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The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The ViVi® Toga Premium is a one-piece head and body cover that is worn by healthcare professionals. The ViVi® Toga Premium is a component of the ViVi® Surgical Helmet System and worn over the air-exchanging surgical helmet. The ViVi® Toga Premium is used with the ViVi® Helmet or the ViVi® Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

ViVi® Toga Premium is designed and has been tested to meet the applicable AAMI PB70 standards for level 4 compliance. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hood area and the lens are exempt from classification under this standard.

The provided FDA 510(k) clearance letter for the ViVI® Toga Premium is for a Class II surgical apparel device. This document primarily details the substantial equivalence of the ViVi® Toga Premium to a predicate device based on non-clinical performance data. It explicitly states that "No clinical evaluation is necessary for this device."

Therefore, this document does not describe a study involving an AI/Machine Learning (ML) algorithm with a test set, ground truth, expert adjudication, or MRMC studies. The device is a physical product (surgical toga/gown), and its "performance" is related to its physical properties and barrier capabilities, not diagnostic or predictive accuracy.

Given the information provided, it's not possible to fulfill the request for acceptance criteria and study details related to an AI/ML device. The "study" mentioned in the document refers to non-clinical laboratory testing of material properties.

However, I can extract the acceptance criteria and the "reported device performance" based on the provided document as it relates to this specific physical device.

Acceptance Criteria and Reported Device Performance for ViVi® Toga Premium (Surgical Apparel)

Based on the provided FDA 510(k) clearance letter for the ViVi® Toga Premium, the acceptance criteria and reported device performance relate to its physical properties and barrier capabilities, as it is a surgical apparel device and not an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and tests performed, with "PASS" indicating successful compliance.

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

• Sample Size: The document does not specify the exact sample sizes (number of garments or material samples) used for each individual non-clinical test. The testing is reported as "tests were conducted and completed," indicating standard laboratory evaluations.
• Data Provenance: Not applicable in the context of clinical data. The tests are material and performance tests conducted in a laboratory setting. No geographical origin of "data" in the sense of patient data is mentioned, as this is a physical product. The manufacturer is THI Total Healthcare Innovation GmbH, based in Austria. The predicate device manufacturer is Zimmer Surgical, Inc.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This device is surgical apparel, and its "performance" is assessed through standardized physical and biological material testing, not through expert human interpretation of data like images or clinical outcomes. There is no "ground truth" in the diagnostic AI sense.

4. Adjudication Method for the Test Set

• Not applicable. As described above, there is no expert adjudication process for this type of device. Performance is determined by meeting pre-defined regulatory standards and test method specifications.

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

• No. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic devices (often imaging-based AI) by comparing the accuracy of multiple human readers with and without AI assistance across multiple cases. This does not apply to a surgical apparel device.

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

• Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

• Not applicable in the context of AI/ML. The "ground truth" for this device's performance is derived from established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, CFR), which define objective physical and chemical properties and test methodologies. Meeting these standards serves as the "truth" for device functionality.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device and does not have a training set or associated ground truth.

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The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories.

The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip.

The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The system is not intended for use on patients receiving intensive medical intervention/therapy.

The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings. The system is not intended for use on neonates.

The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter, the XPER Technology PREMIUM Pro Blood Glucose Test Strips, and the TaiDoc Blood Glucose Control Solutions. This system is a multiplepatient use for the quantitative determination of glucose in capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories as an aid in monitoring the effectiveness of glucose control. The TaiDoc Blood Glucose Control Solutions are used to check that the meter and test strips are working together properly.

Here's a breakdown of the acceptance criteria and study details for the XPER Technology PREMIUM Pro Blood Glucose Monitoring System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the statement "all test results were within acceptance criteria" in various sections. The reported performance is the achievement of these criteria. The specific numerical targets for each criterion are not always explicitly stated (e.g., for precision, linearity, hematocrit, interference), but the document confirms that the device met these criteria.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This document describes a medical device, a Blood Glucose Monitoring System, which does not utilize AI or involve human readers for image interpretation. Therefore, questions related to AI models, human reader improvement with AI assistance, expert adjudication for ground truth related to image analysis, or MRMC studies are not applicable to this device.

