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The Sterile Powder Free Synthetic Rubber Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Sempermed Syntegra IR is a sterile powder-free surgeon glove. It is a disposable device made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. This glove is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

The document describes the acceptance criteria and performance of the "Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves." The device is a surgical glove, and its performance is evaluated against ASTM standards and ISO standards for biocompatibility.

Here's a breakdown of your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information:

The provided document is a 510(k) Premarket Notification summary for a medical device (surgical gloves). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study proving device effectiveness in a diagnostic or treatment context. Therefore, many of the questions regarding clinical study design (sample size for test/training sets, experts, MRMC, etc.) are not applicable to this type of submission.

Here's what can be inferred from the document:

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 in the traditional sense of a diagnostic/AI test set. The "test set" here refers to samples of the manufactured gloves used for physical and biocompatibility testing. The document does not specify the sample sizes for these tests, but they would be governed by the respective ASTM and ISO standard methodologies (e.g., AQL for watertight testing).
• Data Provenance: Not specified, but the manufacturing company is Semperit Investment Asia Pte. Ltd. (Singapore), and the standards applied are international (ASTM, ISO). The tests would likely be conducted by the manufacturer or a certified testing laboratory.

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. For physical and biocompatibility testing of surgical gloves, "ground truth" is established by adherence to standardized measurement and analytical protocols defined by ASTM and ISO organizations, not by expert consensus in the diagnostic sense.

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

• Not Applicable. Adjudication methods are typically for subjective assessments or when there's disagreement among human readers/experts. These tests involve objective measurements and chemical/biological assays.

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 device (surgical glove), not an AI diagnostic tool.

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

• Not Applicable. This is a physical device (surgical glove), not an algorithm.

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

• The "ground truth" for the performance claims about the surgical glove is established by adherence to objective, standardized measurements and biological assays as defined by the referenced ASTM and ISO standards (e.g., tensile strength, elongation, powder content, skin irritation, sensitization, watertightness).

8. The sample size for the training set

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

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

• Not Applicable. As above, no training set for an AI model.

In summary: The document demonstrates that the "Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves" meets established performance standards for surgical gloves, primarily by demonstrating its physical characteristics and biocompatibility conform to ASTM and ISO specifications. The evaluation is focused on non-clinical performance data to show substantial equivalence to a legally marketed predicate device, rather than a clinical comparative study or an AI algorithm validation.

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Syntegra™ is a software application for multi-modality image registration and diagnostic fusion. Images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined functional and anatomical data providing different angular perspectives for interpretation by trained professionals

Syntegra™ is a software application for multi-modality image registration and diagnostic fusion. This application exists within the predicate device, Gemini 16 (K032036). The Gemini 16 is an imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). This PET/CT device includes the processing station and applications contained within, such as image fusion. Syntegra™ may be offered as a standalone software application that has the capability to be utilized on any PC image processing workstations meeting the minimum hardware requirements to support the application.

Registration is the process of aligning two or more images from the same patient so that physical positions within each image are coincident. The images may be from the same imaging modality or different imaging modalities.

Fusion display is the visual combination of two image data sets that allows the data sets to be displayed simultaneously in a blended mode in the same screen window. The level of be arejected by user adjustable opacity values assigned to each data set. A common application of fusion display is the combination of physiological data from SPECT images and anatomical information from CT images.

Images are registered and displayed in a fused format to provide combined functional and anatomical data. The images are presented using various three-dimensional rendering techniques such as multi-planar reformatting, surface rendering with cut-planes, and maximum intensity projections.

Syntegra also offers Region of Interest tools. These are tools, which allow a user to draw two-dimensional contours around areas of interest on the transaxial image planes. The contours may then be exported to Radiation Therapy Planning systems, which use the two dimensional contours to generate three-dimensional volumes, which may be used in therapy planning.

The application operates on WindowXP/Intel Pentium computer systems with the following minimum requirements:

• Graphics Card: 24/32 bit color, support for 1400x1162 screen resolution .
• RAM: 1 GB .
• Processor: Pentium IV and above .
• Clock Speed: 1GHz clock speed .

The provided text describes a 510(k) summary for the Syntegra™ device, which is a software application for multi-modality image registration and diagnostic fusion. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for testing or training sets.

The document focuses on:

• The device's intended use and description.
• Comparison to a predicate device (Philips Medical Systems Gemini 16, K032036).
• A declaration of substantial equivalence to the predicate device.
• The FDA's letter of clearance.

Therefore, I cannot provide the requested information from the given text. The text explicitly states "Syntegra is substantially equivalent to the image fusion software application from the following predicate device, Gemini (K032036), based on similar intended use and technological comparison." This suggests that the substantial equivalence argument was made based on technological comparison to an existing device rather than a new performance study against specific acceptance criteria.

To answer your request, I would need a different document that details the performance study conducted for Syntegra™, including the acceptance criteria and study results.

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