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MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.

MIC-KEY* SF Over-the-Wire Stoma Measuring Device is designed for measuring the length of a stoma prior to placement of a low profile feeding tube. The Stoma Measuring Device comprises a tubular shaft 10 Fr with graduated scale, an inflation valve and retaining balloon. The MIC-KEY* SF Over the Wire Stoma Measuring Device is made of polyurethane tubing, EtO sterilized and for single use. Like the predicate device, it is intended to be use in hospital environment.

This document describes the non-clinical tests performed on the MIC-KEY* SF Over-the-Wire Stoma Measuring Device to demonstrate its performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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The Aero Chrome* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Select Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.

The Aero Chrome* Select Breathable Performance Surgical Gown has a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Select Breathable Performance Surgical Gown in the non-critical zone also has the same Spunbond/Film/Spunbond/Meltblown/Spunbond fabric (SFSMS) that provides ASTM 1671 liquid barrier protection. The Aero Chrome* Select Breathable Performance Surgical Gown is single use, disposable medical device that will be provided in a variety of sizes and sterile and non-sterile packaging configurations.

The provided text describes a medical device, the Aero Chrome* Select Breathable Performance Surgical Gown, and its equivalence to a predicate device. The information details various performance tests and their results, which serve as criteria for establishing substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

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

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gowns, or material samples tested per batch). It only lists the tests performed and that the product "met the predetermined specifications."

The data provenance is industrial testing data, generated by Halyard Health, Inc. or its designated testing facilities, to demonstrate compliance with relevant industrial standards and regulations (e.g., AAMI, ISO, ASTM, CFR). The testing appears to be prospective in nature as it is being conducted to demonstrate the performance of a new 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. The device is a surgical gown, and its performance is evaluated against objective, standardized physical and biological parameters, not subjective expert assessment as would be the case for an AI diagnostic tool.

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

This information is not applicable for this type of device and testing. The tests involve quantifiable measurements according to established methods, not subjective interpretations requiring adjudication.

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

This is not applicable. MRMC studies are typically for diagnostic imaging devices where human interpretation is involved. This device is a surgical gown.

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

This is not applicable, as this is a physical medical device (surgical gown), not a software algorithm.

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

The "ground truth" for this device is defined by the established industry standards and regulatory requirements for surgical apparel. These standards specify objective, measurable performance criteria (e.g., liquid barrier effectiveness, flammability, biocompatibility).

8. The sample size for the training set:

This is not applicable. This is not a machine learning or AI device that requires a training set. The device's performance is tested against predetermined physical and biological standards.

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

This is not applicable, as there is no training set for this type of device. The ground truth for evaluating the device is based on established scientific and regulatory standards.

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The COOLIEF* Cooled Radiofrequency Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.

The COOLIEF* Cooled Radiofrequency (RF) Probe is a sterile, single-use device that delivers RF energy within the area of the active probe tip, while the probe tip is cooled by sterile water that circulates within the probe. Cooling the probe tip creates a larger. more homogenous RF heating area that results in a larger RF lesion in the target tissue. COOLIEF* Cooled RF Probe is used in conjunction with the Halyard RF Generator to create RF lesions in nervous tissue. The shaft of the probe is insulated with a polyimide sheath, and the distal tip consists of a medical grade stainless steel electrode. Sterile water circulates through a cavity in the electrode to cool the electrode tip during the cooled RF ablation procedure. The COOLIEF* Cooled Radiofrequency (RF) Probe is sterilized by ethylene oxide.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a singular section for clinical performance. Instead, it describes the effectiveness endpoint and provides the results.

Mean NRS pain reduction: 4.9 points (from 7.3 to 2.5) at 6 months.

Significant functional improvement: 39.7% reported "Satisfactory Joint Function" vs. 3% in comparison group.

Global Perceived Effect: 91.4% reported "improved" knee condition vs. 23.9% in comparison group. |
| Cytotoxicity | Qualitative Grade = 0; Quantitative = cell death

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The HALYARD* COOLIEF* Cooled Radiofrequency Kit, in combination with the HALYARD* Radiofrequency (RF) Generator (PMG-BASIC/PMG-ADVANCED) (formerly Baylis Pain Management Generator or KIMBERLY-CLARK® Pain Management Generator) is intended for the creation of Radio-Frequency (RF) heat lesions in nervous tissue for the relief of pain, and includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.

The COOLIEF* Cooled Radiofrequency (RF) Kit is similar in construction, materials, energy source, and intended use to the predicate TransDiscal Cooled Radiofrequency Kit, which is a part of the cleared TransDiscal System (K062937) that also includes a "Y connector cable for the probes, a cooling pump, and a pump connector cable that connects to the RF generator. The COOLIEF* Cooled RF Kit includes fluid delivery introducers, cooled probes, and a burette tubing assembly. The subject COOLIEF* Cooled Radiofrequency Kit is available in several configurations based on the anatomic region of use (i.e., available in various introducer and probe lengths, and active tip lengths). The kit is sterilized to a SAL of 10-6 by EO terminal sterilization. The Fluid Delivery Introducer is a sterile, non-pyrogenic single-use cannula with a fluid delivery port. It is used with cooled radiofrequency probes in conjunction with the Halyard Radiofrequency Pain Management Generator, with cooling pump, to create lesions in nervous tissue for the relief of pain.

