(52 days)
The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures.
The PhotonBlade is a single use, sterile, electrosurgical device with a light. The PhotonBlade has an electrode at the distal tip, which delivers RF energy for cutting and coagulation of soft tissue. The electrode tip is located at the distal end of a rotatable and extendable shaft. The device handle is integrated with controls for cut, coagulation, and illumination (light). A universal cable attaches the device to a 510(k) cleared electrosurgical unit.
The provided text describes the PhotonBlade device, an electrosurgical device with illumination, and its comparison to predicate devices for FDA 510(k) clearance. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies for AI devices.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through engineering and bench testing, rather than clinical trials or AI performance evaluations.
Given the information provided in the text, I can only report what is included:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists various performance tests conducted to demonstrate compliance with product requirements, safety, efficacy, and substantial equivalence to the predicate devices. These tests generally assess the device's capability to perform its stated functions.
| Test Category | Description / Performance Demonstrated |
|---|---|
| Mechanical Testing | Conducted on PhotonBlade devices exposed to EO sterilization and simulated transportation to demonstrate compliance with product requirements. |
| Electrical Safety / EMC Testing | Demonstrated compliance with: |
- IEC 60601-1 3rd Edition
- IEC 60601-2-2 |
| Operational Testing | Conducted on PhotonBlade devices exposed to EO sterilization and simulated transportation to demonstrate compliance with product requirements. (Specific operational metrics are not detailed, but it implies the device functions as intended for cutting and coagulation, and illumination.) |
| Ex-vivo Thermal Effects on Tissue Comparisons | Conducted to demonstrate safety and efficacy. (Specific results or comparisons are not detailed, but the aim is to show comparable or acceptable thermal effects to predicate devices. The document states: "PhotonBlade and PlasmaBlade both have insulated electrodes that extend and rotate. Both devices utilize blade electrodes where only the edge of the blade is exposed or active. As such, the principles of operation involved in cutting and coagulation of tissue are the same on either device.") |
| Biocompatibility | Demonstrated compliance with ISO 10993-1. |
| Packaging Evaluation | Conducted to demonstrate compliance with product requirements. |
| Sterilization | Sterile-Ethylene Oxide. |
| Illumination Output | PhotonBlade: 28 lumens (n=29)
PARE Surgical NOVA ES: 30 lumens (n=1)
(This is a comparison point, not an acceptance criterion, but it shows the measured output for the illumination feature). |
| Shelf Life Studies | Product Shelf Life studies for 7 months and 37 months will be conducted. (This indicates ongoing or planned studies, not necessarily completed ones with reported performance for final acceptance in this document.) |
| Overall Conclusion | The data submitted support the substantial equivalence claim for the proposed indications for use; the PhotonBlade is as safe and effective as the predicate device(s). Invuity Inc. considers the PhotonBlade device to be substantially equivalent to the legally marketed predicate device(s) with respect to the device function, intended use, and patient population. Any differences in technological characteristics between the PhotonBlade device and the predicate device(s) do not raise any new issues of safety and effectiveness. |
Missing Information (Not found in the provided text):
2. Sample size used for the test set and the data provenance:
* Not specified in the provided text. The document refers to "Performance testing was conducted on PhotonBlade devices" but does not detail sample sizes for specific tests or the origin of any data (e.g., country of origin, retrospective/prospective). The illumination output mentioned "n=29" for the PhotonBlade, which refers to the number of devices measured for that specific attribute.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This document is for a traditional surgical device, not an AI device requiring expert ground truth for classification/diagnosis.
4. Adjudication method for the test set:
* Not applicable. This document is for a traditional surgical device, not an AI device.
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 document is for a traditional surgical device, not an AI device. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This document is for a traditional surgical device, not an AI device.
7. The type of ground truth used:
* Not applicable in the context of AI algorithms. The "ground truth" for the device's performance relies on engineering specifications, physical measurements, and comparison to the established performance of predicate devices, as demonstrated through bench testing and ex-vivo studies.
8. The sample size for the training set:
* Not applicable. This document is for a traditional surgical device, not an AI device. No training set is mentioned.
9. How the ground truth for the training set was established:
* Not applicable. This document is for a traditional surgical device, not an AI device. No training set or ground truth establishment method for it is mentioned.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.