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ON-Q* Pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative and postoperative regional anesthesia and/or pain management. Routes of administration include: intraoperative site, peripheral nerve block, percutaneous and epidural.

ON-Q* Pump is indicated to significantly decrease pain and narcotic use when used to deliver local anesthetics to or around surgical wound sites, or close proximity to nerves, when compared to narcotic only pain management.

ON-Q* Pump with Bolus device is intended for users 18 years of age and older.

The ON-Q* Pump with Bolus consists of an elastomeric pressure source (i.e. elastomeric pump) with an integrated administration set/line. The ON-Q* Pump with Bolus delivers continuous infusion (basal) and allows incremental fixedvolume boluses to be delivered on demand by the patient. In addition to the optional bolus component, the administration line may contain any of the following optional components:

• Filter
• Select-A-Flow variable flow rate assembly ●
• Y-adaptor ●

The bolus component controls the bolus and/or basal flow rate capability of the administration set that connects to the elastomeric pump. The bolus component is an integrated part of the pump system and cannot be used alone. The patient or healthcare provider presses a button to activate bolus delivery. The refill time determines the patient must wait prior to receiving another full bolus dose.

I am sorry, but the provided text does not contain any information about acceptance criteria for a medical device or a study proving that the device meets those criteria. The document appears to be an FDA 510(k) summary for a device called "ON-Q* Pump with Bolus," which discusses substantial equivalence to a predicate device.

The document includes:

• A brief description of the device and its intended use.
• A comparison of the subject device (ON-Q* Pump with Bolus) to a predicate device (K063530) in terms of indications for use, user population, environment of use, and technological characteristics.
• Discussions of differences in technological characteristics and explanations that these differences do not raise new questions of safety or effectiveness.
• A section on "Performance Testing" which lists various types of bench testing, design validation, human factors evaluation, packaging verification, sterilization verification, biocompatibility, drug stability, and MR compatibility that were performed. However, it does not specify concrete acceptance criteria with numerical targets or report the device's performance against such criteria in a tabular format as requested.
• It explicitly states "Clinical Tests: Not Applicable."

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance, or details about the sample size, data provenance, ground truth establishment, or clinical study methods, as this information is not present in the provided text.

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The Halyard Lavender Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:

• Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes
• Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes
• Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes
• 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes
• Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes
• Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes
• Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes
• Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes
• Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes
• Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes
• Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes
• ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes
  Warning: Not for Use With : Carmustine, ThioTEPA

Halyard® Lavender Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, lavender-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.

The provided text describes the regulatory clearance (510(k)) for a medical device: "Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study evaluating AI-powered diagnostic performance. Therefore, many of the requested elements for AI/diagnostic device acceptance criteria and study design (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training sets) are not applicable to this type of device and regulatory submission.

However, I can extract the acceptance criteria and performance data relevant to this product, which primarily involve physical and chemical resistance standards for medical gloves.

Here's the information gleaned from the provided text, adapted to the context of this device:

Device: Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

Type of Regulatory Submission: 510(k) Premarket Notification (demonstrates substantial equivalence to a predicate device)

Study Focus: Performance of the glove against established consensus standards for medical gloves and resistance to chemotherapy drug permeation. This is not a study evaluating AI diagnostic performance or human reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document doesn't explicitly state the exact sample sizes for each test (e.g., number of gloves tested for holes, powder). However, it indicates compliance with recognized consensus standards (e.g., ASTM D5151-06, ASTM D6319-10, ASTM D6978-05). These standards prescribe specific sampling plans and test methodologies.

• Data Provenance: The studies were conducted by the manufacturer, Halyard Health, Inc., based in Alpharetta, Georgia, USA. The data is prospective, generated specifically for this 510(k) submission to demonstrate compliance with the referenced standards. The country of origin of the data would therefore be the USA.

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 this type of device and study. The "ground truth" for glove performance is established by the specified methodologies and measurement limits defined within the ASTM and ISO standards themselves, not by human expert consensus or interpretation of images. The tests are laboratory-based, objective measurements (e.g., time to breakthrough, AQL for holes, mg of powder, tensile strength).

4. Adjudication Method for the Test Set:

• None. As explained above, the tests are objective laboratory measurements, not subjective human interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for AI-assisted diagnostic devices where human readers interpret medical images or data. This document describes the physical and chemical properties of a medical glove.

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

• No. This question is not applicable. The device is a physical glove, not an algorithm.

7. The Type of Ground Truth Used:

• Objective laboratory measurements and compliance with established consensus standards. The "ground truth" for this device's performance is derived from the results of standardized physical, chemical, and biological tests, as outlined by ASTM and ISO specifications.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve machine learning or AI models, and therefore does not have a "training set" in that context.

