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Tenderfoot is a sterile incision device intended to initiate capillary blood flow via a heel stick with infants and toddlers. For medical device use. For healthcare professional use, prescription only.

Tenderfoot is an automated skin incision device used to collect capillary blood from infants and toddlers by heel stick. The device produces an arc-like incision at a controlled depth to provide blood flow for obtaining a blood sample. The incision is made by a surgical blade that is completely enclosed in a plastic housing and deployed by pressing a trigger. Following deployment, the blade permanently retracts within the housing, rendering the device inoperable for further use. Tenderfoot is provided as a sterile, single-use disposable device intended for use by healthcare professionals only. Sterilization is achieved by gamma irradiation. Tenderfoot is offered in four models covering a range of incision depths sized for different infant populations: Micro-Preemie, Preemie, Newborn, and Toddler.

The provided text is a 510(k) summary for a medical device called "Tenderfoot". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict acceptance criteria through a clinical or algorithmic performance study in the way one might for a novel AI/ML device.

Therefore, the information requested in the prompt, particularly regarding MRMC studies, standalone performance, ground truth establishment for test/training sets, and expert adjudication, is not present in this document. This typically applies to AI/ML software as a medical device (SaMD) where performance is measured against reference standards. The Tenderfoot device is a physical, mechanical blood lancet.

However, I can extract the information that is available about the "performance data" provided.

Understanding the Context

The Tenderfoot device is a physical medical device (a heel incision device/lancet), not a software or AI/ML product. The "performance data" referred to in Section VII of the 510(k) summary are non-clinical bench testing and biocompatibility/sterilization/packaging validation, relevant for mechanical devices and their safety, not for evaluating algorithmic performance or diagnostic accuracy.

The FDA's review for this type of device (a Class II blood lancet, product code FMK) primarily focuses on demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate. This often involves comparing technological characteristics and validating that the device meets relevant performance standards (e.g., incision depth/length accuracy, sharps injury prevention features, sterility, biocompatibility).

What Can Be Extracted from the Provided Text:

Given the nature of the device and the document, the acceptance criteria and supporting study details will pertain to physical performance and safety, not diagnostic accuracy or AI/ML performance.

1. A table of acceptance criteria and the reported device performance:

The document states: "Nonclinical bench testing was performed for cut depth, cut length, trigger activation, and blade retraction before and after stress conditions, such as simulated distribution and aging. The testing met all acceptance criteria."

While the specific numerical acceptance criteria and reported numerical performance values are not detailed in this summary, the statement confirms that the device did meet predefined standards for these physical aspects.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each test. The summary only mentions "Nonclinical bench testing was performed..." without specifying the number of units tested.
• Data Provenance: Not applicable in terms of "country of origin of the data" or "retrospective/prospective" for this type of physical device testing. The tests are bench tests performed on the manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable as the device is a physical lancet, not an AI/ML diagnostic or image interpretation device that requires human expert-established ground truth. The "ground truth" for physical properties like cut depth/length would be measured directly by instruments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for this type of device and testing. Adjudication methods are typically used for establishing ground truth in clinical image or data analysis.

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 study was not done. This type of study is specifically for evaluating the performance of diagnostic devices, often AI-assisted, where human readers interpret medical images or data. The Tenderfoot device is a physical instrument for blood collection.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, a "standalone" study in the context of an algorithm was not done because the Tenderfoot is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For physical attributes like incision depth and length, the "ground truth" would be direct physical measurement using appropriate metrology tools, not expert consensus or pathology. For biocompatibility and sterilization, the ground truth is established by validated laboratory assays and standards (e.g., ISO 10993, ISO 11137).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

• Not applicable. As there is no training set (for AI/ML), there is no ground truth establishment for it.

Summary of missing information and reasons:

The prompt's questions are largely tailored to the evaluation of AI/ML-based medical devices or diagnostic software. The provided document is a 510(k) summary for a physical, mechanical blood lancet. Therefore, many of the requested details (especially those regarding AI performance, human reader studies, and expert ground truth establishment for data sets) are fundamentally not applicable to this type of device or the regulatory pathway it followed. The performance validation documented here pertains to the physical and safety characteristics of the device, demonstrated through bench testing and compliance with recognized standards.

