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The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement. The subject device is to be used only for those indications which have been FDA-cleared for the Model ATL C3 Scanhead (consult transducer manual).

General Purpose ATL Needle Guide Kit for use with ATL Ultrasound Transducers

The provided document is a 510(k) clearance letter from the FDA for a General Purpose Needle Guide Kit. It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information from this document.

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An ultrasound accessory device used for positioning and guiding an ultrasound transducer probe during volume measurements of the prostate. Used in conjunction with a needle guide grid or radiation seed needle placement for the deposit of seeds.

Transducer Positioner

This appears to be a 510(k) clearance letter from the FDA for a device called "Ultrasound Transducer Positioner" (K973622). This type of document is a notification that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, rather than a detailed study report proving its performance based on specific acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment.

A 510(k) clearance typically relies on demonstrating substantial equivalence to a predicate device that has already established its safety and effectiveness. It does not usually involve new clinical trials with detailed performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) or other clinical study reports might.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a detailed performance validation report for the device.

Without that information, I cannot fill out the requested table or answer the specific questions about acceptance criteria and the study that proves the device meets them.

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A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses:

1. General Purpose: Ultrasound scanning
2. Cord cover for an extended sterile field on ultrasound transducer cords.
3. Rectal and vaginal scanning.
4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.

Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.

A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe.

Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyethylene film, with a thickness of .001inches-.003inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.

The provided document describes a 510(k) premarket notification for a Polyethylene Ultrasound Transducer Surgical Drape Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data as would be found for novel technologies or higher-risk devices.

Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types beyond basic material testing) are not applicable in the context of this 510(k) submission for a surgical drape kit. The primary 'study' is a comparison to a predicate device and adherence to recognized standards.

Here's a breakdown of the information that is available in the provided text, mapped to your request:

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

The acceptance criteria are implicitly defined by showing substantial equivalence to the predicate device (Civco Medical K844472) and adherence to industry standards for materials and performance. The 'reported device performance' is therefore its equivalence to the predicate and its compliance with specified standards.

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 (N/A) for a 510(k) of this nature. This submission demonstrates substantial equivalence through material and performance specifications rather than a clinical trial-like test set. The 'test' involves demonstrating the device meets specified material and performance standards (e.g., ASTM F1671-95 for resistance to penetration, ISO-10993 for biocompatibility, tensile strength). The data provenance refers to the standards themselves and internal testing results, not patient data.

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)

N/A. The "ground truth" here is compliance with established engineering and safety standards, and the specifications of the predicate device. This doesn't involve expert medical review of images or clinical outcomes in the same way an AI diagnostic device would.

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

N/A. The assessment is against material properties and performance specifications, not subjective clinical adjudication.

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

N/A. This is a medical device (surgical drape), not an AI diagnostic tool.

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

N/A. This is a physical medical device, not an algorithm.

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

The "ground truth" for this 510(k) submission is based on:

• Material specifications: Polyethylene thickness, properties.
• Performance standards: Adherence to ASTM F1671-95 (standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system).
• Safety standards: ISO-10993 (biological evaluation of medical devices), 29CFR 1910,1200 (hazard communication standard for chemical safety).
• Predicate device characteristics: Demonstrating that the new device has the same design, materials, performance, sterility, etc., as the legally marketed Civco Medical device (K844472).

8. The sample size for the training set

N/A. As this is a physical medical device applying for 510(k) equivalence, there is no AI model or "training set" in the computational sense. The 'training' would refer to the historical data and manufacturing processes that led to the development and standardization of such surgical drapes, but this is not specified in the document.

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

N/A. See point 8.

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A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses;

1. General Purpose: Ultrasound scanning.
2. Cord cover for an extended sterile field on ultrasound transducer cords.
3. Rectal and vaginal scanning.
4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.

A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe.

Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyurethane film, with a thickness of .001-. 003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.

The provided document is a 510(k) premarket notification for a medical device: a Polyurethane Ultrasound Transducer Surgical Drape Kit. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics in the way an AI/ML device submission would.

