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The Prospera Spectruum™ Negative Pressure Wound Therapy System is a wound management system intended for use in acute, extended and home care settings.

When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The Prospera Spectruum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C. Drape components from the V.A.C. Therapy Wound Dressing kit.

The Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) is a component of the Prospera Spectruum Negative Pressure Wound Therapy (NPWT) System.

The Prospera Spectruum™ Negative Pressure Wound Therapy System consists of:

• · Prospera Spectruum™ Negative Pressure Wound Therapy Unit
• · Disposable canister which collects wound exudate
• Prospera Spectruum™ Contour Dome

The Prospera Spectrum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C.Drape components from the V.A.C. Therapy Wound Dressing kit.

The Prospera Spectruum™ Negative Wound Therapy Unit (NP-7000) is a portable, rechargeable battery and mains powered, reusable, software-controlled unit used with a can provide continuous or variable applications of negative pressure to a wound in the user defined range between 25mmHg. The Prospera Spectruum™ Negative Pressure Wound Therapy System is designed for use in home, acute or extended care settings.

The compatible dressing components include a wound interface dressing applied to the wound covered with a semi-occlusive drape and is connected to the canister of the Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) via a dual lumen dressing connection. This connection allows for the distribution of negative pressure to the wound bed and removal of wound exudate which is transported to the collection canister via the lumen.

The software within the Prospera Spectrum™ Negative Pressure Wound Therapy Unit (NP-7000) provides and maintains the prescribed pressure within the user defined range as well as alarming as neduced below the defined threshold. The alarms alert the user to conditions such as tubing blockages, a full canister, inactive therapy, low battery, and leaks in the system.

Additional features include:

• GPS for optional inventory management support
• Therapy history report via USB data port
• · Pre-set therapy options
• Event Log
• · User interface with flat buttons requiring depression for activation to reduce unintentional screen changes

• Confirmation screen to provide a visual notification to the user prior to device shutdown. The Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) will continue delivering therapy and will not power off until the user stops therapy and acknowledges via user interface that the intent is to power off the unit.

This document is a 510(k) premarket notification for a medical device, the Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000). The document focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of clinical efficacy or a multi-reader multi-case study for an AI algorithm.

However, based on the information provided, we can extract details regarding the non-clinical acceptance criteria and the bench testing conducted to support the device's functional performance. The document explicitly states "Clinical Tests: Not Applicable," meaning no direct clinical study was performed to assess patient outcomes or comparative effectiveness against human readers.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set (Bench/Usability): The document does not provide specific numerical sample sizes for the bench testing. For usability testing, it mentions "lay users who represent patients and lay caregivers" and "clinicians" but does not give a number for how many participated.
• Data Provenance: The tests described are non-clinical bench tests and usability tests conducted by the manufacturer (DeRoyal Industries, Inc.). The document does not specify country of origin for test data beyond indicating the company is based in Tennessee, USA. All testing appears to be prospective in nature, as it was conducted to support the 510(k) submission for this specific device.

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

• Non-Clinical Nature: This section is not applicable in the traditional sense of establishing ground truth for a clinical dataset using experts (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests is based on engineering specifications, regulatory standards (e.g., IEC 60601-1), and expected functional performance.
• Usability Testing: For usability testing, "clinicians" and "lay users" were involved, serving as the "evaluators" against usability criteria. Their specific qualifications beyond "clinicians" are not detailed.

4. Adjudication Method for the Test Set

• Not Applicable: Given the non-clinical nature of the tests (bench testing, software assessment, usability testing against predetermined criteria), there was no adjudication method involving multiple experts establishing a "ground truth" for ambiguous cases, as would be common in diagnostic AI studies. Performance was assessed against predefined pass/fail criteria or expected functionality.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, not performed. The document explicitly states: "Clinical Tests: Not Applicable." This device is a Negative Pressure Wound Therapy Unit, not a diagnostic imaging AI algorithm, so an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable (Different Device Type): This is not an AI algorithm performing a diagnostic task. The device does contain software that controls its function (maintains pressure, activates alarms). Therefore, "standalone performance" refers to the device operating according to its specifications without human intervention, which is assessed through the functional bench testing and software assessment. The document confirms these tests show its function as intended.

