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The APPRAISE-HRI is a mobile health app intended to provide a means for military healthcare providers to screen U.S. Service members for hemorrhage risk after a physically traumatic event and stratify casualties who need immediate attention and emergency evacuation from those who are injured but may not be at risk for hemorrhage.

The APPRAISE-HRI is not intended to diagnose or direct treatment. Rather, it is intended to provide situational awareness and inform clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk of hemorrhage.

The Automated Processing of the Physiological Registry for Assessment of Injury Severity (APPRAISE)-Hemorrhage Risk Index (HRI) is an Android application developed by the U.S. Army Medical Research and Development Command (USAMRDC) that uses vital-sign data collected from a trauma patient to provide a risk score that stratifies the patient's risk of hemorrhage. When the application runs, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) vital-sign data are collected from an external monitor [currently only the ZOLL Propaq M (K202375) is supported]. The ZOLL Propaq M monitor connects via Bluetooth with the Android platform running the APPRAISE-HRI application. The APPRAISE-HRI application continuously pulls data from the ZOLL Propaq M monitor to gather the required vital signs (HR, SBP, and DBP) and then runs the hemorrhage risk stratification algorithm to generate an output every one minute.

Once the vital-sign data from the ZOLL Propaq M monitor are transferred, the APPRAISE-HRI provides a stratification of hemorrhage into three Risk Level categories: Low (I), Average (II), or High (II). The APPRAISE-HRI application continuously displays both the input vital signs (HR, SBP, and DBP) and the Risk Level score to the caregiver to provide situational awareness and to inform clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk of hemorrhage.

Here's a summary of the acceptance criteria and study details for the APPRAISE-HRI device, based on the provided document:

Acceptance Criteria and Device Performance

Note: The acceptance criteria were success criteria focusing on the device effectively and consistently differentiating between HRI Levels I, II, and III, and the ground truth for trauma patients tracking consistently with the algorithm results. The specific numerical targets for the Likelihood Ratios are derived from the interpretation in the document where "at least five times less likely," "almost as likely," and "nearly seven times more likely" were stated.

Study Details

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The Gamma Phage assay is a lytic phage assay specific for Bacillus anthracis. The Gamma Phage assay (common name) can be used on suspect non-hemolytic, aerobic, gram-positive, "ground-glass"- appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. The assay is not intended for screening of blood or plasma donors.

Use of this assay is limited to designated laboratory Response Network (LRN) and Department of Defense (D0D).

The gamma phage is a lytic bacteriophage which binds to specific cell-surface components of susceptible bacteria. Their DNA is injected into the bacterium. The gamma phage replicate within the bacterium and produce PlyG lysine (2), resulting in lysis of the infected cell and release of phage. The release of newly synthesized phage leads to another round of phage infection and lysis.

Materials Supplied:

• Bacillus anthracis Gamma Phage Suspension, 0.5 ml
• . Positive Control, Bacillus anthracis Pasteur Strain Spore Suspension, 1.0 ml
• Negative Control, Bacillus cereus Spore Suspension, 1.0 ml ●

Materials required but not supplied:

• . 5% Sheep Blood Agar plate
• . Inoculating loops, 1ul and 10 ul
• Aerosol resistant pipette tips
• . Disinfectant

Equipment required:

• Pipettor, 5-50 µ1
• Incubator, 35+/- 2 °C
• Biological Safety Cabinet, Class II
• Refrigerator, 2-8 ℃ .

Here's a summary of the acceptance criteria and study information for the Gamma Phage Lysis Assay for the Identification of Bacillus anthracis, based on the provided document:

The document describes a Special 510(k) submission (K143592) for the Gamma Phage Lysis assay, which is specific for Bacillus anthracis. The submission states that the only modification made to the previously cleared predicate device (K051794) is a change in the positive control strain from Bacillus anthracis Pasteur strain to Bacillus anthracis Sterne strain. The document claims this change does not impact assay performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity/specificity thresholds) or provide detailed performance metrics (like sensitivity, specificity, accuracy) for the K143592 device itself. Instead, it relies on the substantial equivalence argument, asserting that the performance characteristics are identical to the predicate device because the only change (positive control strain) does not impact assay performance.

Therefore, the "acceptance criteria" can be inferred as maintaining the performance of the predicate device for identifying Bacillus anthracis.

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

The document does not describe a new clinical or laboratory study with a "test set" to establish the performance of the K143592 device independently. The basis for substantial equivalence is that the only change (positive control strain) does not alter the fundamental performance of the assay. Therefore, there is no specific test set sample size or provenance information for K143592 provided in this document as it pertains to proving the performance of the assay itself. The performance relies on the previous clearance of K051794 and the argument that the modification is minor.

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

Not applicable, as no new independent test set study is described for K143592 to establish ground truth for performance. The performance is considered equivalent to the predicate.

4. Adjudication Method for the Test Set

Not applicable, as no new independent test set study is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a rapid diagnostic assay for bacterial identification, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation in the context of an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a laboratory assay. Its performance is inherent to the reagents and protocol. The document does not provide details of an internal "standalone" study for K143592, as its performance is considered unchanged from the predicate device. The assay itself operates "standalone" in the sense that it provides a direct result without human "interpretation" of complex data (like images), but rather observation of lysis.

