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The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and smoke from the surgical site.

The Disposable Suction And Irrigation System is composed of a stainless steel Suction / Irrigation Probe which is connected to a handle having two trumpet type valves. Using the fingers, the action of depressing one valve will control the irrigation fluid from the Poly Venyl Chloride (PVC) tubing through the irrigation probe and be delivered onto the site of surgery. By depressing the other valve would enable the action of suction to remove blood and tissue debris from the site of surgery through the suction probe and these will be transported through the PVC tubing and be deposited into a waste container. The handle is joined to two PVC tubes. One divides itself into two branches to conduct irrigation fluids from a saline bag. The clamp is used to hold the two tubes in a vertical position. This irrigation fluid passes down the tubes, then through the Suction / Irrigation Probe and is deposited onto the surgical site. The other tube will conduct waste tissue debris or blood or smoke. A vacuum pump will be connected to the Suction end to draw the tissue debris or blood or smoke from the site of surgery, through the stainless steel Suction / Irrigation Probe and these are transported through this PVC tubing until they are deposited into a waste container. This device is for single use only.

The provided document describes a 510(k) Premarket Notification for a medical device called the "Disposable Suction And Irrigation System." This type of submission to the FDA focuses on demonstrating substantial equivalence to a currently marketed predicate device, rather than proving novel effectiveness or meeting specific performance acceptance criteria through a standalone study.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) is not present and not applicable to this type of regulatory submission.

Here's why and what information can be extracted:

• Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is "as safe, as effective, and performs very much the same way as" a legally marketed predicate device. This is done by comparing technological characteristics, intended use, and indications for use.
• No "Acceptance Criteria Study" in the sense of a clinical trial: The document does not describe a study designed to prove the device meets specific performance metrics against pre-defined acceptance criteria. Instead, it relies on a comparison to the predicate device.
• No AI Component: The device described is a physical medical instrument for suction and irrigation, not an AI/ML powered device. Therefore, questions regarding AI performance metrics, training sets, and ground truth for AI algorithms are not relevant.

Information Extracted from the Document:

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

   • Not applicable. This document demonstrates substantial equivalence, not performance against specific acceptance criteria. The "performance" assessment is comparative to the predicate device.

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. No test set or clinical study data is described. The comparison is based on device characteristics.

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. No ground truth establishment for a test set is described.

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

   • Not applicable. No test set or adjudication method is described.

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 is not an AI device, and no MRMC study is described.

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

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

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

   • Not applicable. No ground truth is established for device performance in the context of a clinical study. Substantial equivalence relies on comparing the device's design, materials, and intended use to those of a predicate device.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

   • Not applicable. No training set is described.

Information Related to Substantial Equivalence (as found in the document):

• Predicate Device: Applied SI Suction Irrigator
• Basis for Equivalence: "The technological characteristics of The Disposable Suction System as compared to the predicate device - Applied SI Suction Irrigator, are found to be very similar. This device has the same technological characteristics in terms of design, structure, material composition, indication for use, intended use are similar as the predicate device."
• Conclusion: "It is demonstrated that the device Disposable Suction And Irrigation System is as safe, as effective, and performs very much the same way as the predicate device, Applied SI Suction Irrigator. It also has the same design, performance and structure as predicate device. Hence it is substantially equivalent to the predicate device."

In summary, this document is a regulatory submission for substantial equivalence for a physical medical device, not a performance study for an AI algorithm or a clinical trial against specified acceptance criteria.

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It is a monopolar electrode intended for ablation and coagulation of soft tissues by means of electrical energy delivered by an electrical generator. It is used with compatible resectoscopes .

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This document is a 510(k) premarket notification letter from the FDA regarding "Modern Medical Resectoscope Electrodes." It confirms the device's substantial equivalence to legally marketed predicate devices.

The letter explicitly states that "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This type of FDA letter (a 510(k) clearance) indicates that the device has been found substantially equivalent to a predicate device already on the market. A 510(k) clearance typically does NOT involve a comprehensive study with specific acceptance criteria and detailed performance data as would be required for a novel device or a PMA.

Therefore, based on the provided text, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/testing.

The document primarily focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study report.

In summary, none of the requested information regarding acceptance criteria and a study proving device performance can be extracted from the provided text.

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The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Laparoscopic Instrument and Electrode Tips. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it must comply with.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval document, not a study report.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text.