7. The Type of Ground Truth Used

• Engineering Specifications and Regulatory Standards: For functional performance, the "ground truth" is defined by the device's design specifications (e.g., negative pressure range, alarm thresholds) and adherence to recognized industry standards (e.g., IEC 60601-1).
• Usability Criteria: For usability testing, the "ground truth" is established by the usability requirements and design principles outlined in standards like ISO 62366-1 and ANSI/AAMI HE 75.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device that requires a "training set" in the context of learning from data to perform a task like image interpretation. The software controls the device based on pre-programmed logic and parameters, not trained algorithms.

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

• Not Applicable: As there is no "training set" in the AI/ML sense, this question is not relevant to this device submission.

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The DeRoyal Temperature Monitoring Probe is used for routine of the patient's core body or skin surface temperature.

The probe is offered in the following three configurations :

• General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities.

• Adult Skin Temperature Sensor for routine monitoring of skin temperature by application of the probe's adhesive cover to an adult patient's skin surface.

• Tympanic Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion of the ear piece into the auralcanal.

The device is single use and for use by licensed healthcare practitioners only. The probes are designed to interface with DeRoyal- branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport. Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands.

The DeRoyal Temperature Monitoring Probe is used for routine patient temperature monitoring. Each probe is single use and contains a wire set with a blue connector at the proximal end and a thermistor chip at the distal end. The thermistor passively modifies the electrical current traveling through the probe. The connector interfaces with a cable that is connected to an independent temperature monitor used to display the temperature readings.

There are three probe configurations included in this submission:

• 1. An adult skin temperature sensor that consists of the wire set with an adhesive probe cover that is applied to the patient's intact skin for monitoring of skin surface temperature.
• 2. A tympanic temperature probe that consists of the wire set with a foam ear plug that is inserted into the aural canal for monitoring of core body temperature.
• 3. A general purpose temperature probe that consists of the wire set enclosed in a tube that may be inserted into the esophageal, rectal, or nasopharyngeal cavities for monitoring of core body temperature.

All probes are individually packaged. The tympanic configuration is non-sterile. The other two configurations are sold sterile. The probes are designed to interface with DeRoyal-branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport, Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands.

This document is a 510(k) Premarket Notification for a medical device: the DeRoyal Temperature Monitoring Probe. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets an algorithm's acceptance criteria through a study with a test set, ground truth, or expert readers.

Therefore, the provided text does not contain the information required to populate the fields related to an AI/ML algorithm's acceptance criteria and study proving performance. The document is a regulatory submission for a physical thermometer probe, detailing its characteristics, intended use, and comparison to predicate devices, along with the physical tests performed (biocompatibility, electrical safety, accuracy, etc.) to ensure its safety and effectiveness.

Here's why the requested information about AI/ML acceptance criteria and studies is not present:

• Device Type: The device in question is a "DeRoyal Temperature Monitoring Probe," which is a physical clinical electronic thermometer. It measures temperature directly using a thermistor. It is not an AI/ML powered device that would process data or images to provide a diagnosis or prediction.
• Regulatory Pathway: A 510(k) submission for a physical device like this primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, often by comparing technical characteristics and showing adherence to relevant performance standards (e.g., ISO for accuracy and safety). This does not involve large-scale data studies with ground truth established by experts or MRMC studies that are typical for AI/ML device clearances.
• "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" generally refer to the performance specifications (e.g., accuracy within a certain range like ±0.2°C, operating conditions) and safety requirements (biocompatibility, electrical safety) that the device must meet, often defined by recognized national or international standards (e.g., ISO 80601-2-56 for medical thermometers). The study that "proves" these are met involves physical testing of the device prototypes or production samples against these standards, not clinical data studies with expert ground truth.

