Search Results
Found 1 results
510(k) Data Aggregation
(116 days)
ArtiSential Trocar
ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
ArtiSential Trocar is for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. This device is a sterile, single-use instruments consisting of a main body, cannula, obturator. An optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. And a funnel serves as an instrument insertion guide and aids in the insertion of a passive multijoint surgical instrument into the cannula.
Here's an analysis of the acceptance criteria and study information for the ArtiSential Trocar based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance testing relative to a predicate device, focusing on equivalence rather than specific numerical acceptance criteria. The acceptance criteria for many tests are implicitly "passed the test" or "met performance requirements," indicating non-inferiority or equivalence to the predicate.
| Test Category | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Evaluation according to ISO 10993-1, specific endpoints assessed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity. Implicitly, test results should be within acceptable biological safety limits. | All assessed endpoints (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity) were evaluated. The document states "Given the favorable biocompatibility test results, the difference between raw material of proposed device and predicate device does not raise different questions in safety and effectiveness." (Implies all tests passed favorably) |
| Sterilization | EO-Sterilization in accordance with ISO-11135. Implicitly, device must be sterile and maintain sterility. | EO-Sterilization performed in accordance with ISO-11135. "The effectiveness of our sterilization method was verified through the sterilization validation test and the accelerated aging test." (Implies successful sterilization and maintenance of sterility) |
| Shelf Life | Packaging integrity (per ASTM F 88/F88M-15), Sealing strength (per ASTM F 88/F88M-15), Dye penetration (per ASTM F1929), Sterility (per ISO 11737-2), Appearance, Dimension, Leak test, Tensile Strength. All tests passed at 0 and 3 years accelerated aging. | "The device had passed all tests as below" for all listed tests at zero time point and 3 years accelerated aging point. |
| Bench Test | Appearance, Dimension, Leak test, Tensile Strength, and the ability to 1) maintain pneumoperitoneum (with and without instruments inserted) and 2) manipulate instruments for laparoscopic surgery. Implicitly, performance comparable to predicate. | "The testing was conducted side-by-side with the predicate device as following and had passed all performed tests." (Implies equivalence or non-inferiority to predicate) |
| Animal Testing | Tissue insertion and retention forces, Intra-abdominal pressure, Obturator integrity after insertion. Implicitly, performance comparable to predicate. | "The device was conducted side-by-side in vivo (micro pig, M-type) testing with the predicate device as following. The device had passed all performed tests." (Implies equivalence or non-inferiority to predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Bench and Animal Testing: The specific sample sizes (e.g., number of devices for bench tests, number of animals for in vivo tests) are not explicitly stated in the provided text. The text only mentions that testing "was conducted side-by-side with the predicate device."
- Data Provenance:
- Bench Test: Likely conducted in a laboratory setting by the manufacturer, or a contracted testing facility. No specific country of origin is mentioned for the data itself.
- Animal Testing: Conducted "in vivo (micro pig, M-type) testing." This indicates live animal testing. No specific country of origin for the animals or the testing facility is mentioned.
- Retrospective or Prospective: These tests are by nature prospective, as they are specifically conducted to evaluate the performance of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies described are performance tests of a physical device, not diagnostic or interpretive studies that typically require expert-established ground truth. The "ground truth" for these tests would be the measured physical or biological outcomes.
4. Adjudication Method:
This information is not applicable/provided. Adjudication methods (like 2+1 or 3+1) are typically used for interpreting ambiguous results in diagnostic studies, particularly when human readers are involved in establishing ground truth. The tests described here (biocompatibility, sterilization, physical performance) have objective, measurable outcomes.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert human interpretation of cases (e.g., medical images) is being augmented or replaced by AI. The ArtiSential Trocar is a physical surgical tool, not a diagnostic AI system, therefore an MRMC study is not relevant here.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone study was not done. This also applies to AI-powered diagnostic devices. The ArtiSential Trocar is a physical device, and its performance is evaluated through direct physical and biological testing, not through an algorithm.
7. Type of Ground Truth Used:
The ground truth for the performance studies is based on objective, measurable physical and biological parameters assessed during the various tests.
- For biocompatibility: Measured biological responses according to ISO 10993-1.
- For sterilization: Confirmation of sterility and packaging integrity according to ISO 11135, ASTM F 88/F88M-15, ASTM F1929, ISO 11737-2.
- For bench tests: Measured physical properties (dimensions, tensile strength, leak rate) and functional performance (pneumoperitoneum maintenance, instrument manipulation).
- For animal tests: Measured forces, pressures, and visual integrity post-insertion.
8. Sample Size for the Training Set:
This information is not applicable. The ArtiSential Trocar is a physical medical device. It does not employ artificial intelligence or machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
Ask a specific question about this device
Page 1 of 1