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Endocervical Hysterectomy Electrode is indicated for treatment of following Condition

1. Excision of inner cervix during supracervical hysterectomy.

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Here's an analysis of the provided text regarding the acceptance criteria and study for the Gyn LLETZ Electrode (Endocervical Hysterectomy Electrode):

Based on the provided document, the device did not undergo a study to prove its performance against specific clinical acceptance criteria in the manner typically seen for novel medical devices or AI-powered devices. This submission is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving de novo safety and effectiveness through extensive clinical trials.

The provided document (K070877) is a 510(k) submission for the Gyn LLETZ Electrode.

Here's a breakdown based on your requested information:

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

There are no specific clinical performance acceptance criteria listed in this 510(k) submission, nor is there reported clinical device performance that would traditionally be presented in a table for a study.

The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device.

Acceptance Criteria for 510(k) Submission (implied):

• Meet electrical and mechanical requirements.
• Be substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

Reported Device Performance:

• "Meet the electrical and mechanical requirements of ANSI/AAMI HF-18 Standard for Electrosurgical Devices."
• "The subject device is substantially equivalent to the predicate device." (This is a conclusion, not a performance metric.)

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

• Sample size: Not applicable. There was no clinical "test set" in the context of proving device performance described in this 510(k) submission. The submission relies on a comparison to a predicate device.
• Data provenance: Not applicable. Clinical data for device performance was not provided or referenced for this 510(k) submission.

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)

• Number of experts: Not applicable. No clinical ground truth was established from a test set for this 510(k) submission.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. No clinical test set or adjudication method was described.

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

• MRMC study: No. This is not an AI-powered device, and no MRMC study was conducted or reported.
• Effect size: Not applicable.

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

• Standalone performance: No. This is an electrosurgical electrode, not an algorithm, so standalone algorithm performance is not relevant.

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

• Type of ground truth: Not applicable in the context of clinical performance data. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate device.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

• Ground truth for training set: Not applicable.

Summary for this specific device and submission:

The document describes a 510(k) premarket notification for an electrosurgical device (Gyn LLETZ Electrode). The primary mechanism for clearance is demonstrating substantial equivalence to a previously cleared predicate device (Apple Medical Fisher Cone Biopsy Electrode, K061651). The submission does not include data from a clinical study with specific performance acceptance criteria, test sets, or ground truth establishment as would be expected for a novel device or an AI/ML product. Instead, it relies on meeting recognized electrical and mechanical standards (ANSI/AAMI HF-18) and a comparison to the predicate device.

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Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.

Modern Medical Antimicrobial Wound Dressing is made up of darker viscose polyester layer and a lighter layer of non-woven cloth. The darker layer contains nano silver ions (0.5 mg per g) about 1-100 nm in diameter, these provide a barrier protection against microbes. The lighter layer is designed to protect the wound surface. Modern Medical Antimicrobial Burn Dressing is totally made of unwoven cloth. The thicker and stronger texture also contains silver ions (2.6 mg per g) in order to form an effective barrier against microbes. It is intended to be applied directly onto the wound and cover with conventional methods.

The provided text describes the Modern Medical Antimicrobial Wound Dressing and Modern Medical Antimicrobial Burn Dressing. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria and device performance. Therefore, detailed information on acceptance criteria and a study proving device performance in the manner requested (e.g., sample sizes, expert qualifications, HRMC studies, standalone performance with ground truth) is not present in the provided document.

Instead, the document focuses on demonstrating the safety and effectiveness of the device through various performance tests and biocompatibility assessments rather than a direct clinical performance study comparing against specified acceptance criteria for diagnostic or treatment accuracy.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The studies show that the dressings, Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are safe and effective for their intended use." This is a general statement of compliance rather than specific quantitative performance metrics against pre-defined numerical acceptance criteria.

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

This information is not provided in the document. The performance assessments listed (biocompatibility and antimicrobial effectiveness tests) are typically laboratory-based tests. The document does not specify human clinical trial sample sizes or data provenance (country, retrospective/prospective).

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

This information is not applicable/not provided. The listed tests are laboratory assays (e.g., cytotoxicity, skin irritation, antimicrobial efficacy). These tests have defined protocols and endpoints according to standards (ISO, USP, AATCCC), and their results are interpreted by technical experts in those fields, but it's not a "ground truth" establishment in the sense of clinical expert consensus for image or diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1" are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The listed tests are not set up in this manner.

