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510(k) Data Aggregation
(428 days)
The CORE-Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.
The CORE-Trocar has a port to insert endoscopic instruments during endoscopic procedures. It consist of a cannula and a obturator. The Trocar is available in nine (9) models(IC-TC02, IC-TC02S, IC-TC03, IC-TC03S, IC-TC05S, IC-TC05S, IC-TC08, IC-TC10, IC-TC12) and the models are divided into six (6) types according to the kinds of diameter Type : 2mm Type(IC-TC02, IC-TC02S), 3mm Type(IC-TC03, IC-TC03S), 5mm Type(IC-TC05, IC-TC05S), 8mm Type(IC-TC08), 10mm Type(IC-TC10) and 12mm Type(IC-TC12). The cannula assembly have seals(main, secondary), a valve and a stopcock. The obturator has non-bladed tip. Sterilization is done with EO gas and Sterilization Assurance Level(SAL) 10-6. The seals prevent loss of CO2 pneumoperitoneum pressure when instruments are inserted or withdrawn.
The provided text is a 510(k) summary for the CORE-Trocar device and describes acceptance criteria and performance data from various tests. However, it does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop performance evaluation or a standalone AI algorithm performance study. It focuses on the mechanical, biological, and physical/chemical properties of the trocar itself.
Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as they pertain to the performance evaluation of AI/ML-based medical devices, which the CORE-Trocar is not.
Here's the information that can be extracted from the provided text:
Acceptance Criteria and Reported Device Performance
The device underwent various non-clinical performance bench tests and comparative tests against a predicate device.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Test | ||
| Sterility | 10⁻⁶ SAL (Sterility Assurance Level); No evidence of microbial growth. | Passed. No evidence of microbial growth found. |
| Biocompatibility (various tests) | Compliance with ISO 10993-1:2018 (Cytotoxicity, Maximization Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen). | Passed all tests. Device is considered tissue contacting for < 24 hours. |
| Performance Test - Bench | ||
| Dimension | Tolerance of nominal size should be ±10% of the standard. | Passed (implicitly, as it aligns with the standard and the comparison specifies dimensions). |
| Insertion Force | ≤ 1.5 kgf | Averaged 0.964 kgf (min. 0.738, max. 1.095). Complies with requirements. |
| Air Leakage | No air leakage. | No air leakage. |
| Seal Test (Bench) | No air leakage. | No air leakage. |
| Instrument Compatibility Test | No crash, no damage, no strong friction. | All instruments or bars used were compatible. No crash, no damage, no strong friction. Acceptable. |
| Extractable - Nonvolatile Residue | Residue gap, below 15 mg. | Test result: 0.11 mg. Acceptable. |
| Extractable - Residue on Ignition | Residue gap, below 5 mg. | Test result: Not applicable (implicitly means it's below the detectable limit or acceptance criteria). |
| Extractable - Buffering Capacity | Not be darker (implies a specific color change criterion, or a volume of titrant for acid/base). The specific value is 0.02mL. | Test result: 0.02 mL. Acceptable. |
| Extractable - Heavy Metal | Titrant gap (or sum), below 10 mL (implies a specific volume in a titration test, or "not darker" to mean below a visual threshold). The specific threshold is "Not be darker". | Test result: Not be darker. Acceptable. |
| Performance Test - Comparative | ||
| Seal Test (Comparative) | Pressure should be maintained at 12-15 mmHg. | Passed (implicitly as stated in the table, although specific values are not given in the detailed description). |
| Instrument Compatibility Test | No crash, damage, strong friction. | Passed (implicitly as stated in the table, although specific outcomes are not given in the detailed description beyond the table showing "Pass"). |
| Obturator Compatibility | Mated properly without friction, crash, damage. Mating force ≤ 26.7 N. | Passed (implicitly as stated in the table, although specific outcomes are not given in the detailed description beyond the table showing "Pass", and value for force is not mentioned in the detailed description). |
| Insertion & Cannula Stability | Insertion ≤ 67.8 N, Removal < 26.7 N, Fixing ≥ 26.7 N. | Passed (implicitly as stated in the table, although specific outcomes are not given in the detailed description beyond the table showing "Pass"). |
| Air Leakage (Comparative) | Pressure should be maintained at 12-15 mmHg. | Passed (implicitly as stated in the table, although specific outcomes are not given in the detailed description beyond the table showing "Pass"). |
| Shelf Life Test | Accelerated aging to determine product integrity over its lifespan (3 years). Compliance with ASTM F1980. | Accelerated aging studies for 3 years performed with acceptable results. Real-time study in process. |
The following information is not available in the provided text as it pertains to AI/ML device performance, not a physical medical device like a trocar:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical devices tested and materials used (e.g., pig skin for insertion force, various instruments for compatibility).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and biological tests is established through standardized measurements and laboratory protocols, not expert consensus on interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the device's performance studies is based on established engineering standards for mechanical strength, leakage, material properties, and biological compatibility (e.g., ISO, USP ASTM standards).
- The sample size for the training set: Not applicable. There is no AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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