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The LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer's Standard cycle can sterilize:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors,
• Medical devices with single stainless-steel lumen with:
  An inside diameter of 1mm or larger and a length of 125mm or shorter
  An inside diameter of 2mm or larger and a length of 250mm or shorter
  An inside diameter of 3mm or larger and a length of 400mm or shorter

• The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

• Contra-indication: It is contraindicated to sterilize single usable medical devices made up with absorbable materials such as cellulose or wood.
• Intended user: trained nurse level or higher level of healthcare providers
  The validated maximum load conditions
  Total weight:
  The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs).
  Usage of sterilization pouch:
  The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.

The LOWTEM Crystal 120 low-temperature vaporized hydrogen peroxide sterilizer is a selfcontained stand-alone device, using vaporized hydrogen peroxide as the sterilant.
The LOWTEM Crystal 120 includes the LCD touch monitor, Hydrogen Peroxide Supply (HPS) Unit, Sterilization Chamber Door, and Printer on the front of the Sterilizer.

The provided text is a 510(k) summary for the LOWTEM Crystal 120, a low-temperature hydrogen peroxide sterilizer. It outlines the device's indications for use, its technical characteristics compared to predicate devices, and performance data. However, the document does NOT describe the specific acceptance criteria and detailed study that proves the device meets those criteria in the format requested.

The "Performance Data" section (Page 10 and 11) lists various tests performed, their objectives, and an acceptance criterion of "Pass / Fail." It also states "Result: Pass" for all listed tests. This section generally confirms that the device passed general safety, electromagnetic compatibility, risk management, usability, sterilant potency, and sterilization efficacy tests. However, it does not provide the detailed quantitative acceptance criteria (e.g., specific thresholds for D-value or log reduction) beyond "Pass/Fail," nor does it elaborate on the methodology, sample sizes, or expert involvement for the individual tests.

Therefore, based on the provided text, I cannot complete the requested table and answer the detailed questions regarding acceptance criteria and the comprehensive study that proves the device meets specific performance criteria.

The document primarily focuses on regulatory approval based on equivalence to predicate devices, not on a detailed clinical study demonstrating device performance against specific acceptance metrics in a human-in-the-loop or standalone AI context, as might be expected for an AI/ML medical device. This device is a sterilizer, not typically an AI/ML-driven diagnostic or therapeutic device.

Here's what I can extract and what is missing, based on your prompt's structure:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided text):

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 mentions "maximum of 20 lumens per load" for validation testing and "a total weight of 8.9kg(19.6lbs)" for validation loads. It also mentions "three lots of test accessories" for final process qualification. However, specific sample sizes (e.g., number of test cycles, number of devices/items tested for each specific test) are not detailed.
• Data provenance (country of origin, retrospective/prospective) is not mentioned.

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 mentioned, as the device is a sterilizer and its performance is measured by sterilization efficacy (e.g., bacterial kill, D-value) rather than expert interpretation of images or data.

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

• Not applicable/Not mentioned. The tests for a sterilizer are objective performance measures (e.g., spore kill, chemical residuals) rather than subjective assessments 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, as this device is a sterilizer, not an AI-assisted diagnostic tool.

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

• Not applicable. The "standalone" performance here refers to the sterilizer's ability to sterilize, which is inherent to its function and is what the various performance tests assess. There's no AI algorithm performing a separate task.

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

• For a sterilizer, the "ground truth" for sterilization efficacy is typically defined by standardized biological and chemical indicators, as well as validated physical parameters of the sterilization cycle. The document mentions "demonstration of >12 log reduction of Geobacillus stearothermophilus" and "test accessories (SCBI, CI strip and CI tape)" which are standard methods for assessing sterilization success.

8. The sample size for the training set:

• Not applicable as 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 as this is not an AI/ML device that requires a training set.

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The SOUNDSTAR™ CRYSTAL Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO™ 3 EP Navigation Systems, the catheter provides location information. Refer to the Compatibility Matrix Insert for compatible CARTO™ 3 Systems as each catheter is compatible with a specific version of the CARTO™ 3 System and is not backward compatible with previous versions of the CARTO™ 3 EP Navigation System.