This document is a 510(k) Pre-Market Notification for the HALYARD* COOLIEF* Cooled Radiofrequency Kit, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the new device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would.

The information provided describes the device, its intended use, and comparisons to a predicate device (TransDiscal Cooled RF Kit, K062937) and a reference device (Diros OWL Sterile Single-Use Trident R.F. Insulated Cannula models DTR and DTRH, K150371). The "acceptance criteria" here are implicitly the standards and features of the predicate device and the relevant biocompatibility and mechanical test standards.

Here's an analysis of the provided text in the context of your request:

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

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of numerical thresholds for clinical efficacy or diagnostic accuracy. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics, materials, and a series of non-clinical performance tests against established standards and the predicate device.

The "acceptance criteria" can be inferred as:

• Compliance with ISO standards for biocompatibility, sterility, mechanical properties, and electrical safety.
• Similar performance to the predicate device in terms of RF lesion creation, if not explicitly quantified.
• Functionality of the new fluid delivery system (side port with extension tubing).

Here’s a summary table based on the provided "Summary of Non-Clinical Testing (Performance Testing)" and "Biocompatibility Testing":

The "study that proves the device meets the acceptance criteria" is the collection of non-clinical tests summarized, demonstrating compliance with various ISO standards and equivalence in performance to the predicate and reference devices.

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 primarily describes non-clinical (bench) testing. For such tests, "sample size" refers to the number of units tested for mechanical properties, biocompatibility, etc. This specific numerical sample size is not explicitly provided in the summary for individual tests (e.g., how many cannulas were tested for bond strength). The data provenance is from internal testing conducted by the manufacturer (Halyard Health, Inc.), implicitly in the USA. These are prospective tests conducted on the newly designed device components.

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 section is not applicable. The "ground truth" concept is typically relevant for diagnostic or AI-based devices where human expert interpretation is compared to device output. For a physical medical device like a radiofrequency kit, performance is evaluated against engineering specifications, material standards, and functional tests, not against expert-established ground truth in a clinical sense.

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

This section is not applicable for the reasons stated above (non-clinical testing of a physical device).

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 section is not applicable. An MRMC study is relevant for diagnostic imaging devices or AI tools involving human interpretation. This submission is for a therapeutic radiofrequency ablation kit.

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

This section is not applicable. This is not an AI algorithm. The device performance is the physical device's ability to create lesions and deliver fluids, which is tested directly.

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

As mentioned, true "ground truth" as typically defined for AI or diagnostic devices is not applicable. The "ground truth" for this device's performance validation is its adherence to:

• Established ISO standards for biocompatibility and mechanical properties.
• Functional requirements (e.g., fluid flow, lesion size in a tissue model).
• Equivalence to the predicate device's known performance.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The device is validated through engineering and bench testing, not through training on data.

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

This section is not applicable for the reasons stated above.

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The Aero Chrome* Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.

The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization

The Aero Chrome* Breathable Performance Surgical Gowns have a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.

The provided document is a 510(k) premarket notification for a medical device: the Aero Chrome Breathable Performance Surgical Gown*. This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving novel efficacy or safety through primary clinical trials for the device itself. Therefore, the "study" proving the device meets acceptance criteria primarily consists of non-clinical performance testing to show that the new device performs at least as well as, or equivalently to, the predicate device in relevant aspects.

Here's an analysis of the acceptance criteria and the provided information:

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

The document doesn't present a single consolidated "acceptance criteria" table as one might find for a diagnostic AI device with precision/recall metrics. Instead, it details various performance tests demonstrating compliance with recognized standards for surgical gowns. The acceptance criteria for each test are implicitly (or explicitly, as "Pass") stated as meeting the requirements of the specified standard.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. Standard test methods (e.g., ASTM, ISO, AAMI) typically define the minimum sample sizes required for statistically valid testing. For example, for textile testing (tensile strength, abrasion), there would be a specified number of specimens. For biocompatibility (cytotoxicity, irritation, sensitization), there would be a defined number of replicates and control groups.
• Data Provenance: The data comes from the manufacturer's (Halyard Health, Inc.) own non-clinical performance testing. It is not explicitly stated if these were internal labs or third-party labs, but generally, such tests are conducted in controlled lab environments. The document does not specify a country of origin for the data; it's implicit to be associated with Halyard Health's operations for regulatory submission in the US.
• Retrospective or Prospective: These are prospective tests performed specifically to demonstrate that the newly designed Aero Chrome* gown meets the required performance standards for its intended use and for comparison with the predicate device.

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 in the context of this device and submission. This is a surgical gown, not an AI/diagnostic device that relies on expert interpretation of images or patient data to establish ground truth. The "ground truth" for a surgical gown's performance is established by objective, measurable physical, chemical, and biological properties, as defined by recognized consensus standards (e.g., AAMI, ISO, ASTM). The expertise lies in conducting the tests according to the standard protocols and interpreting the quantitative results against the specified pass/fail criteria.

