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Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.

Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from of skin abrasions, lacerations, minor irritations, cuts and intact skin.

Spectricept Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).

Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the bottle in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.

Spectricept Skin and Wound Cleanser is a non-sterile aqueous solution in a 8oz PET bottle.

This document is a 510(k) clearance letter for a medical device called "Spectricept Skin and Wound Cleanser." It states that the device is substantially equivalent to a previously cleared predicate device (K213514). It is a chemical product, not an AI/ML powered device, so many of the requested categories related to AI performance are not applicable.

Here's the summary of the information provided for the Spectricept Skin and Wound Cleanser:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a chemical product clearance, the "acceptance criteria" are related to safety and performance through non-clinical testing, rather than performance metrics like sensitivity, specificity, or AUC as would be seen for an AI/ML device. The "reported device performance" indicates that the device met these criteria.

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

This is not applicable as the device is a chemical cleanser and the evaluation is based on non-clinical laboratory testing, not a dataset of patient cases. The testing involves standardized laboratory procedures and materials.

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

This is not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert labels on medical images) is not relevant here. The "ground truth" for the non-clinical tests is adherence to established international standards and laboratory protocols performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in AI/ML performance studies. Here, the "truth" is determined by the outcome of a standardized laboratory test against a defined pass/fail criterion.

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. The device is a wound cleanser, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This is not applicable. The device is a liquid chemical cleanser, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's clearance is based on:

• Established International Standards: Such as ISO 10993 series and ASTM F756 for biocompatibility.
• Pharmacopoeial Standards: Such as USP and USP for microbiological evaluation.
• Chemical Composition Analysis: Assuring the formulation is as specified.
• The comparison to the predicate device (K213514) relies on the fact that the two devices are identical in formulation, mechanism of action, and intended use, and the additional biocompatibility testing supported an extended contact time.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for this type of device clearance. The device is a chemical product, not an AI/ML model trained on data.

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

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

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The Defendo Fujifilm 700 Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

This device is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

The Defendo Fujifilm 700 Single Use Cleaning Adapter is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Fujifilm endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The Defendo Fujifilm 700 Single Use Cleaning Adapter assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

This document is a 510(k) premarket notification from the FDA for a medical device. It is not a study demonstrating the performance of an AI/ML powered device. Most of the requested information regarding AI/ML study design and results is therefore not applicable.

The device is the "Defendo Fujifilm 700 Single Use Cleaning Adapter," which is a non-sterile, single-use disposable valve intended to pre-clean endoscope air/water channels post-procedure. The submission is a "Special 510(k)" to obtain clearance for a non-sterile version of a previously cleared sterile device (K232329).

Here's the relevant information based on the provided text, with explanations why certain points are not applicable:

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

The document provides a summary table of non-clinical performance testing. The "Acceptance Criteria" column consistently states "Meet acceptance criteria" without detailing the specific numeric or qualitative thresholds for each test. However, the "Results" column consistently states "Pass," indicating that the device met these (undisclosed) criteria for all tests.

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

• Sample Size: The document does not specify the sample size for any of the non-clinical tests conducted.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given that these are benchtop "non-clinical" performance tests for a physical device, the concepts of retrospective/prospective clinical data or patient data provenance do not apply.

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. The device is a mechanical cleaning adapter, not an AI/ML-powered diagnostic tool. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant to its performance testing. The "truth" here is objective physical measurements and functional performance as per engineering specifications.

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

Not applicable. As noted above, this is not a study requiring expert adjudication of clinical findings.

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/ML device, nor is it a clinical study involving human readers.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device's performance testing consists of engineering specifications, material properties, and functional requirements (e.g., specific flow rates, force thresholds, leak prevention). It is established through physical measurements and bench testing against predefined criteria, not against clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI/ML model.

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

Not applicable. This device does not involve a training set for an AI/ML model.

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The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors.

The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels.

Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to confirm the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to prevent ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle to ensure that the device is leak tight after cleaning and liquid chemical sterilization. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle.

The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The provided text is an FDA 510(k) summary for a medical device called the "enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for a modification to the existing device (changing materials in the Chemical Delivery System).

As such, the document does not describe a study involving human readers, AI assistance, ground truth labels from experts for diagnostic tasks, or a training set for an AI model. The "device" in question is not an AI/ML algorithm for image analysis or diagnosis. Instead, it's a machine for sterilizing endoscopes.