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

• Not applicable. As above, there is no training set. The "ground truth" for the performance claims relies on the adherence to and results from validated test methods defined by international standards.

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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

Biocompatibility tests were also conducted and all met acceptance criteria:

• ISO 10993-1
• AAMI ANSI ISO 10993-5
• ISO 10993-10
• ISO 10993-11

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

The document does not explicitly state the specific sample size for each test. However, it indicates "Performance testing on the device under submission was conducted to demonstrate the modified device continued to meet performance specification." The data provenance is not specified, but these are non-clinical verification tests, likely conducted in a laboratory setting by 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:

Not applicable. This study focuses on physical and material performance of a medical device, not on expert interpretation of data. The "ground truth" for these tests are the defined engineering and material standards (e.g., N, Fr size, lbf, psi).

4. Adjudication method for the test set:

Not applicable. These are objective engineering and material tests with pass/fail criteria based on established standards. There is no mention of human adjudication for these non-clinical tests.

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

Not applicable. This device is a physical medical instrument for measuring stoma length, not an AI or diagnostic imaging device that involves human readers.

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

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

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

The ground truth used for the non-clinical tests are established engineering standards, material specifications, and quality control metrics (e.g., EN 1615:2000, ASTM F 2528-06, ISO 14971:2012, ISO 10993 series).

8. The sample size for the training set:

Not applicable. This is a non-clinical performance study of a physical device, not an AI algorithm requiring a training set.

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

Not applicable. There is no training set for this type of device performance study.

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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.

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

• Clinical Study Test Set Sample Size: The document indicates an Intent-to-Treat (ITT) population for the primary effectiveness endpoint.
  • COOLIEF* Cooled RF (CRFA) group: 76 subjects
  • Corticosteroid Injection (IAS) group: 75 subjects
• Data Provenance: The clinical study was a prospective, multicenter, randomized comparative human study. The document does not specify the country of origin, but given the FDA submission, it's typically a US-based or international study adhering to US regulatory standards.

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

This question is not applicable in the context of this device and study. The "ground truth" for the clinical study was based on patient-reported outcomes (Numeric Rating Scale for pain, "Satisfactory Joint Function" report, Global Perceived Effect) and a diagnostic genicular nerve block response for patient selection, not expert consensus on images or pathology.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where subjective assessments (e.g., image interpretation) need to be resolved. This clinical study focused on patient-reported outcomes and objective measures (like pain scale changes), so a formal adjudication method as commonly understood in imaging studies would not be directly applicable. The "ground truth" was directly from the patient or objective measurements.

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

No, an MRMC comparative effectiveness study was not done. The study was a randomized controlled trial comparing the device (COOLIEF Cooled RF Probe) to a control treatment (corticosteroid injection)* for pain management in patients, not a study evaluating human readers' performance with and without an AI algorithm.

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

This is not an AI/algorithm-based device. The COOLIEF* Cooled RF Probe is a medical device that physically delivers radiofrequency energy. Therefore, the concept of a "standalone algorithm performance" does not apply. The study evaluated the device's therapeutic effect.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth for the clinical effectiveness study was:

• Outcomes Data (Patient-Reported Outcomes): Numeric Rating Scale (NRS) for pain reduction, patient reports of "Satisfactory Joint Function," and Global Perceived Effect of knee condition.
• Diagnostic Response: Patients were selected based on a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block, serving as an inclusion criterion rather than a "ground truth" for the clinical outcome itself.

For the non-clinical tests, the ground truth was derived from established scientific and regulatory standards (e.g., ISO guidelines) and laboratory measurements (e.g., cell death percentage for cytotoxicity, animal responses for sensitization/irritation/toxicity).

8. The Sample Size for the Training Set

This is not an AI/machine learning device, so there is no "training set" in the conventional sense for an algorithm. The clinical study was a prospective comparative trial to evaluate the device's performance directly on human subjects.

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

As noted above, there is no "training set" for an algorithm. The clinical data was collected from the prospective human study to directly assess the safety and effectiveness of the device.

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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 EZstim*III is a battery powered Peripheral Nerve Stimulator/Nerve Locator with two (2) indications for use:

(1) on the high (0.05 - 80 mA) output current range, the device is used to monitor the effects of skeletal muscle relaxants during general anesthesia.

(2) on the low (0.05-5.0 mA) output current range, it is used as a Nerve Locator to help locate the tip of a hypodermic needle near the nerve to which local anesthesia is to be delivered in Regional Nerve Block procedures.

The EZstim* III (Model ES500) is both a constant current Peripheral Nerve Stimulator (HIGH output current range) and a Peripheral Nerve Locator (LOW output current range). Output current range is determined by the model of patient lead cable connected to the unit.

