(167 days)
The ORLocate™ system is indicated for use in recording and counting the number of RFID-tagged surgical sponges, laparotomy sponges, towels and other tagged items used during surgical procedures in which counting is required. In addition, the product is indicated for providing a non-invasive means of detecting retained RFID-tagged surgical sponges, towels and other tagged items within a surgical site, as an adjunctive detection method to current surgical counting systems and methods.
Haldor ORLocate™ system is an RFID system providing a solution that enables the enumeration of sponges and surgical manual instruments, utilizing passive tags for keeping track of the items during surgery and to identify counting problems. In addition, the system provides a non-invasive means of locating retained surgical items within a surgical site. The submission consists of the ORLocate™ system which includes: cart and antennas. Additionaly the submission includes accessories which are: associated single use surgical sponges, gauzes, pads and surgical towels each fitted with a uniquely coded RFID tag and uniquely coded RFID tag used for surgical instruments. The RF frequency the system uses is 13.56 MHz according to ISO 15693. The system supplies also a semi-automatic application to help in counting untagged items, the count information is first entered manually and the calculations are automatic.
The ORLocate™ System is an RFID-based system for counting and detecting surgical items. The provided document, a 510(k) Summary, details the device's technical characteristics, intended use, and non-clinical performance data to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. However, based on the non-clinical performance data section, the criteria can be inferred from the tests performed and the conclusion that the device functions as intended and is as safe and effective as predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility of tagged items | Demonstrated |
| Permanent attachment of tags to sponges and instruments | Demonstrated |
| Software functions as intended | Validated, properly counting sponges in body fluids |
| Safety equivalent to predicate devices | Test results demonstrate this |
| Effectiveness equivalent to predicate devices | Test results demonstrate this |
| Proper functioning in body fluids | Software properly counted sponges in body fluids |
| Counting accuracy | Testing performed, deemed "as safe and effective" |
| System interference with OR devices | Testing performed |
| ORLocate sponge X-ray detection | Testing performed |
| ORLocate Tag pull test | Testing performed |
| Electromagnetic compatibility (IEC 60601-1-2:2007) | Testing performed |
| Electrical safety (IEC 60601-1:1988 + A1:1991 + A2:1995 and EN 60601-1:1990 + A1:1993 + A2:1995 + A3:1996) | Testing performed |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Non-clinical testing included demonstrating performance of system and tagged items in laboratory tests." However, it does not specify the sample sizes used for any of the tests (e.g., how many sponges were tested for counting accuracy, how many instruments for tag pull test).
The data provenance is described as "laboratory tests," implying controlled settings rather than real-world clinical data. The document does not mention the country of origin of the data explicitly, but the 510(k) owner is based in Israel, suggesting the testing likely occurred there or in collaboration with international labs. The study is retrospective in the sense that the testing was performed and then reported for the 510(k submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of the non-clinical tests (e.g., biocompatibility, tag attachment, software counting accuracy), ground truth would likely be established through objective measurements and validated procedures rather than solely expert consensus.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given that the non-clinical tests are largely objective performance evaluations (e.g., measuring count accuracy, pull force, EMC compliance), an adjudication method in the context of expert review is unlikely to be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on non-clinical performance data to establish substantial equivalence, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the non-clinical tests described are essentially standalone performance evaluations of the algorithm and device. The "counting accuracy test" and validation that the "software functioned as intended under simulated use, properly counting sponges in body fluids" demonstrate the algorithm's performance without direct human-in-the-loop assistance for the core counting mechanism. The system is designed to perform automatic counts and provide alerts if items are missing, which is a standalone algorithmic function.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests would have been established through:
- Objective measurement/validation: For counting accuracy, the actual number of sponges present would be the ground truth. For tag pull tests, the measured force would be compared against a standard.
- Established standards: Compliance tests like IEC 60601-1-2:2007 and IEC 60601-1:1988 + A1:1991 + A2:1995 refer to external ground truths established by international standards bodies.
- Simulated environment: For the software, simulated body fluids were used to test performance, implying a controlled and known environment against which the device's output was compared.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. The system described is an RFID detection and counting system, which typically relies on pre-programmed logic for tag identification and counting, rather than a machine learning model that requires a "training set" in the conventional sense. If there are any adaptive or learning components, they are not detailed in this summary.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned for machine learning purposes, the method for establishing its ground truth is not applicable/not provided. The system's operational parameters (e.g., RFID tag protocols, counting logic) would be established through engineering design and validation, not model training.
§ 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.