To directly answer your request based on the provided document, the following points can be extracted, while acknowledging that many of your specific questions are not applicable to this type of regulatory submission:

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

   • "Study" Name: Summary of Performance Tests (as described in the document)
   • Device Under Test: DeRoyal Temperature Monitoring Probe (General Purpose, Adult Skin Sensor, Tympanic configurations)

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

   • The document refers to "final, finished products manufactured with the proposed modification" being tested (Page 12), implying physical samples of the device. Specific sample sizes for each test (e.g., how many probes were tested for accuracy or biocompatibility) are not provided in this summary, which is common for a 510(k) summary.
   • Data Provenance: This is not a data study in the sense of patient data. The testing described is laboratory-based performance and safety testing of the manufactured device. There is no information on country of origin for the test data, or if it was retrospective or prospective, as these terms are not applicable to this type of device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This is a physical thermometer, not an AI/ML algorithm that requires expert human interpretation or ground truth labeling from clinical data. The "ground truth" for a thermometer is a calibrated reference thermometer or standard against which its readings are compared, or specific standardized tests for biocompatibility and electrical safety.

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

   • Not applicable. There is no adjudication method described as it's not a clinical data review or AI/ML output review.

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:

   • Not applicable. This is a physical medical device (thermometer probe), not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.

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

   • Not applicable. No algorithm is being submitted for standalone performance evaluation. The device is a direct measurement instrument.

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

   • Not applicable in the AI/ML context. For the accuracy testing, the "ground truth" would be the known, precisely controlled temperatures in a laboratory setting, measured by a validated reference standard. For biocompatibility and electrical safety, the "ground truth" is adherence to the specified limits and test methodologies outlined in the referenced ISO and IEC standards.

8. The sample size for the training set:

   • Not applicable. This device does not have a "training set" as it is not an AI/ML model.

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

   • Not applicable. No training set exists for this device.

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The DeRoyal Foley Catheter with Temperature Sensor is to be used for drainary bladder and simultaneous monitoring of core body temperature.

The Foley Catheter with Temperature Sensor is used for drainage of the urinary bladder and simultaneous monitoring of core body temperature. The device consists of a temperature-sensing wire set secured inside the lumen of a silicone Foley catheter. It is available in 14, 16, and 18 French size catheters. The French size and balloon volume are designated on the device itself. The wire set contains a thermistor chip, which is located near the distal tip of the catheter. The thermistor passively modifies the electrical current traveling through the wire set. A blue connector is located at the proximal end of the device. This connector interfaces with a cable that is connected to an independent temperature monitor used to display temperature readings. The catheters are individually packaged and sold sterile. The subject device is identical to the predicate device with the exception of the encapsulation method of the thermistor chip.

This document describes the regulatory approval for a medical device, specifically a "Foley Catheter with Temperature Sensor." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets strict acceptance criteria through a clinical study in the way an AI/ML device might.

Therefore, many of the typical acceptance criteria and study details requested in your prompt (such as "sample size used for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details") are not applicable to this document. This is because the device is a piece of hardware (a catheter with a temperature sensor), not an AI/ML diagnostic tool.

The document primarily relies on bench testing and biocompatibility testing to prove safety and effectiveness, ensuring the modified device performs similarly to its predicate.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is not:

• Device Type: Hardware Medical Device (Foley Catheter with integrated temperature sensor).
• Purpose: Drainage of the urinary bladder and simultaneous monitoring of core body temperature.
• Regulatory Pathway: 510(k) Premarket Notification – seeking substantial equivalence to a legally marketed predicate device.

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

The document does not provide a quantitative table of acceptance criteria with specific numerical targets and reported performance values for accuracy, sensitivity, or specificity in a clinical context. Instead, it refers to compliance with established medical device standards.

Acceptance Criteria (as implied by the document):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify exact sample sizes for the test set in terms of clinical cases or human subjects. The testing described (biocompatibility, electrical safety, accuracy, time response, leakage current) was performed on "final, finished products manufactured with the proposed modification." This implies a bench test or laboratory setting with a statistically relevant number of manufactured units, rather than a clinical trial with patient data.
• Data Provenance: Not applicable in the context of clinical data. The "data" comes from laboratory and bench testing of the manufactured devices. It is implied to be prospective testing of newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A. This information is not relevant for a hardware device undergoing bench and biocompatibility testing. Ground truth (e.g., true temperature) would be established by calibrated reference instruments in a laboratory setting, not by human experts interpreting data or images.

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

• N/A. No adjudication method is mentioned or relevant, as there is no human interpretation or consensus-building involved in the testing described.

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

• N/A. This is a hardware device, not an AI/ML system. No MRMC comparative effectiveness study was conducted or is applicable.

