Search Results

The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.

The biopsy instrument is a sterile disposable device which features a stainless steel cannula with an echogenic tip, and a stainless steel stylet which is spring loaded and fitted into a plastic handle permitting single handed specimen collection. Sizes are available in 14 - 20 gauge needles. The length of the needles ranges between 9 and 20 cm. The needle is used by advancing the entire device to the site of soft tissue sampling. The needle is advanced with gentle but firm pressure. Once the needle is in position, the sample is taken and the device is removed from the sampling site. The sample can then be expelled from the stylet notch.

The provided text describes a Special 510(k) Premarket Notification for the Manan Bio-Cut Soft Tissue Biopsy Needle. However, it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria and a study proving the device meets them. The document focuses on establishing substantial equivalence to predicate devices and outlines the device's description and intended use.

Here's an attempt to answer the questions based on the available information and, where information is missing, to explicitly state that it is not provided in the text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify quantifiable acceptance criteria or reported device performance metrics from a study. It focuses on the device's description, intended use, and substantial equivalence to legally marketed predicate devices.

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

The document does not describe a specific test set, its sample size, or its data provenance. This type of information would typically be found in a detailed study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention any experts used to establish ground truth or their qualifications. This is because no specific performance study with a test set is detailed.

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

As no specific test set or ground truth establishment method is described, there is no information on an adjudication method.

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

The device described is a physical medical instrument (a biopsy needle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned in the document.

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

This question is not applicable as the device is a physical biopsy needle, not an algorithm or AI system.

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

Since no specific performance study is detailed, the document does not describe the type of ground truth used. For a biopsy needle, performance might be evaluated by factors like sample adequacy (confirmed by pathology), ease of use, or mechanical properties, but these are not specified here.

8. The sample size for the training set

The document does not mention a training set. This is irrelevant for a physical medical device that is not an AI/machine learning product.

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

This question is not applicable as no training set is mentioned for this physical device.

Summary of Study Information in the Document:

The provided 510(k) summary for the Manan Bio-Cut Soft Tissue Biopsy Needle, K052802, is a regulatory submission focused on demonstrating substantial equivalence to predicate devices (Manan Super-Core Biopsy Needle K950732 and Medical Device Technologies Super-Core Biopsy Needle K974814). It describes the device, its intended use, and technological characteristics. The document does not include details about specific performance studies, clinical trials, acceptance criteria, or expert evaluations related to device performance in the way often associated with AI/software devices or more complex diagnostic tools. The FDA's letter confirms that the device is substantially equivalent, allowing it to be marketed under general controls.

Ask a specific question about this device

Ask a specific question about this device

For the spinal administration of anesthetic agents to elicit regional anesthesia.

Spinal Needle

The provided document is a 510(k) clearance letter from the FDA for a spinal needle. It does not contain any information about acceptance criteria, device performance studies, or the use of AI/algorithms.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study designs. The document is strictly a regulatory clearance letter acknowledging substantial equivalence to a predicate device.

Ask a specific question about this device

For simplifying insertion of a guide-wire and/or catheter through various ports(such as a Touhy-Borst) used in intravascular administration sets.

Blunt Needle

This document is a 510(k) clearance letter from the FDA for a "Manan Blunt Needle." It's a regulatory document indicating substantial equivalence to a predicate device, and it does not contain information about acceptance criteria or a study proving device performance as requested.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device

The Manan™ General Utility Drainage Catheter is for percutaneous nephrostomy, abcess, cyst, and other small fluid collection drainage.

Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Pigtailloop(Locking and non-locking), and "J" type. Also included with the catheters are stiffening cannula and trocar sets.

The provided document is a 510(k) summary for the Manan™ General Utility Drainage Catheter. It primarily focuses on demonstrating substantial equivalence to a predicate device for marketing purposes. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria in the same way a clinical trial or a novel AI/software medical device submission would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. This submission relies on demonstrating similarity to an already approved device rather than presenting new performance data against specific, pre-defined acceptance criteria.

However, I can extract the information that is available:

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

This document does not define specific "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as it is a 510(k) submission for a physical medical device (a drainage catheter) based on substantial equivalence, not a software or AI device. The "performance" demonstrated is primarily through comparison to a predicate device.

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

Not applicable. There is no "test set" in the context of performance evaluation for an AI or diagnostic device. The substantial equivalence is based on device description (materials, configurations, intended use) to an existing predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no ground truth establishment in this type of submission.

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

Not applicable.

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 a physical medical device, not an AI or diagnostic tool involving human readers.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of available information relevant to "performance" in this 510(k) context:

The document describes the device's technical characteristics and intended use, comparing it to an already approved device to demonstrate substantial equivalence.

