(211 days)
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
The subject device is an endoscopic electrosurgical knife incorporating the saline feeding function for Endoscopic Submucosal Dissection (ESD).
The provided document is limited to the summary of non-clinical testing for the Olympus Single Use Electrosurgical knife (K171158) in comparison to its predicate devices. It describes tests performed to establish substantial equivalence but does not provide detailed acceptance criteria or numerical reported device performance for these specific tests in a table format, nor does it detail a study that explicitly proves the device "meets" acceptance criteria with quantifiable metrics. Instead, it states that the results were "evaluated as substantially equivalent."
Therefore, I cannot fully complete the requested table or answer all questions with specific numerical data from the given text. However, I can extract the available information and indicate where details are missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Device Performance Aspect | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cutting Performance (Test A) | Equivalency to primary predicate device 1 (KD-620LR, K092309) in cutting ex-vivo porcine digestive tract mucosa. | Evaluated as substantially equivalent to the primary predicate device. |
| Lifting Performance (Test B) | Equivalency to predicate device 3 (Hybridknife, K083608) in lifting ex-vivo porcine digestive tract mucosa. | Evaluated as substantially equivalent to predicate device 3. |
| Thermal Damage (Test C) | Equivalency to predicate device 3 (Hybridknife, K083608) in the degree of thermal damage on ex-vivo porcine digestive tract. | Evaluated as substantially equivalent to predicate device 3. |
| Knife Operation | Works as intended with compatible endoscopes. | Confirmed to work as intended. |
| Dimensions | Specific dimensional requirements. | Confirmed to meet requirements. |
| General Durability | Specific durability requirements. | Confirmed to meet requirements. |
| Risk Analysis | In accordance with established in-house acceptance criteria based on ISO 14971:2007. | Risk analysis carried out, and design verification tests identified and performed. |
| Shelf-life | Demonstrated stability for 3 years (accelerated aging). Ongoing 3-year aging test will be performed for longer stability. | Accelerated aging test performed in accordance with ASTM F1980-16. Results support stability. |
| Sterilization | Sterilization in accordance with ISO 11135:2014. | Validation carried out with Half-cycle approach. |
| Biocompatibility | In accordance with FDA Guidance, ISO-10993. | Testing performed. |
| EMC, Electrical, Thermal Safety | Compliance with relevant IEC standards (implied by "confirmed"). | Confirmed. |
Missing Information:
- Specific numerical values or quantitative metrics for "equivalency" in cutting, lifting, and thermal damage.
- The exact acceptance criteria thresholds (e.g., "within X% of predicate," "no statistically significant difference at alpha=0.05").
- Futher details on "performance" for knife operation, dimensions, and general durability.
Study Details:
The document describes several non-clinical tests rather than a single unifying "study" with a single test set. The information below is a synthesis based on the provided text.
2. Sample size used for the test set and the data provenance:
- Test Sets (Ex-vivo porcine digestive tract mucosa): Used for cutting, lifting, and thermal damage tests (Tests A, B, C).
- Sample Size: Not explicitly stated (e.g., number of tissue samples or repetitions per test).
- Data Provenance: Ex-vivo porcine (pig) digestive tract mucosa (esophagus, stomach, and colon). The specific country of origin for the porcine tissue is not mentioned. These are in-vitro or ex-vivo laboratory tests, not human data.
- Other Performance Testing: No specific sample sizes mentioned for knife operation, dimensions, general durability, risk analysis, shelf-life, sterilization, biocompatibility, or safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as these are non-clinical, ex-vivo tests comparing device performance metrics, not diagnostic or clinical accuracy involving human expert interpretation. For histological evaluation (Test C), a pathologist would typically establish ground truth, but the number or specific qualifications are not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for these non-clinical, ex-vivo performance tests.
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, an MRMC comparative effectiveness study was not done. This device is an electrosurgical knife, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical electrosurgical knife, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Cutting (Test A) and Lifting (Test B): The "ground truth" for comparison was the performance demonstrated by the predicate devices (KD-620LR for cutting, Hybridknife for lifting). The comparison aimed for "equivalency" in direct physical performance metrics.
- For Thermal Damage (Test C): Histological study was carried out to evaluate the degree of thermal damage. The ground truth here would be the pathological assessment of tissue changes attributed to thermal damage, again benchmarked against the predicate device's performance.
- For Other Tests: Engineering specifications, functional requirements, and adherence to recognized standards (e.g., ISO, ASTM, IEC).
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable (no training set for a physical device).
§ 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).