• . When the Halyard NSL-5 patient lead cable is connected, the unit automatically sets to the HIGH output current range (0.05 to 80 mA), with no stimulus mode selected (null mode). When the user selects a stimulus mode (i.e., 1 or 2 Hz Twitch, 50 Hz Tetanus, 100 Hz Tetanus, Double-Burst, or Train-of-Four), the unit functions as a nerve stimulator for use in monitoring the effects of skeletal muscle relaxants on the neuromuscular junction.
• . When the Halyard RBW-5U patient lead cable is connected, the unit automatically sets to the LOW output current range (0.05 to 5.0 mA). In this range, the unit functions as a nerve locator for use in regional nerve block procedures.

The provided documentation describes the Halyard Health EZstim* III Peripheral Nerve Stimulator/Nerve Locator (Model ES500), which is a medical device. This device is not an AI/ML device, therefore, many of the requested criteria are not applicable.

Here's an analysis of the acceptance criteria and study information provided for this medical device, tailored to what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test mentioned (e.g., number of devices tested for EMC, number of software modules tested). It generally states that "testing of the EZstim* III Peripheral Nerve Stimulator/Nerve Locator was performed."

• Data Provenance: The tests are non-clinical (laboratory-based) and conducted to demonstrate compliance with recognized standards and internal design requirements. They are presumably prospective in the sense that the tests were designed and executed specifically for this device submission. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities or accredited test labs.

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

• This question is not applicable as the device is a hardware medical device, and the evaluation relies on engineering and regulatory compliance testing rather than expert-derived ground truth as would be used for AI/ML diagnostic devices.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus, which are not relevant to the non-clinical engineering and regulatory compliance tests performed for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• This question is not applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers in interpreting medical images or data. The EZstim* III is a peripheral nerve stimulator/locator, a hardware device with a direct physiological function, not an interpretative AI. No human reader assistance is involved in its direct function.

6. Standalone (Algorithm Only) Performance

• This question is not applicable. The device is not an algorithm; it is a physical hardware device with embedded software. The software verification test (mentioned in the table) assesses the software's functionality as part of the overall device system, but there is no "standalone algorithm" performance assessed separately from the device's hardware.

7. Type of Ground Truth Used

• The "ground truth" for the tests performed is based on engineering specifications, recognized international standards (IEC 60601-1, IEC 60601-1-2, ASTM D4169-14), and internal design input requirements. These are objective, measurable performance benchmarks rather than expert consensus, pathology, or outcomes data, which are typically used for diagnostic or predictive AI/ML models.

8. Sample Size for the Training Set

• This question is not applicable. The device is not an AI/ML algorithm that undergoes a "training phase." The "training set" concept is not relevant to its development and testing.

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

• This question is not applicable for the same reason as point 8.

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The ON-Q* EchoSpark* Echogenic Catheter is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.

The ON-Q* EchoSpark* Echogenic Catheter is indicated for patients undergoing continuous regional anesthesia and pain management procedures.

The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.

The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for patients undergoing continuous regional anesthesia and pain management procedures.

The ON-Q* Echogenic Catheter is a closed tip catheter composed of polyamide nylon (Pebax) tubing that contains two radiopaque barium sulfate stripes, black pad printed depth markings, and a stainless steel echogenic screw tip that is visible under ultrasound. The catheter assembly will also include a stylet composed of Nitinol wire with an ABS Finger holder and a polypropylene thread assist guide in a sterile Tyvek and polyester pouch.

ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is designed for the Regional Anesthesia market to deliver medication for regional anesthesia and pain management. The Kit contains multiple components; one being Halyard Health's new Echogenic Catheter. The Echogenic Catheter is a closed tip catheter composed of polvamide nylon (Pebax) tubing that contains two radiopaque barium sulfate stripes, black pad printed depth markings, and a stainless steel echogenic screw tip that is visible under ultrasound. The catheter assembly will also include a stylet composed of Nitinol wire with an ABS Finger holder and a polypropylene thread assist quide in a sterile catheter sleeve composed of Tyvek and polyester.

Here's a breakdown of the acceptance criteria and study information, based on the provided document. It's important to note that this document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit acceptance criteria for performance metrics like sensitivity/specificity.

The provided documents describe two devices:

1. ON-Q EchoSpark Echogenic Catheter** (K161232)
2. ON-Q T-bloc Echogenic Continuous Nerve Block Kit** (K161232)

Both devices reuse part of the same summary. The information provided heavily emphasizes comparison to predicate devices and adherence to standards, rather than defining specific performance metrics against clinical ground truth.

