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The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic and histological examination.

The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit contains items for obtaining and handling of cytologic and histological specimens in the context of a transbronchial aspirating needle procedure.

This submission describes a kit composed of several components, not a single device with a specific performance. The regulatory review (510(k)) found the kit substantially equivalent to legally marketed predicate devices because all its components were either already cleared, exempt from notification, or had undergone their own 510(k) process. This means the individual components were likely evaluated for their individual performance and safety, but there isn't a single study describing the overall performance of the kit in terms of specific acceptance criteria.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, MRMC study, standalone performance) are not applicable to this particular 510(k) submission, as it focuses on the equivalence of a combination of components.

Here's an attempt to answer the questions based on the provided document, noting where information is not available or not applicable:

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

Based on the provided K983122 510(k) summary, there are no specific performance acceptance criteria or reported device performance metrics for the overall kit as a single device. The submission focuses on the substantial equivalence of its individual components to already legally marketed devices. The "performance" in this context refers to the intended function of each component, which is assumed to be met based on their prior clearances or exempt status.

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. This 510(k) is about substantial equivalence of a medical device kit composed of pre-existing components. There is no specific test set or clinical study described in this document for the kit itself. The performance and safety of the individual components would have been established in their respective original clearances or through their general purpose exemption status.

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. As there is no specific test set or clinical study for the kit's performance, there's no mention of experts establishing a ground truth for such a study in this submission.

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

Not applicable. No test set is described for the kit's performance.

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 submission is for a medical device kit for specimen collection and preparation, not an AI-assisted diagnostic tool.

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

Not applicable. This submission is for a medical device kit, not a standalone algorithm.

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

Not applicable. There is no explicit mention of a ground truth being established for the kit's performance in this document. The "ground truth" for each component implicitly relates to their established safety and efficacy for their individual intended uses, as determined during their original regulatory pathways.

8. The sample size for the training set

Not applicable. This submission does not involve a training set for an algorithm or model.

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

Not applicable. There is no training set mentioned in this submission.

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The Transbronchial Needle Aspiration Cytology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic examination.

The Transbronchial Needle Aspiration Cytology Procedural Kit contains items for obtaining and handling of cytologic specimens in the context of a transbronchial aspirating needle procedure.

The provided text describes a 510(k) summary for a "TBNA Cytology Procedural Kit." This document is a premarket notification for a medical device to demonstrate its substantial equivalence to a legally marketed predicate device.

Crucially, the provided text does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document primarily focuses on:

• Identifying the submitter, contact, and proprietary name of the device.
• Stating the common name, classification name, and providing a statement of equivalence.
• Listing the components of the kit, their 510(k) status, and classification.
• Describing the device and its intended use.
• Asserting that the technological characteristics of the kit components do not vary from those used individually.
• An official FDA letter granting substantial equivalence.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, and performance metrics as this information is not present in the provided document. This type of regulatory submission (510(k)) for a kit often relies on the established safety and effectiveness of its individual components rather than requiring a new clinical performance study for the assembled kit itself, especially if the components are already cleared or exempt.

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The intended use of the subject device is to electrosurgically remove GI tract polyps through the channel of an endoscope

The device consists of a handle, cable, snare loop and cable. The loop is attached to the handle assembly by means of the cable. The sheath is also connected to the handle assembly and collapses the loop upon its retraction into the sheath.

The provided text describes a 510(k) premarket notification for a medical device called the "Mill-Rose Disposable Polypectomy Snare." This is a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

Based on the provided documents, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for AI/software devices.

Here's why and what can be extracted based on your questions:

• Type of Device: The Mill-Rose Disposable Polypectomy Snare is a physical medical instrument used for electrosurgical removal of GI tract polyps. It is not an AI/software device, imaging device, or diagnostic tool that would typically have performance metrics like sensitivity, specificity, or reader improvement studies.
• Regulatory Pathway: The 510(k) pathway focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This typically involves comparing material, design, technological characteristics, and intended use to the predicate device, not necessarily conducting performance studies in the way an AI/diagnostic device would. The goal is to show it performs as safely and effectively as the predicate, not necessarily to quantify its performance against a set of statistical cutoffs like an AI model.

Therefore, the requested information categories (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or not provided in this type of regulatory submission for this type of device.

Here's what can be answered from the provided text, largely by stating "Not Applicable" or "Not Provided" due to the nature of the device and submission:

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

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

• Sample Size for Test Set: Not Applicable / Not Provided. This type of performance testing with a "test set" and ground truth is not described for this physical device in a 510(k) submission.
• Data Provenance: Not Applicable / Not Provided.

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)

• Number of Experts: Not Applicable / Not Provided.
• Qualifications of Experts: Not Applicable / Not Provided.

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

• Adjudication Method: Not Applicable / Not Provided.

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

• MRMC Study: No, Not Applicable. This is a physical device, not an AI system.
• Effect Size of Human Readers with AI: Not Applicable.

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

• Standalone Performance: No, Not Applicable. This is a physical device, not an algorithm.

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

• Type of Ground Truth: Not Applicable / Not Provided. Performance is based on substantial equivalence to predicate devices, not on a ground truth established for diagnostic accuracy.

8. The sample size for the training set

• Sample Size for Training Set: Not Applicable / Not Provided. This is a physical device, not an AI/machine learning model that requires a training set.

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

• Ground Truth Establishment for Training Set: Not Applicable / Not Provided.

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The device is intended to be used through a laryngoscope for the therapeutic injection the larynx for various laryngeal disorders such as paralysis, tissue deficiency, contact ulcers and spasmodic dysphonia.

The device consists of an outer catheter and an inner catheter to which a needle is mounted. The inner catheter slides within the outer catheter such that the needle tip may advance a pre-determined distance past the end of the outer catheter and remains totally within the lumen catheter when the needle is fully retracted.

The provided text describes a medical device (Mill-Rose Laryngoscopic Injection Needle) and its 510(k) summary for regulatory approval. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document focuses on:

• Administrative details: Submitter, contact person, preparation date, classification, and common/proprietary names.
• Predicate devices: Listing similar, previously approved devices (K914181, K820973).
• Device description: Explaining the physical components (outer catheter, inner catheter, needle).
• Intended use: Specifying its therapeutic purpose for laryngeal injection.
• Technological characteristics: Stating it's similar to predicate devices in materials and design.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method for a test set.
3. MRMC study details or effect size.
4. Standalone performance details.
5. Type of ground truth used.
6. Training set details (sample size, ground truth establishment).**

This type of information (device performance, clinical study results, acceptance criteria) would typically be found in a separate section of a 510(k) submission, not in the summary provided. The summary confirms the device's substantial equivalence to previously cleared devices based on its intended use, technological characteristics, and safety and effectiveness, rather than presenting new performance data.

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The device is intended to allow blind, non-directed, protected specimen brush sampling of the lower respiratory tract secretions or to perform surveillance cultures or to diagnose pneumonia in patients receiving mechanical ventilation.

The subject device is sterile and consists of a flexible polymeric inner sheath which is contained within an outer sheath. Within the inner sheath is a twisted wire brush. The outer sheath is occluded with a polyethylene glycol wax plug. Upon use, the inner sheath is advanced, the plug expelled and the brush advanced to provide a sterile, non-contaminated specimen brush.

The provided text is a 510(k) summary for a medical device submitted in 1996. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information in a table or answer the specific questions about device performance studies, sample sizes, ground truth establishment, or expert involvement.

The 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results with specific acceptance criteria that would be found in a modern clinical validation study. In 1996, the requirements for 510(k) submissions might have been different, and the information contained in this summary does not include the type of detailed performance data and study design requested in your prompt.

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