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A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device

The Surgical Light Handle Cover is a polycarbonate injection molded device shaped to fit a surgical light that has release buttons protruding from the surgical light handle. The Surgical Light Handle Cover has apertures located at the end of the device, proximal to the surgical light, which correspond to the release buttons on the surgical light handle. When the Surgical Light Handle Cover is attached to the light, the release buttons will interface with the apertures to secure the Surgical Light Handle Cover to the light handle.

The Surgical Light Handle Cover is hollow in the center, with transparent polycarbonate located near the distal end. The transparent end permits the use of a recording device, which may be mounted onto the surgical light. The transparent end allows light to pass through for the purpose of recording images, it does not provide image enhancement or magnification.

The provided text describes the acceptance criteria and the study results for the "Surgical Light Handle Cover" device (K133554).

The study did not involve AI assistance, human readers, or the establishment of ground truth by experts in the context of diagnostic accuracy. This device is a physical medical accessory, and its performance evaluation focuses on manufacturing, sterility, biocompatibility, and physical functionality rather than diagnostic capabilities.

Here's a breakdown of the requested information based on the provided text, with clarifications where the questions are not directly applicable to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test listed in the "Performance Data Summary." For tests like "Simulated Distribution Test" (ASTM D4169), "Dye Migration Test" (ASTM F1929), "Seal Peel Test" (ASTM F88), "Sterility" (ISO 11135-1), "EO/ECH Residuals" (ISO 10993-7), "Cytotoxicity" (ISO Elution), and "Material Leachables" (USP Physical-Chemical Analysis), the sample sizes would typically be determined by the specific ASTM/ISO standards referenced, but they are not detailed in this summary.

For the functional requirements ("Product must be easily installed and removed" and "Product must not interfere with the functionality of surgical light"), the test method indicates empirical assessment on a surgical light, but no specific number of trials or devices tested is provided.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but given that it's a 510(k) submission for a medical device manufacturer, the testing would have been conducted by or for Microtek Medical Inc., an Ecolab Company, likely in a controlled laboratory setting.

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

This question is not applicable to the evaluation of this device. The "ground truth" for this type of medical accessory is not established by clinical expert interpretation or diagnostic accuracy. Instead, it's based on objective engineering specifications, regulatory standards (ASTM, ISO), and functional performance against predefined criteria. For example:

• Sterility: Achieved if the Sterility Assurance Level (SAL) meets 10^-6 as per ISO 11135-1.
• Packaging: Pass/fail based on meeting the requirements of ASTM standards.
• Functionality: Pass/fail based on whether the device can be attached/detached and doesn't impede light movement or clarity.

No clinical experts or radiologists were involved in establishing "ground truth" for these performance metrics.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient data where there might be inter-reader variability. For this device, the tests are objective: either a package seal passes ASTM F88 or it doesn't; either an item is sterile to the specified SAL or it isn't. Discrepancies would be resolved by re-testing or reviewing the test methodology rather than expert consensus on an interpretation.

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, an MRMC comparative effectiveness study was not done. This device is a physical surgical light handle cover, not an AI-powered diagnostic or assistive tool. Therefore, there is no AI component, no human reader performance to improve, and no effect size to report in this context.

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

No, a standalone (algorithm only) performance evaluation was not done. This device is a physical product and does not involve any algorithms or AI for standalone performance assessment.

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

As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic AI is not relevant here. The "ground truth" for this device's performance is defined by:

• Adherence to established international standards (e.g., ASTM, ISO) for material properties, sterility, and packaging integrity.
• Meeting predefined functional specifications (e.g., ease of installation, non-interference with light function).
• Compliance with biocompatibility requirements for medical devices.

8. The sample size for the training set

This question is not applicable. This device is not an AI algorithm, and therefore there is no "training set" in the machine learning sense. The device is manufactured based on a design and then tested against the criteria outlined above.

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

This question is not applicable. As there is no training set for an AI algorithm, there is no "ground truth" to establish for such a set.

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The Venodyne DVT Advantage 810 is designed to compress the lower limbs aiding the blood flow back toward the heart to prevent DVT (Deep Veep Thrombosis) in patients at risk.

The Venodyne DVT Advantage 810 compression system is a microprocessor controlled pneumatic pump that inflates and deflates a set of single chamber leg garments (sleeves) or foot garments (sleeves), which are placed on the patient's lower limbs or feet. During the inflation cycle, the inflatable garments compress the limb or foot along with the veins contained within to a preset pressure. This assists in propelling blood from the lower limbs or feet towards the heart. During the deflation cycle, the veins are allowed to fill with blood. The cycle is repeated intermittently.

The provided document is a 510(k) summary for the Microtek Medical, Inc. Venodyne DVT Advantage, 810 Compression System. It describes the device, its intended use, and its technological characteristics. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML device.

