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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.

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.

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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:

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.

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The SurgiCount Medical Safety-Sponge System™ is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges and towels used during surgical procedure.

The Safety Sponges include surgical sponges, laparatomy pads and surgical towels, each unit of which contains a unique identification label permanently fused to the gauze or fabric. The labels allow the sponges and towels to be individually recognized by a commercially available sight laser imager.

The Safety Sponge Counter is a commercially available mobile computer with specialized software designed for mobile data collection. Integrated imaging technology allows capture of the information coded in the unique identification label on the sponges, pads and towels. The computer counts the initial number of sponges opened, and using the custom software program, reports the total sponges used at the end of the procedure or on demand, and compares that number to the original. Individual sponges may be identified as entered into the surgical field but not discarded, so that the surgical field can be explored before surgically closing the patient.

Here's an analysis of the provided text regarding the SurgiCount Medical Safety-Sponge System's acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be >99%"). Instead, it focuses on qualitative substantial equivalence and functional performance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated. The clinical study involved a "surgical setting" but the number of procedures, sponges, or specific data points is not quantified.
• Data Provenance: Clinical data was prospective ("tested clinically under non-significant risk IRB approvals in a surgical setting"). The country of origin is not specified, but given the 510(k) submission to the FDA, it is highly likely to be the United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The document mentions "operating personnel's assessment," but it doesn't specify if these personnel established ground truth for sponge counts or if their assessment was for user experience.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No Multi-Reader, Multi-Case (MRMC) study was explicitly mentioned. The study compared the device (AI) to traditional hand counting and assessed accuracy and time efficacy. It did not evaluate human readers with and without AI assistance in the traditional MRMC sense.
• Effect Size: Not applicable, as an MRMC study of human readers with/without AI assistance was not performed. The text does state the system makes its use "more effective than hand counting sponges" and provides "improved accuracy," but no specific quantitative effect size is given for human performance enhancement.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Yes, a standalone performance study was done. The core of the product is a "mobile computer with specialized software" that performs the counting. The "software validation of the hand-held scanning device" and "simulated finished product testing of the total system" where the software "properly counting sponges in simulated body fluids" directly demonstrate algorithm-only performance. The clinical study also validates the system's ability to "accurately counted surgical sponges into and out of the field, on both clean and soiled sponges," implying standalone algorithm accuracy.

7. Type of Ground Truth Used

Based on the description, the ground truth was likely established through manual, independent counting of sponges for comparison with the device's count. The description implies that the study aimed to verify the accuracy of the device's count against a known correct count (the actual number of sponges).

8. Sample Size for the Training Set

This information is not provided in the document. The document describes the system as using "commercially available" components and software "similar to the predicate software" for inventory control, suggesting it may not have required extensive de novo training data for a complex machine learning model in the modern sense. It's more likely a rule-based or OCR-like system.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, and it's unclear if a distinct "training set" with ground truth, as understood in modern AI development, was even used. Given the technology described (reading unique ID labels with a laser imager), the system might be more of a deterministic counting system rather than an AI model requiring a large, annotated training set. Its functionality relies on reliable label reading and matching, not "learning" from diverse input data to classify or detect.

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The Baxter Emergency Relief TM System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance.

The Baxter Emergency Relief ™ System is designed as one large unit which houses various first aid kits Each mini kit contains various individual components traditionally used for first aid treatment. Each individual component is a finished good with an established regulatory path where applicable. All components are purchased as finished goods and packaged in the appropriate mini kit, including direction for use inserts. All direction for use inserts correspond to the instruction manual accompanying the system.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is a summary of safety and effectiveness for the Baxter Emergency Relief™ Kit System, detailing its components, classification, intended use, and substantial equivalence to predicate devices. It explicitly states: "Testing of the system was deemed not applicable as all regulated devices has an established regulatory path and is obtained in finished good form." This indicates that no specific performance study was conducted for the overall kit system as its components are already approved finished goods.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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Removal of suture from the epidermis.

Not Found

The provided documents are 510(k) clearance letters from the FDA regarding "CPR Lap Sponges", "Basic Set-Up Tray", and "CPR Suture Removal Kit". These documents establish that the devices are substantially equivalent to devices marketed prior to May 28, 1976. This correspondence is primarily administrative and regulatory in nature.

There is no information in these documents about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to the technical performance of an AI/ML powered medical device.

The document dated April 9, 2024, is an administrative update to a previous 510(k) letter from March 28, 1996, indicating a re-categorization of the device technology under a new product code (GDY for Nonabsorbable gauze for internal use). It explicitly states, "Please note that the 510(k) submission was not re-reviewed."

The original 510(k) letter from March 28, 1996, makes a determination of substantial equivalence based on the devices being "marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)." This indicates that the clearance was based on equivalence to predicate devices already on the market, not on a detailed performance study as would be required for a novel device, especially an AI/ML one.

Therefore, I cannot provide the requested information from these documents as they do not contain details about:

1. A table of acceptance criteria and reported device performance
2. Sample sizes or data provenance for test sets
3. Number or qualifications of experts
4. Adjudication method
5. Multi-reader multi-case comparative effectiveness study or effect size
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

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