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The indications for use of the product is to remove the cold from the bucky by placing this sheet between patient's breast and the image receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

Comfort Cover is a single-use disposable cover placed between the patient's breast and the image receptor plate during mammography. The purpose of this product is to allow the patient to feel more comfortable and less cold during the mammographic examination without interfering with image quality. Comfort Cover will allow for artifact-free images in both Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT), patient radiation dose is equivalent to that when using no Comfort Cover and the Image quality is equivalent to images exposed without Comfort Cover.

Comfort Cover is designed to fit small and large image receptor plates of all leading mammographic equipments. The product is constructed of a fabric material with a purple printed design and has adhesive backing with a paper liner. Both the material and adhesive backing of the product do not affect imaging.

The product is directly applied wrinkle free to the image receptor plate of the mammographic machine by the adhesive backing exposed by peeling off the liner. After the patient's mammogram, the product is peeled off the image receptor plate and disposed. As the product removes cleanly without leaving behind any residue, the image receptor plate does not need to be cleaned between Comfort Covers nor between patients.

The provided document, a 510(k) Premarket Notification for the "Comfort Cover," describes the device, its intended use, and comparative testing against a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a regulatory submission for a device involving AI or complex performance metrics. The Comfort Cover is a disposable cover for mammography plates to enhance patient comfort without affecting image quality.

Below is an attempt to extract and synthesize the requested information based on the document, noting where specific details are not provided or are not applicable to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

• Irritation and Skin Sensitization: Pass ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization). | - The subject device passed all tests (ISO 10993-5 and ISO 10993-10). |
  | Mechanical/Physical Performance | - Visual and Dimensional: No visible defects, correct dimensions.
• Thermal Conductivity: Performance in line with material properties (implied comparison to predicate).
• Ink Smear: No ink smearing as per ASTM D5264-98.
• Peel Adhesion: Adequate peel adhesion as per ASTM D6252-98 (90° Angle).
• Removes Cleanly: Product removes cleanly without leaving residue (in-house method). | - The subject device passed all visual and dimensional examinations.
• Thermal Conductivity Test was performed.
• Ink Smear Test was performed and passed.
• Peel Adhesion Test was performed and passed.
• Removes Cleanly Test was performed and passed (removes cleanly from mammographic equipment without leaving residue). |
  | Radiological Performance | - Artifact-free images: Allow for artifact-free images in both Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) when using Comfort Cover.
• Patient Radiation Dose: Equivalent to that when using no Comfort Cover.
• Image Quality: Equivalent to images exposed when using no Comfort Cover.
• Radiolucent: Does not image, no artifacts, quality of images not affected. | - Comfort Cover allows for artifact-free images in both FFDM and DBT.
• Patient radiation dose is equivalent to that when using no Comfort Cover.
• Image quality is equivalent to images exposed when using no Comfort Cover.
• The device is radiolucent. |
  | Usability | - Fulfill design requirements of making mammography examination more comfortable.
• Not negatively impact patient positioning. | - The Comfort Cover fulfilled its design requirements of making the mammography examination more comfortable.
• The Comfort Cover did not negatively impact patient positioning. |
  | Comparison to Predicate (Overall) | - Similar Indications for Use, Target Population, Where Used, Product Size, Packaging and Labeling, Biocompatibility, Sterility, Dispensing Method, and Environment Compatibility.
• Minor material differences (fabric type, ink color) do not affect safety and effectiveness.
• Provides comfort and removes cold without affecting image quality.
• Allows for artifact-free images and image quality equivalent to images exposed without Comfort Cover.
• Removes cleanly without residue.
• Printed ink does not smear.
• Remains where placed.
• Radiolucent. | - All "None" in the "Significant Differences" column of Table 5-1 indicate similarity.
• Stated: "Safety and performance testing results have shown that the slight differences in material composition do not affect safety and effectiveness."
• Stated: "Provides comfort and removes cold during a mammographic examination without affecting quality of the images."
• Stated: "Allows for artifact-free images and image quality equivalent to Comfort Cover."
• Stated: "Removes cleanly from the mammographic equipment without leaving behind any residue."
• Stated: "Printed ink does not smear."
• Stated: "Remains where placed."
• Stated: "Does not image, no artifacts, quality of images not affected, radiolucent." |

2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes (e.g., number of covers, images, or participants) for the test sets. It states that "a number of non-clinical performance tests" were completed.

• Biocompatibility: Testing was conducted per ISO 10993-5 and ISO 10993-10 on the subject device.
• Mechanical Testing: Performed on "both the subject and the predicate devices."
• Radiological Studies: Phantom image testing was performed "as per MQSA regulations and with relevant International Electro technical Commission (IEC) standards (62220-1-2:2007 and 61223-3-2)." This implies the use of standardized phantoms, not patient data.
• Usability Studies: Included "radiologists, radiology technologists and patients." The number of each group is not specified.

Data provenance (country of origin, retrospective/prospective) is not specified, but given the nature of the tests (lab-based, phantom studies, usability feedback), it is likely all internal data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For the usability studies, "radiologists" and "radiology technologists" were involved, but their number and specific qualifications (e.g., years of experience) are not detailed. For radiological studies, phantom images were used, implying objective measurements rather than expert human interpretation for ground truth.

4. Adjudication method for the test set
Not applicable or not described. The tests are primarily objective measurements (e.g., passing a specific ISO standard, conforming to ASTM methods, measuring radiation dose, image quality metrics from phantom images). For usability, it simply states that user needs were fulfilled, but no adjudication method for consensus 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
No MRMC study was done, nor is this device related to Artificial Intelligence (AI). The Comfort Cover is a physical accessory for patient comfort during mammography.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used

• Biocompatibility: In-vitro and in-vivo (skin irritation/sensitization) test results against ISO standards.
• Mechanical Testing: Objective measurements (e.g., ASTM standards, in-house developed test for residue).
• Radiological Studies: Objective measurements from phantom images (e.g., presence/absence of artifacts, radiation dose measurements, image quality metrics) compared to baselines (without Comfort Cover) and regulatory/IEC standards.
• Usability Studies: User feedback (radiologists, technologists, patients) on comfort and impact on positioning.

