(178 days)
This device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate organs and tissues to provide better access as well as visualization and stabilization of surgical sites.
The Surgical Retractor is a Reusable device intended for mobilizing and maneuvering organ and tissue within the cavity during laparoscopic Surgical procedures.
The provided text describes a 510(k) premarket notification for a "Surgical Retractor." This device is a reusable surgical instrument, not an AI/ML-driven device or a diagnostic tool that would typically have performance metrics like sensitivity, specificity, or accuracy, or require studies involving ground truth, expert readers, or training sets in the way the prompt describes.
Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable to this type of device and is not present in the provided documentation.
However, I can extract the relevant information from the document:
Device Type: Surgical Retractor (a physical, reusable surgical instrument).
Acceptance Criteria and Reported Device Performance:
Since this is a physical surgical instrument, the "acceptance criteria" are related to its functional and safety performance, implied by its "substantial equivalence" to predicate devices. The document does not provide specific numerical performance metrics for acceptance criteria and reported device performance. Instead, the device is deemed acceptable because it is substantially equivalent to legally marketed predicate devices.
| Acceptance Criteria Category (Implied for Surgical Instruments) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Intended Use: Mobilizing and maneuvering organs/tissue during laparoscopic procedures. | Meets Intended Use: Designed as an organ and tissue retractor for use in minimally invasive surgical procedures to elevate organs and tissues to provide better access, visualization, and stabilization of surgical sites. |
| Material Compatibility & Biocompatibility: (Not explicitly stated in provided text, but assumed for surgical devices) | (Implied to be acceptable based on predicate devices) |
| Sterilization & Reusability: (Device is stated as "Reusable") | (Implied to be acceptable based on predicate devices and presumably verification testing as per manufacturing controls) |
| Mechanical Performance (e.g., strength, durability): (Not explicitly stated in provided text, but assumed for surgical devices) | (Implied to be acceptable based on predicate devices and presumably verification testing as per manufacturing controls) |
| Safety: (Compatibility with surgical environment, lack of sharp edges causing unintended harm, etc.) | (Implied to be acceptable based on predicate devices) |
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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. The document does not describe a "test set" in the context of clinical data for performance evaluation in the way an AI/ML device would. Substantial equivalence for this type of device relies on comparisons to predicate devices and adherence to general controls, likely supported by engineering testing rather than clinical study 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 diagnostic/AI sense is not established for this type of device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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 a surgical instrument, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable.
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The sample size for the training set:
- Not applicable. This is a physical surgical instrument, not an AI/ML model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of the study/submission for this device:
The "study" or justification for market clearance is based on the concept of substantial equivalence to legally marketed predicate devices. The submission (K112659) details that the "Surgical Retractor" is "substantially equivalent" to:
- Laparoscopic Retractors (Diamond-Flex) (K092684) - Cardinal Health
- Nathanson Liver Retractor (K942002) - Automated Medical Products
- Endo-Retract (K914190) - Covidien
This substantial equivalence argument implies that the device performs as safely and effectively as these predicates for its intended use, and therefore meets the necessary regulatory "acceptance criteria" for a Class II medical device under 21 CFR 876.1500 (Endoscope and accessories, Product Code GCJ). The document does not detail specific performance studies beyond this declaration of equivalence.
§ 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.