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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 (

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 Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures:

• Aspiration of adipose (fatty) tissue
• Harvesting adipose (fatty) tissue
• Filtering adipose (fatty) tissue
• Extraction of autologous adipose (fatty) tissue

Device Functions:

• 1. Single Use closed loop system collection device (same)
• 2. Canister contains ports on lids for interface between: Jordy Connection System to Canister and aspirator pump.
• 3. Connection system to connect tubing to interfaces
• 4. Funnel to enable fat to separate from fluids
• 5. Channel for fluid evacuation.
• Toomey Syringe to extract fat from device. 6.

Device Design:

• 1. Owner holds patent to predicate device and has improved performance and safety through this design.
• 2. Non-Sterile, Single Use
• 3. Canister able to withstand 30 in/Hg (18 in/Hg maximum vacuum used for collection of adipose (fatty tissue) for harvesting.
• 4. Tissue enters canister through collection port on canister lid.
• 5. Funnel perforation large enough for only adipose (fatty) tissue to be collected
• 6. Waste material is removed from canister by closing valve on center of lid.
• 7. Remaining adipose (fatty) tissue can be withdrawn through tissue port on bottom of center of canister for autologous adipose (fatty) tissue extraction.

Physical Properties and Materials Used:

• 1. Canister, Funnel and Outer Lid made from Polycarbonate
• 2. Evacuation spout and pinch clamps made from Polypropylene
• 3. Tubing made from silicone

Intended use of Device:
For use in aspirating subcutaneous fatty tissue including autologous fat collection.

The provided document describes a medical device, "The Red Head and Jordy Connection System," and its substantial equivalence to a predicate device, "Lipisystems Aquavage." This is a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence rather than independent clinical efficacy studies typically associated with new drug applications or novel high-risk devices. Therefore, the information required for directly answering all parts of your request about acceptance criteria and a study proving the device meets the acceptance criteria in the context of an AI/algorithm-driven device is largely not present in this document.

Here's an analysis based on the provided text, focusing on what is available and explaining the gaps:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests conducted to demonstrate the device operates as designed and functions as intended, often in comparison to a predicate device.

Notes on "Acceptance Criteria" for this device:

• This is a physical medical device for collection of adipose tissue, not an AI or diagnostic algorithm. Therefore, the "acceptance criteria" are related to mechanical integrity, material safety, and functional equivalence to a predicate device, rather than diagnostic accuracy.
• The document states, "Performance testing has demonstrated that the subject device operates as designed and functions as intended." This general statement serves as the "reported performance" for the functional tests.

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

The document does not specify sample sizes for any of the performance tests (e.g., number of units tested for leak, implosion, etc.), nor does it mention data provenance in terms of country of origin or retrospective/prospective nature. This level of detail is typically not required nor provided in a 510(k) summary for this type of device.

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

This information is not applicable and therefore not provided. The "ground truth" for a physical device like this is not established by human experts in the way it is for diagnostic algorithms. Instead, it's determined by engineering specifications and material science for the mechanical/biocompatibility tests, and potentially by laboratory analysis for tissue viability.

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

This is not applicable and therefore not provided. Adjudication methods are relevant for subjective assessments or disagreements in diagnostic tasks (e.g., by experts for an AI model), not for objective physical device testing.

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 and therefore not provided. An MRMC study is relevant for evaluating the performance of diagnostic algorithms, often with human readers. The Red Head and Jordy Connection System is a physical device for tissue collection and is not an AI-assisted diagnostic tool.

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

This is not applicable and therefore not provided. This device is not an algorithm.

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

As explained in point 3, the concept of "ground truth" in the context of an AI algorithm based on expert consensus, pathology, or outcomes data is not directly applicable to this physical device.

The closest equivalent to "ground truth" for the performance tests would be:

• Engineering specifications/standards: For functional tests like implosion, leak, pull-off force.
• Standardized laboratory tests: For biocompatibility (ISO 10993) which involves specific in-vitro or in-vivo assays with established pass/fail criteria.
• Laboratory analysis of tissue samples: For tissue viability. The document states "Tissue viability testing found no adverse effect on adipose tissue with use of the subject device," implying laboratory assessment of the collected tissue.

8. The sample size for the training set

This is not applicable and therefore not provided. The device is a physical product, not an algorithm that requires a "training set."

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

This is not applicable and therefore not provided.

In Summary:

The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through functional, mechanical, and biocompatibility testing. The questions regarding AI/algorithm performance metrics, expert adjudication, MRMC studies, and training/test sets for algorithms are not applicable to the information presented in this regulatory submission for "The Red Head and Jordy Connection System."

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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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The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.

