(581 days)
The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.
Ultrasonic Surgical System consists of a generator, a foot switch, a scalpel and a hand piece. In addition, a cart is provided as an optional component. The electrical energy supplied by the generator will be converted into mechanical motion by the transducer in hand piece, which will drive the scalpel vibrate longitudinally. The foot switch is used to control the activation of energy output. The scalpels are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.
The provided text describes a 510(k) submission for the K500 Ultrasonic Surgical System, asserting its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven device.
The study described is a non-clinical performance comparison test to ensure that the proposed device, an ultrasonic surgical system, meets its design specifications and is substantially equivalent to a predicate device. This is a traditional medical device submission, not specifically an AI/ML device submission that would involve human-in-the-loop performance or standalone algorithm performance testing.
Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment cannot be fulfilled from the provided document.
Here's a breakdown of the available information based on the provided text, acknowledging that it's for a traditional medical device and not an AI/ML device performance study:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative table for device performance in the way one would for an AI/ML model (e.g., sensitivity, specificity thresholds). Instead, it describes performance comparison tests to demonstrate substantial equivalence to a predicate device.
Table 1: Non-Clinical Performance Testing and Outcomes
| Test Category | Specific Test | Purpose | Outcome/Finding |
|---|---|---|---|
| Functional Performance | Vessel burst pressure | To ensure effective sealing of blood vessels. | Not explicitly detailed, but implied to meet design specifications and be comparable to the predicate. |
| Thermal spread | To assess minimal thermal injury. | Not explicitly detailed, but implied to meet design specifications and be comparable to the predicate. | |
| Acute animal vessel sealing study | To evaluate immediate vessel sealing capabilities. | No significant difference found compared to the predicate device despite slight tip diameter difference. | |
| Chronic animal survival study | To assess long-term effects and safety in a living organism. | Not explicitly detailed, but implied to meet design specifications and be comparable to the predicate. | |
| Biocompatibility | Skin sensitization (ISO 10993-10) | To evaluate potential for allergic reactions. | Pass |
| Intracutaneous reactivity (ISO 10993-10) | To evaluate local tissue compatibility. | Pass | |
| Cytotoxicity (ISO 10993-5) | To assess potential toxicity to cells. | Pass | |
| Pyrogenicity (ISO 10993-11) | To detect fever-inducing substances. | Pass | |
| Systemic toxicity (ISO 10993-11) | To evaluate potential for adverse effects on organ systems. | Pass | |
| Electrical Safety & EMC | AAMI/ANSI ES 60601-1, IEC 60601-2-18, IEC 60601-1-2 | To ensure electrical safety and electromagnetic compatibility. | Complies with relevant standards (AAMI/ANSI/ES 60601-1, IEC 60601-2-18, IEC 60601-1-2). |
| Sterility Assurance | GB18280:2007 (IDT ISO 11137: 2006) | To ensure adequate sterilization (for sterile components). | 10-6 SAL (Sterility Assurance Level) |
| Seal Strength | ASTM F88/F88M-15 | Standard method for seal strength of flexible barrier materials (likely for packaging). | Complies with the standard. |
| Software Verification/Validation | Software V&V testing | To ensure software functions as intended and is safe. | Conducted and documentation provided in accordance with FDA guidance for software in medical devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the non-clinical tests (e.g., number of vessels, number of animals).
- Data Provenance: Not specified. "Animal study" mentioned without country or specific details. The manufacturer is Miconvey Technologies Co., Ltd. from Chongqing, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the study described is a non-clinical performance and biocompatibility study for a surgical device, not a diagnostic or AI/ML study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of non-clinical device performance study.
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
Not applicable. This is not an AI/ML device or a diagnostic device where human readers would be involved in interpreting data assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The "device" is an ultrasonic surgical system, a physical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests:
- Performance Metrics: Measured directly (e.g., burst pressure, thermal spread, physical dimensions) against established engineering specifications and comparison to the predicate device's known performance.
- Biocompatibility: Assessed against ISO standards (e.g., presence/absence of irritation, cytotoxicity).
- Animal Studies: Observed physiological effects and outcomes (e.g., vessel sealing success, survival).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
N/A