(255 days)
The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB Interface Control, SCB Media Control or ACC Control and enables the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.
The Karl Storz SCB/Covidien ForceTriad Interface Module is an accessory to integrate the third party device Covidien ForceTriad Energy Platform (K102913) into the SCB network and allow remote settings adjustment.
The provided text describes a 510(k) summary for the Karl Storz SCB/Covidien ForceTriad Interface Module. This device is an accessory designed to integrate the Covidien ForceTriad Energy Platform into the Karl Storz SCB network, allowing for remote settings adjustment.
The submission is for a device that seems to be a hardware accessory with software that facilitates communication and control between two existing medical devices. The primary purpose of the supporting "study" (software testing) is to demonstrate that this integration functions as intended and is equivalent to a previously cleared predicate device.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Performance equivalence to predicate device (Karl Storz SCB/ConMed ESU Interface Module) | "The Karl Storz SCB/Covidien ForceTriad Interface Module demonstrated performance equivalence by software verification and validation testing." |
| Ability of the SCB system to interface with the Covidien ForceTriad Energy Platform | "In which the device was installed into the SCB control device and the system's ability to interface with the Covidien ForceTriad Energy Platform was tested." |
| No new issues of safety and effectiveness compared to predicate device | "The differences between the SCB/Covidien ForceTriad Interface Module and the predicate device are minor and raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices." |
| Substantial equivalence to predicate device | "The Karl Storz SCB/Covidien ForceTriad Interface Module was found to be substantially equivalent to the predicate Karl Storz SCB/ConMed ESU Interface Module." and "The Karl Storz SCB/Covidien ForceTriad Interface Module is substantially equivalent to the predicate device, as both devices have the same intended use and basic design." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "software verification and validation testing," but does not specify the number of test cases, test runs, or the amount of data used in these tests.
- Data Provenance: Not explicitly stated. It's internal company testing ("software verification and validation testing"). It's highly likely to be a prospective test conducted by the manufacturer, but no country of origin for the data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
Given the nature of the device (an interface module for control), the "ground truth" would likely be defined by specific functional requirements and expected outputs, which would be established by internal engineering and quality assurance teams, rather than medical experts in a clinical context.
4. Adjudication method for the test set:
- Adjudication Method: Not mentioned. For software verification and validation, adjudication typically involves comparing test results against predefined expected outcomes or specifications.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation of medical images or data is involved. The device described here is an interface module for controlling surgical equipment, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not directly applicable in the terms of an "algorithm only" performance study as commonly understood for AI/diagnostic devices. The software component of this device is operating "standalone" in the sense that it carries out its programmed functions (interfacing and remote control) without continuous human intervention during its operation. However, the performance is in the context of its function as an interface, not as a decision-making algorithm. The "software verification and validation testing" did evaluate the device's functional integrity.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for this device would be based on functional specifications and expected operational behavior. Essentially, the device functions correctly if:
- It successfully integrates the Covidien ForceTriad Energy Platform into the SCB network.
- It allows for accurate remote adjustment of settings of the ForceTriad Energy Platform via the SCB-RUI.
- It performs these actions reliably and without errors that could compromise safety or effectiveness.
This is established through engineering design, requirements specifications, and direct testing against those specifications.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is an interface module, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is hard-coded or configured based on engineering design.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable as there is no "training set" for this type of device. The "ground truth" for its design and functionality is established through engineering principles, regulatory requirements, and the specifications of the devices it is designed to interface with.
§ 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.