Tissu Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue,

Tissu Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:

• Plastic and Reconstructive Surgery
• Neurosurgery
• Gastrointestinal and Affiliated Organ surgery
• Urological Surgery
• Orthopedic surgery
• Gynecological Surgery
• Thoracic surgery
• Laparoscopic Surgery

The Tissu Trans Filtron is provided in a sterile, two piece packaged assembly: The Tissu Trans Filtron. The Tissu Trans Filtron is a single-use, sterile, disposable device designed to utilize an FDA, cleared house vacuum to create suction within the physician supplied hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the autologous tissue into the collection canister.

The Tissu Trans Filtron is a sterile, single-use, manual device consisting of a medical grade polycarbonate canister, a medical grade polypropylene lid with various ports, medical grade silicone connection tubings for aspiration of waste, harvesting of tissue and transferring of filtered autologous tissue. A polypropylene clamp is included for clamping off the tubing as needed. A medical grade polyester mesh filter lining is contained within the canister.

The provided text is a 510(k) summary for the Shippert Medical Technologies Tissu Trans Filtron, a suction lipoplasty system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them as would be seen in a clinical trial for a new therapeutic device.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "reported device performance" is summarized as being "safe and effective," and performing "as desired," implying it met the functional expectations for a device of its type and was comparable to the predicates in terms of safety and efficacy.

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For use in aspirating subcutaneous fatty tissue including autologous fat collection.

Device function: 1. Contains port interfaces between: Canister to tubing & aspirator to canister. 2. Sterile tubing to connect the interfaces 3. Funnel to interface port to tubing. 4. Syringe to collect fat.
Device design: 1. Contents subjected to sterility
Material used: Plastic Canister, Syringe, silicone tubing
Physical properties: Plastic & Silicone

This document is a 510(k) premarket notification for the "LipiSystems AquaVage" sterile canister system, a device intended for aspirating subcutaneous fatty tissue, including autologous fat collection. It seeks to demonstrate substantial equivalence to a predicate device, the "LS Liposuction Aspirator" (K081593).

Regarding the device's acceptance criteria and studies, the provided text contains very limited information on performance evaluation beyond the claim of substantial equivalence to a predicate device.

Here's an attempt to structure the available information per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or specific physical performance metrics with numerical targets). Instead, it relies on demonstrating substantial equivalence to a predicate device.

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

• Test Set Sample Size: Not specified.
• Data Provenance: The document states that the determination of substantial equivalence was based on "non-clinical data." No further details are provided regarding the origin (country, retrospective/prospective) of this data. Given the "non-clinical" description and the nature of the device (a sterile canister system for fluid collection), it's highly probable that this data pertains to bench testing, material compatibility, and sterilization validation, rather than clinical patient data.

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

This information is not provided in the document. The substantial equivalence claim is based on "non-clinical data," implying that expert consensus or clinical ground truth as typically understood for diagnostic or image-based AI devices would not be applicable here.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device and the reliance on "non-clinical data," a formal adjudication method by experts for a test set (as would be seen in human-in-the-loop or standalone AI performance studies) is unlikely to have been performed or required for this type of submission.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact of AI on human reader performance. The LipiSystems AquaVage is a sterile canister system; therefore, an MRMC study would not be 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 conducted or reported. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The document mentions "non-clinical data" as the basis for substantial equivalence. For a sterile canister system, this would typically involve:

• Engineering/Performance Specifications: Verifying that the device meets physical dimensions, material properties, flow rates, vacuum integrity (if applicable), and connection compatibility.
• Sterilization Validation: Demonstrating that the sterilization process achieves the required sterility assurance level (SAL).
• Biocompatibility Testing: Ensuring materials are safe for patient contact.

These types of "ground truth" are established through standardized testing protocols against pre-defined engineering and regulatory standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The LipiSystems AquaVage is a physical medical device (sterile canister system), not a software or AI-driven device that requires training data.

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

This information is not applicable and not provided as there is no "training set" for this type of device.

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The GYNECARE PROSIMA* Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

The GYNECARE PROSIMA Anterior, Posterior, and Combined Pelvic Floor Repair Systems consist of pre-cut GYNECARE GYNEMESH PS Mesh Implant(s), and instruments to facilitate Mesh Implant placement and postoperative support.

The provided document is a 510(k) premarket notification for the GYNECARE PROSIMA Pelvic Floor Repair Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics for a novel technology like AI/ML.

Therefore, many of the requested categories are not applicable to this kind of regulatory submission. The document explicitly states that the approval is "Based on the similarities to the predicate devices identified in this submission," rather than a study against a pre-defined performance criterion for the new device.

Here's an attempt to address the request based on the provided text, indicating where information is not applicable:

Acceptance Criteria and Study Analysis for GYNECARE PROSIMA Pelvic Floor Repair Systems

This 510(k) submission for the GYNECARE PROSIMA Pelvic Floor Repair Systems establishes substantial equivalence to predicate devices, rather than demonstrating performance against pre-defined acceptance criteria for a novel device through a clinical study. The "performance data" section focuses on material biocompatibility and functional bench/cadaver testing.

