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The World Wide Medical Technologies StrandPort intended use is to provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures.

disposable carrier for seed strands containing radionuclide seeds

This document is a 510(k) clearance letter from the FDA for a medical device called "Worldwide Medical Technologies StrandPort."

Based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

• Device Name: Worldwide Medical Technologies StrandPort
• Regulation Number: 21 CFR 892.5730
• Regulation Name: Radionuclide brachytherapy source
• Regulatory Class: II
• Product Code: KXK
• Indications For Use: To provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures (transperineal approach for radionuclide seed application in and around the prostate). It is a sterile, single-patient-use product.
• FDA Clearance: The letter states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This allows the company to market the device subject to general controls.

The document does not contain any of the following information requested:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a regulatory clearance document, not a detailed technical report of a performance study.

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The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "Readi-Strand Model PS-Strand." This document is a regulatory approval letter and does not contain specific details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot extract the requested information from the provided text. The letter only confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

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The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures.

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This document is a 510(k) clearance letter for the "Readi-Strand Model PSStrand" device, which is a radionuclide brachytherapy source carrier. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the FDA has reviewed Worldwide Medical Technologies, Inc.'s premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the device's indications for use: "to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland."

To answer your specific questions, information regarding acceptance criteria, device performance results, study design details (sample size, data provenance, expert qualifications, adjudication methods, etc.), and ground truth establishment would typically be found in the 510(k) summary submitted by the manufacturer, which is a separate document from this clearance letter.

Therefore, I cannot provide the requested information based on the provided text.

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The Worldwide Medical Technologies Readi-Load intended use is to provide a pre-sterilized needle carrier for radionuclide seeds for the introduction of radionuclide seeds into the body for Brachytherapy procedures.

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This document is a 510(k) premarket notification letter from the FDA regarding the "Readi-Load System." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study demonstrating the device's performance against such criteria. The letter is an administrative notification of FDA clearance, not a scientific study report.

Therefore, I cannot fulfill your request as the necessary information is absent from the provided input.

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The Spiritus™ Respiratory System is a patient interface accessory intended for use with devices that administer CPAP (continuous positive airway pressure) and bi-level airway pressure in treating adult patients.

The Spiritus™ Respiratory System is a single-patient interface accessory intended for use by patients who have been prescribed positive airway pressure treatment (PAP) including CPAP and BiPAP.

The device is a single-patient-use, patient interface accessory for patients receiving positive airway pressure treatment including CPAP and BiPAP and comprises the nasal/tubing assembly and associated headgear.

The nasal cannula protuberances fit into the patient's nares effecting a substantially artight seal, facilitating the delivery of the positive airway pressure. Tubing is fitted to the nasal cannula via elbow connectors which may be used to secure the detachable headgear. The tubing fits to a "Y" connector to effect connection to the flow generator output tube.

The nasal cannula, tubing and connectors may be cleaned with mild soap and water for use by the same patient.

The provided text describes a medical device, the Spiritus™ Respiratory System, a patient interface accessory for positive airway pressure treatment. However, the document is a 510(k) summary and approval letter, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance studies with acceptance criteria in the manner typically seen for novel AI/ML devices.

Therefore, much of the requested information (like sample size for test/training set, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods) is not available in this document. The document describes traditional engineering performance testing, not studies of diagnostic accuracy that would involve expert readers or AI algorithms.

Here's a breakdown of what can be extracted 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 corresponding performance metrics in the way that would be expected for a diagnostic AI device. Instead, it lists the types of performance tests conducted and asserts that these tests confirmed the device's performance. The implied acceptance criterion for these tests is "meets performance expectations for a substantially equivalent device."

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

• Test Set Sample Size: Not specified. Standard engineering-style performance testing was performed, not studies on patient data.
• Data Provenance: Not applicable in the context of device performance testing described. These are likely bench or laboratory tests.

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

• Number of Experts: Not applicable. These were engineering performance tests, not human-read diagnostic studies.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. The device is a patient interface accessory, not a diagnostic imaging device or an AI algorithm that would typically undergo MRMC studies.

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

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

7. The Type of Ground Truth Used

• Type of Ground Truth: Engineering standards, specifications, and comparison to the predicate device's known performance for flow resistance, enclosed volume, and intentional leak rate.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain any information about acceptance criteria or a study proving the device meets said criteria. The document is a regulatory approval for the World Wide Medical Technologies ReadiStrand Model PSStrand, a radionuclide brachytherapy source carrier.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or answer any of the subsequent detailed questions about the study, as this information is not present in the provided text.

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The intended use of the Worldwide Medical Technologies Bone Marrow Aspiration/Core Needle is to obtain samples of aspirates and bone marrow for cytologic and histologic examination in the diagnosis and treatment of various diseases. The samples are typically taken by percutanious puncture of the posterior iliac crest of the pelvic bone.

Worldwide Medical Technologies AspirCore

The provided text is a 510(k) premarket notification letter from the FDA regarding the Worldwide Medical Technologies AspirCore, a bone marrow aspiration/core needle. This document does not contain information about acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, ground truth establishment, or any details of a study that proves the device meets specific acceptance criteria.

The letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to the "indications for use" but does not detail any performance metrics or studies to support those indications beyond substantial equivalence to existing devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

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The Worldwide Medical Technologies Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate.

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This looks like an FDA 510(k) clearance letter and an 'Indications For Use' statement, not a study report. This type of document generally does not contain the information requested regarding acceptance criteria, device performance results, study design details, or ground truth establishment.

A 510(k) clearance letter indicates that the FDA has found a device to be substantially equivalent to a predicate device already on the market, meaning it's as safe and effective as the predicate. It does not typically involve the submission of detailed performance studies against pre-defined acceptance criteria in the same way a Premarket Approval (PMA) would.

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

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The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.

Worldwide Medical Technologies Introducer Needle for Biopsy Needles

The provided documents, K981889, are a 510(k) clearance letter and an Indications For Use statement for the Worldwide Medical Technologies Introducer Needle. These documents do not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, which does not necessarily require new clinical studies if existing data or non-clinical tests are deemed sufficient.

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The intended use for the Worldwide Medical Technologies Intracervical Block Needle is to inject anesthetic in the cervical area.

Worldwide Medical Technologies Intracervical Block Needle

The provided text is a 510(k) clearance letter from the FDA for the "Worldwide Medical Technologies Intracervical Block Needle." This document primarily addresses regulatory approval based on substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against specific acceptance criteria.

As such, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth methods, MRMC studies, or standalone algorithm performance) is present in the provided document.

The document indicates that the device's substantial equivalence was determined based on its intended use "to inject anesthetic in the cervical area" and comparison to devices marketed before May 28, 1976. This regulatory pathway does not typically require the submission of clinical performance data in the same way that a novel device might.

Therefore, I cannot populate the requested table or answer the questions based on the given text.

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