(57 days)
The RF Surgical Systems Inc. Detection System is intended to provide a non-invasive means of locating retained surgical sponges, gauze and other tagged items within a surgical site. It is to be employed as an adjunctive detection method to current surgical sponge and gauze counting systems and methods
The RF Surgical Systems Inc. Detection System consists of:
- The Power/Control Console contains the electronics that power and control the detector/scanner. The console also includes the user interface for system operation and communication of the system status, operation and alarms to the user.
- The Transponder/Tag is a single use electrically passive device that is designed to radiate a magnetic signature when stimulated by magnetic impulses from the detector/scanner. The tag does not store or communicate any information or unique code and is to be mechanically attached to guaze sponges at the manufacturing site and processed as part of the item
- The Detection Wand is a transceiver type antenna designed to stimulate the transponder tag assembly with magnetic impulses and then detect the resultant magnetic signature from the tag. The Power/Control Console provides the power and control to the detection scanner. The detection scanner is intended and designed to be a single-use disposable device and will be supplied in a sterile condition as it will enter the surgical field.
Here's an analysis of the acceptance criteria and study information for the RF Surgical Systems Inc. Detection System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, it describes functional requirements and then states that the device "performed as intended."
Based on the "Technological Characteristics" and "Non-Clinical Performance Data" sections, here's an interpretation of the implied acceptance criteria and the reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-invasive means of locating retained surgical sponges, gauze, and other tagged items within a surgical site. | "The RF Surgical Systems Inc. Detection System performed as intended." |
| Detection of tagged objects within a minimum range of 16" from the detector aperture surface into a patient of average size. | Not explicitly quantified, but overall performance "as intended" implies this was met. |
| Tags outside of the patient and more than 36" outside of the scan area must not result in false positives. | Not explicitly quantified, but overall performance "as intended" implies this was met. |
| System capable of reading the tag signal through blood, bodily fluids, and the body wall. | Stated as a characteristic; implicit in "performed as intended." |
| Biocompatibility of the transponder tag comparable to commercially available predicates. | "Biocompatibility of the transponder tag was illustrated and is comparable to the commercially available predicates." |
| Validated software functions as intended, properly locating all tags. | "The validated software functioned as intended under simulated use, properly locating all tags." |
| Meets electrical safety standards: IEC 60601-1. | "The console has also been designed to meet the following electrical safety standards..." (does not explicitly state met in testing, but implies compliance in design). |
| Meets electromagnetic compatibility standards: IEC 60601-1-2 (Second Edition, 2001). | "The console has also been designed to meet the following ... electromagnetic compatibility standards..." (does not explicitly state met in testing, but implies compliance in design). |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not provide a specific numerical sample size for the test set used in non-clinical testing. It mentions "simulated use in patient models" and "Animal studies using large swine species."
- Data Provenance:
- Simulated Use in Patient Models: These are likely laboratory or in-house simulations.
- Animal Studies: "large swine species" were used. The country of origin for these animal studies is not specified, but it's implied to be part of the manufacturer's testing process for FDA submission.
- Retrospective or Prospective: Both "simulated use" and "animal studies" would typically be considered prospective in nature, as they were conducted specifically to test the device.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state that experts were used to establish ground truth in the traditional sense of consensus reading for image analysis. Rather, the ground truth for "locating all tags" in the simulated and animal studies would have been the known physical presence and location of the tagged sponges or items.
4. Adjudication Method for the Test Set
Given the nature of the device (detection of physical tags) and the described testing (simulations, animal studies where tags are physically present), an adjudication method like 2+1 or 3+1 for expert consensus is not applicable. The "ground truth" is directly observable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a standalone performance study of the device itself (detecting tags), not a comparative effectiveness study involving human readers with and without AI assistance (which is not an AI device in the typical sense, but rather a detection system). Therefore, no effect size of human reader improvement is reported.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was conducted. The "Non-Clinical Performance Data" section describes testing where the "RF Surgical Detection System performed as intended" and "the validated software functioned as intended under simulated use, properly locating all tags." This indicates an evaluation of the device's ability to detect tags independently.
7. Type of Ground Truth Used
The ground truth used was:
- Known physical presence and location of tagged items: In simulated patient models and animal studies, the researchers would have known precisely where the tagged sponges were placed.
- Biocompatibility data: For biocompatibility, the ground truth would be established through standard biological testing methods and comparison to known safe materials (predicates), likely through laboratory analysis rather than expert consensus on images.
8. Sample Size for the Training Set
The document does not provide information about a "training set" for the device. This device is described as an RF detection system using transponder tags and a detection wand, not an AI/machine learning system that typically requires a large training dataset. The "software" mentioned likely refers to control and processing logic rather than a trainable AI algorithm.
9. How Ground Truth for the Training Set Was Established
As no training set is indicated, this question is not applicable based on the provided text. The device's operation is based on physical principles of radio frequency detection, not on learning from data.
§ 880.2740 Surgical sponge scale.
(a)
Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.