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The GEM® Hemochron™ 100 System is a battery-operated portable instrument that performs individual in vitro quantitative coagulation tests on fresh whole blood. The system is intended to be used with test cartridges available from the manufacturer and include tests for Activated Clotting Time (ACT+) and Low Range Activated Clotting Time (ACT-LR). The system is intended for use only in point-of-care settings for patients aged 18 years and above.

The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is mended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL.

The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to the anticoagulation effects of UFH concentrations up to 2.5 units/mL.

For in vitro diagnostic use. For Professional Use, Rx Only ..

GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+):

The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring . anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL.

The GEM® Hemochron™ 100 ACT+ test can be performed on the GEM® Hemochron™ 100 System and any model of Hemochron™ Signature Series device. Each instrument is portable, which allows testing at the point-of-care. For in vitro diagnostic use.

For Professional Use, Rx Only

GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR):

The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation effects of UFH concentrations up to 2.5 units/mL.

The GEM Hemochron 100 ACT-LR test can be performed on the GEM® Hemochron™ 100 system and any model of Hemochron™ Signature Series device. Instruments are portable, which allows testing at the point-of-care. For in vitto diagnostic use.

For Professional Use, Rx Only.

directCHECK Whole Blood Controls:

The directCHECK™ Whole Blood Quality Controls are dried whole blood preparations which have been assayed and are intended to be used to perform quality control assays using the Hemochron™ test cartridges

For in vitro Diagnostic Use. For Professional Use, Rx Only.

The GEM® Hemochron™ 100 system is a battery-operated, point-of-care coagulation analyzer that represents the next generation platform of the predicate Hemochron™ Signature Elite microcoagulation system. The analyzer employs the same fundamental opto-mechanical clot detection technology and the same analytical algorithms used by the predicate device for calculating test results. The single-use test cartridges for Activated Whole Blood Clotting Time Plus (ACT+) or Low Range ACT (ACT-LR) assays are identical to the cartridges used by the predicate analyzer. Whole Blood Controls used on the GEM® Hemochron™ 100 system are identical to those used on the Hemochron™ Signature Elite. The system is intended for use only in clinical settings requiring point of care testing. ACT results for patient blood samples or liquid control material are displayed as ACT Celite-equivalent values (CEV) in seconds.

The analyzer contains a test chamber which warms a test cartridge to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cartridge and the test is started by the operator. The user interface includes a color touch screen that displays various action keys and an external barcode scanner for reading Operator identification number (OID), Patient identification (PID) number and lot numbers and expiry dates of liquid quality controls (QC). The operator uses the touch screen to select a command, set software configurations or enter information. The GEM® Hemochron™ 100 system is POCT1-A2 compliant and has Wi-Fi and Ethernet networking capability. It has increased storage for 10,000 patient and QC records. ACT+ and ACT-LR cartridge labels are modified to include a 2D barcode that identifies test type, lot number and expiry date, which is readable by the internal camera. Quality control features such as designation of QC levels, tagging of test results with date and time, and entry of OID and PID numbers are included and are similar to the predicate device.

The GEM® Hemochron™ 100 system is intended for use at the point of care professional healthcare environments such as the Cardiovascular Operating Room and Catheterization lab and is designed to perform its essential tasks of performing in-vitro diagnostic blood coagulation-time tests without the use of a network connection. The device contains an 802.11 interface which supports WPA2 encryption as well as EAP authentication framework. The device is able to connect to a Wireless Local Area Network (WLAN) via 802.11 b/g/n connections at 2.4 and 5 GHz. The communications interfaces supported by the device are utilized to configure or update the device software by supervisory staff before deployment to the intended use environment and in the reporting of test results to the Laboratory or Hospital Information Systems (LIS/HIS) by the clinical operators at the point of care. Test results are used directly at the point of care in aiding medical decision making, and the device's intended use is not reliant on the device's ability to transmit the information to the LIS/HIS.

