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SmartBag is intended for use inside and out of hospitals for any patient with a diversionary urinary or fecal stoma. It works in conjunction with 11 Health's care management platform known as Alfred. The SmartBag system uses integrated sensors to continuously monitor bag filling and drainage, providing cumulative output data to the patient and clinical team. The system also monitors skin condition, the occurrence of leaks and visual condition of the stoma.

SmartBag's intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11 Health's care management platform known as Alfred, designed for patients and medical professionals. The SmartBag system (including the wafer and Hub), offers a continuous ostomy monitoring system, tracks the estimated volumetric filling of the bag and visual condition of the stoma using integrated sensor technology.

The SmartBag Sytem is for adult use only. (22 years and above)

The SmartBag with integrated thermistors and capacitive sensors can be used in place of a traditional ostomy bag. It notifies patients or medical professionals of any potential leaks around the peristomal skin as well as giving an estimate of the output volume within the bag.

Alfred software is a companion software suite for SmartBag. It consists of Alfred mobile app and Alfred hospital app. Alfred mobile app is a companion application for mobile phone. The application provides SmartBag user easy access to bag status, hydration tracking and restroom search functionalities. The SmartBag could operate without Alfred mobile app.

The sensors in the bag and the wafer will be able to transmit data to the hub via NFC protocol communication. The data from the hub will be transmitted to the cloud via LTE-M data transfer via secure MQTT protocol and then this data can be downloaded to web supported devices – such as an iPhone.

The provided text is a 510(k) summary for the SmartBag (SmartPouch) device. While it describes the device's indications for use, comparison to predicate devices, and non-clinical performance data, it does not contain a table of acceptance criteria or a detailed study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity against a defined ground truth on a test set.

The document primarily focuses on demonstrating the functionality and usability of the device's volumetric and leakage detection features through a series of bench experiments and simulations. It concludes that the SmartBag prototype is "proven to be functional for volumetric measurement and leakage detection from our simulated bench tests."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone performance. The document does not describe a clinical study with these elements.

However, I can extract information about the types of non-clinical tests performed, which could be considered a form of "acceptance criteria demonstration" for basic functionality:

Non-Clinical Performance Data (Functionality Testing):

Here's why the other requested information cannot be provided from this document:

• Sample size for the test set and data provenance: The document details "in-house non-clinical bench experiments" and "simulated" tests, some on "human volunteers." It doesn't specify a rigorous, statistically powered "test set" in the context of typical AI/medical device clinical studies (where cases are adjudicated against a ground truth). It refers to test reports like "028_Testing Report 3_SmartBag Prototype Water and Apple Infusion Simulation Test," suggesting a focus on engineering verification rather than clinical validation. The provenance is "in-house."
• Number of experts and qualifications, adjudication method: Not applicable as the testing described is primarily engineering bench testing and simulation, not expert-adjudicated clinical data.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The device's primary function is continuous monitoring and data collection, not an AI assisting human readers with interpreting medical images or data for diagnostic purposes in a comparative setting.
• Standalone (algorithm only) performance: While the device collects data autonomously, the "performance" described is functional operation in simulated environments rather than a quantifiable diagnostic or predictive accuracy.
• Type of ground truth used: The "ground truth" for these tests appears to be the known conditions of the simulations (e.g., specific volumes of fluid infused, presence/absence of simulated leaks, known temperatures, known viscosities). It's not a clinical ground truth like pathology or patient outcomes.
• Sample size for the training set and how ground truth for training was established: The document does not describe a machine learning model that was "trained" in the typical sense with a separate dataset. The "sensors" and "algorithms" (implicitly) seem to be based on physical principles and engineering design, not data-driven machine learning from a large training dataset.

In summary, this 510(k) summary focuses on demonstrating the engineering functionality and safety of the SmartBag device through non-clinical bench tests and simulations, rather than providing clinical performance data from a statistically designed study involving ground truth established by experts.

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The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient.

The OSTOM-i™ Alert is indicated for all patient populations.

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the hospital environment.

The OSTOM-i™ Alert is indicated for all patient populations.

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn the health care provider when their patients' bags are close to being full, or to the patient in the post-hospital setting.

The flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag. This information is relayed to the tablet generating an additional report on bag status versus the visual one now available.