• Identified Predicate Device: Manan Medical Products General Utility Drainage Catheter (K953713)
• Device Description:
  • Made from biocompatible implantable urethane (Tecoflex).
  • Material softens at body temperature.
  • Comes in various end configurations: Pigtail-loop (locking and non-locking), and "J" type.
  • Includes stiffening cannula and trocar sets.
• Indications for Use: Percutaneous nephrostomy, abscess, cyst, and other small fluid collection drainage.

The "study" in this context is the submission of documentation to the FDA demonstrating that the new device is sufficiently similar to the predicate device in terms of materials, design, technological characteristics, and intended use to be considered safe and effective for its stated purpose. This does not involve clinical performance data or AI model evaluation.

Ask a specific question about this device

The MananTM Nephrostomy Drainage Catheter is for percutaneous nephrostomy.

Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Locking pigtail-loop and non-locking pigtail. Also included with the catheters are stiffening cannulas.

The provided text describes a 510(k) submission for the Manan™ Nephrostomy Drainage Catheter. This is a premarket notification for a medical device seeking substantial equivalence to a predicate device, not a study describing its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Available. The provided document is a 510(k) summary and FDA letter, which do not detail specific acceptance criteria or performance data from a new study. The submission relies on "substantial equivalence" to a 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 Available. No new test set or study data is presented.

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 Available. No new test set requiring expert ground truth is described.

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

• Not Available. No new test set 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/Not Available. The device is a physical drainage catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not Applicable/Not Available. As above, this is a physical medical device, not an algorithm.

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

• Not Applicable/Not Available. No new study is presented requiring a "ground truth." The submission relies on substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not Applicable/Not Available. This is not an AI or machine learning device that requires a training set.

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

• Not Applicable/Not Available. As above, no training set is relevant or described.

Summary of available information from the document:

• Device Name: Manan™ Nephrostomy Drainage Catheter
• Applicant: Medical Device Technologies, Inc.
• Common Name: Nephrostomy drainage catheter
• Classification Name: §878.4200-Introduction Drainage Catheter and Accessories
• Indications for Use: The Manan™ Nephrostomy Drainage Catheter is for percutaneous nephrostomy.
• Predicate Device: Manan Medical Products, Nephrostomy Drainage Catheter (510(k) No. K953547)
• Device Description: Made from biocompatible implantable urethane (Tecoflex) that softens at body temperature. Comes in various end configurations (locking pigtail-loop, non-locking pigtail) and includes stiffening cannulas.
• Regulatory Determination: The FDA determined the device is substantially equivalent to the predicate device.

Ask a specific question about this device

The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.

The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study results related to the Manan™ VS Access Needle/Set. The document is a 510(k) summary for a medical device cleared in 1998, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data against specific acceptance criteria.

The 510(k) summary states the following about the device:

• Device Name: Manan™ VS Access Needle/Set
• Intended Use: For the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
• Substantial Equivalence: To the Manan Medical Products V.S. Access Needle/Set (K963767).

To address your request, I would need a different type of document, such as a clinical study report, a validation study, or a more detailed technical file that outlines the device's performance characteristics and how they were evaluated against specific acceptance criteria.

Ask a specific question about this device

The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.

The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.

The provided document is a 510(k) summary for the "Manan™ Galactography Kit," a manual surgical instrument. It primarily outlines the administrative details of the submission and states that the device is substantially equivalent to a previously marketed device.

Based on the content, the document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Here's what can and cannot be answered from the provided text:

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

   • Not available. The document does not specify any performance acceptance criteria or report performance metrics from a study.

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

   • Not available. There is no mention of a test set, sample size, or data provenance.

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 available. There is no mention of ground truth establishment or experts.

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

   • Not available. No 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 device is a manual surgical instrument, not an AI or imaging interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

   • Not applicable. This is a manual surgical instrument, not an algorithm.

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

   • Not available. No ground truth is described.

8. The sample size for the training set:

   • Not applicable. This is a manual surgical instrument, not a learning algorithm.

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

   • Not applicable. This is a manual surgical instrument, not a learning algorithm.

Conclusion:

The provided 510(k) summary is a regulatory document indicating the "Manan™ Galactography Kit" is substantially equivalent to a predicate device (Manan Medical Products Galactography Kit, K881671). It does not contain the details of performance studies, acceptance criteria, sample sizes, expert ground truth establishment, or any information related to AI or algorithm performance that your questions seek. Such information is typically found in detailed technical reports or clinical study summaries, which are not part of this 510(k) summary.

Ask a specific question about this device

The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.

Manan drainage catheters are made from a biocompatible urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in malecot end configuration. Also included with the catheters are flexible stiffening cannula.

