(78 days)
The Carbon Medical Technologies Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during endoscopic procedures.
The Carbon Medical Injection Needle consists of a stainless steel needle attached to two or more luer lock hubs. A standard syringe can be attached to the hubs for injection of materials through the lumen of the needle into tissue. Multiple needle lengths and gauges are available.
The provided text describes a 510(k) summary for the Carbon Medical Technologies Injection Needle. This submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics, biocompatibility, and bench testing. It does not contain information about a study that assesses performance against specific acceptance criteria for diagnostic or AI-driven devices. Therefore, I cannot provide the detailed information requested in your prompt.
The document states:
"Technological Characteristics and Performance
The technological characteristics are substantially equivalent to the predicate devices. Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device."
This indicates that the submission relied on demonstrating that the new device's design and materials are similar to previously cleared devices, and that standard engineering tests (bench testing) confirmed its basic function and safety (biocompatibility). There is no mention of a clinical study, performance metrics like sensitivity or specificity, or any evaluation involving human readers or AI.
To answer your specific questions in the context of this document:
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A table of acceptance criteria and the reported device performance: Not applicable. The document does not define specific performance acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity) for comparison. The performance claim is general substantial equivalence to predicate devices based on technological characteristics and bench testing.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set involving patient data is described. The evaluation was based on bench testing and characterization of technological similarity.
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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. No ground truth based on expert review is mentioned, as there was no study involving patient data or diagnostic interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method is mentioned.
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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: Not applicable. This device is an injection needle, not an AI or diagnostic imaging device. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for diagnostic performance is not relevant to this device's submission. The "ground truth" for this submission would be the established performance and safety of the predicate devices, which the new device is claimed to be substantially equivalent to, based on bench testing.
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The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.
In summary, the provided 510(k) summary for the Carbon Medical Technologies Injection Needle is for a hardware medical device (an injection needle) and relies on demonstrating substantial equivalence to pre-existing predicate devices through technological characteristics, biocompatibility, and bench testing, rather than performance studies requiring the criteria you've outlined, which are typical for diagnostic or AI-powered devices.
§ 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.