The SOUNDSTAR CRYSTAL Ultrasound catheter is disposable and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheter is to be used only on systems with which they have been tested and found compatible. The proposed device, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® 3 EP Navigation System.

The provided text is a 510(k) premarket notification for the SOUNDSTAR™ CRYSTAL Ultrasound Catheter. It does not describe a study involving acceptance criteria and device performance in the context of AI/algorithm performance.

The document states: "The SOUNDSTAR™ CRYSTAL Ultrasound catheter in this submission uses the same intended use, technology and principles as the predicate device and hence clinical data is not required to establish substantial equivalence." This indicates that the regulatory submission primarily relies on demonstrating equivalence to a previously cleared device through non-clinical testing, rather than presenting a study proving performance against specific acceptance criteria with human or AI assessment.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study (especially a clinical or AI-centric one) is not included in this submission. The "Performance Testing" section lists various engineering and safety standards (e.g., ISO, ANSI/AAMI, IEC) that the device complies with, but these are not presented as acceptance criteria for performance in the way described in your prompt (e.g., sensitivity, specificity, or human reader improvement with AI).

If you have a different document that details a clinical study or AI algorithm performance, I would be happy to analyze that.

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The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The AcuNav Crystal Ultrasound catheter is disposable and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheter is to be used only on systems with which they have been tested and found compatible.

The provided text is a 510(k) summary for the AcuNav Crystal Ultrasound Catheter. It outlines the device's characteristics and its substantial equivalence to a previously cleared predicate device. However, it explicitly states that clinical data was not required to establish substantial equivalence because the new device uses the same intended use, technology, and principles as the predicate device.

Therefore, the document does not contain information regarding a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy (e.g., sensitivity, specificity). It only lists non-clinical tests related to safety and manufacturing standards.

Consequently, I cannot provide the requested information about acceptance criteria for device performance, given that no such performance study was conducted or presented in this 510(k) summary.

Here's what can be inferred from the document regarding non-clinical acceptance criteria:

• Acceptance Criteria for Non-Clinical Performance (Implicit): The device is expected to conform to various safety and manufacturing standards. The "acceptance criteria" for these would be successful adherence to the requirements of the listed standards.

• Study Proving Device Meets Acceptance Criteria (Non-Clinical): The document states: "The device has been evaluated for acoustic output, biocompatibility, sterilization, packaging, shelf life as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards." This is the "study" proving it meets these non-clinical acceptance criteria.

Specifically, the document does NOT contain the following information that would be relevant to a clinical performance study:

• A table of acceptance criteria and reported device clinical performance (e.g., diagnostic accuracy metrics).
• Sample size used for a test set (clinical).
• Data provenance (e.g., country of origin of clinical data, retrospective or prospective).
• Number of experts used to establish ground truth for a test set and their qualifications.
• Adjudication method for a test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set (as no AI algorithm requiring a training set is mentioned for performance).
• How the ground truth for the training set was established.

In summary, based on the provided text, no clinical performance study was conducted or described because the device demonstrated substantial equivalence through technological comparison and adherence to non-clinical safety standards.

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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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Esaote's Model 6425 Ultrasound System is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The model 6425 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D. Model 6425 is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. Model 6425 is also equipped with a height adjustable/rotating keyboard. A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel. Model 6425 can drive phased (PA), convex array (CA), linear array (LA) probes, Doppler probes and Volumetric probes. Model 6425 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

The provided text is a 510(k) Pre-market Notification for the Esaote S.p.A Model 6425 Ultrasound System. It details how the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense. Instead, it demonstrates substantial equivalence to predicate devices for its intended uses and technological characteristics. The "performance" is implicitly deemed acceptable if it matches or is comparable to the already cleared predicate devices.

The acceptance criteria are implied to be meeting the safety and performance standards of the predicate devices (Model 6400 and Model 6420) and conforming to relevant medical device safety standards.