The provided document is a 510(k) summary for a medical device called the Manan™ Malecot Basket Drainage Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria.

Here's why the requested information is absent:

• Acceptance Criteria and Device Performance Table: This document is a regulatory submission for substantial equivalence. It focuses on comparing the new device to a legally marketed predicate device (Manan Medical Products' Malecot Basket Drainage Catheter, K954147), not on demonstrating performance against pre-defined acceptance criteria through a clinical study.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size, and Training Set Ground Truth: These are all elements typically found in a clinical study report or a detailed validation study, especially for AI/ML-based devices. The Manan™ Malecot Basket Drainage Catheter is a physical medical device (a catheter), and its 510(k) submission largely relies on material compatibility and design similarity to its predicate, rather than on performance metrics from a diagnostic or algorithmic standpoint.

Summary:

This 510(k) submission is for a physical medical device (a catheter) and aims to demonstrate substantial equivalence to a predicate device. It does not include information about clinical studies with specific acceptance criteria, test sets, expert ground truth, or AI/ML performance metrics.

Ask a specific question about this device

The Manan™ Manta Catheter Fixation Disk is intended for the fixation of percutaneous drainage catheters.

The Manan Manta Catheter Fixation Disk is made of soft silicone. It is sutured or adhered to the skin and a drainage catheter is snapped into the device. A nylon tie-wrap is used to secure the catheter into the device.

The provided document is a 510(k) summary for the Manan™ Manta Catheter Fixation Disk, dated April 22, 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance. This type of regulatory submission in 1998 would typically not include the detailed performance study information requested in the prompt, especially not in the format of acceptance criteria tables, sample sizes for training/test sets, expert qualifications for ground truth, or discussions of AI algorithms and MRMC studies, as these concepts relate to more recent advancements in medical device evaluation, particularly for AI/ML devices.

Therefore, many of the requested data points (such as acceptance criteria, reported performance against those criteria, detailed study designs, ground truth methodologies, and AI-specific metrics) are not present in this document. The document confirms that the device is a simple mechanical fixation device, not an AI-powered diagnostic or therapeutic system.

Based on the provided text, here is what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain an explicit table of acceptance criteria or reported device performance for the Manan™ Manta Catheter Fixation Disk. The substantial equivalence determination is based on the device's similarity in design and intended use to a legally marketed predicate device (Manan Medical Products Manta Catheter Fixation Disk, 510(k) No. K954132), rather than performance against pre-defined quantitative acceptance criteria in a detailed clinical study.

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

Not applicable. The document describes a substantial equivalence submission, not a performance study requiring a test set of data in the context of AI/ML or a detailed clinical trial. The device is a physical catheter fixation disk, and its evaluation would likely involve engineering tests (e.g., tensile strength, biocompatibility – not detailed here) and potentially limited human factors evaluations, but not a "test set" of patient data in the manner implied by the prompt.

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

Not applicable. This information pertains to performance studies for diagnostic or prognostic devices, particularly those involving image interpretation or complex data analysis. The Manan™ Manta Catheter Fixation Disk is a mechanical fixation device, and the concept of "ground truth" established by experts for a test set is not relevant to its regulatory submission as presented.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as above. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data or outcomes in performance studies.

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. An MRMC study is used to evaluate the performance of diagnostic devices, often involving human readers and potentially AI assistance. This device is a mechanical catheter fixation device and does not involve "readers" or "AI assistance."

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

Not applicable. This device is not an algorithm and does not have standalone performance in the context of AI/ML systems.

7. The Type of Ground Truth Used:

Not applicable. The concept of "ground truth" as typically discussed in performance studies (e.g., pathology, outcomes data, expert consensus) is not directly relevant to the 510(k) submission for this mechanical device. The substantial equivalence is based on comparing the device's design, materials, and intended use to a predicate device.

8. The Sample Size for the Training Set:

Not applicable. Training sets are relevant for machine learning algorithms. This device is a physical product.

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

Not applicable for the same reason.

Summary based on the document:

The Manan™ Manta Catheter Fixation Disk is a soft silicone device intended for the fixation of percutaneous drainage catheters. Its 510(k) submission (K981229) demonstrated substantial equivalence to a predicate device, the Manan Medical Products Manta Catheter Fixation Disk (K954132). The regulatory classification is Class II (21 CFR 876.5130/Procode: 78 KNY). The document does not provide details on specific performance studies with acceptance criteria, sample sizes, expert-established ground truth, or AI-related metrics because it is a submission for a mechanical device undergoing a substantial equivalence review, not an AI/ML device requiring a clinical performance study as described in the prompt.

Ask a specific question about this device