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The OtoSet - Ear Cleaning System (OtoSet) is indicated to remove earwax from the external ear canal with irrigation and suction in adults.

The OtoSet – Ear Cleaning System (OtoSet) is an automated ear irrigation device used to remove earwax, or cerumen, from the external ear canal of adults. The OtoSet consists of an adjustable head strap, two ear units, two single-patient-use disposable ear tips, and two singlepatient-use disposable waste containers.

In addition to the disposable ear tips and waste containers, each ear unit houses a solution container, liquid pump, vacuum pump, printed circuit board electronics, rechargeable batteries, and electrical and plumbing elements to connect these items together. The device can be used to clean the left, right, or both external ear canals at the same time.

The OtoSet includes components that come in contact with the patient during use. The singlepatient-use disposable ear tips, ear pads and head strap pad (all made of silicone rubber) are surface contacting components having limited contact duration (< 24 hours) with intact skin.

The provided text describes the submission of the SafKan OtoSet Ear Cleaning System for 510(k) clearance. The focus of the clinical testing was to demonstrate the effectiveness of earwax removal and equivalence to a predicate device, rather than strictly defining acceptance criteria with specific thresholds for performance metrics.

However, based on the information provided, we can infer some "acceptance criteria" through the objective of the clinical studies and the results presented.

Here's an attempt to structure the information based on your request, acknowledging that explicit numerical acceptance criteria are not detailed in this FDA document for this Class I device.

Implied Acceptance Criteria and Reported Device Performance for the OtoSet Ear Cleaning System

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

2. Sample Sizes and Data Provenance for the Test Set

• Study 1 (Equivalence):
  • Sample Size: 31 subjects, 62 ears.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given that it's clinical testing for a 510(k) submission, it's highly likely to be prospective data collected specifically for this purpose.
• Study 2 (Effectiveness):
  • Sample Size: 23 subjects, 31 ears.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Likely prospective.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish ground truth or their qualifications.
• The studies used a "0-3 Degree of Occlusion Scale" to assess earwax removal. This scale likely involves a clinical assessment by a trained medical professional (e.g., an ENT specialist, nurse, or physician) examining the ear canal, but the specific individuals establishing this "ground truth" for the study are not detailed.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method (e.g., 2+1, 3+1) for the ground truth assessment in the clinical studies. Since the "ground truth" here is a clinical assessment of earwax obstruction rather than, for example, image interpretation, a multi-reader adjudication method might not have been applicable in the traditional sense. It's more likely a single trained clinician made the assessment.

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

• No, an MRMC comparative effectiveness study was not explicitly done. The clinical studies focused on comparing the device's performance to a predicate device and evaluating its standalone effectiveness in earwax removal. This is a Class I device, and the type of comparative effectiveness study typically seen with AI algorithms reading medical images (i.e., human readers with/without AI assistance) is not relevant here.

6. Standalone (Algorithm Only) Performance

• This concept is not applicable here. The OtoSet is a physical medical device, not an AI algorithm. Its "standalone performance" refers to its direct application in earwax removal by a user (clinical staff or patient, depending on prescription status). The clinical studies evaluated the performance of the device itself (though operated by a user), not an algorithm's performance independent of human interaction.

7. Type of Ground Truth Used

• The ground truth used was based on a "0-3 Degree of Occlusion Scale" which represents a clinical assessment of earwax removal. This is a form of clinical assessment/outcome data related to the device's intended use.

8. Sample Size for the Training Set

• Not applicable / Not disclosed. This device is a physical medical device. It does not use machine learning algorithms that require "training sets" in the conventional sense. The "training" for this device would refer to its design and engineering iterations, followed by verification and validation testing (non-clinical and clinical), but not a data-driven "training set" for an algorithm.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As stated above, there is no "training set" in the context of machine learning for this device.

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The Single Cannula Extended Applicator is intended for medical purposes to irrigate or instill fluids to a wound or body cavity.