For the ON-Q EchoSpark Echogenic Catheter (K161232):**

The acceptance criteria here are primarily about demonstrating substantial equivalence to the predicate device (ON-Q* Pain Relief System, QuikBloc* Over-the-Needle Catheter Set, K143164) and compliance with relevant performance standards and biocompatibility requirements. There are no explicit quantitative performance metrics like sensitivity/specificity for the echogenic catheter's visibility that are stated as acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the sense of patient data for evaluating diagnostic performance. The testing described is primarily engineering performance testing (e.g., against ISO standards, biocompatibility).

• Sample Size: Not specified for any clinical or image-based test set, as such a study is not detailed. For engineering tests, the sample sizes would be described within the individual test protocols (e.g., number of catheters tested for tensile strength, number of animals in biocompatibility).
• Data Provenance: Not applicable for a clinical test set from this document. The engineering tests likely originate from the manufacturer's labs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical test set with human-established ground truth is described.

4. Adjudication Method for the Test Set
Not applicable. No clinical test set with expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study is not mentioned. The device is a physical medical device (catheter) for drug delivery, not an AI diagnostic algorithm. The primary "improvement" is the echogenic tip for better visibility under ultrasound, which is a design feature rather than an AI-driven enhancement.

6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical catheter, not a standalone algorithm.

7. Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on adherence to recognized international and national standards for medical devices (ISO, ASTM, EN), biocompatibility testing results, and the safety and performance characteristics of its predicate device. For the "echogenic" attribute, the ground truth would be the physical property of being visible under ultrasound, demonstrated through product design and potentially in vitro/in vivo bench testing.

8. Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained.

9. How the Ground Truth for the Training Set Was Established
Not applicable.

For the ON-Q T-bloc Echogenic Continuous Nerve Block Kit (K161232):**

Similar to the individual catheter, the acceptance criteria are predominantly about demonstrating substantial equivalence to its predicate device (Peripheral Nerve Block Tray, K073187) and compliance with relevant standards. The key distinguishing feature is the inclusion of the new Echogenic Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance
Not applicable for a clinical "test set" in the AI sense. Primarily engineering and component-level testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable.

4. Adjudication Method for the Test Set
Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study is not mentioned.

6. Standalone (Algorithm Only) Performance
Not applicable.

7. Type of Ground Truth Used
The "ground truth" for this kit's acceptance is based on adherence to recognized standards, biocompatibility, and the safety and performance of its predicate device, incorporating the design and testing of the Echogenic Catheter component.

8. Sample Size for the Training Set
Not applicable.

9. How the Ground Truth for the Training Set Was Established
Not applicable.

Overall Summary regarding AI/Software Performance:

The provided documents are for physical medical devices (an anesthesia catheter and a nerve block kit). They do not describe an AI or software device, nor do they detail clinical studies with human readers or AI algorithms for diagnostic performance. Therefore, many of the requested points related to AI performance metrics, training/test sets, expert ground truth, and reader studies are not applicable to this submission. The focus is on demonstrating substantial equivalence in terms of intended use, technology, materials, and compliance with general device safety and performance standards.

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HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes.

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12" disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that have been tested for use with chemotherapy drugs.

The provided text describes the acceptance criteria and performance data for HALYARD PURPLE NITRILE – XTRA Powder-Free Exam Gloves**, specifically regarding their resistance to chemotherapy drugs and other physical properties.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for permeation, holes, etc.). However, it refers to industry standards (ASTM, ISO) which typically include defined sampling plans.

• Data Provenance: The testing was conducted by Halyard Health, an American company. The data is retrospective, as it was submitted for a 510(k) premarket notification to demonstrate substantial equivalence to an already marketed device. The specific country of origin for the raw test data is not stated but would presumably be the testing labs contracted by Halyard Health.

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

This information is not applicable to this type of device and study. The "ground truth" here is based on objective, standardized laboratory tests according to ASTM and ISO standards, not expert interpretation of medical images or clinical outcomes. The results are quantitative measurements (e.g., breakthrough time, physical dimensions, AQL values) determined by laboratory protocols.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the tests are objective, standardized laboratory measurements, not subjective evaluations requiring adjudication.

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

This is not applicable. This is a study on the physical and chemical barrier properties of medical gloves, not an AI-based diagnostic device requiring MRMC studies.

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

This is not applicable. This is a physical medical device (gloves), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" is established through standardized laboratory testing and measurements based on widely accepted international and national standards (ASTM D6978-05, ASTM D5151-06, ASTM D6124-06, ASTM D6319-10, ISO 10993-10, ISO 10993-11). These standards define the methodologies for assessing properties like chemical permeation, presence of holes, residual powder, and physical characteristics.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device being tested against established performance standards, not an AI model that requires a "training set."

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

This is not applicable for the same reason as point 8.

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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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