The documentation focuses on demonstrating substantial equivalence to predicate devices. The "study" mentioned is primarily focused on safety and performance verification against established electrical safety, radio disturbance, radio noise emissions, and electromagnetic compatibility standards, along with general controller features, compression cycle operation, alarm modes, and battery operations.

Here's a breakdown of the requested information based only on the provided text, and where the information is absent:

1. Table of acceptance criteria and the reported device performance

Note: The document states that "Testing results demonstrate the proposed device is substantially equivalent to the legally marketed predicate device(s)." This is the overarching "performance" reported in relation to the standards and functional tests. Specific quantitative acceptance thresholds (e.g., "must meet X% accuracy" or "must not deviate by more than Y units") are not provided in this summary. The acceptance criteria essentially infer meeting the standards listed or performing comparably to the predicate device in functional tests.

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

This information is not provided in the document. The testing described is for engineering and functional verification, not clinical data testing with a "test set" in the context of an AI/ML device.

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 applicable and therefore not provided in the document. The device is a pneumatic compression system, not an AI/ML diagnostic system requiring expert-established ground truth.

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

This information is not applicable and therefore not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (a pneumatic compression system).

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

This information is not applicable and therefore not provided in the document, as it's not an algorithm-only device. The testing focused on the physical device's performance against safety and functional standards.

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

This information is not applicable and therefore not provided in the document. The "ground truth" for the tests performed would be the specifications outlined in the referenced electrical safety, EMC, and functional standards.

8. The sample size for the training set

This information is not applicable and therefore not provided in the document, as this is not an AI/ML device requiring a training set.

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

This information is not applicable and therefore not provided in the document, as this is not an AI/ML device requiring a training set with ground truth.

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The Freedomaire III Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA regarding the "Freedomaire III Surgical Helmet System." It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and does not contain detailed information about specific acceptance criteria or an overarching study proving the device meets said criteria.

Therefore, I cannot provide the requested information from this document. The document focuses on regulatory approval based on equivalence rather than performance study results against specific criteria.

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THE SURGICAL GOWN/TOGA IS INTENDED TO BE WORN Room BOTH THE SURG PROCEDURES TO PROTE RODM PERSONAL TRANSFER OF MICROORGANIST ARTICULATE MATER MATERIAL

The Microtek gown/toga consists of a non-woven material and woven cuff material manufactured to protect the wearer and patient from contamination during various procedures throughout the clinical setting. This gown/toga is similar to other gowns/togas currently being marketed for the same intended use.

The provided text describes a 510(k) premarket notification for a surgical gown/toga. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies as might be required for a novel device. Therefore, the information provided does not fully align with all the questions typically asked about acceptance criteria and detailed study designs for AI/ML devices.

However, based on the available text, here's an attempt to answer the questions within the given context:

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 does not specify the exact sample sizes used for the testing of the materials or the final product. It only states that the "materials have been tested alone and together" and the "final finished product conforms" to the standards. The 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 (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The performance evaluation relies on standardized laboratory testing (e.g., ASTM, ISO, ANSI/AAMI) for physical properties and barrier effectiveness, rather than expert judgment on a dataset.

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

This information is not applicable and not provided. The testing involves objective measurements against established standards, not subjective adjudication of cases.

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, an MRMC comparative effectiveness study was not done. This device is a surgical gown, not an AI/ML-powered diagnostic tool, so such a study would not be relevant.

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

This question is not applicable. The device is a physical product (surgical gown) and does not involve an algorithm or AI.

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

The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the referenced industry and international standards (e.g., ASTM F1671 for viral penetration, ISO 10993-1 for biocompatibility, ANSI/AAMI PB-70:2003 for general product performance). These standards dictate the methodologies and acceptable limits for various physical and biological properties.

8. The sample size for the training set

This question is not applicable. There is no "training set" for a physical medical device like a surgical gown.

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

This question is not applicable. There is no "training set" for this device.

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Microtek Medical, Inc. Patient Warming Drape is intended to be used to provide patient warming during a variety of surgeries or procedures in the clinical setting.

The Microtek Patient Warming Drape consists of a non-woven surgical drape, similar to other surgical drapes currently being marketed, with the exception of an added channel (with holes) that is adhered to the drape and allows the passage of warm air.

The retrieved document is a 510(k) Premarket Notification for a Patient Warming Drape. This type of device is a physical product used for warming patients, not an AI/ML software device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not applicable to this document.

The 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is a different regulatory pathway than what would require performance criteria and studies as described in the prompt's questions for an AI/ML device.

Here's the relevant information from the document:

Device Name: Microtek Medical, Inc., Patient Warming Drape

Intended Use: To provide patient warming during a variety of surgeries or procedures in the clinical setting.

Statement of Substantial Equivalence: The Microtek Medical, Inc. Patient Warming Drape is stated to be equivalent to:

1. Cincinnati Sub-Zero Convective Air Warming Blankets
2. Nellcor (Tyco) Warmtouch Warming Blankets

Since this is not an AI/ML device, the detailed study requirements outlined in your request are not present in this 510(k) submission.