The Single Cannula Extended Applicator has two components: an applicator instrument and a replaceable spray tip. The spray tip is assembled to the instrument by the user. The assembled applicator product is installed on a standard medical syringe, and allows fluids to be applied from the syringe to a treatment site that is otherwise difficult to access. The entire device is packaged sterile and labeled for single-use. The applicator instrument contains a stainless steel hypodermic tube with a molded polymer luer lock connector on the input (proximal) end. It is enclosed in a stainless steel sheath that provides rigidity and allows the device to effectively seal off in a 5mm endoscopic cannula. A replaceable molded polymer spray tip is attached to the output (distal) end of the sleeve by the user. A replacement tip is included in the package.

The provided document describes a 510(k) submission for a medical device called the "Single Cannula Extended Applicator." This device is intended for medical purposes to irrigate or instill fluid to a wound or body cavity. The submission aims to demonstrate substantial equivalence to a predicate device, the "Biomaterial Spray Syringe" (K982372).

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details nonclinical tests performed to demonstrate the device's design suitability for its intended use. The document states, "All test results meet the acceptance criteria and demonstrate that the device is appropriately designed for the intended use." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of tests performed.

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

The document does not specify the sample sizes for the nonclinical tests (Leak test, Flow test, Pull test, Fit and sealing, ISO-594-1). It only states that "Micromedics, Inc. conducts risk analysis and design verification tests are based on the result of these analyses."

Regarding data provenance, all listed tests are nonclinical, performed by the manufacturer, Micromedics, Inc. Therefore, the data provenance is internal to the manufacturer, within the United States (where Micromedics, Inc. is located). The testing is prospective for the current device and retrospective in terms of experience with the predicate.

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

This information is not applicable as the document describes nonclinical tests, not a study involving expert-established ground truth for medical imaging or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states: "No clinical tests have been performed on the Single Cannula Extended Applicator or the predicate."

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not conducted. This device is a manual, mechanical applicator, not an algorithm or software. The "performance" is demonstrated through nonclinical engineering tests.

7. Type of Ground Truth Used

The "ground truth" for the nonclinical tests was established by engineering specifications, recognized standards (like ISO-594-1), and design requirements derived from risk analysis. It does not involve expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm or a system that requires a "training set" for its development. Its performance is based on its mechanical design and materials.

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

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

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Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired.
Tissu-Trans™ is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.

Tissue-Trans™ is a sterile, single use, disposable syringe device used in the harvesting, filtering and transferring of autologous fat. Used by acinso asounding procedures,Tissue Trans™ simplifies and reduces the steps prysiolane in the collection and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection.
Tissu-Trans™ is a piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small10cc syringe is placed inside a larger 60cc barrel type tube, which is attached to a medical grade tubing and aspiration machine. As the autologous fat is collected into the 10cc syringe, the waste products are strained through the holes in the 10cc syringe into the large 60cc barrel tube and suctioned into a waste container. The small syringe is removed from the large 60cc tube, a sleeve is attached to the small 10cc syringe around the barrel and the autologous fat is re-injected into the patient at desired locations.

The provided document is a 510(k) summary for a medical device called Tissu-Trans™ by Shippert Medical Technologies. It focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for the device itself is not available in this type of submission.

Here's an attempt to answer the questions based on the provided text, while also noting what information is not available in this type of regulatory document.

Explanation of the Submission Type:
A 510(k) premarket notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process often relies on comparisons of technological characteristics, intended use, and materials to show that the new device is as safe and effective as the predicate. It does not typically require extensive clinical trials or performance studies with detailed acceptance criteria and ground truth validation for the new device as would be seen for novel technologies or higher-risk devices.

Acceptance Criteria and Study Details for Shippert Medical Technologies Tissu-Trans™

Given the nature of a 510(k) premarket notification, the "acceptance criteria" for the device itself in terms of specific performance metrics (like accuracy, sensitivity, specificity, or error rates) are not explicitly stated or demonstrated through a formal performance study with a test set, ground truth, or expert adjudication as one might see for an AI/CAD system. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. This means that if the new device has similar technological characteristics, intended use, and materials to a legally marketed predicate, it is deemed acceptably safe and effective.