The provided document describes the Ostom-i™ Alert, an accessory for ostomy bags. The device monitors the filling of the bag and sends an alert via Bluetooth to a tablet computer when the bag is close to being full. The document focuses on demonstrating the device's substantial equivalence to a predicate device (Hollister, Inc.'s Two Piece Ostomy System, K813269) rather than presenting a traditional clinical study with acceptance criteria and statistical performance metrics for diagnostic accuracy.

Here's an attempt to extract and synthesize the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide specific diagnostic accuracy metrics (like sensitivity, specificity, accuracy) for the Ostom-i™ Alert. Instead, it focuses on qualitative performance and safety aspects as part of demonstrating substantial equivalence. The "performance" reported is primarily about its function and usability, not diagnostic accuracy against a ground truth.

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

The document does not specify a numerical sample size for the "test set" in the traditional sense of a diagnostic performance study.

• For the "Usability and Label Comprehension Study by Intended User," it mentions "nurses who would use this in a hospital setting" but does not give a number of participants.
• For "Patient Usability Testing," it refers to "Patients" but does not specify how many patients or simulations were involved.

The data provenance is not explicitly stated in terms of country of origin, nor is it clearly categorized as retrospective or prospective for a clinical study. The usability and performance testing described appear to be prospective tests conducted as part of the device development and submission process.

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

This information is not provided. Since the device's function is to alert based on physical fill rather than interpret complex imagery or physiological signals, the "ground truth" for the fill level would likely be objective (e.g., measured volume, physical observation of a full bag). The "experts" involved were primarily "nurses" for the usability study, but their role was to evaluate usability, not to establish ground truth for a diagnostic task.

4. Adjudication Method

No adjudication method is mentioned for establishing ground truth, as the studies described are not focused on diagnostic accuracy requiring expert consensus.

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

No MRMC study is mentioned. The document does not describe a study comparing human readers (with vs. without AI assistance) or quantifying an effect size of improvement. The device acts as a direct monitor and alert system, not an AI to assist human interpretation.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted, though it's not a "standalone algorithm performance" in the typical sense of a diagnostic AI. The "Performance Testing" section describes various tests (patient usability, environmental robustness, biocompatibility, EMC, wireless coexistence) that evaluate the device's function and safety independently. The device's core function is to detect and report bag fullness, which was tested by simulating an alert condition.

7. Type of Ground Truth Used

The ground truth implicitly used for the device's primary function (alerting when the bag is full) is physical observation/simulation of a full bag. This is supported by:

• "An alert was simulated by curving the bag to the filling of the bag thereby creating the alarm condition."
• The "flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag."

For usability studies, the ground truth is subjective user feedback and observation of task completion.

8. Sample Size for the Training Set

This information is not applicable or provided. The Ostom-i™ Alert appears to be a sensor-based device that directly measures and converts physical changes (flex/curvature) to volume, rather than an "algorithm" in the machine learning sense that requires a training set of data.

9. How Ground Truth for the Training Set Was Established

This information is not applicable or provided, as there is no mention of a training set for a machine learning algorithm.

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The VITALA™ Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released.

To be used only with a 1 ¾ in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin barrier.

The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts a stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam insert that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. The Air Seal will re-inflate to remain in contact with the stoma retracts or moves away from the Air Seal.

The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ¾" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters.

This 510(k) notification concerns a design modification for the Vitala™ Continence Control Device to allow its use with ConvaTec Moldable Technology™ skin barriers.

The information provided describes a 510(k) premarket notification for a design modification of the VITALA™ Continence Control Device, primarily focusing on its compatibility with ConvaTec Moldable Technology™ skin barriers. The document outlines a clinical study and some bench testing.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, pre-defined manner typical of clinical trial endpoints. Instead, it describes outcomes and draws conclusions based on those outcomes. We can infer performance against safety and effectiveness observations.

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

• Sample Size (Clinical Study):
  • Enrolled: 28 subjects.
  • Completed: 24 subjects (85.7%).
  • Wore device: 27 subjects (total who wore the Vitala™ device).
• Data Provenance: USA (multi-center clinical study). The study was initiated on September 17, 2010, and completed on November 11, 2010, making it a prospective study for the purpose of this notification.

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

The document does not specify the number of experts for ground truth or their qualifications. The study was "non-randomized, open-label," and included "investigator" determination for subject needs. Safety and effectiveness were assessed via AE reporting and "objective and subjective measurements," but the specific roles and qualifications of those evaluating these measures (e.g., clinicians, nurses, specialists) are not detailed as explicitly "expert" ground truth adjudicators in the medical imaging sense.