1. Table of Acceptance Criteria and Reported Device Performance

• Mesh Implant: Made from GYNECARE GYNEMESH* PS Nonabsorbable PROLENE* Soft Mesh, identical polymers to current Ethicon product.
• Vaginal Support Device-Balloon Assembly: Provides support to vaginal canal to reduce contracture, stenosis, adhesions; balloon inflated with air (like predicate); made of silicon (like predicate); remains in vaginal canal for up to four weeks (predicate up to twelve weeks).
• Intended Use: For tissue reinforcement and stabilization of fascial structures of the pelvic floor, and maintenance of vaginal canal during healing. |

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

This document does not describe a clinical "test set" with human subjects in the context of an AI/ML algorithm evaluation. The testing mentioned is "bench and cadaver testing." No specific sample sizes for these tests are provided, nor is data provenance in terms of country of origin or retrospective/prospective status for clinical data, as it's not a clinical study.

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

Not applicable. There is no mention of "experts" establishing ground truth for a test set in the context of this 510(k) summary. The evaluation focuses on material properties and functional tests, not diagnostics or interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is mentioned as there is no diagnostic test set requiring human consensus for ground truth.

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

Not applicable. This is not a study involving human readers or AI assistance.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

For the biological reactivity, the "ground truth" (or standard of acceptability) was established by ISO Standard 10993-1. For functional performance, the "ground truth" was whether the device "meets or exceeds all functional requirements," which would be defined by internal engineering specifications or industry standards for mechanical performance. No pathology, outcomes data, or expert consensus serving as ground truth for clinical performance is described.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable.

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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 PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.

The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

This submission (K040149) is a 510(k) premarket notification for a medical device called "The PSI TEC III Peristaltic Infiltration Pump." A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for the new device as would be seen for novel technologies or higher-risk devices.

Based on the provided document, there is no information available about acceptance criteria, a specific study proving the device meets those criteria, or most of the requested details about such a study.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This confirms that the approval was based on substantial equivalence, not on a standalone performance study with defined acceptance criteria for the new device K040149 itself.

Here's an attempt to answer the questions based on the available text, highlighting what is not present:

1. Table of acceptance criteria and the reported device performance

   • Not provided. The document does not specify performance acceptance criteria for the new device (PSI TEC III Peristaltic Infiltration Pump) or report specific performance metrics against such criteria. The submission is framed around substantial equivalence to existing devices.

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

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary. The approval is based on substantial equivalence to predicate devices, not on a performance study of the PSI TEC III itself.

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. This information pertains to a performance study, which is not detailed in this 510(k) summary.

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

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed 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

   • Not applicable. This device is an irrigation/infusion pump, not an AI-assisted diagnostic tool. No MRMC study would be relevant here.

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

   • Not applicable. This device is a pump, not an algorithm. Standalone performance for a physical device would refer to its functional specifications (e.g., flow rate accuracy, pressure), but these are not detailed as specific performance study results in this summary. The substantial equivalence argument implicitly assumes its performance is comparable to predicates.

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

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

8. The sample size for the training set

   • Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

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

   • Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

Summary of available information related to equivalence:

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Predicate Devices for Substantial Equivalence Claim:

• Product: Bi-Phasic Infiltrator
  • Manufacturer: Reliance Medical
  • 510(k) Number: K012044
  • Substantial Equivalence Date: August 28th, 2001
• Product: Autofuse V Infiltration Pump
  • Manufacturer: Randolph-Austin
  • 510(k) Number: K980394
  • Substantial Equivalence Date: March 25th, 1998
• Product: Wells-Johnson Infusion System
  • Manufacturer: Wells-Johnson
  • 510(k) Number: K991437
  • Substantial Equivalence Date: August 30th, 1999

The substantial equivalence claim is based on the "principles of operation and technology incorporated" being similar to these predicates, specifically mentioning that the PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing, similar to other peristaltic irrigation systems. It also mentions that, like all peristaltic pumps, it contacts only the tubing and not the fluid, thus maintaining sterility.

In conclusion, for this specific 510(k) submission, the device did not undergo a study to meet defined acceptance criteria in the way a novel diagnostic or therapeutic device might. Its approval was based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices.

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The Subcutaneous Illuminator is indicated for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

The Smith & Nephew Subcutaneous Illuminator transfers light to the surgical site via glass fiber optics and includes irrigation via an irrigation channel. The Subcutaneous Illuminator allows it to gain access to the surgical site.

The provided K99/323 510(k) summary for the Smith & Nephew Subcutaneous Illuminator does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use. The FDA letter confirms the substantial equivalence primarily based on these comparisons.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

The primary "proof" of the device's acceptability in this context is its substantial equivalence to already legally marketed devices, rather than a specific performance study with measured acceptance criteria.

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General surgical fluid irrigation and infiltration.
The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.

The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.

This document is a 510(k) summary for the Byron Medical Psi-Tec Syringe Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to previously cleared devices for the purpose of market clearance, rather than presenting performance study data against specific acceptance criteria.

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