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

• N/A. This is a hardware device, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's "standalone" performance as a hardware unit is demonstrated through the laboratory testing against standards (e.g., accuracy of the temperature sensor).

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

• For temperature accuracy: The ground truth would be established by a primary, highly accurate, and calibrated temperature standard in a laboratory environment, as per ISO 80601-2-56.
• For electrical safety/leakage: Ground truth is defined by the limits set in the relevant IEC standards.
• For biocompatibility: Ground truth is established by the cellular responses or systemic effects observed in validated biological assays following ISO 10993 standards.

8. The sample size for the training set

• N/A. This device does not use machine learning or AI, so there is no "training set."

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

• N/A. As there is no training set, this question is not applicable.

Summary of Device Performance and Equivalence Claim:

The core of the submission is to demonstrate that the small change in the thermistor chip's encapsulation method does not alter the device's safety or effectiveness compared to the predicate. The document concludes:

"The results of performance testing demonstrate the Foley Catheter with Temperature Sensor is as safe and effective as the predicate. The proposed device is substantially equivalent to the predicate."

This 510(k) summary focuses on engineering validation and compliance with standards rather than clinical study results typically associated with AI/ML device clearances.

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The DeRoyal Esophageal Stethoscope with Temperature Sensor is to be used for routine monitoring of core body temperature, as well as heart and respiratory sounds in an anesthetized patient by inserting the stethoscope tube into the esophagus.

The DeRoyal Esophageal Stethoscope with Temperature Sensor is inserted into the esophagus of anesthetized patients to monitor core body temperature as well as heart and respiratory sounds. The probe consists of a small diameter plastic tube upon which a blue cuff is placed. When inserted in the esophagus, the cuff facilitates transmission of sound to an ear piece attached at the proximal end of the tube. Additionally, a wire set is placed inside the plastic tube. This wire set contains a thermistor chip at the distal end that passively modifies the electrical current traveling through the probe. A blue connector at the proximal end of the wire set interfaces with a cable that is connected to an independent temperature monitor that is used to display the temperature readings.

The probe is sterile and individually packaged. It is available in 9, 12, 18, and 24 French sizes and may come with 400 or 700 series sensors. The stethoscope has a male luer fitting for attachment to standard ear pieces.

The provided text describes a 510(k) submission for a medical device, the "DeRoyal Esophageal Stethoscope with Temperature Sensor". This submission is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Crucially, this document is NOT about proving an AI/ML algorithm's performance. It's about a hardware medical device (a stethoscope with a temperature sensor). Therefore, many of the requested points, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "ground truth for the test set," and "training set," are not applicable to this type of device submission.

The document discusses performance tests for manufacturing quality and safety, not for an AI model's diagnostic accuracy.

However, I can extract the relevant information regarding the device's acceptance criteria and the proofs provided within the scope of this hardware device submission.

Acceptance Criteria and Device Performance (for a Hardware Device)

The device in question is the DeRoyal Esophageal Stethoscope with Temperature Sensor. Its primary functions are:

1. Monitoring core body temperature.
2. Monitoring heart and respiratory sounds.

The submission aims to prove substantial equivalence to a predicate device, the DeBusk Temperature Systems Esophageal Stethoscope (K925789).

Here's a table summarizing the acceptance criteria (as implicitly defined by equivalence to the predicate and relevant standards) and the reported device performance:

Study Details (Relevant to Hardware Device Testing)

Since this is a hardware device and not an AI/ML algorithm, many of the requested categories are not directly applicable. I will address the relevant ones and explicitly state when a category is not applicable for this context.

1. A table of acceptance criteria and the reported device performance: (Provided above)

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

   • Sample Size: The document repeatedly states "All testing was performed on a final, finished device manufactured with the proposed modification." It does not specify a quantitative sample size (e.g., N units). This is typical for engineering verification and validation of medical devices where tests are performed on a representative sample of finished products to ensure design specifications are met.
   • Data Provenance: The testing was performed internally by the manufacturer (DeRoyal Industries, Inc.) or by contracted labs following specified standards (e.g., ISO, IEC). No information about "country of origin of the data" or "retrospective/prospective" studies in the clinical sense is provided as it's not a clinical trial of a diagnostic algorithm.

