(6 days)
The ClearCount Medical Solutions SmartSponge™ PLUS System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparatomy sponges and towels used during surgical procedures, as well as for providing a non-invasive means of locating retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site.
The SmartSponge™ PLUS System includes surgical sponges, laparatomy pads and surgical towels, each of which contains a unique radio frequency identification (RFID) tag permanently attached to the gauze or fabric. The tags allow the sponges and towels to be individually recognized by an RFID reader.
The SmartBucket is a specially designed cart containing a microcontroller unit with specialized software designed for mobile data collection. Integrated RFID technology allows capture of the information coded on the unique RFID tag on the sponges, pads and towels. The microcontroller unit counts the initial number of sponges introduced into a surgical case, and using the custom software program, reports the total sponges discarded at the end of the procedure, and compares that number to the original. By providing a count of the items entered into surgery, and a count of those discarded and removed permanently from the surgical field, personnel can be alerted to sponges that may still remain in the surgical field prior to closing the patient.
A Detection Wand is an additional antenna that is tethered by a cable to the SmartBucket. It is powered and controlled by the SmartBucket. The antenna functions as an additional RFID antenna to the system, functioning in an identical manner to the internal SmartBucket antennas. By using a keypad the user may select activate the Detection Wand antenna. When in Detection Wand mode, the system uses the Wand antenna to recognize RFID-tagged items that may be inside the surgical site.
A Detection Mat is a disposable or reusable element with multiple RFID tags embedded inside, along with several passive printed circuit traces. Like the RFID-tagged sponges, the Detection Mat tags contain unique identifying numbers and are distinguishable by the system software. The Detection Mat is placed on the operating room table before the patient is brought into the room and is covered by the standard sheets or drapes used in surgery, thus not making contact with the patient. The RFID tags in the Matt provide feedback to the user that the Detection Wand is being held close enough to the patient to ensure proper reading. The tags in the Detection Mat also ensure that the Detection Wand scan has covered the appropriate areas of the patient. The passive circuit traces help to enhance the readability of the RFID tags in the Detection Mat.
Here's an analysis of the provided text regarding the ClearCount Medical SmartSponge™ PLUS System, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Counting Functionality: Accurately count and record the initial number of RFID-tagged surgical items and the number discarded post-procedure. | The SmartBucket (part of the system) "counts the initial number of sponges introduced into a surgical case, and using the custom software program, reports the total sponges discarded at the end of the procedure, and compares that number to the original." This function is implicitly stated to work as intended. "The customized software program uses the scanned information to count the number of items used at the beginning of a surgical procedure, and then again before surgical closure." No specific numerical accuracy rates are provided for the counting function in this document. |
| Detection/Localization Functionality: Non-invasive means of locating retained RFID-tagged surgical items within a surgical site. | "Non-Clinical testing included simulated use in patient models that represented worst case biological situations... and in all cases the ClearCount SmartSponge™ PLUS System performed as intended." "The validated software functioned as intended under simulated use, properly locating all tags." |
| RFID Tag Readability: Read tags through blood, bodily fluids, and tissue. | "The scanner can read the tag through blood and other bodily fluids and tissue." (This is a design claim rather than a measured performance metric from the study specifically.) |
| Biocompatibility of Transponder Tags: Tags are safe for contact within the surgical environment. | "Biocompatibility of the transponder tag was illustrated and is comparable to the commercially available predicates." |
| Electrical Safety Standards: Compliance with IEC 60601-1. | "The system has also been designed to meet the following electrical safety standards and electromagnetic compatibility standards: IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety" |
| Electromagnetic Compatibility Standards: Compliance with IEC 60601-1-2. | "The system has also been designed to meet the following electrical safety standards and electromagnetic compatibility standards: IEC 60601-1-2 (Second Edition, 2001) Medical Electrical Equipment - Part 1: General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests" |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "simulated use in patient models that represented worst case biological situations." However, no specific sample size (number of simulated cases, number of sponges, or number of tests) for the test set is provided.
The data provenance is from non-clinical testing, using simulated patient models. The document does not specify the country of origin, but given the FDA submission, it's presumably conducted under U.S. regulatory standards or by a manufacturer seeking to market in the U.S. It explicitly states "Non-Clinical testing," confirming it's not a prospective or retrospective study involving actual patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for the simulated use in patient models would likely have been established by the study designers or engineers setting up the scenarios of "worst case biological situations" and knowing the expected location and quantity of tagged items. There is no mention of independent experts establishing this ground truth.
4. Adjudication Method for the Test Set
This information is not provided. Without details on who assessed the device's performance in the "simulated use," an adjudication method cannot be determined.
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. The device's primary function is to automate sponge counting and aid in detection, not to assist human readers in interpreting medical images in the traditional sense of an MRMC study. The "Detection Wand" is a tool for locating tagged items, not for improving human interpretation of visual data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance was implicitly evaluated for the detection component. The statement "The validated software functioned as intended under simulated use, properly locating all tags" suggests the algorithm's ability to locate tags independently within the simulated environment. While a human operates the Detection Wand, the core detection by the RFID system and its interpretation by the software is a standalone algorithm function. The counting function is also purely algorithmic.
7. The Type of Ground Truth Used
The ground truth used was based on pre-defined scenarios within simulated patient models where the exact quantity and location of RFID-tagged items would be known to the experimenters. This is an engineered or experimental ground truth, not derived from expert consensus, pathology, or outcomes data from real patients.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. The device appears to rely on established RFID technology and programmed logic, rather than a machine learning model that would typically require a training set in the conventional sense. If there was any "training" (e.g., for system calibration), its details are not mentioned.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned or implied for a typical machine learning model, this information is not applicable / not provided. The functionality seems to be based on direct sensing and programming, not a learned model 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.