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MICROTEK MEDICAL EQUIPMENT DRAPES ARE TO BE USED TO COVER A VARIETY OF SURGICAL AND NON-SURGICAL EQUIPMENT IN VARIOUS SETTINGS THE CHOUSE HOUSE THE CUNICAL SETTING. THESE DRAPES ARE USED TO PROFECT THE OQUIPMENT FROM CONTAMINATION DURING VARIOUS PROCEOURES.

The Microtek Equipment Drapes consist of poly film and non-woven material, separately and in combination, manufactured to protect a variety of surgical and non-surgical equipment from contamination during various procedures throughout the clinical setting. These equipment drapes are similar to other equipment drapes currently being marketed for the same intended use.

The provided text describes a 510(k) premarket notification for "Microtek Medical, Inc., Equipment Drapes." This device is a surgical drape designed to protect equipment from contamination. The information provided heavily focuses on regulatory aspects and substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria typically seen for AI/ML-based medical devices or devices with measurable diagnostic/performance outputs.

Based on the provided text, the acceptance criteria and study information are limited and primarily refer to material testing rather than clinical performance with human readers or AI.

Here's an attempt to extract and format the requested information, noting where specific data is not present in the provided text:

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

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: Not specified for the ASTM F 1671 testing.
• Data Provenance: Not specified.

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)

• Experts: Not applicable. The testing described (ASTM F 1671) is a laboratory material testing standard, not a clinical study requiring expert reviews for ground truth.
• Qualifications: Not applicable.

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

• Adjudication Method: Not applicable. This is not a clinical study involving 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

• MRMC Study: No. The device is a surgical drape, not an AI-assisted diagnostic tool.

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

• Standalone Performance: No. The device is a physical product (surgical drape), not an algorithm.

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

• Ground Truth: For the material testing (ASTM F 1671), the "ground truth" would be established by the standardized methods and controls defined within the ASTM standard itself, which dictates how viral penetration is measured and interpreted. It's a laboratory standard, not a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/ML product developed with training data.

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

• Training Set Ground Truth: Not applicable. This device is not an AI/ML product developed with training data.

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ChillBuster™ Portable Electric Blanket is to be used to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.

The ChillBuster™ Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Cabling, Battery, AC adapter, Carrying Bag.

This document appears to be a 510(k) Pre-market Notification Summary for a medical device called the "ChillBuster™ Portable Electric Blanket." It primarily serves to establish substantial equivalence to a legally marketed predicate device, rather than providing extensive details about a study demonstrating performance against specific acceptance criteria.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided in this type of submission.

Here's the breakdown based on the provided text, indicating where information is present versus where it's absent or not relevant for this document type:

Acceptance Criteria and Device Performance Study Details (K022903)

This 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than presenting a performance study with explicit acceptance criteria. The "acceptance criteria" here implicitly refer to meeting the requirements of the standards listed and performing equivalently to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. This document does not detail a specific performance study with a test set of data points or patients. The testing referenced is related to compliance with electrical and safety standards for the device itself, not a clinical data set.

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 / Not provided. No ground truth establishment for a test set is discussed in this 510(k) summary.

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

• Not applicable / Not provided. No test set or related adjudication method is mentioned.

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 portable electric blanket, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical medical device, not an algorithm.

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

• Not applicable / Not provided. No ground truth for a performance study is mentioned. The "ground truth" for this submission is implicitly the established safety and performance benchmarks of the predicate devices and the requirements of the cited industry standards.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/algorithm device, so there is no training set in the typical sense.

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

• Not applicable / Not provided. (See #8).

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VivoSonic™ will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between patient and medical imaging electronics and to lubricate the insertion and passage of imaging devices, such as ultrasound transducers and endoscopes.

VivoSonic™ is intended for use in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and opthalmic ultrasound imaging.

VivoSonic™ is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures which currently use and ultrasound coupling gel or fluid alone or in combination with a latex, non-latex, polyurethane or polyethylene transducer cover where sterility and/or in vivo biocompatibility are required.

VivoSonic™ is an in vivo biocompatible sterile ultrasound couplant and lubricant that couples or conducts ultrasound between the body and the ultrasound transducer and electronics.

The VivoSonic™ formulation is in vivo biocompatible with tissue and body fluids and is recognized as safe for oral administration (1)

This is a 510(k) Premarket Notification for the VivoSonic™ Diagnostic Ultrasound Imaging Coupling Media. This document does not contain information about the performance of an AI/ML device.

The provided text describes a medical device (ultrasound coupling media) and its intended use, and states that it is substantially equivalent to other legally marketed predicate devices. It covers regulatory information, device classification, and indications for use.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, study details, ground truth establishment, or human-in-the-loop performance, as these topics are not present in the provided submission for this type of device.

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