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

   • Not Applicable. This is a hardware device; "ground truth" in the AI/ML sense (e.g., expert labels on images) is not established. Device performance is measured against established engineering standards (e.g., temperature accuracy to ± 0.2°C, electrical safety limits). The "ground truth" is typically defined by metrological standards and calibrated reference instruments.

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

   • Not Applicable. Adjudication methods are relevant for subjective interpretations (like medical image reading). Hardware device testing involves objective measurements against predefined specifications.

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:

   • Not Applicable. This is a hardware medical device, not an AI/ML diagnostic system. No human reader studies or AI assistance are involved.

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

   • Not Applicable. There is no algorithm. The device's performance is inherently "standalone" in that its physical functions (temperature sensing, sound transmission) are tested directly.

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

   • Ground Truth: For temperature accuracy, the "ground truth" would be established by measurements using a highly accurate, calibrated reference thermometer in a controlled environment (e.g., a water bath at a known temperature). For electrical safety, the "ground truth" refers to compliance with the limits set by standards like IEC 60601-1. For acoustic responsiveness, it would be measured against expected sound transmission properties. This is about physical properties and engineering standards, not medical diagnoses.

8. The sample size for the training set:

   • Not Applicable. There is no AI/ML model, hence no training data or training set.

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

   • Not Applicable. As there is no training set.

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The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.

The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor consists of a probe used to monitor a neonate's skin surface temperature used as an accessory while the patient is on an infant radiant warmer. The probe is a wire set with a thermistor chip at the distal end that passively modifies the electrical current traveling through the device. A colored connector at the proximal end of the wire set interfaces with the warming bed or a cable that interfaces with the bed. The probe is packaged with an adhesive pad used to affix the sensor to the patient's skin surface. The device is non-sterile and individually packaged in a resealable plastic bag.

Based on the provided text, the device in question is the HYDRO-TEMP Neonatal Skin Surface Temperature Sensor.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set in terms of the number of individual devices or patients. It mentions that "All testing was performed on final, finished product manufactured with the proposed modification." However, it does not specify how many units constituted this "final, finished product."

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies performed are primarily technical performance tests.

4. Adjudication Method

This information is not applicable and not provided in the document, as the studies are technical performance tests rather than clinical evaluations requiring expert adjudication.

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

No. An MRMC comparative effectiveness study was not done. The device is a temperature sensor, and the studies performed are related to its technical performance and safety, not diagnostic interpretation by human readers.

6. Standalone Performance Study

Yes, standalone performance studies were done. The document states:

• "Accuracy testing was performed to IEC 60601-2-21 demonstrating the tolerance range of temperature readings with the proposed change."
• "Additionally, a time response test in accordance with ISO 80601-2-56 also was performed."
• "Evaluation and testing according to IEC 60601-1 and IEC 60601-1-2 also was performed to ensure the change to the thermistor encapsulation did not affect the electrical safety of the device."
• "The following biocompatibility tests were performed on the final, finished proposed device in accordance with ISO 10993 and FDA guidance: cytotoxicity, sensitization, and irritation."

These are all standalone tests evaluating the device's technical performance and safety characteristics.

7. Type of Ground Truth Used

The ground truth for the performance tests was based on established engineering standards and specifications:

• Accuracy: Reference to IEC 60601-2-21, implying comparison against a calibrated temperature standard.
• Time Response: Reference to ISO 80601-2-56, implying comparison against a defined response time standard.
• Biocompatibility: Reference to ISO 10993 and FDA guidance, ensuring compliance with established biological safety benchmarks.
• Electrical Safety: Reference to IEC 60601-1 and IEC 60601-1-2, ensuring compliance with established electrical safety standards.

8. Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical sensor, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable and not provided in the document. The device is a physical sensor, not an AI or machine learning algorithm that requires a training set and associated ground truth.

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The DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere the thermistor of the temperature probe to the patient and insulate the thermistor from ambient room temperature ensuring correct temperature readings.

The HYDRO-TEMP® Neonatal Skin Temperature Probe Cover is an accessory to be used with DeRoyal-branded NICU neonatal skin temperature probes used with an infant radiant warmer. They have not been evaluated for use with other manufacturer's products. It is an adhesive pad used to affix a temperature sensor to a neonate's skin to monitor the skin surface temperature. The cover also insulates the temperature sensor from ambient room temperature to ensure temperature readings are accurate.

