(27 days)
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment of the bag with the use of the biasing arms.
The provided FDA 510(k) clearance letter for the DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (K250411) does not contain information related to software, artificial intelligence (AI), diagnostic performance, or studies involving human readers or ground truth for diagnostic accuracy.
The document describes a medical device, a specimen retrieval system, and its non-clinical testing to demonstrate substantial equivalence to a predicate device. The information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment is not applicable to a submission for a physical surgical device like this.
Therefore, I cannot populate the requested table or answer the specific questions related to AI-driven diagnostic studies based on the provided text.
Here's a summary of what is available regarding acceptance criteria and studies, framed according to the nature of this physical device:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" and "device performance" are primarily related to its physical characteristics, functionality, and safety as compared to a predicate device, rather than diagnostic accuracy.
| Characteristic/Criterion | Acceptance Methodology | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Intended Use | Comparison to predicate | Matches predicate: "receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery." |
| Material Biocompatibility | Conformance to ISO 10993 series standards (1, 5, 7, 10, 11, 23) | Conforms to specified ISO 10993 standards. |
| Sterilization Efficacy | Conformance to ISO 11135:2014 for Ethylene Oxide (EtO) sterilization to an SAL of 10^-6 | Sterilized using EtO to an SAL of 10^-6. |
| Aging Stability | Aging Study | Successfully passed aging study (details of specific criteria not provided in this document). |
| General Device Operation | Performance Studies (e.g., deployment, function) | Met design specifications (details of specific metrics not provided). |
| Bag Opening | Performance Studies | Successfully demonstrates bag opening (details of specific metrics not provided). |
| Bag Volume | Performance Studies | Available volumes from 120 to 1500 mL, matching predicate. |
| Bag Integrity & Seam Strength | Performance Studies | Successfully demonstrates integrity and seam strength (details of specific metrics not provided). |
| Introducer Diameter | Design Specification | 5, 10, and 12mm, matching predicate. |
| Prescription Use | Regulatory Classification | Prescription Use (Part 21 CFR 801 Subpart D), matching predicate. |
| Intended Environment | Design Specification | Professional Healthcare Facility (Surgical Room or Operating theatre), matching predicate. |
Given that this is a 510(k) for a physical medical device (a specimen retrieval system) and not an AI/software-as-medical-device, the following points are not applicable as they pertain to AI/diagnostic studies:
- Sample sizes for test set and data provenance: Not applicable. No test set of diagnostic data was used.
- Number of experts used to establish ground truth & qualifications: Not applicable. No ground truth for diagnostic accuracy was established.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. No human readers were evaluated for improvement with AI assistance.
- Standalone (algorithm only) performance: Not applicable. There is no algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. There is no training set for an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
The "studies" conducted for this device were non-clinical performance and biocompatibility tests to demonstrate the device's physical and material safety and functionality, and its substantial equivalence to a legally marketed predicate device.
§ 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.