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

1. Sample sizes used for the test set and data provenance:

   • Clinical Accuracy (Capillary Blood): 414 patients.
     • Provenance: Clinical study conducted at 3 U.S. sites and 6 Taiwan sites. Data is prospective as it was collected during an active clinical study with patients.
   • Accuracy at Extremes: 100 samples (50 for 300 mg/dL).
     • Provenance: "Blood samples were collected and allowed to glycolyze or were spiked with high concentration glucose solution". Implies a laboratory-controlled, prospective or specially prepared sample set.

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

   • Not Applicable in the traditional sense of 'experts' interpreting data. For blood glucose monitoring systems, the "ground truth" is established by a highly accurate reference method.
   • The ground truth for the clinical and extreme glucose value studies was the YSI Model 2300 Glucose Analyzer. This is a laboratory-based, well-established, and highly accurate reference method for glucose measurement, not human experts.

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

   • Not Applicable. As ground truth is established by an automated reference analyzer (YSI-2300), there is no human interpretation or adjudication process involved in setting the ground truth for glucose values.

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

   • Not Applicable. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. There are no human readers or AI assistance in the interpretation of results from this device in the same way as an imaging study.

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

   • Yes, in essence. Blood glucose meters are inherently "standalone" in their function of measuring glucose. The clinical study directly compares the device's numerical output (algorithm's result) to the YSI-2300 reference method without human interpretation of the device's output influencing the direct comparison. The "human-in-the-loop" for this device is the user taking and reading the measurement, but the performance evaluation is on the accuracy of the numerical reading itself, independent of user interpretation for the primary outcome.

6. The type of ground truth used:

   • Reference Method: The YSI Model 2300 Glucose Analyzer, a laboratory-based, highly accurate method for quantitative glucose determination. Comparisons are quantitative.

7. The sample size for the training set:

   • Not directly applicable/not explicitly stated in terms of an "AI training set." This device is a traditional electrochemical biosensor, not an AI/machine learning model that undergoes a distinct "training" phase with a large dataset in the way a deep learning algorithm would. The development and calibration of such a device involve extensive laboratory testing and optimization, which could be considered an analogous "training" or development process for its internal algorithms, but it's not described as a separate, quantifiable "training set" with ground truth in the context of AI regulatory submissions.

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

   • Not applicable in the AI context. For this type of device, ground truth for development/calibration (analogous to "training") would be established through a combination of:
     • Highly controlled laboratory experiments using reference solutions of known glucose concentrations.
     • Comparisons to established reference methods (like YSI-2300) with well-characterized samples.
     • Controlled studies to characterize and mitigate interferences (e.g., hematocrit, medications).

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Resona A10S, Resona A20 Pro, Resona A20S, Resona A20W, Resona A20, Resona A20, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, mode(B+M, PW+B, Color+B, Power+B, Combined PW+Color+B. Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STO, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp. Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided document is a 510(k) premarket notification summary for a diagnostic ultrasound system. It outlines the device description, indications for use, comparison to predicate devices, and the non-clinical tests performed. Crucially, the document states "Not applicable" for clinical studies and explicitly says, "The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, based on the provided text, there is no information available regarding acceptance criteria and a study that proves the device meets those criteria in the context of an "AI" or "software" performance evaluation as typically seen for AI/ML-enabled devices. The new features mentioned (e.g., Super Resolution CEUS, Smart Scene) are presented as improvements or enhancements based on cleared functions, or new options that passed related tests without introducing new clinical risks. The focus of this 510(k) is on demonstrating substantial equivalence to predicate ultrasound devices through non-clinical testing and shared technological characteristics.