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

The document explicitly states: "No clinical tests were performed." Therefore, there is no test set sample size or data provenance related to clinical performance in this submission. The basis for clearance is substantial equivalence to previously cleared devices which would have undergone testing.

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

Since no clinical tests were performed for this specific submission, there is no information regarding experts used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

As no clinical tests were performed, there is no mention of an adjudication method for a test set.

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

No, the document explicitly states, "No clinical tests were performed." Therefore, no MRMC comparative effectiveness study was conducted for this submission. The device is cleared based on demonstrating substantial equivalence to predicate devices, not on proving improved effectiveness with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is an "Ultrasound System," implying it is a hardware and software system for image acquisition and display, operated by a human. There is no mention of an "algorithm only" or "standalone" performance evaluation in the context of AI or automated analysis. The clearance is for the ultrasound system itself.

7. The Type of Ground Truth Used

Given that no clinical tests were performed, there is no information on a specific ground truth used for this submission. The clearance relies on the established safety and performance of the predicate devices.

8. The Sample Size for the Training Set

No information is provided regarding a training set as the submission focuses on substantial equivalence of a new ultrasound hardware system rather than an AI/ML algorithm that would typically require a training set.

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

As no training set is mentioned in the context of an AI/ML algorithm, this information is not applicable and is not provided in the document.

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Vertu® & Vertu® Ti-Bond devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/C3 disc space to the C7/T disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. 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. Two screws should be used to ensure adequate fixation of the implant.

Crystal® & Crystal® Ti-Bond devices are intended for spinal fusion at one or two contiguous levels 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 from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic 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 non-operative treatment prior to being treated with these devices.

The Vertu and Vertu Ti-Bond Cervical Interbody System is composed of an implant body made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or polyetheretherketone (PEEK-Optima®) conforming to ASTM F2026 or PEEK-Optima® coated with commercially pure titanium per ASTM F1580 and fixation screws made from Ti-6Al-4V per ASTM F136 or ISO 5832-3 with a Nitinol clip conforming to ASTM F2063. All implant bodies have a titanium insert lining the internal surface of the screw holes conforming to ASTM F136 or ISO 5832-3. The implant body is generally boxshaped 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. 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 Crystal and Crystal Ti-Bond Cervical Interbody devices are generally a box-shaped device with various holes located throughout its geometry to allow for packing of bone graft material. The body of the implant is made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3 or polyetheretherketone (PEEK-Optima®) conforming to ASTM F2026 or PEEK-Optima® coated with commercially pure titanium per ASTM F1580. Superior and inferior surfaces of the device have teeth that help keep the device from migrating once placed in its desired location.

This FDA 510(k) Premarket Notification document (K153352) describes the Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody Systems. Per the document, "No changes were made to the existing Vertu. Vertu Ti-Bond. Crystal Ti-Bond devices nor were any new components added to the system. Therefore, no additional testing was required or performed." This implies that new acceptance criteria and a study to prove these devices meet those criteria were not established for this specific submission. Instead, the document relies on the substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be directly extracted from the provided text for this specific K153352 submission:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated as new criteria or performance data were generated for this submission. The device is determined to be substantially equivalent based on existing data and characteristics of predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable as a new test set was not created for this submission. The submission references previous clearances (K122771, K133218, K073351) for the predicate devices, which would have had their own testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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. These are interbody fusion devices, not AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The provided document (K153352) is a 510(k) premarket notification for expanded indications for the Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody Systems. The FDA determined the device is substantially equivalent to legally marketed predicate devices. The basis for this determination is that no changes were made to the existing devices, and no new components were added, thus no additional testing was required or performed for this specific submission. The substantial equivalence is argued based on a comparison of indications for use, technological characteristics, surgical technique, design features, and instrumentation to established predicate devices.

The acceptance criteria and performance data for the original clearances of these devices and their predicates would be found in the associated 510(k) submissions (K122771, K133218, K073351, K150053, K142264, K133653), which are not included in this document.

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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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