GEM® Hemochron™ 100 ACT+ cartridges are single-use disposable test devices with a well for application of liquid QC and whole blood samples. When a liquid QC or patient test is requested, the instrument prompts the Operator to insert a cartridge into the instrument. After the instrument warms the cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge. The ACT+ test cartridge is a self-contained disposable test chamber preloaded with a dried preparation of silica, kaolin, phospholipid, stabilizers, and buffers that provide maximum activation as defined by clinical practice guidelines. Each cartridge is sealed in a foil pouch labeled with lot number and expiry date. Reagents in GEM® Hemochron™ 100 ACT+ cartridges (000GACT+) are identical in composition to those in the predicate Hemochron™ ACT+ cuvettes (JACT-LR). A 2D barcode added to the cartridge label identifies the test type, lot number and expiry date. This information is automatically read by the internal camera. Each box of GEM® Hemochron™ 100 ACT+ cartridges contain 45 pouches, each pouch containing one GEM® Hemochron™ 100 ACT+ cartridge and one desiccant packet.

GEM® Hemochron™ cartridges are single-use disposable test devices with wells for application of samples. When a patient test or an LQC test is requested, the instrument prompts the Operator to insert a cartridge into the instrument. After the instrument warms the cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge. Each GEM® Hemochron™ 100 ACT-LR cartridge is sealed in a foil pouch labeled with lot number and expiry date. The cartridge is a self-contained disposable test chamber preloaded with a dried preparation of Celite and silicon dioxide activators, potato dextrin, stabilizers, and buffers to provide maximum activation as defined by clinical practice guidelines. Reagents in GEM® Hemochron™ 100 ACT-LR cartridges (000GACT-LR) are identical in composition to those in the predicate Hemochron™ ACT-LR cuvettes (JACT-LR). A 2D barcode added to the cartridge label identifies the test type, lot number and expiry date. This information is automatically read by a new internal camera. Each box of GEM® Hemochron™ 100 ACT-LR cartridges contain 45 pouches, each pouch containing one GEM® Hemochron™ 100 ACT-LR cartridge and one desiccant.

Blood coagulation instruments and assays should be quality controlled prior to and during routine use. Performance ranges are provided with each control product against which users should compare results. Quality assurance programs include instrument service, quality control and complete performance records. directCHECK™ Quality Control products are to be used with Hemochron Systems (GEM® Hemochron™ 100 and Hemochron™ Signature Series). Level 1 and Level 2 QC products are provided in separate packaging. These preparations consist of dried fixed bovine red blood cells, rabbit cephalin, buffered sheep and horse plasma. Assayed clotting time values are provided with each lot of material. Each control preparation is provided in a dropper vial. Each dropper vial also contains diluent used to rehydrate the dried whole blood control. Diluent preparations consist of distilled water, sodium chloride, Tween® 20, ProClin®, and anticoagulant.

The provided text details the 510(k) summary for the Accriva Diagnostics, Inc. GEM Hemochron 100 System and associated tests and controls. This document aims to demonstrate the substantial equivalence of the new device to existing legally marketed predicate devices. The study described focuses on the comparison between the new GEM Hemochron 100 system and the predicate Hemochron Signature Elite, rather than proving the device meets acceptance criteria in a traditional sense of a clinical trial with predefined success/failure thresholds against a ground truth.

Instead, the provided text describes performance data collected to demonstrate substantial equivalence to an already cleared predicate device. This is a common pathway for FDA 510(k) clearance, where a new device is compared to a legally marketed predicate to show it is as safe and effective.

Here's an attempt to answer your questions based on the provided text, reinterpreting "acceptance criteria" as the performance metrics and comparability demonstrated for substantial equivalence:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, "acceptance criteria" for performance studies are typically framed as demonstrating equivalence or non-inferiority to the predicate device within acceptable statistical bounds. The reported performance is then compared to that of the predicate. The document doesn't explicitly state quantitative acceptance criteria in a "pass/fail" table format, but rather presents the results of equivalence studies.