Here's why the requested information cannot be provided from this document:

• No AI/ML Performance Claim: The document does not describe the device as an AI/ML-enabled diagnostic tool in the sense of providing automated analysis, detection, or diagnosis that would require specific performance metrics like sensitivity, specificity, or AUC based on ground truth. The "Smart Calc" feature mentioned is simply an analysis package.
• Focus on Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new ultrasound system is substantially equivalent to existing, legally marketed predicate devices primarily through engineering, safety, and functionality comparisons.
• No Clinical Study Performed/Required: The document explicitly states that clinical studies were "Not applicable" and "not required to support substantial equivalence." This means there was no de novo performance study with a test set, ground truth, or expert readers to evaluate specific diagnostic accuracy or AI assistance.

Table of Acceptance Criteria and Reported Device Performance (as inferable from the document's scope):

Regarding the specific questions about an AI/ML performance study, the answers are "N/A" (Not Applicable) because such a study was not performed or required for this 510(k) clearance:

1. A table of acceptance criteria and the reported device performance: See table above for inferable, non-AI criteria.
2. Sample sized used for the test set and the data provenance: N/A (no clinical test set for AI performance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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 MRMC study for AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study was performed.
7. The type of ground truth used: N/A.
8. The sample size for the training set: N/A (no mention of a training set for an AI model).
9. How the ground truth for the training set was established: N/A.

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The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

The SOLTIVE™ Laser System is a thulium fiber laser, producing a pulsed beam of coherent nearinfrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam. The SOLTIVE Laser System is comprised of a choice of two models - Premium Laser System and Pro Laser System, laser fibers and accessories. The Premium laser has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz and a secondary, foldable screen is provided. The Pro laser can operate at a maximum power of 35 Watts and Frequency output limited to 100Hz. Both systems are compact, designed to fit onto an optional laser cart and are operated with a footswitch (wired or wireless). The Soltive Laser System must be operated with a Soltive Laser Fiber, offered in quartz core diameters from 150 - 940 microns.

The provided document is a 510(k) Premarket Notification for the SOLTIVE™ Laser System. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a traditional clinical study with a defined test set and ground truth.

The "Performance Data" section (Section VII) describes non-clinical testing and software verification. Since this is a 510(k) submission, the primary goal is to show the device is as safe and effective as a legally marketed predicate, not necessarily to establish de novo "acceptance criteria" against clinical outcomes in the same way one might for a novel AI diagnostic device.

Therefore, many of the requested details (like sample size for a test set, expert involvement for ground truth, MRMC studies, and standalone performance) are not applicable or not provided in the context of this 510(k) for a medical laser system. The "study" here is primarily non-clinical and software-based to support the claim of substantial equivalence despite minor changes.

However, I can extract the relevant information from the provided text regarding the closest equivalent to "acceptance criteria" and the "study" conducted.

Here's a breakdown of the available information based on your request:

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

The document describes "acceptance criteria" within the context of design verification testing.

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

• Sample Size: Not explicitly stated as a "sample size" for a typical test set. The non-clinical testing involved "porcine ureter tissue" for thermal effect testing and "simulated stones" for ablation testing. The number of samples/tests is not quantified in the provided text.
• Data Provenance:
  • Country of Origin: Not specified for the non-clinical testing data.
  • Retrospective/Prospective: These were non-clinical, in-vitro tests, so the concept of retrospective or prospective doesn't directly apply in the same way as for human clinical data. They were conducted specifically for this submission.

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

• Not Applicable. For this type of submission (510(k) for a laser, with non-clinical and software testing), expert-established ground truth on a test set (e.g., for diagnostic accuracy) is not typically required or reported. The "ground truth" for the non-clinical tests would be the measured physical properties (e.g., thermal effect depth, ablation rate).

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

• Not Applicable. This is not a diagnostic device or a study involving human readers/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:

• No. This is a surgical laser system, not an AI diagnostic device. MRMC studies are not relevant here.