There are two configurations of the probe cover. Both of these configurations contain a release liner, a patient-contacting hydrogel adhesive, and a metallized polyester backing. One configuration contains an additional foam material that is placed in between the hydrogel adhesive and metallic backing. The device is non-sterile and can be packaged on its own in a foil pouch or in a resealable plastic bag with a temperature probe.

The provided text describes the regulatory filing for the DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Cover (K191425) and its equivalence to a predicate device. The information is focused on mechanical and biocompatibility testing, rather than a clinical study evaluating the device's performance in terms of temperature reading accuracy.

Therefore, many of the requested categories related to clinical study design, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, and training set information, cannot be fully addressed from the provided document.

Here's a summary of the available information structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The proposed device is similar to the predicate but with a modified hydrogel material to improve the adhesive strength, which is supported by performance testing." This implies the acceptance criterion for adhesive strength was to be at least equivalent to, if not better than, the predicate. The data shows it is better.

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

• Sample size: Not specified for any of the individual tests (peel force, pull test, insulation, accuracy, biocompatibility).
• Data provenance: The tests were conducted internally by DeRoyal Industries, Inc. (or contracted labs for biocompatibility) as part of their 510(k) submission. The data is retrospective for the purpose of demonstrating substantial equivalence to a legally marketed predicate device. Country of origin not explicitly stated, but DeRoyal is a U.S.-based company.

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

Not applicable. This was not a clinical study involving human judgment or "ground truth" established by experts in the context of diagnoses or interpretations. The tests were objective mechanical and biological safety assessments.

4. Adjudication method for the test set

Not applicable. This was not a study requiring adjudication of expert opinions.

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

Not applicable. This device is a passive accessory (probe cover) and does not involve AI or human "readers" making interpretations.

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

Not applicable. This device is a physical medical accessory, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests would be the standardized testing methods themselves (e.g., ASTM D903-98 for peel strength, IEC 60601-2-21 for accuracy, ISO 10993 for biocompatibility) and the physical measurements obtained from those tests. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it might be for a diagnostic device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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Abrasions and lacerations, dermal wounds, donor sites, first- and second-degree burns, surgical incisions, vascular access sites, pressure ulcers stages I-IV, stasis ulcers, venous ulcers.

Algidex Ag® silver alginate wound dressings are an antimicrobial barrier for up to three (3) days. The dressings utilize a formulation of ionic silver combined in an alginate and maltodextrin matrix. The silver is intended to prevent microbes from passing through the dressing during use. The dressings are offered in two configurations:

1. a paste;
2. a paste applied to a non-adherent polyurethane foam layers in various sizes and shapes;
   The device is sterilized by gamma irradiation.

The provided document is a 510(k) premarket notification for a medical device (wound dressing) and DOES NOT contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

This document describes a traditional 510(k) for a physical medical device, the "Algidex Ag Silver Alginate Wound Dressing." The submission focuses on demonstrating substantial equivalence to predicate devices (SilverSite and Calgitrol Ag) based on technological characteristics and performance tests related to the physical properties and antimicrobial effectiveness of the wound dressing.

The questions you've asked (about acceptance criteria, sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets) are highly relevant to AI/ML medical device submissions, where algorithms are evaluated for their diagnostic or predictive performance against established ground truth.

Therefore, I cannot extract the requested information from this document because it is not an AI/ML device submission.

The document discusses "performance tests" for the wound dressing, which are entirely different from the performance evaluation of an AI algorithm. For instance, it mentions:

• AATCC 100 test method: This is a standard test for antibacterial activity of fabrics.
• Antimicrobial barrier testing: Evaluating the dressing's ability to prevent microbial passage.
• Absorbency test: Measuring fluid absorption.

These are not related to AI model performance metrics like sensitivity, specificity, AUC, human reader improvement, or ground truth established by expert consensus on imaging data.

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The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection of tissue, organs, and calculi during laparoscopic surgical procedures.

The DeRoyal Laprador Specimen Retrieval System consists of a handle, a cylindrical tube, a string, and a ripstop nylon bag. The system deploys and retracts the nylon bag, which encloses tissue specimens for retrieval during laparoscopic surgical procedures. The device is designed for introduction and use through appropriately sized trocars. The device is sterilized by ethylene oxide.

