(164 days)
The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.
The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the The disposable portion of the system is sterilized via irradiation and has limited (
The provided FDA 510(k) summary for the troCarWash™ System focuses on a device that removes visual obstructions from laparoscope lenses during surgery. The submission describes various non-clinical tests (packaging, sterilization, biocompatibility, electrical safety/EMC, software verification/validation, and bench performance testing) to demonstrate substantial equivalence to a predicate device.
However, the provided text does not contain the specific information required to answer many parts of your request, particularly regarding:
- Acceptance criteria values for performance (e.g., target accuracy, sensitivity, specificity, or specific cleaning efficacy metrics). The text states "the troCarWash™ system was able to achieve acceptable cleans" but doesn't quantify what "acceptable" means.
- Detailed study design for performance evaluation beyond "Bench Performance Testing." While it mentions "wash efficacy," it doesn't provide specific metrics.
- Sample size and data provenance for a "test set" in the context of AI/ML or comparative studies with human readers.
- Details on expert ground truth establishment, adjudication methods, or MRMC studies.
- Information about a training set for an AI/ML model or how its ground truth was established. This device is a mechanical cleaning system, not an AI/ML diagnostic or therapeutic device, so these concepts (training set, experts for ground truth) likely don't apply in the way you're asking.
- Standalone performance metrics (e.g., Sensitivity, Specificity, AUC) typical of AI/ML devices.
Based on the provided document, here's what can be inferred and what information is missing:
Device Description: The troCarWash™ system is a laparoscopic lens cleaning device consisting of a reusable control unit and a disposable, sterile, single-use trocar. It removes visual obstructions (condensation, blood, tissue particulates) from the distal lens of a laparoscope to maintain a clear image during surgery. It uses medical-grade CO2 and saline for cleaning.
Nature of Device: This is primarily a mechanical/electromechanical device, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of your questions related to AI/ML specific performance metrics (e.g., human reader improvement with AI assistance, training data, ground truth establishment by experts for AI models) do not directly apply to the described device and the information provided. The "Software Verification and Validation Testing" section explicitly states the software was considered "minor" level of concern, implying it's not performing complex diagnostic or decision-making functions typically associated with AI.
Table of Acceptance Criteria and Reported Device Performance
As the document does not specify quantitative acceptance criteria or performance metrics for wash efficacy (e.g., percentage of debris removed, clarity score), a table as requested cannot be fully populated. The closest statement is:
| Acceptance Criteria Category | Acceptance Criteria (Quantified) | Reported Device Performance |
|---|---|---|
| Wash Efficacy | (Not specified in document) | "achieve acceptable cleans" |
| Packaging Validation | Passed standards (ASTM, ISO) | Passed all listed tests |
| Sterilization Validation | Passed standards (ANSI AAMI ISO) | Passed all listed tests |
| Biocompatibility | Passed standards (ISO) | Passed all listed tests |
| Electrical Safety & EMC | Complies with IEC 60601-1, -2 | Complies with all listed standards |
Study Information (Based on available text):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Wash Efficacy: Not explicitly quantified in the provided text. It states "acceptable cleans."
- Reported Device Performance for Wash Efficacy: "The study demonstrated that with various scope angles and brands, the troCarWash™ system was able to achieve acceptable cleans." (No quantitative metrics provided).
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Sample sized used for the test set and the data provenance:
- Sample Size: "29 disposable sets (trocar, obturator, and tubing set) preconditioned with sterilization and accelerated aging and 8 disposable sets preconditioned with sterilization and simulated transportation and distribution were tested for wash efficacy." This totals 37 disposable sets.
- Data Provenance: The document does not specify the country of origin. The study was a "benchtop model" performance test, implying controlled laboratory conditions rather than retrospective or prospective clinical 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. This device is evaluated for its mechanical cleaning performance, not for diagnostic accuracy requiring expert interpretation or ground truth labeling in the context of an AI/ML model. The "acceptable cleans" would likely have been determined against pre-defined visual or technical criteria, not expert consensus on medical images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in studies involving human interpretation (e.g., radiology reads) to resolve disagreements and establish ground truth for image-based diagnostic systems. It is not relevant for a mechanical cleaning efficacy test.
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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, an MRMC study was not done. The document explicitly states: "No clinical data was necessary to support a claim of substantial equivalence." This type of study is typically performed for AI/ML diagnostic aids to show improvement in human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Bench Performance Testing" section describes testing the system's ability to clean without direct human intervention in the cleaning process itself (though human operation initiates the cycle). However, this is not "standalone algorithm performance" in the context of AI/ML, but rather the performance of the device's mechanical function. No specific quantitative diagnostic metrics (like sensitivity, specificity, AUC) are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For wash efficacy: The ground truth would likely be defined by pre-established physical/visual criteria for lens cleanliness after contamination, rather than expert consensus on medical images or pathology. The document doesn't detail these criteria, only that "acceptable cleans" were achieved.
- For other tests (packaging, sterilization, biocompatibility, electrical safety): Ground truth is established by compliance with recognized industry standards and test methods.
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The sample size for the training set:
- Not applicable / Not specified. This device is not an AI/ML model that requires a "training set" in the computational sense. Its design and operation are based on engineering principles, and its software is "minor" in terms of risk, suggesting it's primarily for control, not learning.
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How the ground truth for the training set was established:
- Not applicable. As no AI/ML training set is mentioned or implied, this question does not apply.
Summary of Gaps: The provided text is a 510(k) summary for a mechanical device, emphasizing its substantial equivalence through non-clinical performance and safety testing. It lacks the quantitative performance metrics, study design details, and specific AI/ML related information (training sets, expert ground truth, adjudication, MRMC studies) that your questions are designed to uncover for AI/ML medical 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.