate device (MPort (MP-30)) by comparing technological characteristics and intended use. The "performance" assessment is implied through validation activities.

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

• Not applicable / Not provided. As a 510(k) submission for an IOL delivery system, the "test set" would typically refer to the various IOLs and viscoelastic materials validated for use with the device and performance testing to ensure the device consistently delivers these IOLs without damage. Specific sample sizes for such tests are not detailed in this summary. Data provenance is also not specified as there are no clinical trials mentioned.

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

• Not applicable / Not provided. Ground truth, in the context of diagnostic device validation, is not relevant here. For a device like an IOL inserter, the "truth" is whether it successfully delivers the IOL undamaged, which is determined through engineering and performance testing.

4. Adjudication method for the test set

• Not applicable / Not provided. Adjudication methods are typically used in clinical studies with human readers/assessors. For a mechanical device, performance is evaluated against 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 / Not provided. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of results. This device is an IOL delivery system.

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

• Not applicable / Not provided. This is also relevant for AI-powered diagnostic devices. The Crystalsert is a mechanical delivery system. Its "standalone performance" would be assessed by its ability to reliably fold and insert an IOL, which is implied by the "Validations" section.

7. The type of ground truth used

• Not applicable / Not provided. For this type of device, ground truth would be synonymous with demonstrable mechanical performance and successful, undamaged IOL delivery, established through bench testing and engineering validation, rather than expert consensus, pathology, or outcomes data from a clinical trial.

8. The sample size for the training set

• Not applicable / Not provided. Training sets are used for machine learning algorithms.

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

• Not applicable / Not provided. Training sets are used for machine learning algorithms.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics, materials, and intended use, supported by internal validation testing (e.g., IOL compatibility). It does not involve the types of clinical studies or AI-related assessments that would provide the requested information about sample sizes, expert ground truth, or reader studies.

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When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft. When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin 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.

Spinal Elements' Crystal device is a generally box-shaped devices with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device may be made from titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK).

Here is an analysis of the provided 510(k) summary regarding the Crystal® device:

Acceptance Criteria and Device Performance Study for Crystal®

The provided document describes a 510(k) premarket notification for the Crystal® Intervertebral Body Fusion Device. It outlines the device's description, intended use, and a claim of substantial equivalence. However, it does not explicitly detail acceptance criteria or a clinical study proving device performance against those criteria in the way a typical AI/software device submission would.

For medical devices, particularly those claiming substantial equivalence, the "acceptance criteria" are often implied by meeting the performance characteristics of the predicate device(s) and relevant FDA guidance. The "study" typically refers to specific testing (mechanical, biocompatibility, etc.) that demonstrates the device's safety and effectiveness for its intended use, aligning with the performance of predicate devices.

Based on the provided text, here is the information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a table of explicit acceptance criteria or detailed performance metrics from a clinical study. Instead, it states that the device was found substantially equivalent to predicate devices based on mechanical testing. The "acceptance criteria" can be inferred as meeting the mechanical performance standards of similar legally marketed intervertebral body fusion devices.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. This document describes mechanical testing and a comparison to predicate devices, not a clinical trial with a "test set" of patients.
• Data Provenance: Not applicable. The "data" refers to mechanical test results, which would have been generated in a laboratory setting.

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

• Not applicable. There was no "ground truth" derived from human experts in the context of a clinical test set for this type of device submission. Ground truth for mechanical devices is typically established through recognized engineering standards and validated testing methodologies.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring an adjudication method.

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

• No MRMC study was done. This device is a passive implantable medical device (an intervertebral body fusion device), not an imaging or AI-assisted diagnostic tool that would typically involve an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This is a physical medical device, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. Type of Ground Truth Used

• Mechanical Performance Standards and Predicate Device Characteristics: The "ground truth" for this device's performance would be the established biomechanical properties and safety profiles of legally marketed predicate intervertebral body fusion devices, as demonstrated through adherence to relevant ASTM or ISO standards for spinal implants, and successful performance in preclinical mechanical testing (e.g., compression, shear, fatigue, expulsion resistance).

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a software or AI device that requires a "training set."

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

• Not applicable, as there was no training set.

Summary of the K073351 Filing:

The provided 510(k) summary for the Crystal® Intervertebral Body Fusion Device indicates that substantial equivalence was established through mechanical testing comparing Crystal® to legally marketed predicate intervertebral body fusion devices. The FDA's letter concurs with this determination, allowing the device to be marketed. This type of filing for a physical implantable device relies heavily on engineering data and material science rather than clinical trials with patient populations or studies involving expert consensus on images, which are more common for AI/software devices.

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