Therefore, the document does not contain information typically required to describe acceptance criteria and a study proving device performance for an AI/ML diagnostic or prognostic device. The context is a physical medical device (surgical drape), not a software algorithm.

However, I can extract information related to the "performance" of this physical device in the context of its 510(k) submission, comparing it to its predicate device. This "performance" refers to physical and biological properties, not diagnostic accuracy.

Here's an interpretation based on the provided text, recognizing the different nature of the device:

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

The "acceptance criteria" here are implicitly the characteristics of the predicate device, which the new device must be "substantially equivalent" to (or exceed for safety/effectiveness). The "reported device performance" are the characteristics of the PROTEK device.

Regarding the "study that proves the device meets the acceptance criteria":

The document states: "These new products have the same intended use as legally marketed devices. The same end users. The same material manufactures and the same tests and processes as Civco's legally marketed devices under 510(k) K844472." This indicates that the claim of meeting the "acceptance criteria" (i.e., substantial equivalence) is based on a direct comparison of characteristics and the assertion that similar materials, tests, and processes were used. The document lists "Microbial Challenge," "Biocompatibility (ISO-10993)," "Mechanical Safety (Tensile Strength)," and "Standards Met (Global Test Methods for Resistance to Penetration)" as performance aspects where the new device is equivalent to the predicate. However, it does not provide details of specific studies conducted or their results for the PROTEK device beyond listing these categories. It's a statement of equivalence rather than a report of specific test outcomes.

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

This information is not applicable to this 510(k) submission for a physical surgical drape. There is no "test set" in the context of an AI/ML algorithm evaluation. The evaluation is based on material and design comparison to a predicate 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. Ground truth is not established in this manner for a physical device like a surgical drape. Equivalence is based on material specifications, manufacturing processes, and adherence to recognized standards.

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

This information is not applicable. There is no "test set" or adjudication method for a physical device in this context.

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. This is a physical medical device, not an AI-assisted diagnostic tool.

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

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

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

This information is not applicable in the AI/ML sense. For a physical device like this, "ground truth" implicitly refers to established material properties, sterilization efficacy, biocompatibility, and mechanical strength evaluated against recognized standards and the performance of the predicate device. For example, "Microbial Challenge" implies testing against microbial penetration, and "ISO-10993" refers to biocompatibility standards.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes "training."

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

This information is not applicable. As above, there is no "training set" for this type of device.

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A needle guidance device for prostate biopsies or radiation seed placement/needles used as an accessory with an ultrasound transducer and system.

Needle Guide/Grid

The provided text is a 510(k) clearance letter from the FDA for a device called "Needle Guide/Grid for Ultrasound Transducer." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The letter primarily concerns the substantial equivalence determination of the device to legally marketed predicate devices, allowing it to be marketed. It lists the regulatory class and Procode, and outlines general controls provisions.

Therefore, I cannot fulfill your request for information on the acceptance criteria and the study that proves the device meets them, as this data is absent from the provided document.

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Ultrasound System Drape Kit - Polyethylene Drapes for covering Monitors, Keyboards, Floorpedals, and Equipment Arms

Not Found

I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Ultrasound Systems Drape Kit." This document explains the FDA's decision regarding substantial equivalence and the regulatory classification of the device.

It does not contain any information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given input.

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A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants

A sterile bag to contain a non-sterile ultrasound transducer probe during a sterile procedure. A disposable, single use, sterile instrument cover/drape to protect the patients from cross contamination from bacteria's of a non-sterile ultrasound transducer probe. A sterile barrier between patient and ultrasound transducer probe.

This document is a 510(k) premarket notification for a Latex Ultrasound Transducer Surgical Drape, which is a medical device. Therefore, the questions related to device performance, study details, and AI/human reader performance are not directly applicable to this type of regulatory submission. This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the effectiveness or performance of a new treatment or diagnostic algorithm.

