(56 days)
The Flex-THOR System is indicated for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.
The Flex-THOR System includes two main components: (1) the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR), and (2) the Camera Control Unit (CCU). The insertion shaft of the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR) has an outer diameter of 2.9 mm and a working length of 675 mm with 8.5 Fr elliptical shaped distal tip (major diameter of 3.2 mm and minor diameter of 2.4 mm). Users can access the 1.2 mm working channel through the Luer ports.
This FDA 510(k) summary for the KARL STORZ Flex-THOR System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness.
Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (electrical safety, EMC, and reprocessing validation) and a comparison of technological characteristics.
Therefore, I cannot fulfill the request to provide details about acceptance criteria and a study that proves the device meets them in the context of clinical performance or diagnostic accuracy.
Here's what can be extracted from the provided text:
Acceptance Criteria and Device Performance (Not applicable for clinical performance/diagnostic accuracy)
As mentioned, there are no specific acceptance criteria for clinical performance or diagnostic accuracy provided in this document. The focus for this 510(k) submission is on demonstrating safety and effectiveness through substantial equivalence, primarily via non-clinical testing.
The document does report performance against safety and reprocessing standards:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| ANSI/AAMI ES:60601-1:2005 | Compliance |
| IEC 60601-1-2:2007 | Compliance |
| AAMI TIR 12:2010 | Compliance |
| ISO 15883-5:2005 | Compliance |
| AAMI TIR 30:2011 | Compliance |
| AAMI/ANSI/ISO 11737-1:2006/ (R)2011 | Compliance |
| ASTM E1837-96:2014 | Compliance |
Study Information (Primarily Non-Clinical)
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Sample size used for the test set and the data provenance (country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. The document discusses non-clinical bench testing for electrical safety, EMC, and reprocessing. These types of tests typically involve devices/prototypes and simulated conditions, not a "test set" of patient data in the sense of clinical performance or diagnostic accuracy.
- Data Provenance: Not specified, but generally, bench testing is performed in a controlled laboratory environment. It is not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of clinical expert consensus is not part of this 510(k) submission for this device. The non-clinical tests rely on established engineering and microbiological methodologies.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for expert review of images or data, which is not described here.
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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: No MRMC study was done, as this device (an endoscope) does not involve AI or image interpretation for diagnostic assistance that would require such a study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests:
- Electrical Safety & EMC: Compliance with international standards.
- Reprocessing: Verification based on microbiological testing (reduction of microbial load) and visual inspection against established reprocessing protocols outlined in the standards.
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The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm.
Summary of what the document does provide:
- Clinical Performance Data: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
- Purpose of Non-Clinical Data: The non-clinical data covered electrical safety, electromagnetic compatibility (EMC), and reprocessing validation, all to demonstrate the device is as safe and effective as the predicate device.
- Conclusion: The submission concludes that based on non-clinical performance data and comparison of device characteristics, the Flex-THOR System is substantially equivalent to the predicate device, and the differences do not raise new questions of safety and effectiveness.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.