Here's a breakdown of the acceptance criteria and the study information for the DeRoyal Laprador Specimen Retrieval System, based on the provided text:

Acceptance Criteria and Device Performance

A table of acceptance criteria and reported device performance is not explicitly detailed with quantitative outcomes in the provided document. The document states that "All tests were performed on the DeRoyal Laprador Specimen Retrieval system, the predicate device, and an additional competitor, Applied Medical Specimen Retrieval System (K100959). The proposed device passed all design verification tests and performed comparable to at least one competitor device, thus demonstrating it meets performance specifications and functions safe and effectively."

However, we can infer the types of performance criteria that were assessed:

Note: The document does not provide specific numerical thresholds for "passing" or detailed comparative metrics (e.g., "bag burst resistance was X Newtons, which exceeded the predicate's Y Newtons"). It only states that the device "passed all design verification tests" and "performed comparable to at least one competitor device."

Study Information

Due to the nature of this document (a 510(k) summary for a specimen retrieval system), the type of study described is a bench testing study for device performance and comparison. It is not a clinical study involving human subjects or AI algorithms. As such, many of the requested fields are not applicable in this context.

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

   • Sample Size: Not explicitly stated how many units of each device (DeRoyal, Anchor, Applied Medical) were tested for each criterion. The document refers to "bench testing" without detailing the number of units.
   • Data Provenance: The testing was conducted internally or by a contracted lab for DeRoyal Industries, Inc. This is a prospective test in the sense that the new device was built and then tested, but not a prospective clinical trial. The country of origin of the testing itself is not explicitly stated but can be inferred to be associated with DeRoyal's operations (USA or Dominican Republic based on company locations listed).

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

   • Not applicable. This was a bench test of physical device performance, not a diagnostic or interpretive task requiring expert medical opinion to establish ground truth.

3. Adjudication method for the test set:

   • Not applicable. This was a direct measurement/performance test, not a subjective assessment requiring adjudication.

4. 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:

   • Not applicable. This is a physical medical device; there is no AI component or human reader interpretation involved in its direct function.

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

   • Not applicable. This is a physical medical device without an algorithm component.

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

   • The "ground truth" for this study was the pre-defined performance specifications for each characteristic (e.g., a specific pressure leak rate limit, a minimum puncture resistance). The device either met these objective physical parameters or it did not.

7. The sample size for the training set:

   • Not applicable. There is no AI model or training set involved.

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

   • Not applicable.

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DeRoyal Angiography Kits are intended for use by licensed physicians. The intended use of individual medical products assembled in these kits will not be changed from the manufacturer's original intended use. These kits are assembled of devices used during cardiac catheterization laboratory procedures such as cardiac catheterization, angiography, arteriogram, etc.

DeRoyal Angiography Kits (sometimes referred to as Challenge Kit or Standard Heart and Vascular Kit in this submission) are kits assembled of legally marketed medical devices- either exempt, marketed according to a 510(k), or pre-amendment devices-intended for prescription use during procedures occurring in the cardiac catheterization laboratory. The kits are assembled using DeRoyal and other manufacturer's medical devices. DeRoyal purchases the medical device components assembled in these kits bulk, non-sterile. DeRoyal assembles the kits, packages, and sterilizes the kits.

The DeRoyal Angiography Kit components intended use are unchanged from that of the original manufacturers intended use. These kits are assembled according to customer specifications who specify the contents, quantity of devices and placement of the devices in the kit. DeRoyal customers may request that certain components be bonded prior to placement in the kit for convenience purposes in reducing set up time prior to a procedure. The devices used in the DeRoyal Angiography Kits are standard items used in catheterization laboratory procedures. These kits are assembled in a controlled manufacturing environment and are sterilized by Ethylene Oxide.

The provided text describes a 510(k) submission for DeRoyal Angiography Kits and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic device. As such, the typical structure for AI/diagnostic device studies (sample size, expert ground truth, MRMC, etc.) does not directly apply.

However, I can extract the relevant information regarding the testing performed to demonstrate the device meets its stated safety and effectiveness for a 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a medical kit (an assembly of existing devices), the "acceptance criteria" are primarily related to the manufacturing, sterilization, and material safety of the kit as a whole, focusing on demonstrating these aspects are equivalent to predicate devices and do not raise new safety or effectiveness concerns.