The study that "proves" the device meets these criteria is primarily the comparison to predicate devices described in the 510(k) submission.

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 the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: For a 510(k) submission based on substantial equivalence to an existing device, there isn't typically a "test set" in the sense of a dataset used to validate performance metrics like accuracy or error rates for the new device. The "test" is the comparison to the predicate device's design, materials, and intended use. No specific data provenance (country, retrospective/prospective) is relevant to this type of comparison.

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: As there is no "test set" with performance metrics requiring ground truth in this 510(k) summary, no experts were involved in establishing ground truth for a performance study of the Tissu-Trans™ device. The FDA reviews the provided information to determine substantial equivalence.

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

• Not Applicable / None: No adjudication method was used for a test set, as no such performance study is described in this 510(k) summary.

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

• No: This is not an AI/CAD device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• No: This is not an AI/CAD device. Therefore, no standalone algorithm performance study was done.

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

• Not Applicable / None: No ground truth was established for a performance study of the Tissu-Trans™ device itself. The "ground truth" for a 510(k) is effectively the established safety and effectiveness of the predicate device(s).

8. The sample size for the training set

• Not Applicable / None: This is not a machine learning or AI device that would require a training set.

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

• Not Applicable / None: As there is no training set for this device, no ground truth was established for it.

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The QS Delivery System is intended for the delivery of hemostatic agents that can be mechanically mixed and delivered to bleeding sites.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "QS Delivery System." This document is a regulatory approval letter and an "Indications for Use Statement." It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the given text. The document confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed, but does not detail the scientific studies or performance data that would typically be included in a technical report or submission summary.

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The SUB-Q, Inc. Irrigation Syringe Kit is intended to be used in body cavities and wound sites to irrigate or deliver general wound management materials, such as saline, and other FDA cleared solutions.

Irrigation Syringe Kit

This document is a 510(k) clearance letter for an "Irrigation Syringe Kit" and does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

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The Zerowet Splashield is intended for use as an accessory to an irrigation syringe. It is intended to be attached to the end of said syringe during wound irrigation, in place of the commonly used needle, thereby eliminating the use of a needle during this procedure. Additionally, the Zerower Splashield protects the user from contaminated (bloody) fluid splashing back during wound irrigation.

The device of the current submission is an unsterilized styrene bell-shaped unit, with a 19g nozzle integrated in the stem which attaches to the end of a syringe. The intended use is as attached to the end of an irrigation syringe, during wound irrigation, to protect the user from (a) needlesticks (by eliminating the use of a needle), and (b) bloody splash during this procedure.

This submission, K974288, is for a modified version of an existing device, the Zerowet Splashield. The only difference is the sterility level. The original device was gamma-radiation-sterilized, while the new submission is for an unsterilized, clean device. The manufacturer is arguing for substantial equivalence based on the premise that the sterility level does not impact the device's integrity or performance for its intended use.

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

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary, not a full study report. It primarily contains assertions made by the applicant and the FDA's decision based on that information. It does not present detailed study results or data to prove these acceptance criteria were met through a formal study.

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

The provided text does not describe any formal test set or corresponding sample size. The primary argument is based on:

• Requests/Opinions from end-users: "requests from a number of end users who are themselves specialists in the field of emergency wound care"
• Assertion of no "reasonable likelihood" of adverse impact: This is a qualitative argument, not based on a statistically designed test set.
• Assumption of equivalence in integrity/performance: This is also asserted without presenting data from a test set.

Given this, there is no information on data provenance (country of origin, retrospective/prospective).

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

• Number of experts: The text refers to "a number of end users who are themselves specialists in the field of emergency wound care." A specific number is not provided.
• Qualifications of experts: They are described as "specialists in the field of emergency wound care." Further details like years of experience or specific credentials (e.g., surgeon, emergency physician) are not given.
• Ground truth: Their opinions formed the basis of the applicant's assertion regarding the adequacy of an unsterilized device for traumatic, contaminated wounds. This is a qualitative "ground truth" based on expert opinion, not a quantitative measurement.