Here's an analysis based on the provided text, addressing the applicable questions:

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

The document does not present acceptance criteria in the typical sense of a diagnostic or therapeutic device with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily related to material properties and sterility, aligning with the predicate devices.

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

The document does not detail specific "test sets" for performance studies in the way one would for a diagnostic algorithm. The testing appears to be centered on material properties and adherence to manufacturing standards. The provenance of the data is implicit through adherence to established standards (ASTM, ISO, CFR). Specific sample sizes for each test mentioned (e.g., tensile strength, penetration resistance) are not provided in this summary document.

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. The device is a surgical drape, and its "ground truth" is typically established through adherence to material standards and manufacturing processes, rather than through expert interpretation of a test set, as would be the case for an imaging or diagnostic device.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

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. The device is not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on:

• Material Specifications: Conformance to natural latex rubber properties and thickness.
• Established Standards: Adherence to ASTM-ES-22, ISO-10993, and 29CFR 1910.1200.
• Manufacturing Processes: "Dipped Latex" method and ETO sterilization.
• Predicate Device Characteristics: The existing qualities and performance of legally marketed surgical drapes from Civco Medical, Amedic of Sweden, and Microtek.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not a machine learning algorithm.

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

This information is not applicable for the reasons stated above.

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Accessory-Needle Guides used for Vaginal Ultrasound Transducers for performing Vaginal Biopsies.

A tube, a cannula that is an accessory that snaps or rests(depending on configuration) onto an ultrasound transducer(884.2960)
A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system
A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers

The provided document is a 510(k) premarket notification for a Transvaginal Needle Guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data to prove novel safety and effectiveness. Therefore, the information typically found in a study proving acceptance criteria for a new medical device (like detailed performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies) is largely absent.

Instead, the document highlights that the new device (PROTEK Medical Products Inc.'s Transvaginal Needle Guide) is "substantially equivalent" to existing, legally marketed devices, primarily those by Civco Medical Instruments and Amedic. The equivalence is based on similar design, materials, manufacturing, intended use, and performance claims rather than a new clinical study.

Here's an analysis based on the information provided, explicitly noting what is not available as it's not typically required for a 510(k) of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for this 510(k) submission are implicitly defined by the characteristics and performance of the predicate devices. The "reported device performance" is essentially a claim of identical or highly similar characteristics and performance to these predicates. The document explicitly states: "These new devices are the same as devices being legally marketed by several companies." and "The new devices design, manufacturing, labeling and its intended uses are the same as many existing devices currently being marketed by Civco Medical Instruments, and Amedic among others."

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

• Not Applicable / Not Provided: The document does not describe a new clinical "test set" or study in the traditional sense with specific sample sizes. The claim of equivalence is based on the known performance and design of predicate devices already on the market. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a new study.

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

• Not Applicable / Not Provided: No new clinical test set is described, so there's no mention of experts establishing a ground truth for such a set. The "ground truth" for the device's functionality is assumed to be established by the long-standing use and acceptance of the predicate devices in clinical practice. The document does mention "Doctor" as a designer for both the new and predicate devices, implying clinical input in the initial design of similar devices.

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

• Not Applicable / Not Provided: No new clinical test set is described, so no adjudication method is mentioned.

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 Provided: This device is a mechanical needle guide accessory for ultrasound transducers, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness data is irrelevant and not provided.

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

• Not Applicable / Not Provided: This is a mechanical device, not an algorithm. Standalone performance for an algorithm is not relevant here.

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

• Implied Ground Truth: The ground truth is implicitly based on the established safety and efficacy of the predicate devices in clinical use, which would have been validated through their own historical regulatory pathways, including clinical experience and potentially outcomes data over time (though not explicitly detailed in this document for those devices). For the PROTEK device, the ground truth is that it performs "the same" as these predicate devices.

8. The sample size for the training set:

• Not Applicable / Not Provided: As this is a mechanical device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

• Not Applicable / Not Provided: See point 8.