4. Adjudication method for the test set

The document does not describe an adjudication method in the context of multiple readers/experts reaching consensus on a particular finding, which is typically found in imaging studies. The assessment of safety and effectiveness appears to be primarily based on reported adverse events, subject feedback, and clinical observations (e.g., stoma vascularity results).

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

There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a physical medical device, not an AI/software-as-a-medical-device (SaMD).

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

This question is not applicable as the device is a physical medical device, not an algorithm. However, its "standalone" performance as a device was evaluated in the clinical study, with human users ("human-in-the-loop" in the sense of operating it), but without a pre-existing "without AI assistance" baseline for improvement.

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

The ground truth for the clinical study was established through a combination of:

• Clinical observation and assessment: By investigators for adverse events and stoma health (e.g., stoma vascularity, SO2).
• Subjective feedback/Patient-reported outcomes: Subject responses regarding continence restoration, ease of use, preference, odor prevention, and stoma noise prevention.
• Objective measurements: While not explicitly detailed, "objective measurements" were mentioned for continence during 12-hour wear, presumably including direct observation or measurement of leakage.

8. The sample size for the training set

The document describes a clinical study and bench tests for this specific 510(k) submission. It does not mention a training set in the context of machine learning. The clinical study described in detail here is effectively the "test set" for validating the modified device.

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

Not applicable, as there is no mention of a training set for an AI model.

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The VITALA™ Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released.

To be used only with a 1 ¾ in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin barrier. Not intended for use with ConvaTec Moldable Technology™ skin barriers.

The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts a stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam insert that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. The Air Seal will re-inflate to remain in contact with the stoma if the stoma retracts or moves away from the Air Seal.

The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ½" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters.

The Vitala™ Continence Control Device is indicated for individuals with end colostomies. The device is not intended for use until the abdomen and peristomal area have fully healed from bowel surgery (typically 6-12 weeks post surgery), or for use with a stoma protrusion greater than 2 cm (when lying down). The device should also not be used in individuals with end colostomies with a history of chronic liquid stool. ConvaTec Moldable Technology™ skin barriers should not be used with the Vitala™ device.

This 510(k) notification concerns modification of the labeling for the Vitala™ Continence Control Device to allow an expanded wear time of up to 12 hours per day for the device as well as expanded compatibility with ConvaTec Natura® convex products. Otherwise, the design, materials, and manufacture of the device remain unchanged from its description in 510(k) Premarket Notification K083785, except that its deflation shield is now made from polypropylene.

The provided document describes two clinical studies conducted to demonstrate the safety and effectiveness of the Vitala™ Continence Control Device for an extended wear time of up to 12 hours per day and its compatibility with ConvaTec Natura® convex products.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on safety and effectiveness, rather than specific acceptance criteria thresholds. However, we can infer the primary objectives of the studies served as the de facto acceptance criteria.

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

• Study #1:
  • Sample Size: 78 subjects enrolled; 66 subjects wore the Vitala™ device.
  • Data Provenance: Multi-national (USA and Europe), Prospective, Open-label.
• Study #2:
  • Sample Size: 27 subjects enrolled.
  • Data Provenance: USA, Prospective, Open-label.

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

The document does not mention the involvement of "experts" in establishing a ground truth in the traditional sense (e.g., for image analysis). The studies are clinical trials where patient outcomes, adverse events, microbiology, and vascularity measurements directly constitute the data. Clinical investigators would interpret these findings. No specific number or qualifications of "experts" are provided to establish a separate "ground truth" for the test set beyond the clinical evaluation itself.

4. Adjudication Method for the Test Set:

The document does not describe a formal "adjudication method" in the context of resolving discrepancies in expert interpretations, as would be common in diagnostic studies. The clinical studies collected safety and effectiveness data directly from subjects and medical assessments. Adverse events would likely be classified and reviewed by study investigators and reported, but no specific adjudication process (like 2+1 or 3+1) is detailed.

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:

This device is a physical medical device (continence control device), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable and was not performed.

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

This device is a physical medical device and does not involve an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The Type of Ground Truth Used:

The "ground truth" for these studies is based on:

• Self-reported patient outcomes: Continence perception, adverse events.
• Clinical assessments: Severity of adverse events, stoma and skin condition.
• Objective measurements: Microbiology results, stoma vascularity (oxygen saturation).