Here's a summary of the performance data presented, emphasizing the comparison to the predicate:

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The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from the manufacturer.

For in vitro Diagnostic Use. For professional use. Rx only.

The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery operated hand-held instrument. The system is intended for use in clinical settings requiring point of care testing. Whole blood test results are displayed as clotting times (in seconds). The instrument also displays correlated Celite® equivalent ACT values, APTT and PT plasma equivalent values, and the PT INR value.

The Hemochron™ Signature Elite Whole Blood Microcoagulation System contains a test chamber which warms a test cuvette to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cuvette and the test is started by the operator. The front panel contains a keypad with various action keys as well as a number pad. The operator uses the keypad to select a command or enter information. The instrument also includes a barcode scanner for reading of barcode identifications (IDs).

Data management capabilities are included with the instrument. These capabilities include storage of up to 600 patient results and 600 quality control results, designation of quality control levels, tagging of test results with date and time, entry of Patient ID and/or Operator ID or Operator PIN and printing of results

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hemochron™ Signature Elite device.

This document describes a Special 510(k) submission for a software update (Version 2.3 to 2.4) to an already cleared device, the Hemochron™ Signature Elite (K050016). Special 510(k)s are used when the modifications do not significantly alter the device's fundamental scientific technology, indications for use, or safety and effectiveness, and when well-established methods are available to evaluate the change. This means that a full de novo study with extensive acceptance criteria and performance data is generally not required for such submissions. Instead, the focus is on demonstrating that the software change itself does not introduce new risks or affect the established performance of the device.

Therefore, the "acceptance criteria" here are primarily satisfied by demonstrating substantial equivalence to the predicate device, particularly by showing that the software update does not change the prior performance claims. The study is a comparison of the updated device to its predicate, confirming that critical specifications remain substantially equivalent.

1. Table of Acceptance Criteria and Reported Device Performance

For this Special 510(k) with a software update, the acceptance criteria are implicitly that the updated device performs equivalently to the predicate device across all listed operational and performance characteristics. The reported device performance is that these characteristics remain "Substantially Equivalent" after the software update.

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

The document does not specify a separate "test set" in the context of a new performance study. The submission is a Special 510(k) for a software update, claiming that "Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change." The comparison detailed is against the predicate device (K050016), implying that previously established performance characteristics of the predicate are used as the benchmark.

Therefore, no new sample size for a test set is explicitly provided or required in this summary for the software update. The data provenance is implicitly the performance data established for the predicate device (K050016) in its original clearance process.

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

Given that this is a Special 510(k) for a software update and does not describe a new clinical or analytical study requiring expert ground truth establishment for a novel test set, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As no new test set is described or required for this type of submission, no adjudication method is mentioned. The evaluation is based on a comparison to the established specifications of the predicate device.

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

The device, Hemochron™ Signature Elite, is a point-of-care coagulation system. It measures clotting times. There is no indication of AI or human reader interpretation involved in its operation. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was done or reported here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is not an AI-based algorithm for interpretation. It's an in-vitro diagnostic instrument that objectively measures clotting times. Therefore, a standalone algorithm performance study (in the context of AI) is not applicable and not mentioned. The device operates as a standalone instrument for its intended use.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For this type of device (a coagulation measurement system), the "ground truth" for its accuracy and precision would typically be established by comparing its measurements to a recognized reference method (e.g., a laboratory gold standard coagulation analyzer) or by using calibrated control materials with known values. This information would have been established during the original clearance of the predicate device (K050016). For this Special 510(k), the "ground truth" is that the updated software does not alter the device's ability to accurately perform these measurements as previously established.

8. The Sample Size for the Training Set

The document does not describe the development of a predictive model or an AI algorithm that would require a "training set." The submission pertains to a software update for a measurement device.

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

As there is no training set mentioned or implied for this device's function, this question is not applicable.

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