4. Adjudication Method for the Test Set

No formal adjudication method is described because no structured test set with adjudicated outcomes is presented. The "ground truth" relies on the collective opinion of unspecified "specialists."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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 medical accessory (splash shield), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth primarily used in this submission is expert opinion/consensus (from "specialists in the field of emergency wound care") and the assertion of common practice/clinical judgment that an unsterilized device is adequate for traumatic, contaminated wounds.

There is no mention of pathology, outcomes data (e.g., wound infection rates from a comparative study), or other empirical data to establish ground truth.

8. The Sample Size for the Training Set

There is no mention of a training set in the context of this device. This submission relies on justifying the equivalence of a modified (unsterilized) version of an existing device based on clinical judgment and the perceived lack of clinical impact.

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

Since no training set is mentioned, this question is not applicable.

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The RMI Dual Fluid Irrigating Syringe consists of two Becton Dickinson 10cc syringes pre-assembled in a PVC holster. The dual lumen applicator tip of the Dual Fluid Irrigating Syringe consists of two separate lines of tecoflex tubing that form a "Y" connection, then remain parallel to deliver two separate solutions or fluids simultaneously onto the surgical site. A three-way stopcock is connected to each syringe to accommodate attachable 36" fluid transfer sets used to draw prescribed solutions or fluids into each syringe. The plunger ends of the 10cc syringes are coupled together with an LDPE yoke. The RMI Dual Fluid Irrigating Syringe is ethylene oxide (EtO) sterilized and is sold as a disposable, single use, non-pyrogenic device.

The provided text describes a medical device, the RMI Dual Fluid Irrigating Syringe, and its testing for safety and effectiveness. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in the context of an AI/ML algorithm or a comparative effectiveness study involving human readers.

The document focuses on the device itself and its manufacturing, biocompatibility, and basic functional performance, comparing it to predicate devices. It does not involve any AI components, image analysis, or diagnostic capabilities that would typically be evaluated with metrics like those commonly used for AI in healthcare (e.g., sensitivity, specificity, AUC).

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related study details, as these are not present in the provided text.

Specifically, the following information is missing or not applicable based on the provided text:

• A table of acceptance criteria and the reported device performance: While there is a "Table of Tests and Results" for functional parameters (leak, flow, pull), these are for the physical device, not for an AI algorithm's performance against clinical acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set for an AI algorithm is mentioned. The sample sizes for functional tests (e.g., 13 units for leak/flow tests) refer to physical devices.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no AI algorithm requiring ground truth from experts.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the functional tests, the "ground truth" is simply the physical measurement or observation (e.g., "Passed" leak test).
• The sample size for the training set: Not applicable as there's no AI algorithm.
• How the ground truth for the training set was established: Not applicable.

The document primarily covers:

• Product Description: RMI Dual Fluid Irrigating Syringe.
• Component Materials: List of materials in contact with fluids.
• Predicate Device Identification: Micromedics, Inc. Surgical Sealant Dispenser (SSD) and Duoflo™ Dispenser.
• Summary of Biocompatibility: Various tests (skin irritation, sensitization, cytotoxicity, systemic toxicity, hemocompatibility, pyrogenicity, muscle implantation, Ames test) and their results, all indicating acceptable biocompatibility for medical device use.
• Functional/Performance Information:
  • Functional Testing: Leak tests, flow tests, and pull tests on stopcocks/tubing with reported results (e.g., "Passed," "all pulled to 17 lbs. or more").
  • Performance Testing: States the device is substantially equivalent in performance to two separate 10cc syringes or two taped-together syringes in delivering fluids simultaneously and in an equal 1:1 ratio.
• Comparison to Predicate Device (Micromedics SA-4310): Tabular comparison of characteristics like model, syringe volume, assembly, applicator tip configuration, and sterilization method.

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