Essentially, a combination of patient-reported outcomes and clinical/physiological data served as the basis for evaluating safety and effectiveness.

8. The Sample Size for the Training Set:

This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set." Therefore, no training set was used.

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

Not applicable, as there was no training set.

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To prevent the release of stool from an end colostomy while allowing any gas that is present at the stoma to be deodorized and released. To be used only with a 1 ¼" (45 mm) or 2 1/2' (57 mm) ConvaTec Natura® skin barrier. Not intended for use with ConvaTec Moldable Technology™ skin barriers or convex products.

The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts the stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam inserts that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. This Air Seal will re-inflate to remain in contact with the stoma if the stoma retracts or moves away from the Air Seal. The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ¼" (45mm) or 2 ¼" (57mm) ConvaTec SUR-FIT Natura® skin barrier, and will accommodate a range of stoma diameters. The device is designed to be worn up to eight hours per day.

This document describes the safety and efficacy studies for the Vitala™ Continence Control Device, but it does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., "device must achieve X% reduction in leakage"). Instead, it concludes overall safety and efficacy based on a series of clinical trials.

Therefore, the table below will summarize the reported device performance and the overall conclusions that imply the device met the implicit acceptance of being safe and effective.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria are not provided. The acceptance hinges on the overall conclusion of safety and efficacy from the clinical trials.

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

The primary "test set" data for the final evaluation appears to come from Study #7.

• Sample Size: 25 subjects.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies were conducted by ConvaTec, an international company, but the specific location of the trials is not provided within this summary for Study #7. The context of the FDA submission implies US relevance.
• Retrospective/Prospective: These were Phase II and Phase III clinical trials, which are inherently prospective studies.

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

The document does not detail the use of "experts" in the sense of independent assessors establishing a ground truth for the clinical trial results. Clinical trials (like Study #7) generate their own data (e.g., adverse events, device performance observations, objective measurements like oxygen saturation) directly from subject use and follow-up. The "ground truth" essentially comes from the clinical observations and measurements made by the study investigators and reported by the subjects themselves.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the clinical trial data. Safety events were reported and assessed for relatedness to the device, but the specific process for resolving discrepancies or reaching consensus on these events is not detailed.

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 typically involves multiple human readers interpreting medical images or data, with and without AI assistance, to measure diagnostic performance. The Vitala™ device is a medical device for ostomy management, not an imaging or diagnostic AI system. The clinical trials focused on direct device performance, safety, and efficacy in patients.

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

The concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here. The Vitala™ Continence Control Device is a physical medical device used by patients, not an algorithm. Its performance is intrinsically linked to its interaction with the human body and user application.

7. The Type of Ground Truth Used

For the clinical trials (specifically Study #7 which evaluated the final design):

• Clinical Observations: Direct measurements of safety (e.g., adverse events, stoma condition, microbiology studies, vascularity testing) and efficacy (ability to control stool, allow flatus, wear time).
• Subject Reporting: Patients reported their experiences with the device, including adverse events and comfort/ease of use.
• Objective Measurements: Microbiology studies (detection of toxins, microbial flora), vascularity testing (mean oxygen saturation (SO2) values of the stoma).

So, the ground truth is a combination of expert clinical assessment, objective physiological measurements, and patient-reported outcomes.

8. The Sample Size for the Training Set

The document describes seven clinical trials conducted for "evolving concepts" and "various designs" of the Vitala™ device prior to the final product design being tested in Study #7. These earlier studies (Study #1 to #6) can be considered analogous to "training data" in the sense that their results informed and refined the device design.

• Total Sample Size (across all preceding studies): Not explicitly stated as a single number. The document mentions "six Phase II or Phase III clinical trials" prior to the final design determination (referring to Studies #1-6). The sample size for each individual study #1-6 is not provided in this summary.

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

For the "training set" (data from Studies #1-6 that informed design iterations):

The ground truth was established through similar methodologies as the final study:

• Clinical Observations: Early prototypes were evaluated for performance (e.g., leakage rates in Study #4), safety (e.g., GI and stoma adverse events in Study #6), and interaction with skin barriers.
• Subject Reporting: Patient feedback informed changes, for example, the elimination of the absorptive foam ring after Study #2, and issues with application force for the 45mm device after Study #6.
• Engineering/Design Testing: Issues like "high leakage rates due to partial or complete disconnection of the device from the wafer (skin barrier)" in Study #4 led to design improvements in the coupling system.
• Specific Tests: Microbiology studies and vascularity testing were conducted on the most recent prototype design (presumably incorporated into later 'training' studies or the final Study #7).