Therefore, many of the requested points, such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and AI model training details, are not applicable to this type of device and the information provided in the document.

However, I can extract the acceptance criteria and performance related to the modification of this physical device.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance for the Modified Enspire 3000 System

The study described is not for an AI/ML diagnostic device, but rather for a physical medical device (an endoscope reprocessor) that has undergone a material change in one of its components. The acceptance criteria and performance relate to the safety and efficacy of the modified reprocessing system.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, which is primarily relevant for AI/ML diagnostic devices, it is not found in this document because the device is not an AI/ML system.

Here's why each point is Not Applicable (N/A) in this context:

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

  • N/A: The "test set" here refers to physical tests conducted on the modified device and its components, not a dataset of medical images or patient data. The document mentions "multiple processing cycles" and "representative endoscope" but no specific numeric sample sizes for these qualitative/quantitative tests. Data provenance in terms of country of origin or retrospective/prospective is not relevant for this type of device testing.

• 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)

  • N/A: Ground truth for diagnostic AI models is established by human experts (e.g., radiologists). For this device, "ground truth" is based on established engineering and chemical standards (e.g., ISO standards, acceptable chemical residual levels, non-cytotoxicity). No human experts are described as "establishing ground truth" in the way they would for a diagnostic AI study.

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

  • N/A: Adjudication methods are used in AI studies where multiple human readers disagree on a diagnosis or annotation. This is a physical device subject to engineering and chemical validation tests.

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

  • N/A: An MRMC study is relevant for evaluating the impact of AI assistance on human diagnostic performance. This device is an endoscope reprocessor, having no direct interaction with human diagnostic reading.

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

  • N/A: "Standalone performance" refers to the accuracy of an AI algorithm in performing a diagnostic task without human intervention. This device performs a physical reprocessing function, not a diagnostic one.

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

  • N/A: As explained in point 3, the "ground truth" for this device's performance relies on engineering specifications, chemical analysis, and biocompatibility standards rather than medical diagnostic ground truth sources like pathology or patient outcomes.

• 8. The sample size for the training set

  • N/A: This device is a physical machine, not an AI/ML model that requires a "training set."

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

  • N/A: As this is not an AI/ML model, there is no training set or associated ground truth to establish in that context.

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The Single Use Cleaning Adapter is intended to be used only to pre-clean an endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

This device is intended as part of the pre-cleaning process, to help clear the air/water channel of Olympus GI endoscopes post procedure.

The Defendo Single Use Cleaning Adapter for Olympus Endoscopes is a single use, sterile disposable valve that fits onto the air/water cylinder of Olympus endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes through high-level disinfection and/or sterilization. The adapter is attached to the air/water channel of an endoscope. When the adapter is attached to the endoscope, air can flow down the channel of the endoscope. If water is desired to flow down the channel, the device is depressed. When released, air will once again flow down the endoscope channel. The Defendo Single Use Cleaning Adapter for Olympus Endoscopes assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

The provided document is a 510(k) premarket notification from STERIS Corporation to the FDA for a medical device called "Defendo Single Use Cleaning Adapter for Olympus Endoscopes." However, this document does not contain information about an AI/ML-driven device or studies related to AI/ML performance.

The listed tests (Button cycling/leak test, Fluid Flow Path, Air Flow Rate, CO2 Flow Rate, Water Flow Rate, Backpressure Hold Test, Valve to Port Attachment Force, Valve to Port Removal Force, Valve Depression Force, Cap breakage strength, Sterile Barrier: Visual Inspection, Sterile Barrier: Dye Penetration) are all related to the mechanical and physical performance of a cleaning adapter, not to the performance of an AI algorithm.

Therefore, I cannot extract the information requested about acceptance criteria and studies proving the device meets criteria in the context of an AI/ML device. The document describes a physical medical device (a cleaning adapter) and its non-clinical performance testing.

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The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)× 5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.

The provided FDA 510(k) summary (K241022) for the Sterile single use tip cleaner (WK800-S10, WK800-S20) does not contain information on how the acceptance criteria were established or details of a study that proves the device meets specific performance criteria related to clinical efficacy.

