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Found 10 results
510(k) Data Aggregation
(70 days)
Horizons Rotatabel Snare and Polyp Catcher TORNADO™ is intended to Electrosurgically Remove and collect Polyps from the Gastro Intestinal Tract Under Endoscopic Visualization.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Horizons Rotatable Snare and Polyp Catcher TORNADO™". This letter confirms substantial equivalence to a predicate device, allowing the manufacturer to market the device.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance). The letter is an administrative communication from the FDA, not a technical report or study summary.
Therefore, I cannot provide the requested table and information based on the given text.
To answer your request, I would need a different type of document, such as:
- A clinical study report
- A performance testing report
- A detailed regulatory submission document (e.g., the 510(k) submission itself, if it included performance data)
In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies.
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(102 days)
Polypectomy Snares are used for cutting of polyps.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Horizons Reusable Polypectomy Snares." This document is a regulatory approval and does not contain information about acceptance criteria, device performance studies, or details regarding AI algorithms.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on clinical performance metrics or studies as typically described for AI device evaluations.
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(105 days)
Horizons Reusable Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Horizons Reusable Hot Biopsy Forceps). This type of document does not contain the information requested regarding acceptance criteria and study results.
The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials with detailed performance metrics like accuracy, sensitivity, specificity, or sample sizes for testing AI algorithms. Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- Multi reader multi case (MRMC) comparative effectiveness study information
- Standalone (algorithm-only) performance information
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document primarily states that the device is substantially equivalent to predicate devices for its intended use, which is "transendoscopic, dissecting, and grasping tissue for biopsy." It also lists regulatory information such as the regulation number, name, and product code.
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(11 days)
Horizons ANSO Transbronchial Aspiration Needle is intended to be used in the flexible endescope for submucosal aspiration biopsy of the bronchial tree.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Horizons International Corp. regarding their ANSO Transbronchial Aspiration Needle. This document determines substantial equivalence to a predicate device, allowing the manufacturer to market the device.
However, the provided document does not contain any information about acceptance criteria for the device's performance, nor does it describe any studies that prove the device meets such criteria.
The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish safety and effectiveness against specific performance criteria in the same way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information from the provided text. The document does not include:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets, data provenance, or study types (retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies or effect sizes.
- Results of standalone algorithm performance studies.
- The type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
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(23 days)
Horizons Cytology Brush is intended to be used in the flexible endescope to collect cell sampling, or to perform surveillance cultures.
Not Found
This document is an FDA 510(k) clearance letter for the "Horizons Cytology Brush Endoscopic Accessory." It indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.
However, the provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance letter, not a scientific study report.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.
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(29 days)
Horizons Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Horizons Hot Biopsy Forceps." It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested.
The letter explicitly states that the device is found to be "substantially equivalent" to legally marketed predicate devices, which means it doesn't require a new premarket approval application (PMA). This type of clearance generally relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. Formal clinical studies with acceptance criteria and detailed performance metrics are typically not required for 510(k) submissions unless specifically requested by the FDA due to unique concerns.
Therefore, I cannot fulfill your request using the provided input. The document does not contain the necessary information.
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(78 days)
HORIZONS POLYPECTOMY SNARES ARE INTENDED TO ELECTROSURGICALLY REMOVE POLYPS IN THE GI TRACT UNDER ENDOSCOPIC VISUALIZATION
Not Found
I am sorry, but this document contains no information about acceptance criteria or the study that proves whether the device meets those criteria. It is a 510(k) clearance letter for a medical device (Horizons Polypectomy Snares), indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.
The letter confirms that the device can be marketed but does not include details on:
* Acceptance criteria for device performance
* Specific study data or methodology
* Sample sizes used
* Ground truth establishment
* Expert qualifications
* Adjudication methods
* Details of multi-reader multi-case (MRMC) comparative effectiveness studies
* Standalone algorithm performance studies
* Training set information
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(90 days)
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(183 days)
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(183 days)
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