(60 days)
The DISPOSABLE BIOPSY FORCEPS FB-211D/221D/231D/241D are intended to be used to collect tissue within the tracheobronchial tree in combination with a bronchoscope
The Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, and FB-241D (also known as "EndoJaw") have been designed to collect tissue within the tracheobronchial tree in combination with a flexible bronchoscope. The Disposable Biopsy Forceps are inserted into the channel of a bronchoscope to collect tissue by biting the surface of the lesion with a pair of forceps located at the distal end of the device. The Disposable Biopsy Forceps are withdrawn from the channel and the tissue sample is collected.
The Disposable Biopsy Forceps consists of a handle and an insertion portion. The handle consists of a handle body and slider. The insertion portion consists of a sheath, metallic coil (operating wire), cups, and forceps cap. The slider is connected to the operating wire in the insertion portion and the cups are opened/closed by advancing/retreating the slider with the function of the connection parts. The subject device is available in multiple distal end cup shapes; FB-211D – Alligator jaw-step, FB-221D – Alligator jaw-step with needle, FB-231D – Oval type, and FB-241D – Oval type with needle.
This response is based solely on the provided FDA 510(k) Clearance Letter for the Olympus Disposable Biopsy Forceps.
Analysis of the Provided Document:
The provided document is an FDA 510(k) Clearance Letter for a medical device: Disposable Biopsy Forceps. This type of clearance is for devices that are "substantially equivalent" to legally marketed predicate devices. The key takeaway from this document is that the clearance is based on comparing the new device to a predicate device through non-clinical bench testing, not on clinical performance studies involving human subjects or AI-assisted diagnostic accuracy.
Therefore, the questions regarding ground truth, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets related to diagnostic accuracy (which would be typical for an AI/software as a medical device) are not applicable to this specific 510(k) clearance documentation.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications tested during the non-clinical bench testing to demonstrate substantial equivalence to the predicate device.
Responses based on the provided FDA 510(k) Clearance Letter:
1. A table of acceptance criteria and the reported device performance
The document states: "All test samples passed pre-defined acceptance criteria." However, the specific quantitative acceptance criteria for each test and the detailed reported performance metrics are not explicitly provided in this summary. The document only lists the types of performance tests conducted.
| Test Performed (Non-Clinical Bench Testing) | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance |
|---|---|---|
| Insertion Performance into the Bronchoscope | (Implied: Smooth insertion without obstruction/damage) | Passed acceptance criteria |
| Withdrawal Performance from the Bronchoscope | (Implied: Smooth withdrawal without obstruction/damage) | Passed acceptance criteria |
| Opening and Closing of the Forceps Cups | (Implied: Consistent and complete opening/closing) | Passed acceptance criteria |
| Visual Inspection of the Insertion Portion | (Implied: No defects, damage, or manufacturing flaws) | Passed acceptance criteria |
| Performance After Repeated Insertion and Withdrawal Operations | (Implied: Maintained performance and integrity over repetitions) | Passed acceptance criteria |
| Performance After Repeated Open/Close Operations | (Implied: Maintained performance and integrity over repetitions) | Passed acceptance criteria |
| Connection Strength Between the S-Cover and the Coil Sheath | (Implied: Sufficient strength to prevent separation) | Passed acceptance criteria |
| Visual Inspection for Defects of the Needle and Forceps Teeth | (Implied: No visual defects on critical components) | Passed acceptance criteria |
| Biocompatibility Testing | (Implied: Meets ISO 10993-1 standards for cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity) | Passed acceptance criteria |
| Sterilization Validation (SAL 10⁻⁶) | (Implied: Achieves required sterility assurance level) | Passed acceptance criteria |
| Shelf-Life Testing (5 years) | (Implied: Maintains packaging integrity and product performance over 5 years, per ASTM F1980-21, ISO 11607-1/2) | Passed acceptance criteria |
| Human Factors Evaluation | (Implied: Safe for intended users, uses, and use environments) | Determined safe |
2. Sample sizes used for the test set and the data provenance
- Sample Size: The document mentions "All test samples" but does not specify the numerical sample sizes used for each of the non-clinical bench tests.
- Data Provenance: The tests were conducted by Olympus. The document does not specify country of origin for data as this is a device clearance based on manufacturing and performance testing, not patient data from clinical studies. The testing was prospective in the sense that the tests were designed and executed to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this 510(k) clearance is for a physical medical device (biopsy forceps) and is based on engineering performance demonstration through non-clinical bench testing, not on clinical diagnostic accuracy or interpretation of medical images/data (which would require expert ground truth).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the reasons stated in point 3. Adjudication methods are relevant for subjective image interpretation or clinical outcomes, not for objective bench test measurements of a physical device.
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
This question is not applicable as the clearance is for a physical biopsy forceps and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the clearance is for a physical biopsy forceps and does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This question is not applicable as the device is cleared based on non-clinical performance characteristics (e.g., insertion, withdrawal, force of jaws, sterility, shelf-life) which are evaluated against predefined engineering specifications and physical measurements, not against clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
This question is not applicable as this is a physical medical device clearance, not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
§ 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.