(60 days)
These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.
This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.
These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.
This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.
These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
The regulatory filing provided (K023984) is a 510(k) premarket notification for Olympus Bronchoscopes (BF-40, 240, and 160 series). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way one might expect for a novel AI/software device.
Instead, the submission details a change in material for a component and argues that this change does not affect safety and effectiveness. Therefore, the information requested regarding acceptance criteria and a study proving their fulfillment, especially in the context of an AI device, is largely not present in this document.
However, I can extract the information that is implicitly part of a 510(k) substantial equivalence submission for a physical medical device like a bronchoscope:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of performance acceptance criteria or specific reported performance metrics for the reasons stated above. The "acceptance criterion" in a 510(k) for device modifications is primarily demonstrating that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that the change does not introduce new questions of safety or efficacy.
| Acceptance Criterion (Implicit for 510(k) Device Modification) | Reported Device Performance (Implicit for this submission) |
|---|---|
| Clinical safety and effectiveness unchanged by material change | Assessed to be unchanged |
| Biocompatibility of new material | Expected to be compatible (implied by typical pre-market processes for material changes) |
| Mechanical integrity and function maintained | Expected to be maintained |
| Intended Use remains consistent | Consistent with predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not directly applicable or provided in the context of this 510(k) submission. A material change typically involves engineering tests, biocompatibility testing (often in vitro or animal studies if new to medical devices), and potentially some form of simulated use or bench testing, rather than a clinical "test set" as one might see for an AI algorithm. No specific sample sizes for such tests are mentioned.
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. This type of information is relevant for studies relying on expert review for ground truth, which is not the case for this physical device modification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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, as this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device with a material change, "ground truth" typically relates to objective engineering specifications, material properties, and functionality tests, rather than clinical diagnostic agreement.
8. The sample size for the training set
Not applicable, as this is not an AI-powered device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI-powered device.
Summary of Study (as per 510(k) for this device):
The "study" or evidence provided in this particular 510(k) is the assertion that the difference between the predicate devices and subject devices is only a change in material of the Biopsy Port, and that this change in material would not affect safety and effectiveness of the device. This is the core of the substantial equivalence argument.
While the document K023984 references "clinical data" in other sections, the publicly accessible portions of this specific 510(k) summary do not detail specific clinical studies for these devices beyond stating their intended use and comparing them to a predicate device when a material change is involved. For a material change, the supporting evidence would typically include:
- Material characterization: Data showing the physical and chemical properties of the new material.
- Biocompatibility testing: According to ISO 10993 or similar standards, to ensure the new material is safe for patient contact.
- Bench testing: To demonstrate that mechanical performance (e.g., flexibility, strength, torqueability, fluid paths) of the bronchoscope with the new biopsy port material is equivalent to or better than the predicate.
- Sterilization validation: Ensuring the new material can withstand the validated sterilization process without degradation.
The 510(k) process focuses on demonstrating substantial equivalence, often through a combination of engineering analysis, bench testing, and sometimes non-clinical or limited clinical data, rather than a full-scale clinical trial with specific performance acceptance criteria like those expected for novel technologies or AI.
§ 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.