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

• Not applicable in the AI sense. The "device" itself (the laser system) was tested in a standalone fashion in a lab setting (non-clinical tissue and simulated stone testing), but this is "device performance" rather than "algorithm only" in the context of an AI-driven device.

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

• Measured Physical Properties:
  • For Soft Tissue Thermal Effect Testing: The "ground truth" involved measurements of "tissue thermal effect depths and widths."
  • For Simulated Stone Ablation Testing: The "ground truth" involved characterizing the "stone ablation rate."

8. The sample size for the training set:

• Not Applicable. This device is a laser system and its software manages system parameters; it does not employ machine learning that would require a "training set" in the typical sense of AI/ML.

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

• Not Applicable. (See point 8).

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Premium Teeth Resin, when utilized to print 3D printed dental appliances such as denture teeth for complete and partial removable dentures, try-in dentures, provisional full arch implant-supported restoration and provisional restorations such as temporary crowns and bridges, inlays, onlays and veneers, is indicated to replace or restore missing tooth structures or missing teeth.

Formlabs Premium Teeth Resin is a light-curable polymer-based resin of 3D printed dental appliances, such as denture teeth for complete and partial res, try-in dentures, provisional full arch implant-supported restoration, and provisional restorations including temporary crowns and bridges, inlays, onlays and veneers. Formlabs Premium Teeth Resin is used to fabricate patient-specific dental appliances in a stereolithographic (SLA) 3D printer using layer additive manufacturing.

This document is a 510(k) summary for a medical device (Premium Teeth Resin) and does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device.

The provided text focuses on demonstrating substantial equivalence of a new 3D printing resin (Premium Teeth Resin) to a legally marketed predicate device (VarseoSmile Temp) for dental applications. It details the product, its intended use, and compares its technological characteristics and performance to the predicate through non-clinical testing.

Therefore, I cannot extract the information required for your request from this document. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" as they relate to AI/ML device performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment, sample sizes for AI model training/testing) are not present in this regulatory submission for a material.

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The Evenflo Premium Double Electric Breast Pump (Model 4018) is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. It is intended for a single user.

The Evenflo Electric Breast Pump (Model 4018) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and should be cleaned and disinfected prior to first use according to the instructions for use. The breast pump can be used on one breast (single pumping) or on both breasts at the same time (double pumping).

The device consists of a pump unit, AC power adapter, power cable, AdvancedFit flange kit and bottle kit. The AdvancedFit flange kit consists of a flange body, flange insert, check valve (valve and membrane), diaphragm, diaphragm cap, and tubing for each breast, a tubing adapter to connect the kit to the pump unit and a tubing adapter plug to convert for single pumping. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power.

The breast pump uses cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the device. The device is capable of producing peak suction levels between -50 and -250 mmHg in double pumping mode and between -85 and -250 mmHg in single pumping modes at speeds between 30 and 80 cycles per minute. There are 9 distinct levels of suction and 6 speeds available for each suction level.

The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The provided text is a 510(k) summary for the Evenflo Premium Double Electric Breast Pump (Model 4018). It focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, and non-clinical performance testing.

However, the document does NOT contain information about acceptance criteria for a device that uses AI/algorithm or a study involving human readers or expert consensus for ground truth establishment, which are typical for AI/ML-enabled medical devices.

Based on the provided text, I can answer some of your questions, but many will be marked as "Not applicable" or "Not provided" because the device is a breast pump, not an AI/ML diagnostic tool, and the summary focuses on equivalence to a predicate device rather than de novo performance studies as would be seen for an AI/ML device.