7. The Type of Ground Truth Used

For the predicate device (K051794) and by extension for K143592, the ground truth for Bacillus anthracis identification would typically be established through:

• Culture and biochemical identification: Standard microbiological methods to identify bacterial species.
• Molecular methods: Such as PCR, targeting specific B. anthracis genes.
• Referral laboratory confirmation: Confirmation by a qualified reference laboratory using a suite of confirmatory tests.

The document implicitly relies on these established methods for identifying Bacillus anthracis to validate the specificity and lytic activity of the gamma phage. The positive and negative controls provided with the kit (e.g., Bacillus anthracis Sterne strain and Bacillus cereus spore suspension) serve as internal ground truth checks for each run of the assay.

8. The Sample Size for the Training Set

Not applicable. This is a traditional diagnostic assay, not a machine learning or AI model that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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The BRDSS-C is indicated for use in the care of adult patients and adolescent patients 17 years of age or older who weigh 40kg (88lbs) or more with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for fluid recommendations. The BRDSS-C is intended to be initiated within 24 hours of the burn incident and completed by 72 hours post burn. The BRDSS-C is not indicated for use in patients who are less than 17 years of age.

The Burn Resuscitation Decision Support System – Clinical (BRDSS-C) is a burn decision support software application for assisting healthcare professionals in managing fluid resuscitation of burn patients during the initial 24 - 72 hours post burn. The system provides hourly (or half-hour) fluid calculations and recommendations for patients with 20% or greater Total Body Surface Area (TBSA) burn injuries, in addition to providing users with a graphical user interface to display volume status, Intake and Output (I/O) volumes, and other relevant fluid balance information.

The provided document is a 510(k) premarket notification for the Burn Resuscitation Decision Support System - Clinical (BRDSS-C), v. 1.0. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results and acceptance criteria as would be found in a clinical trial report.

Therefore, the information requested regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not fully available within the provided text.

However, I can extract the available information and point out what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it demonstrates validation against software requirements and usability, and establishes substantial equivalence to a predicate device.

Missing Information for this section: Specific quantitative thresholds for "passing" or "compliance" with software and usability requirements are not detailed. Performance metrics related to fluid calculation accuracy or clinical outcomes are also not provided.

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

The document mentions "software verification and validation as well as clinical user validation" and a "human factors study." However, it does not specify the sample size for any test sets used in these validations or for the human factors study.

It also does not specify the data provenance (e.g., country of origin, retrospective/prospective) for any data used in these validation efforts.

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

The document does not describe the establishment of a "ground truth" for a specific test set in the context of clinical performance, as it is a fluid resuscitation calculator and relies on an established algorithm.

For the "clinical user validation," it implies that burn care professionals were involved, but does not specify the number of experts or their qualifications used to evaluate the device. The device is "intended for use by healthcare professionals with burn care experience," suggesting that these individuals, or similar ones, would have been involved in the validation.

4. Adjudication Method for the Test Set:

Given that the document does not describe a clinical test set requiring ground truth, no adjudication method is mentioned or implied. The validation focuses on software functionality, usability, and equivalence to a predicate device running the same core algorithm.

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

No MRMC comparative effectiveness study is mentioned. The device is a "decision support system" providing fluid recommendations, not an imaging analysis tool typically associated with MRMC studies. The focus is on the algorithm's calculation and the software's usability and safety, not on how human readers' performance improves with or without AI assistance in interpretation.

6. Standalone Performance Study:

The document describes the BRDSS-C as a "fluid resuscitation calculator for fluid recommendations" and a "burn decision support software application." Its validation is described as: "The BRDSS-C has passed software verification and validation as well as clinical user validation based on the FDA's Quality System Regulation requirements under 21 CFR Part 820."

This indicates that its performance as a standalone algorithm (without human intervention in its core calculation logic) was indeed evaluated through software verification and validation testing. However, specific quantifiable metrics of this standalone performance (e.g., accuracy of fluid recommendations against a gold standard in a clinical dataset) are not provided in this summary. The evaluation focuses on whether the software correctly implements its algorithm and meets its functional and usability requirements.

7. Type of Ground Truth Used:

For the core function of the device (fluid calculations), the "ground truth" is inherently the mathematical output of the underlying burn decision support algorithm, which is the same as that used in the predicate device. The validation confirms that the software correctly implements this algorithm and provides accurate calculations based on the input.

For software validation, the "ground truth" would be the defined software requirements and specifications. For human factors validation, it would be usability standards and successful task completion by representative users. Clinical outcomes data are not mentioned as a ground truth for the device's validation in this document.

8. Sample Size for the Training Set:

The BRDSS-C uses the same burn decision support algorithm as the predicate device (BRDSS - Burn Navigator). This existing algorithm would have been developed and "trained" (in a broader sense, meaning its parameters and logic established) prior to the development of the BRDSS-C.

The document does not specify a sample size for a training set used to develop or re-train the algorithm for BRDSS-C, as it states the algorithm itself is the same.

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

Since BRDSS-C utilizes an existing algorithm from its predicate, the document does not describe how a "ground truth" for a new "training set" was established for the BRDSS-C specifically.

The original algorithm (used by both BRDSS and BRDSS-C) would have been developed based on medical knowledge, clinical guidelines for burn fluid resuscitation (e.g., Parkland formula variations), and potentially validated against historical patient data or expert consensus in its initial inception. However, this information is not detailed in the provided 510(k) summary for BRDSS-C.

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