The document focuses on non-clinical performance testing for physical characteristics and manufacturing-related residuals, primarily to establish substantial equivalence to a predicate device. There is no mention of clinical studies, human reader performance, AI assistance, or related metrics.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: These acceptance criteria are for non-clinical, physical, and manufacturing characteristics, not for clinical performance or diagnostic accuracy.

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 specifies "Non-clinical Performance Testing" but does not provide details on the sample size for these tests (e.g., how many units were tested for peel strength or appearance). It also does not mention the data provenance beyond it being conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. in China. Given the nature of these tests, they would be prospective manufacturing quality and material property tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The tests performed are non-clinical, evaluating physical properties and chemical residuals, not requiring expert clinical interpretation or ground truth establishment in the way a diagnostic imaging device would.

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

Not applicable. This is not a study involving human interpretation or adjudication. The results are from physical measurements and observations 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

No. This device is a sterile single-use tip cleaner, an accessory for electrosurgical cauterization. It is a physical medical device, not an AI or software-driven diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its regulatory submission.

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

No. As explained above, this device is not an AI algorithm. The performance tests are for its physical properties and sterility.

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

For the non-clinical tests, the "ground truth" or reference is the predefined technical specifications and standards (e.g., "free from damage, cracking," "peel strength ≥ 2N/CM," "FTO Residual ≤ 4mg/pcs"). These are established engineering and quality control criteria.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

Not applicable, for the same reasons above.

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Dentis s-Clean SQ-SL Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.

The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).

The dimensions of fixtures are as following:

Tolerance of dimension shall be within ± 1% range.

s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:

s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:

Denis s-Clean SQ-SL Fixture is provided sterilized.

Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

This document is a 510(k) Summary for the Dentis s-Clean SQ-SL Fixture, a dental implant. It does not contain information about the acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information regarding AI/algorithm acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The "Non-Clinical Test Data" section describes engineering and biocompatibility tests conducted on the device, not an AI algorithm.

Non-Clinical Test Data Summary (from the document):

• Tests performed on the subject device: Fatigue Testing (ISO 14801:2016).
• Tests performed on predicate devices and leveraged for the subject device:
  • Sterilization Validation Test on Fixtures (ISO 11137-1,2,3 referenced in K192688).
  • Shelf-Life Test on Fixtures (ASTM F1980 referenced in K153639).
  • Biocompatibility testing on fixtures (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639).
  • Bacterial Endotoxin Test Report on Fixtures (ANSI/AAMI ST72:2011, USP , and USP referenced in K192688).
• Acceptance Criteria for these non-clinical tests: "met the criteria of the standards" (e.g., ISO 14801:2016 for fatigue).
• Study Design/Purpose: To demonstrate substantial equivalence to predicate devices.
• MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to evaluate magnetic safety, addressing magnetically induced displacement force and torque.

This document describes a traditional medical device (dental implant) clearance process, not one involving Artificial Intelligence.

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The Cleaner™ Plus 18F Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ 18F Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement.

The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes an aspiration control and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the external vacuum reservoir with pump known as the Aspiration Canister.

The system is inserted percutaneously into the vessel using an introduction catheter, the system Aspiration Catheter and Dilator may be placed over-the-wire to the site of thrombus. The device macerates intra-lumen and wall adherent thrombus with a maceration wire. The macerated thrombus is removed from the vessel using an aspiration system. The aspiration of the clot can be performed simultaneous or independently.

Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.

The provided text describes information about the Cleaner™ Plus 18F Thrombectomy System, a medical device, and the basis for its FDA clearance through a 510(k) premarket notification (K233909). The information primarily focuses on establishing substantial equivalence to a predicate device (K211798), rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested items related to AI/ML device study design (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this document, as it concerns a mechanical thrombectomy system, not an AI/ML-driven device.

However, I can provide the available information regarding the device's performance assessment and the basis for its clearance.

Acceptance Criteria and Device Performance (Non-AI/ML Medical Device)

The document does not present a table of numerical "acceptance criteria" in the same way one might find for an AI/ML model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device are qualitative, based on established industry standards, guidance, and the successful outcome of various performance and safety tests demonstrating substantial equivalence to a predicate device.

The "reported device performance" refers to the successful completion and meeting of predefined parameters for each test, indicating the device performs as intended and is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical device, not an AI/ML system, the "acceptance criteria" are the successful completion of various tests and the demonstration of substantial equivalence. The "reported device performance" refers to the outcomes of these tests.

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