Here's the breakdown of the information from the document in response to your questions:

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

The document does not present acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC) or human reader performance. Instead, it describes performance testing for a breast pump, focusing on engineering specifications.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices tested for each performance criterion. The document refers to "testing" conducted.
• Data Provenance: Not specified directly for the testing. It's implied that the testing was conducted by Evenflo Feeding, Inc. or their designated testing facilities.
• Retrospective or Prospective: Not applicable or specified 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

Not applicable. Ground truth as understood for AI/ML clinical studies (e.g., radiologist reads) is not relevant for the testing of a breast pump's mechanical and electrical performance. The "ground truth" here is the design specification or established engineering standard.

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

Not applicable. Adjudication methods are typically used in clinical studies with human readers or image analysis, not for mechanical/electrical testing of a breast pump.

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 breast pump, not an AI system intended to assist human readers in, for example, diagnosing medical conditions from images.

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

Not applicable. The device does not contain an AI/ML algorithm for diagnostic purposes. Its software is for operational control (e.g., suction/speed settings).

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

Not applicable. The "ground truth" for this device's performance testing is based on engineering specifications, adherence to international standards (e.g., ISO, IEC), and functional requirements for a breast pump (e.g., vacuum levels, backflow prevention).

8. The sample size for the training set

Not applicable. This document is for a physical medical device (breast pump), not an AI/ML model that requires training data.

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

Not applicable. (See #8)

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The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.

It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended tc be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.

This document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for their M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System.

Based on the provided text, the device in question is a general diagnostic ultrasound system, and the submission is for the addition of a new transducer, P8-2s, to an already cleared system (K210416).

Therefore, the performance data provided is not for a new AI/ML-driven medical device requiring extensive clinical or standalone performance studies against set acceptance criteria, but rather for a modification to an existing device.

The document explicitly states:
"8. Clinical Studies Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

This indicates that a formal study proving the device meets specific acceptance criteria in the way a novel AI/ML device would is not present in this submission. Substantial equivalence for this modification is based on non-clinical tests and comparison to a predicate device.

Given this, I cannot provide the detailed information requested regarding acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these types of studies were not deemed necessary for this particular 510(k) submission.

The "acceptance criteria" for this submission are fundamentally satisfied by demonstrating:

1. Technological Characteristics Similarity: The new P8-2s transducer has comparable design principles and parameters to existing transducers.
2. Safety Compliance: The device and the new transducer comply with recognized electrical, physical, and acoustic safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6).
3. Biocompatibility: Materials used are biocompatible (specifically Valox 3706, MLG-34-G/MLG-34-N, RTV162, RTV167 for the P8-2s probe shell, acoustic lens, and mucilage glue).
4. Cleaning, Disinfection, and Sterilization Effectiveness: The design allows for effective reprocessing.
5. Acoustic Output: The acoustic output is below the FDA limits (Ispta.3

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The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser. producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam.

The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns.

The system includes:

• Laser console
• Laser fibers sterile single use and reusable
• Foot pedal, wireless or wired
• Accessories power cord. HDMI cable, safety goggles/glasses, fiber cutter, fiber cleaver, fiber stripper and cart

The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.

The provided text is a 510(k) Summary of Safety and Effectiveness for the SOLTIVE Laser System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through a labeling modification. This document does not contain the information requested regarding acceptance criteria and the results of a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

The study described here is limited to performance testing of the laser system, which is stated to be identical to the predicate device. The changes are solely in updated labeling to clarify existing cleared Instructions for Use.

Therefore, I cannot provide the requested information. The document explicitly states:

• "The subject of this 510(k) is a labeling modification to the SOLTIVE Laser Systems. The device hardware and software design is identical to the predicate. The subject change to the labeling clarifies currently cleared Instructions for Use." (Page 5)
• "Performance testing was conducted in support of the predicate devices and equivalently applies to the subject device as the labeling clarifications fall within the existing performance envelope of the laser system. Testing demonstrated that all performance requirements met the prescribed acceptance criteria, including the proposed labeling change." (Page 9)

No information specific to a clinical study, AI performance, or human reader effectiveness is present in this document. The acceptance criteria mentioned refer to the intrinsic performance specifications of the laser system itself, not to a diagnostic or assistive AI's performance as would be detailed in an MRMC or standalone study.

