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510(k) Data Aggregation
(81 days)
OPTICAL FORCEPS
To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes
The Optical Forcep consists of two components - a. Telescope - b. Biopsy Forcep
The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Pilling Weck Surgical Optical Forcep, focusing on its substantial equivalence to a predicate device, its intended use, and its classification. It explicitly states that the technological characteristics are "the same as, or equivalent to, predicate devices."
Therefore, I cannot provide details for the following requested information as it is not present in 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 for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The 510(k) summary is primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with specific acceptance criteria.
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