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

• Sample Size: The document mentions "The validation was conducted on the DeRoyal Angiography Kit 77-400980". This implies at least one specific kit configuration was tested for bench testing (visual, pull, air leak). Specific numbers of individual samples (e.g., how many bonds were pulled, how many kits were tested for air leaks) are not specified in this summary.
• Data Provenance: This is internal company bench testing. No country of origin for external data is mentioned, as it's not a clinical study involving patients. It is retrospective in the sense that it's performed on manufactured kits to validate the manufacturing process.

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

Not applicable. This is not a study requiring expert ground truth in the context of diagnostic accuracy. The "ground truth" for manufacturing and material safety is established by compliance with recognized standards (ISO, ASTM) and successful completion of bench tests.

4. Adjudication method for the test set

Not applicable for this type of submission. Bench tests typically involve direct measurement against a predefined specification.

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. This type of study is relevant for diagnostic devices involving human interpretation of clinical data, which is not the nature of an angiography kit 510(k) submission.

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

No, a standalone performance study (algorithm only) was not done. This is not an AI or algorithm-based device. The "device" is a physical medical kit.

7. The type of ground truth used

The "ground truth" for this submission revolves around:

• Compliance with recognized standards: ISO 10993 series and ASTM F756 for biocompatibility.
• Successful completion of bench tests: Visual inspection, pull tests for bonded components, and air leak tests. These tests would have internal specifications representing acceptable manufacturing quality and safety.
• Substantial equivalence: The primary ground truth is demonstrating that the kit's characteristics (intended use, contents, assembly, sterilization, etc.) are fundamentally the same as legally marketed predicate devices and thus do not raise new questions of safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

Not applicable, for the same reason as above.

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Intervertebral Body Fusion Device: The DeRoyal Spine Spacers are intended for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment. The device is indicated for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine.

Vertebral Body Replacement Device: The DeRoyal Spine Spacer System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine from T1 to L5. The devices are intended for use with supplemental fixation and with autograft or allograft bone. The Spine Spacer System is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The DeRoyal Spine Spacer System consists of PEEK cages having the basic shape of a structural column. The top and bottom surfaces feature teeth to engage the bony endplates. The implants include a large vertical cavity which is packed with bone graft material to promote fusion of the adjacent vertebral bodies. The implants are offered in a variety of heights, widths, lengths and lordotic angles to accommodate varying patient anatomy.

The DeRoyal Spine Spacer System is a medical device and its performance is evaluated through mechanical testing rather than a study involving human subjects or AI algorithms. As such, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth types) are not applicable.

Here's an analysis of the provided text based on the nature of the device and its evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. For mechanical testing, devices are typically tested in batches to ensure consistency and statistical significance, but a specific number is not provided in this summary. It mentions "worst case Spine Spacer," implying representative samples.
• Data Provenance: The mechanical testing was conducted by DeRoyal Industries, Inc. (the manufacturer) and presumably in a controlled laboratory environment. This is prospective testing of manufactured devices.
• Country of Origin of the Data: United States (based on the sponsor's location and FDA submission).

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

• Not Applicable. For mechanical testing of a medical implant, the "ground truth" is defined by established engineering standards (ASTM F2077, ASTM F2267, ASTM Draft Standard). There are no human experts "establishing ground truth" in the way one would for diagnostic imaging. The experts involved would be engineers and quality control personnel performing and interpreting the tests according to the standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints. Mechanical testing relies on objective measurements against predefined criteria and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This is a mechanical device, not a diagnostic or AI-driven system that would involve human readers interpreting cases.

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

• Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of AI does not apply.

7. The Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance. The "ground truth" for the DeRoyal Spine Spacer System's mechanical performance is defined by the requirements outlined in the specified ASTM standards (ASTM F2077, ASTM F2267, ASTM Draft Standard) and the performance characteristics of the legally marketed predicate devices that the DeRoyal system aims to be substantially equivalent to.

8. The Sample Size for the Training Set

• Not Applicable. This device uses mechanical testing for performance evaluation, not machine learning, so there is no "training set."

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

• Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

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