4. Adjudication method for the test set:

• This question is not applicable. Since the "ground truth" is established through objective laboratory testing against predefined standards (e.g., a specific resistance value, a pass/fail for bacterial penetration), there is no human "adjudication" in the sense of multiple readers or experts reviewing subjective data. The test results are quantitative/qualitative outcomes of physical/chemical processes.

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 question is not applicable. This is a physical medical device (surgical gown), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

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

7. The type of ground truth used:

• The ground truth for this device's performance is established by objective, quantitative measurements and qualitative assessments derived from standardized laboratory test methods (e.g., AAMI PB70:2012, ASTM D5034, ISO 10993 series). These standards define specific criteria (e.g., pressure resistance, microbial penetration, tensile strength limits, cytotoxicity levels) that the device must meet. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic tool would be.

8. The sample size for the training set:

• This question is not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The manufacturing process of surgical gowns involves material selection, design, and fabrication, which are validated through process controls and quality assurance, not through a "training set" of data.

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

• This question is not applicable for the reasons stated above.

In summary: The submission for the Aero Chrome* Breathable Performance Surgical Gown focuses on demonstrating substantial equivalence to a predicate device (Aero Blue* Performance Surgical Gown) by providing comprehensive non-clinical performance test results against established industry standards. The "acceptance criteria" are the "Pass" outcomes for each of these standardized tests, indicating that the gown meets the specified physical, chemical, and biological performance requirements relevant to its intended use as protective apparel. The evaluation does not involve clinical studies with human "readers" or AI algorithms.

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The Expanded Chamber Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The product is a face mask utilizing an expanded chamber design consisting of nonwoven spunbond, nonwoven meltblown, and nonwoven inside layer material, nosepiece, and nonwoven ties and may be produced with or without a visor.

This document describes the regulatory clearance for the FLUIDSHIELD* Surgical Mask with Expanded Chamber (K143287). The information provided is primarily for regulatory purposes and focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study with detailed performance metrics in humans.

Here's a breakdown of the requested information based on the provided text:

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

The device is evaluated against the ASTM F2100-11 Level 2 Surgical Mask standard. The acceptance criteria are implicitly defined by this standard, and the device reports meeting these.

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

The document does not provide details on sample sizes for the performance tests (e.g., how many masks were tested for BFE or PFE). The data provenance is also not mentioned, as these are likely laboratory tests conducted for regulatory compliance by the manufacturer.

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

This is not applicable as the document describes physical and biological performance testing of a surgical mask, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the adherence to established industry performance standards (ASTM F2100-11).

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

Not applicable. The performance testing of surgical masks against standards does not typically involve adjudication methods like those used in clinical studies with human readers.

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 document is for a physical medical device (surgical mask), not an AI-powered diagnostic tool.

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

Not applicable. This document is for a physical medical device (surgical mask), not an algorithm.

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

The "ground truth" used for evaluating the device's performance is adherence to established industry performance standards (ASTM F2100-11 for Level 2 surgical masks) and other relevant standards (MIL-M-36954C, ASTM F2299, ASTM F2101, 16 CFR Part 1610, ASTM F1862, ISO 10993). These standards define the acceptable range or threshold for each performance characteristic.

8. The sample size for the training set

Not applicable. This document describes the regulation of a physical product, not a machine learning model.

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

Not applicable. This document describes the regulation of a physical product, not a machine learning model.

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The MiniStim* MS-IVB is a battery powered Peripheral Nerve Stimulator for monitoring the effects of skeletal muscle relaxants.

The MS-IVB is a nerve stimulator with selectable stimulus output waveforms and adjustable output amplitude. The stimulus output is intended for monitoring the depth of patient muscle and nerve relaxation while

This document is a 510(k) summary for the MiniStim* Peripheral Nerve Stimulator – Model MS-IVB, indicating it is a premarket notification for a medical device. This type of document is not designed to contain acceptance criteria and detailed study results in the typical sense of a clinical trial or algorithm performance study.

Instead, the "acceptance criteria" here refer to the device meeting various standards and demonstrating substantial equivalence to a predicate device through non-clinical testing. The "study" that proves the device meets these criteria is a series of non-clinical tests.

Here's a breakdown of the requested information based on 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
The document discusses non-clinical testing of the device itself, not a test set of data from patients. Therefore, sample size and data provenance in the context of patient data are not applicable. The "sample" would refer to the physical device(s) tested. The provenance of the testing is internal to the manufacturer (Halyard Health, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes non-clinical engineering and software verification tests for the device, not a study evaluating human interpretation or a machine learning algorithm's performance against expert-established ground truth.

4. Adjudication method for the test set
This is not applicable for the same reasons as points 2 and 3. The testing involves verifying device specifications and adherence to standards, not human expert adjudication of diagnostic outcomes.

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 document describes a traditional medical device (peripheral nerve stimulator), not an AI/ML-driven diagnostic or assistive technology that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" would be established engineering specifications and international standards (e.g., IEC 60601 for safety, predefined waveforms for output verification, expected software behavior).

8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.

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