(261 days)
The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
The CORE-SPORT, an surgical instrument that provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery, and consists of a Port-Assay and a Retractor.
Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports.
The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-use and shall be not reused or re-sterilized.
Based on the provided text, the device in question is CORE-SPORT, a surgical instrument for minimally invasive laparoscopic surgery. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, the performance data presented is primarily bench testing and comparative testing against self-defined criteria, rather than clinical studies involving human patients or complex AI algorithms requiring ground truth establishment by experts.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Test Name | Acceptance Criteria | Reported Device Performance and Conclusion |
|---|---|---|---|
| Safety Tests | |||
| Sterility | Sterility Validation | Demonstrate a 10⁻⁶ SAL (Sterility Assurance Level). No evidence of microbial growth. | Passed. No evidence of microbial growth found; complies with sterility test. |
| Biocompatibility | Cytotoxicity | N/A (Tests conducted in accordance with ISO 10993-1:2018 requirements.) | Passed. |
| Animal Intracutaneous Reactivity | N/A | Passed. | |
| Guinea Pig Maximization | N/A | Passed. | |
| Acute Systemic Toxicity | N/A | Passed. | |
| Pyrogen | N/A | Passed. | |
| Performance Tests - Bench | |||
| Bench Test | Tensile Strength Test | No defects found after loading 10N of force. | Met the criteria. No defects were found after loading 10N in both sheath and ring body/remover parts. |
| Bench Test | Air Leak Test | Pressure maintained over 15mmHg for 30 seconds after injecting air at 25mmHg. | Met the criteria. All test results met the criteria. |
| Physical/Chemical | Extraction Test (USP 38 ) | Nonvolatile Residue, Residue on Ignition, Heavy Metal, Buffering Capacity at acceptable level. | Met the criteria. All components were at acceptable levels. |
| Performance Tests - Comparative | |||
| Comparative Test | Cavity Access Test | Measured widest width does not exceed 30mm when flattening 1/3 of the retractor ring body. | Verified. Size is appropriate for cavity access; test result did not exceed setting criteria. |
| Comparative Test | Maintenance of Pneumoperitoneum | Maintain 12-15 mmgH pressure for 30 seconds under given pressure. | Satisfied. Test results satisfied the standard. |
| Comparative Test | Ability to Manipulate Instruments | No friction, crash, or damage when applying instruments. (Insufficient if even one occurs.) | Confirmed. Set criteria were satisfied even in the worst case of applying a maximum of 4 surgical instruments. |
| Shelf Life Test | |||
| Shelf Life Test | Accelerated Aging Studies | Demonstrate product integrity over a 3-year lifespan (ASTM F1980). | Acceptable results. Accelerated aging studies for start and three years were performed, showing acceptable results. Real-time aging study is ongoing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify specific sample sizes for each test. It generally states that tests were "conducted" or "performed." For device performance, the data provenance is from bench testing and comparative testing within a laboratory setting. The company is INCORE CO., LTD. from Republic of Korea. The studies described are pre-market testing for regulatory submission, and therefore are inherently prospective in their design (intended to evaluate the device against pre-defined criteria).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a medical device (surgical port), not an AI-assisted diagnostic device. Therefore, the concept of "ground truth established by experts" (e.g., radiologists interpreting images) is not applicable in the context of these described performance tests. The "ground truth" for these tests is based on objective physical measurements, adherence to industry standards (e.g., ISO, USP, ASTM), and the predefined acceptance criteria for mechanical and material properties. There is no mention of human expert readers for "test sets" in the diagnostic sense.
4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)
Since this is not an AI diagnostic study relying on human interpretation for "ground truth," there is no adjudication method described or necessary. The "adjudication" is essentially the device passing or failing against the established objective metrics and standards.
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 MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic AI devices where human performance with and without AI assistance is being evaluated. The CORE-SPORT is a physical surgical instrument, not an AI or diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, this question is primarily relevant for AI algorithms. The "standalone performance" described here refers to the device's physical and material properties and its function (e.g., air leak, tensile strength). The tests are designed to show the device's inherent capabilities and safety without human intervention in its functionality, but the evaluation is performed by human testers against these criteria.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed on COR-SPORT is based on:
- Industry Standards: ISO 11135 (sterility), ISO 10993 (biocompatibility), USP 38 (extraction), ASTM F1980 (accelerated aging).
- Engineering Specifications and Bench Test Parameters: Pre-defined force limits (10N for tensile strength), pressure maintenance values (15mmHg for 30 seconds for air leak), and size parameters (30mm for cavity access).
- Absence of Adverse Events: "No defects," "no evidence of microbial growth," "no friction, crash, damage."
8. The Sample Size for the Training Set
The concept of a "training set" applies to machine learning or AI models. Since CORE-SPORT is a physical medical device, there is no training set in this context. The manufacturing process and quality control would be based on established engineering principles and production runs, not data training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a physical medical device, this question is not applicable.
§ 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.