In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence to predicate devices already on the market. It does not present novel study data to prove the device meets acceptance criteria because the criteria are based on the established performance of its legally marketed counterparts. The safety and effectiveness are argued to be the same due to similar design, materials, intended use, and manufacturing processes.

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Used to assist doctors when performing a prostate biopsy. Used to guide a needle, biopsy or catheter into the prostate gland. Used as an accessory in conjunction with an ultrasound transducer (892.1570). Used to improve needle placement vs. guiding needle with the finger. Needle Guides for Rectal Ultrasound Transducers used in prostate biopsies.

A tube, a cannula that is an accessory that snaps or rests (depending on configuration) onto an ultrasound transducer (892.1570). A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system. A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers.

This document describes the Premarket Notification (510(k)) for a Transrectal Needle Guide, an accessory for ultrasound transducers. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study to prove acceptance criteria through performance metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical performance targets and reported device performance data in the way one might expect for a diagnostic or therapeutic device with measurable outcomes (e.g., sensitivity, specificity, accuracy).

Instead, the "acceptance criteria" are implied by the Substantial Equivalence Comparison Chart (Appendix D), which compares the new device (PROTEK Medical Products Inc.) with a predicate device (Civco Medical K875128/A) across various characteristics to demonstrate that the new device is as safe and effective as the predicate.

Here's a re-interpretation of the Appendix D chart in the context of "acceptance criteria" through substantial equivalence:

Key takeaway: This 510(k) relies on demonstrating that the new device is the same as or very similar to existing, legally marketed devices, rather than providing novel performance data against specific, quantitative acceptance criteria via a clinical study. The "study" here is primarily a comparison analysis against predicate devices.

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

The document does not describe a "test set" in the traditional sense of a dataset used for clinical evaluation of a device's performance (e.g., images for an AI algorithm, patient outcomes). The "study" is a comparison against predicate devices.

• Sample Size for Test Set: Not applicable/not provided for clinical performance
• Data Provenance: Not applicable/not provided for clinical performance. The comparison is based on the specifications, design, materials, and intended use of existing predicate devices.

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

Not applicable. "Ground truth" in the clinical performance sense (e.g., confirmed disease status) is not established or used in this submission. The "ground truth" for the comparison is the established characteristics and regulatory status of the predicate devices. The "experts" involved are the device manufacturers and potentially regulatory bodies who approved the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

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

No. This type of study (MRMC) is typically performed for diagnostic devices (e.g., imaging software) to assess the impact of AI assistance on human reader performance. The device in question is a simple mechanical accessory (needle guide), not a diagnostic algorithm.

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

No. The device is a physical accessory and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the new device's characteristics are substantially equivalent to these predicates, it shares the same safety and effectiveness profile.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. No training set is described.

Summary of the "Study" and "Acceptance Criteria" for K971115:

For this 510(k) submission, the "study" is primarily a comparison analysis against well-established, legally marketed predicate devices. The "acceptance criteria" are met by demonstrating substantial equivalence in terms of:

• Intended Use: The device shares the same intended use as the predicate (guiding needles/catheters in conjunction with ultrasound for prostate biopsies).
• Technological Characteristics: The device is made of similar materials (stainless steel, medical grade plastic), manufactured using similar methods, and designed to meet similar fundamental quality and safety standards (e.g., sterilization, biocompatibility, mechanical safety as confirmed by "end product tests" which are not detailed but are assumed to be similar to the predicate's). The only stated deviation is in "size and shape," which is considered a minor modification that doesn't alter the fundamental safety or effectiveness.
• Performance: The document mentions "Performance: Target fixtures, Mil Std 105E." This refers to manufacturing quality control standards and the ability to accurately guide a needle to a target, presumably demonstrated through standard manufacturing and design verification activities, rather than a clinical outcome study. The reference to "Mil Std 105E" implies statistical sampling plans for inspection, typical for manufacturing acceptance.

The FDA's decision (Section 4) of "substantial equivalence" confirms that the device meets the regulatory acceptance criteria by demonstrating it is as safe and effective as devices already on the market, without requiring new clinical performance data.

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