8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model and does not have a "training set."

9. How the ground truth for the training set was established
Not applicable.

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The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the curd dries and shrinks after the birth.

The Securline® Umbilical Cord Clamp is a single use, disposable, molded plastic device, unit packaged, (sterile) or bulk packaged (nonsterile).

The provided text describes a 510(k) summary for the Securline® Umbilical Cord Clamp. This type of device (a medical clamp) typically does not rely on complex algorithms or AI; instead, its performance is assessed through mechanical and biological compatibility tests. Therefore, many of the typical AI/ML study components, such as ground truth establishment with experts, MRMC studies, and standalone algorithm performance, are not applicable here.

Here's an analysis based on the information provided and typical medical device regulatory submissions for non-AI devices:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the biocompatibility or mechanical performance tests. The testing was conducted by an independent laboratory. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it would typically be prospective testing conducted in a laboratory setting. No human patient data is mentioned for these specific tests.

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

This is not applicable in the context of this device and its testing. For a simple mechanical device like an umbilical cord clamp, "ground truth" is established through standardized laboratory tests (e.g., biocompatibility standards, mechanical testing protocols) rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., image reading by multiple experts). For the physical and biological testing of a cord clamp, objective measurements and predefined pass/fail criteria from test protocols are used, not subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation, particularly in diagnostic imaging or clinical assessment where the device assists human readers. This device is a physical medical instrument, not an AI or imaging diagnostic aid.

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

No, a standalone "algorithm only" performance study was not done. This device does not contain an algorithm or AI component. Its performance is entirely mechanical and biological (biocompatibility).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through:

• Standardized Biocompatibility Tests: Laboratory tests against recognized standards for cytotoxicity and skin irritation.
• Mechanical Measurement Protocols: Objective measurements of closing and gripping forces, compared against predicate devices.
• Predicate Device Equivalence: The primary "ground truth" for regulatory submission is often the performance and safety profile of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.

No pathology or outcomes data is mentioned as being used directly for establishing "ground truth" for the performance tests. Clinical outcomes (like prevention of blood loss) are the intended use facilitated by the device, but the performance criteria are based on laboratory testing and comparison to predicates.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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This product is to be used in a labor and delivery environment to secure a uterine contraction monitor to the mother's abdomen. The monitors are used to track contractions and baby's heartbeat rate. Two styles of straps are available. The first contains a buttonhole and the second contains Velcro slots on each end (watchlike). Therefore, one style of strap contains multiple "button holes" for adjustment and the second style of strap is made with Velcro hook and loop for adjustment and securing.

The straps are made of stretch fabric material and intended to be single-patient use. Both types of straps are packaged in pairs (one pink, one blue) shrink-wrapped and are available in quantities of fifty (50) pairs per box.

I am sorry, but the provided text does not contain the information required to answer your request. The documents are a FDA 510(k) clearance letter and an Indications For Use statement for "Securline® Umbilical Disposable Fetal Monitoring Abdominal Straps". These documents confirm that the device is substantially equivalent to a predicate device and describe its intended use, but they do not disclose any detailed study information such as acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications, which would be typical for a clinical study report.

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The Securline® Umbilical Cord Clamp Clipper is used to cut the umbilical cord clamp off a newborn's umbilical cord. The clipper jaws are placed over the "hinge" area of the umbilical cord clamp. Once appropriately located and engaged, pressure is applied to the clipper grips and the hinge is cut in half, removed, and disposed of properly.

Precision Dynamics Corporation purchases the packaged umbilical cord clamp clipper (non-sterile) from DeRoyal Industries. Precision Dynamics Corporation upon receipt of the non-sterile finished product from DeRoyal Industries plans to distribute this device as the Securline ® Umbilical Cord Clamp Clipper.

The provided text is a 510(k) summary for the Securline® Umbilical Cord Clamp Clipper. It describes the device, its intended use, and indicates that it has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations. The document is a regulatory submission summary and an FDA clearance letter, not a study report.

Therefore, I cannot answer your request based on the provided input.

To provide the requested information, the input would need to include details of studies conducted to evaluate the device's performance against specific acceptance criteria.

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The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a Newborn at delivery. The device is used to hold the cord securely and prevent blodd loss and seepage as the cord dries and shrinks after the birth.

Precision Dynamics Corporation purchases the umbilical cord clamp (non-sterile) from Alpha Unlimited, Inc (refer to the 510k K894646) and then contracts the packaging and sterilization through ARMM, Inc. ARMM, Inc. packages the umbilical cord clamp in a plastic/film pouch and contract sterilizes the packaged product per Precision Dynamics Corporation specifications. Precision Dynamics Corporation upon receipt of the sterile finished released product from ARMM plans to distribute the Securline ® Cord Clamp.

This document is a 510(k) summary for the Securline® Umbilical Cord Clamp #3500. It details the device's purpose, classification, and the substantial equivalence determination by the FDA. However, it does not contain the specific information required to answer your questions about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through novel studies. The FDA's letter explicitly states that the review determined the device is "substantially equivalent... to legally marketed predicate devices." This typically means the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.

Therefore, many of the details you've requested regarding specific performance criteria, study design, and data provenance are generally not included in a 510(k) summary, as the primary goal is to establish substantial equivalence to a predicate, not to present de novo performance data.

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