(250 days)
The Disposable Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
The Disposable Polypectomy Snare consists of an insertion part and a handle part. The insertion part includes cutting loop(a flexible wire cable), traction wire, and sheath; the handle part includes sheath sleeve, locking sleeve, rotating sleeve, electrode connector, slider and a handle. The cutting loop can be extended and retracted from the Snare's flexible outer sheath using a three ring handle. The cutting loop can also be rotated 360° using the rotating actuator on the handle. The inner diameter of the sheath is PTFE to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.
The Disposable Polypectomy Snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance.
The cutting loop of disposable polypectomy snare has four shapes to be used in clinical practice:
Ellipse type (E type), Hexagonal type (H type), Crescent type (C type), Round type (R type), and the loop can extend, retract from the snare's flexible outer sheath.
The materials used for construction of Disposable Polypectomy Snare are typical for this type of medical device. Materials of Cutting Loop is stainless steel 06Cr19Ni10, the Sheath is made of PTEF, the Electrode Connector is made of stainless steel SUS304. The Handle, Slider, Rotating Sleeve and Locking Sleeve are made of ABS, the Sheath Sleeve is made of HDPE.
The provided text is a 510(k) summary for a Disposable Polypectomy Snare, a medical device used for removing and cauterizing polyps in the gastrointestinal tract.
Based on the information provided, this document does not describe a study involving an AI/Machine Learning device or a study that establishes ground truth based on expert consensus, pathology, or outcomes data.
Instead, it focuses on the substantial equivalence of a new medical device (the Disposable Polypectomy Snare) to a previously cleared predicate device. The performance validation relies primarily on bench testing and adherence to consensus standards, rather than clinical studies or evaluations of diagnostic accuracy typically associated with AI/ML systems.
Therefore, I cannot populate the table or answer most of your questions as they pertain to AI/ML device acceptance criteria and studies proving their performance. The information related to sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the evaluation described in this document.
Here's what I can extract from the provided text, but it's important to understand this is for a non-AI/ML medical device:
1. A table of acceptance criteria and the reported device performance
The document details performance bench testing rather than diagnostic performance against a specific condition. The "acceptance criteria" are implied by meeting the compliance testing standards and internal requirements.
| Test Item | Description/Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Appearance | Integrity, cleanliness, hygiene | Confirmed to be integrity and cleanliness and hygiene |
| Dimension | Complied with company's requirements | Complied with company's requirements |
| Physical Properties | Functionality, tensile strength, cutting wire strength, electrical resistance, compatible endoscopes | Verified |
| Conduction Resistance | The resistance between the connector and the Cutting Loop shall be ≤ 30Ω. | Verified (meets criteria) |
| Corrosion Resistance | Should be no corrosive marks on the Cutting Loop. | Verified (no corrosive marks) |
| Chemical Properties | pH, Total content of heavy metals, Potassium permanganate reductive substance, Evaporative residues and Ultraviolet Absorbance meet related requirements. | Verified (meets related requirements) |
| Sterility | Shall be sterile (sterilized by ethylene oxide). | Verified (sterile) |
| EO Residue | EO residue shall be ≤ 10 μg/g. | Verified (meets criteria) |
| Biocompatibility | Fulfilled given criteria in ISO 10993 (non-toxic and biocompatible). | Verified (non-toxic and biocompatible) |
| Shelf Life | 2 years | Successfully tested according to ISO 11607-1, 2 years shelf life |
| Electromagnetic Compatibility and Electrical Safety | Conform to IEC 60601-1:2005+A1:2012, IEC 60601-2-2:2017 and IEC 60601-1-2:2020. | Verified (conforms) |
Regarding the other questions, they are largely not applicable to this 510(k) submission for a non-AI/ML device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes bench testing, not a clinical test set with patient data. No specific "sample size" of specimens is explicitly mentioned for each bench test, but implies sufficient testing to meet standards.
- Data provenance: Bench testing conducted by the manufacturer (Beijing ZKSK Technology Co., Ltd. in China). The statement "Results from testing performed confirms that the design requirement specification and user needs have been met" suggests internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth as typically defined for diagnostic AI/ML models (e.g., expert consensus on images, pathological confirmation) was not established or used. The ground truth for bench testing is adherence to physical/chemical specifications and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no human reader adjudication process is described for this device's performance validation.
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
- No. This is not an AI-assisted device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is adherence to established engineering specifications, material standards (e.g., ISO, IEC), and functional requirements determined through bench testing.
8. The sample size for the training set
- Not applicable. This is not a machine learning device and therefore does not have a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).