(100 days)
The Invuity BriteField™ McCulloch Retractor System is intended to provide surgical site illumination from a high intensity light source.
The Invuity BriteField™ McCulloch Retractor System is a blade-based retraction system designed to provide surgeons with the ability to retract tissue through any combination of blades and hooks, when these devices are assembled onto a retractor frame. The Invuity BriteField™ McCulloch Retractor System is similar in design and function to current existing McCulloch Retractor Systems (Class I Exempt) with the exception that it features optional accessory illumination devices (waveguides) that can be attached to the Invuity BriteField" McCulloch Retractor System's blades and hooks. The BriteField McCulloch Waveguides are designed to deliver light from any hospitalprovided ACMI compatible 300-watt surgical light source via fiber optic cables to a targeted output area in the surgical field. BriteField McCulloch Retractor components and fiber optic cables of the Invuity BriteField™ McCulloch Retractor System are. reusable and supplied non-sterile: BriteField McCulloch Waveguides are single-use devices which are provided sterile.
The provided 510(k) premarket notification for the Invuity BriteField™ McCulloch Retractor System describes a surgical retractor system with an optional illumination feature. This device is classified as a Class II surgical lamp. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, function, and intended use, rather than presenting a performance study with acceptance criteria in the context of diagnostic accuracy or a new therapeutic claim.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device and submission.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) process for a device like this, which is seeking substantial equivalence to existing devices, typically relies on bench and animal/cadaver testing to demonstrate that the new device performs as intended and does not raise new safety or efficacy issues. The document does not specify quantitative acceptance criteria in the manner one would see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" can be inferred as the device successfully performing its intended function without failure during testing and demonstrating an equivalent profile to its predicates.
| Criteria | Reported Device Performance | Comments |
|---|---|---|
| Functional Equivalence to Predicate Devices (Mechanical retraction and illumination delivery) | "The Invuity BriteField™ McCulloch Retractor System is similar in design and function to current existing McCulloch Retractor Systems... [with] optional accessory illumination devices (waveguides) that can be attached." | |
| "The BriteField McCulloch Waveguides are designed to deliver light from any hospital-provided ACMI compatible 300-watt surgical light source via fiber optic cables to a targeted output area in the surgical field." | ||
| "Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy." | The acceptance here is implicit: the device must perform the core functions of retraction and light delivery as effectively and safely as its predicate devices. The document states this was achieved. | |
| Material Compatibility & Biocompatibility (Implied for components in contact with tissue) | Reusable components (retractor components, fiber optic cables) and single-use sterile components (waveguides) are mentioned. | While not explicitly stated as "acceptance criteria," surgical devices must be biocompatible. The fact that the device was approved implies these aspects were covered in the "bench testing." |
| Sterility (for single-use waveguides) | "BriteField McCulloch Waveguides are single-use devices which are provided sterile." | The acceptance criterion is simply that these components are sterile as presented to the user. This would have been confirmed through sterilization validation studies, which are standard for sterile medical devices. |
| Durability / Reusability (for specified components) | "BriteField McCulloch Retractor components and fiber optic cables of the Invuity BriteField™ McCulloch Retractor System are reusable and supplied non-sterile." | The acceptance criterion is that these components withstand repeated use and reprocessing as specified by the manufacturer without degradation that impacts safety or performance. This would have been demonstrated via "bench testing." |
| Safety and Efficacy Equivalence (Overall absence of new safety/efficacy concerns) | "All necessary bench and cadaver testing was conducted on the Invuity BriteField™ McCulloch Retractor System to support a determination of substantial equivalence to the predicate devices." | |
| "Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy." | This is the overarching acceptance criterion for a 510(k): the device must be as safe and effective as its legally marketed predicate devices. The conducted testing aimed to prove this. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "All necessary bench and cadaver testing was conducted on the Invuity BriteField™ McCulloch Retractor System to support a determination of substantial equivalence to the predicate devices."
- Test Set Sample Size: Not specified. "Bench testing" typically refers to laboratory tests on the device itself (e.g., light output, material strength, durability). "Cadaver testing" involves using human cadavers to simulate surgical use. The number of cadavers or specific tests performed are not detailed.
- Data Provenance: The testing was conducted by Invuity, Inc. or its contracted labs. The data would be considered prospective in the sense that the tests were performed specifically for this 510(k) submission. The origin (e.g., country) is not specified but is implicitly tied to the manufacturer's location or their testing facilities. This is not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The device is a surgical tool, and the testing described (bench and cadaver) would involve engineers, technicians, and potentially surgeons for usability assessments in cadavers. There isn't a "ground truth" in the diagnostic sense that requires multiple expert readers/interpreters. The "truth" is whether the device performs its physical functions correctly and safely.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no diagnostic or interpretive ground truth established by experts, an adjudication method for conflicting expert opinions is not relevant. Results from bench and cadaver testing would be objectively measured and reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is typically conducted for diagnostic imaging devices to assess how AI affects human performance (e.g., radiologists interpreting images). The Invuity BriteField™ McCulloch Retractor System is a physical surgical tool with an illumination function, not an AI-powered diagnostic aide.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This refers to the performance of an AI algorithm on its own. The Invuity BriteField™ McCulloch Retractor System is a physical device, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is based on objective measurements and observations from bench testing (e.g., light intensity output, mechanical stability, material properties, durability under stress, successful sterilization cycles) and functional assessment in cadavers (e.g., ease of use, adequate illumination of the surgical field, ability to retract tissue without issue). It is not dependent on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.
8. Sample Size for the Training Set
- Not Applicable. This pertains to machine learning models. The Invuity BriteField™ McCulloch Retractor System is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, this is for AI/ML models, not for physical medical devices.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.