(9 days)
The ClearCount Medical Solutions SmartSponge™ System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparatomy sponges and towels used during surgical procedures.
The SmartSponge™ System includes surgical sponges, laparatomy pads and surgical towels, each unit 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.
The ClearCount Medical Solutions SmartSponge™ System is designed to count and record RFID-tagged surgical sponges, laparotomy sponges, and surgical towels during surgical procedures. The provided text outlines non-clinical performance data and results.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Permanence of the RFID tag on gauze pads | "Results showed that the tags are permanently attached." |
| Biocompatibility of the RFID tag material | "material is comparable to commercially available predicates in terms of biocompatibility." |
| Manufacturing validation: each item has one and only one unique tag | "manufacturing validation that one and only one unique tag was placed per item." |
| Software validation of the SmartBucket scanning device: proper counting in simulated body fluids | "The validated software functioned as intended under simulated use, properly counting sponges in simulated body fluids." |
| Overall system performance: safety and accuracy compared to manual counting | "Test results demonstrate the RFID tagged sponges are as safe as the predicate device, and the software installed on the microcontroller unit performs accurately, making its use more effective and more accurate than hand counting sponges." |
2. Sample size used for the test set and the data provenance:
The document states "simulated finished product testing of the total system" and "properly counting sponges in simulated body fluids." However, it does not specify the sample size for this test set nor the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. The ground truth for counting accuracy was established through "simulated use, properly counting sponges in simulated body fluids," implying a controlled experimental setup rather than expert interpretation of medical images or conditions.
4. Adjudication method for the test set:
The document does not specify an adjudication method (such as 2+1 or 3+1) for the test set. Given the nature of the device (counting sponges), the ground truth for counting accuracy would likely be directly observable and verifiable rather than requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The document compares the device's accuracy and effectiveness to "hand counting sponges" but does not provide specific effect sizes for human readers with or without AI assistance in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done implicitly. The "software validation of the SmartBucket scanning device" and "simulated finished product testing of the total system" describe the device's ability to "properly count sponges" without human intervention for the counting process itself. The system is designed to provide a count that personnel then use to determine if sponges remain.
7. The type of ground truth used:
The ground truth used for the counting accuracy of the SmartSponge System was directly observable and verifiable counts in simulated use conditions, specifically "properly counting sponges in simulated body fluids." This is an objective measurement of the device's functionality rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
The document does not specify the sample size for any training set. Given the context of a 2007 510(k) submission for a device using RFID for counting, it's possible that traditional "training sets" in the modern machine learning sense were not explicitly defined or reported in the same way. The software validation suggests a designed and tested algorithm rather than a continuously learning AI model.
9. How the ground truth for the training set was established:
The document does not describe how ground truth for a training set (if one was formally used) was established. The software validation likely involved testing against known, correct counts of sponges in controlled environments.
§ 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.