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PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

This device consists of a power supply unit, a cooling system, a controller, and a laser resonator, and is controlled by a microprocessor. When electric energy pumping is applied to the flash lamp, the laser is emitted through a device laser module that oscillates a laser with a wavelength of 311mm, and the laser is radiated through the end of the optical fiber, which is a laser carrier.

The provided text is a 510(k) Summary for the PALLAS Premium device, a Solid-State Ultraviolet laser system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance studies typical for novel AI/ML medical devices.

Therefore, the information required to answer your prompt, specifically concerning acceptance criteria and detailed study performance (like MRMC studies, specific performance metrics, ground truth establishment for test/training sets, and expert qualifications for data annotation), is not present in the provided text.

The "Performance Data" section discusses compliance with various electrical safety, electromagnetic compatibility, laser safety, and software validation standards, but it does not include any clinical performance data or acceptance criteria related to the device's efficacy or accuracy in treating the specified conditions (psoriasis, vitiligo, atopic dermatitis, and leukoderma). The document asserts equivalency based on technical characteristics and intended use, implying that clinical performance is expected to be similar to the predicates.

This type of 510(k) submission generally relies on the established safety and effectiveness of the predicate devices. The device described, PALLAS Premium, is a physical laser system, not an AI/ML algorithm requiring studies to demonstrate diagnostic or prognostic accuracy.

If this were an AI/ML device, the detail you requested would be crucial for determining its clinical utility and safety. However, for a laser surgical instrument, the focus of the 510(k) submission is on demonstrating safety through adherence to recognized standards and technical similarity to legally marketed devices.

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DENTCA Base Resin is a light-curable resin indicated for the fabrication and repair of removable denture bases in dental laboratories, including full and partial dentures as well as immediate dentures, and baseplates. DENTCA Base Resin can also be used for the fabrication of try-in dentures for the evaluation before fabricating the final dentures. Fabrication of these prostheses with DENTCA Base Resin requires a digital denture file, additive printer, and curing light equipment. DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.

DENTCA Base Resin is a light-curable resin intended to fabricate removable dentures in a CAD/CAM system using an additive printing process. This material is used as an alternative to traditional heat cured and auto polymerizing denture base resins and is available in multiple shades. DENTCA Base Resin can also be utilized to repair the printed denture and to bond printed teeth onto denture base.

The provided text does not contain information about an AI/ML powered device, but rather a dental resin material. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets these criteria for an AI/ML device.

The document is a 510(k) premarket notification for a dental resin called "DENTCA Base Resin," which is a light-curable resin for fabricating and repairing removable denture bases. The "Performance Data" section discusses:

• Biocompatibility Testing: Conducted according to ISO 7405:2018 and FDA Guidance for medical devices in dentistry.
• Software Verification and Validation Testing: For the additive printing (3D printer) operation software, in accordance with FDA guidance for "Off-The-Shelf Software Use in Medical Devices" and "Technical Considerations for Additive Manufactured Medical Devices."
• Performance Bench Test: Conducted according to ISO 20795-1:2013, which specifies requirements for denture base polymers.

The table 5.2 "Comparison of Performance Bench Test" shows the acceptance criteria (specifications of Type 4 resin) and the reported performance of the subject device (DENTCA Base Hi-Impact and Premium), the predicate device (Halley Resin), and a reference device (DENTCA Denture Base II). All listed devices "Meet the consensus STD" or are "Not Detectable" for Residual Methylmethacrylate, indicating they meet the specified physical properties.

This document describes the testing for a physical material, not an AI/ML algorithm. Therefore, the requested details about multi-reader multi-case studies, ground truth establishment for AI, sample sizes for training sets, or expert qualifications are not applicable and not present in the provided text.

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