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 information is not applicable/not provided. This device is a wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This information is not applicable/not provided. This device is a physical wound dressing and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance assessments are established by the pre-defined endpoints and methodologies of the international and national standards described:

• Biocompatibility: ISO 10993 (Parts 1, 3, 11) - These standards define methods for evaluating biological risks, and the "ground truth" is adherence to the safety limits and observations specified within these protocols (e.g., absence of cytotoxicity, irritation, sensitization).
• Antimicrobial Effectiveness: United States Pharmacopoeia (USP 51) and American Association of Textile Chemists & Colorists (AATCCC Test Method 147) - These standards prescribe specific bacterial or fungal challenge tests and measure the reduction in microbial population. The "ground truth" is meeting the specified reduction criteria defined in these standards.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is not an AI algorithm that requires a training set.

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

This information is not applicable/not provided. This device is not an AI algorithm that requires a training set or associated ground truth.

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It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Modern Medical Non Stick Electrode." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested table and study details from the given text.

The information I can extract, which is not directly related to acceptance criteria or performance studies but is present in the document, includes:

• Trade/Device Name: Modern Medical Non Stick Electrode
• Regulation Number: 21 CFR 878.4400
• Regulation Name: Electrosurgical cutting and coagulation device and accessories
• Regulatory Class: II
• Product Code: GEI
• Indications For Use: It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
• 510(k) Number: K043036

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Indications For Use: The Smoke Evacuation Attachment is intended to remove smoke and aerosols from the surgical site.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Smoke Evacuation Attachment." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment as typically found in clinical validation studies.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the relevant indications for use and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was approved based on its substantial equivalence to a predicate device, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria. The FDA determined that the new device is as safe and effective as the predicate device.

Therefore, I cannot provide the requested information from the given text.

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Softseal Catheter (a uterine manipulator/injector) is used to access the uterine cavity for the injection and retention of contrast fluid (or gas) into the uterus to enable the visualization of the uterine cavity and fallopian tubes. This device is not for intrafallopian procedure. The following clinical indications are some of the applications:

1. Infertility
2. Menorrhagia
3. Dysmenorrhea Due to Uterine Synechia
4. Suspected Endometrial Polyp
5. Submucous Fibroid
6. Uterine Synechia (Asherman Syndrome)
7. Congenital Uterine Abnormality

Softseal HSG Catheter (a uterine manipulator/injector)

I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. This document is a 510(k) clearance letter from the FDA for a device called "Softseal HSG Catheter." It confirms that the device has been found substantially equivalent to a legally marketed predicate device.

The letter does not include:

• A table of acceptance criteria and reported device performance.
• Details of any specific study conducted to prove the device meets acceptance criteria. This type of information would typically be found in the 510(k) summary or detailed submission, not in the clearance letter itself.
• Sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study results, or standalone algorithm performance. These are all details of a clinical or performance study, which are not present in this document.
• Training set information.

The document only states the device's indications for use and confirms its clearance based on substantial equivalence. It does not provide the underlying data or studies that established this equivalence.

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The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.

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This document is a letter from the FDA regarding clearance for "Laparoscopic Instruments and Electrode Tips" and an "Indications for Use" statement. It does not contain information about acceptance criteria or a study proving how the device meets those criteria. Therefore, I cannot extract the requested information from the provided text.

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Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation

Reusable bipolar forceps

This document is a 510(k) clearance letter from the FDA for a Reusable Bipolar Forceps manufactured by Modern Medical Equipment Manufacturing Ltd. It states that the device is substantially equivalent to legally marketed predicate devices.

However, a 510(k) clearance letter does not typically contain the detailed acceptance criteria and study results you are asking for. This type of information is usually found in the original 510(k) submission document, which is a much more extensive technical file that sponsors submit to the FDA.

The provided document doesn't include:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets, data provenance, or the number/qualifications of experts.
• Adjudication methods.
• Details on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• The type of ground truth used or sample sizes/ground truth establishment for training sets.

The letter simply provides the regulatory decision that the device is substantially equivalent for the Indications For Use stated in the enclosure. The enclosure (Page 2 of the document) confirms the intended use: "Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation."

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and the study that proves the device meets them because that information is not present in this 510(k) clearance letter.

To get the information you're looking for, one would need to access the full 510(k) submission (K032327) that Modern Medical Equipment Manufacturing Ltd. submitted to the FDA.

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