(143 days)
This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area within the respiratory organs.
Olympus Medical Systems Corp., intends to introduce the Guide Sheath for use in the respiratory organs. This Guide Sheath,XBO1-836-13 has been designed to be used with Olympus bronchoscopes with 2.8 mm instrument channel, accessories and ultrasonic probe unit for performing diagnostic and therapeutic procedures. The Guide Sheath allows physicians to advance the endo-therapy accessories or guide the ultrasonic probe precisely to the targeted lesions repeatedly.
This Guide Sheath, XBO1-836-13 consists of tube sheath and piece of flouro tip, which shows the distal end position when X-ray was monitored.
The provided text describes a 510(k) submission for a medical device, the "Olympus Guide Sheath, XBO1-836-13". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that the device meets specific acceptance criteria through a study in the way a new drug or novel medical device might.
Therefore, the document does not contain the detailed information typically associated with acceptance criteria, reported device performance figures, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or comparative effectiveness study details as requested. These elements are primarily relevant for AI/ML device evaluations or clinical trials for novel devices with specific measurable performance endpoints.
However, I can extract the information that is present regarding the clinical evaluation.
Summary of Device Evaluation Information from the Text:
Since the provided document is a 510(k) summary for a guide sheath, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against quantitative acceptance criteria for a new, complex device (like an AI algorithm).
- Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The 510(k) submission focuses on substantial equivalence based on performance, materials, and specifications being "basically identical" to a predicate device.
- Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Olympus sponsored prospective clinical evaluation of the subject device which support the safe and effective use of the subject device for its intended use." The number of participants or cases in this evaluation is not detailed.
- Data Provenance: Prospective (as stated: "prospective clinical evaluation"). Country of origin is not specified, but the applicant and manufacturer are Japanese companies, while the regulatory submission is to the US FDA.
- Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable/not specified. The "ground truth" concept is more relevant for diagnostic devices or AI, not a guide sheath. The evaluation would likely have focused on clinical use parameters, safety, and functionality, observed by clinicians, rather than establishing a "ground truth" for a diagnostic outcome.
- Adjudication Method for the Test Set: Not applicable/not specified.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is specifically for evaluating the effectiveness of a diagnostic tool, often with and without AI assistance, comparing human readers' performance. This is not reported for a guide sheath.
- Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No. This device is a physical instrument for aiding human procedures, not an algorithm.
- Type of Ground Truth Used: Not applicable in the context of diagnostic "ground truth". The "ground truth" for this device would be its demonstrated functional safety and efficacy in guiding instruments during bronchoscopy, which would be assessed through clinical observation and outcomes.
- Sample Size for the Training Set: Not applicable/not specified. The device is a physical instrument, not an AI algorithm requiring a training set.
- How the Ground Truth for the Training Set Was Established: Not applicable.
Key takeaway from the document: The 510(k) submission for the Olympus Guide Sheath relies on demonstrating substantial equivalence to a legally marketed predicate device (Cytology Brush: BC-14/15/16C, K931154). While a "prospective clinical evaluation" was sponsored to support safe and effective use, the detailed methodology, sample sizes, and specific performance metrics typically associated with acceptance criteria for novel or AI-driven devices are not disclosed in this summary. The primary argument for approval is that the device is "basically identical to the predicate device in performance, materials and specifications," differing only in intended use.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.