(115 days)
The Disposable Trocars have applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments in abdominal area.
Disposable Trocars are medical devices that penetrate the abdominal wall during laparoscopic surgery. They provide a passageway for the surgical device insertion and removal and maintain pneumoperitoneum during surgical procedures.
The model numbers of Disposable Trocars include AVTB 5-70, AVTB 5-100, AVTB 10-70, AVTB 10-100, AVTB 12-70, AVTB 12-100, AVTC 5-70, AVTC 5-100, AVTC 10-70, AVTC 10-100, AVTC 12-70, AVTC 12-100, AVTC 15-70, and AVTC 15-100.
The AVTB Disposable Trocars comprise an upper sealing component, a casing component, and a puncture rod component.
The upper sealing component is composed of a seal lid, an upper retaining ring, a wave seal ring, a conical sealing ring, a lower retaining ring, and a retaining cover for locking. The casing component is composed of choke valve, self-commissioning sealing cap, casing seat, seal ring, trocar sleeve, gas injection valve, and gas injection switch. The puncture rod component is composed of an upper fixing cover, a locking buckle, a puncture rod, and a lower fixing cover.
AVTC Disposable Trocars comprise casing component, puncture rod component, upper sealing component, and converter component (only applicable to AVTC 15 specification).
The casing component is composed of choke valve, self-commissioning sealing cap, casing seat, sealing ring, trocar sleeve, gas injection valve, and gas injection switch. The puncture rod component is composed of an upper fixing cover and a puncture rod. The upper sealing component (5/10/12 specification) is composed of seal lid, an upper retaining ring, a wave seal ring, a conical sealing ring, a lower retaining ring, and a retaining cover for locking. The upper sealing component (15 specifications) is composed of a seal lid, an elastic seal ring, and a retaining cover for locking. The converter component (15 specifications) is composed of converter, converter cover, sealing cap of upper converter cover, and upper converter cover.
Disposable Trocars are divided into B and C according to different shapes. According to the inner diameter of the trocar, it is divided into four sizes: 5, 10, 12, and 15. According to the length of the trocar, it is divided into two sizes: 70 and 100.
The provided FDA 510(k) clearance letter and summary for Sinolinks Medical Innovation, Inc.'s Disposable Trocars (K250820) do not contain information about acceptance criteria or a study proving the device meets the acceptance criteria in the context of an AI/ML-enabled device evaluation.
The document pertains to a traditional medical device (Disposable Trocars) and its non-clinical performance testing (bench, ex vivo, biocompatibility, sterility, packaging, shelf-life, transport, etc.) to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot extract the information required to answer your prompt, which is tailored for AI/ML device evaluations. The document explicitly states: "No clinical study is included in this submission." and the "Summary of non-clinical testing" section details a range of physical, mechanical, and biological tests relevant to a non-AI/ML medical device.
To answer your prompt for a device that is not an AI/ML device, the following would be the most relevant information:
Acceptance Criteria and Device Performance for Disposable Trocars (K250820)
The acceptance criteria for the Disposable Trocars are demonstrated through a series of non-clinical tests which show the device meets its design specifications and performs comparably to the predicate device. The "performance" in this context refers to the successful completion and passing of these tests.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI/ML device, the "acceptance criteria" are embodied in the successful completion of the various non-clinical tests to predefined standards. The "reported device performance" is that the device met these standards.
| Acceptance Criteria Category/Test | Reported Device Performance (Met/Passed) |
|---|---|
| Functional Performance | |
| Compatible with endoscope and endoscopic stapler | Met |
| Flexibility | Met |
| Parts compatible with each other | Met |
| Airtightness and air resistance | Met |
| Connection strength | Met |
| Luer connector performance | Met |
| Insertion and pull-out performance of puncture rod | Met |
| Gas leak rate | Met |
| Material & Biocompatibility | |
| Endotoxin limit (20 EU per device) | Met |
| Cytotoxicity | No cytotoxicity detected |
| Sensitization | No sensitization detected |
| Skin Irritation | No irritation detected |
| Pyrogenicity | No pyrogen detected |
| Physical & Mechanical | |
| Dimension verification (Shaft Diameter, Length, Trocar Width, Total Length) | Met design specifications (specific values detailed in summary) |
| Penetration force (ex vivo on porcine tissue) | Evaluated and met expectations |
| Fixation force (ex vivo on porcine tissue) | Evaluated and met expectations |
| Tip integrity after insertion (ex vivo on porcine tissue) | Evaluated and met expectations |
| Sterility & Packaging | |
| Sterility Assurance Level (SAL 10⁻⁶) | Achieved (EO sterilized) |
| Shelf-life (3 years) | Supported by accelerated aging (real-time ongoing) |
| Simulated transport testing (ASTM D4169) | Supported product and packaging performance |
| Seal Strength (ASTM F88/F88M) | Tested and met |
| Seal Leaks (ASTM F1929) | Tested and met |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the numerical sample size for each bench or ex vivo test. It mentions "porcine tissue" for ex vivo studies. It does not provide explicit data provenance in terms of country of origin for the datasets used in these non-clinical tests, though the manufacturer is based in China. The data would be considered prospective for the purposes of these clearance tests, as they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to the non-clinical testing of a traditional medical device like a trocar. "Ground truth" established by experts is a concept primarily relevant to diagnostic AI/ML models where human interpretation serves as the reference standard. For a trocar, the "ground truth" is determined by established engineering standards, material science principles, and biological safety evaluations.
4. Adjudication method for the test set:
Not applicable for non-clinical performance testing of a traditional device. Adjudication methods (e.g., 2+1 reader consensus) are used in human-in-the-loop or standalone AI/ML studies to resolve discrepancies in expert labeling or diagnoses.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This type of study is specifically for evaluating the impact of AI/ML assistance on human reader performance, which is irrelevant for a disposable trocar.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is an AI/ML specific evaluation. The "device" itself performs its function (e.g., creating an entry path) without an "algorithm" in the diagnostic sense.
7. The type of ground truth used:
For this traditional medical device, the "ground truth" is effectively:
- Established engineering specifications and performance standards for mechanical and physical properties (e.g., dimensions, strength, air-tightness).
- Industry consensus standards for biocompatibility (e.g., ISO 10993 series), sterility (e.g., ISO 11135), and packaging (e.g., ASTM standards).
- Biological responses (e.g., no cytotoxicity demonstrated on cell cultures, no irritation in animal models for biocompatibility).
8. The sample size for the training set:
Not applicable. The concept of a "training set" refers to data used to train an AI/ML algorithm. This device does not use AI/ML.
9. How the ground truth for the training set was established:
Not applicable, as there is no AI/ML training set.
§ 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.