Essentially, each study provided feedback (ground truth) on the performance, safety, and usability of that particular design iteration, which then guided subsequent design changes.

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Smith & Nephew's "No Sting Skin Prep™" is intended for use as a liquid film - forming product that when applied to intact skin, forms a film for skin attachment sites for drainage tubes, external catheters, surrounding ostomy sites and adhesive dressings.

a) "No Sting Skin Prep™" applies a coating that prepares the skin for adhesives and provides a protective interface that may reduce friction during the removal of tap:. "No Sting Skin Prep™" is indicated for skin attachment sites for draining tubes, external cather.ers, surrounding ostomy sites and other adhesive dressings.
b) "No Sting Skin Prep™" can be used in sensitive stoma areas as a skin protectant and may reduce irritation from contact with body wastes and stoma fluid.
c) "No Sting Skin Prep™" forms a protective film on skin that serves a: a skin protectant which may reduce exposure to urine and feces.

No-Sting Skin Prep™ is a water based alcohol free liquid impregnated on to a nonwoven wipe or tufted swab applicators.

This product is sold OTC for use by ostomates and other individuals who wish to reduce trauma to skin upon removing adhesive devices/products. The product is applied to the skin and allowed to dry. The solvent base evaporates leaving a polymeric film on the skin. After drying, the adhesive device, dressing, Ostomy device, tape, etc., is attached.

This document describes the 510(k) submission for Smith & Nephew's "No-Sting Skin Prep" product. The acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics beyond general safety and biocompatibility.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit, quantitative acceptance criteria in the typical sense (e.g., minimum sensitivity/specificity). Instead, the studies aim to demonstrate that the device is biocompatible and not a dermal irritant or sensitizer, which are key safety aspects for a medical device that contacts skin. The "performance" is therefore reported in terms of passing these safety tests.

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

• Cytotoxicity: Not specified, but involved cell cultures. This is an in vitro study.
• Contact Sensitization: "the guinea pig" – implies a conventional number of guinea pigs for such a study, but not explicitly stated. This is an in vivo animal study.
• Animal Primary Irritation: "the rabbits" – implies a conventional number of rabbits for such a study, but not explicitly stated. This is an in vivo animal study.
• Preservation: Not specified, but involved inoculation of the product. This is an in vitro study.

Data Provenance: The studies are animal and in vitro laboratory tests conducted to evaluate safety and biocompatibility rather than clinical performance on human subjects for diagnostic accuracy. The original location of these tests (country) is not specified but would typically be in a certified lab. The studies are prospective in design for evaluating specific characteristics of the device.

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

This type of information is not applicable to the provided document. The studies conducted are laboratory-based biocompatibility, irritation, and preservation tests. "Ground truth" in the context of expert consensus or pathological diagnosis is typically relevant for interpretative diagnostic devices or those involving subjective clinical assessment. For these safety tests, the "ground truth" is determined by standardized laboratory protocols and objective measurements/observations (e.g., cell lysis, irritation scores).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers/experts in diagnostic studies to establish a "ground truth" or reference standard. The studies described here (biocompatibility, irritation, preservation) involve objective laboratory assessments and observations, not subjective human reader interpretation requiring adjudication.

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 evaluating the impact of a new diagnostic algorithm or tool on human reader performance for tasks like diagnosis or detection. The "No-Sting Skin Prep" is a skin preparation product, not a diagnostic device.

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

Not Applicable. The device is a physical product (skin prep solution), not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The described studies assess the product's inherent properties (biocompatibility, safety, preservation).

7. The Type of Ground Truth Used

• Cytotoxicity: Objective assessment of cell lysis/toxicity based on standardized in vitro biological assays (e.g., macroscopic and microscopic examination of cell cultures).
• Contact Sensitization: Objective assessment of dermal reactions in guinea pigs based on standardized in vivo animal assays.
• Animal Primary Irritation: Objective assessment of skin irritation in rabbits based on standardized in vivo animal assays with calculated Primary Irritation Index.
• Preservation: Objective assessment of microbial growth based on standardized USP 23 protocols.
• Functional Equivalence: Comparison of product composition and intended mechanism of action to legally marketed predicate devices, with the ground truth being the established characteristics and regulatory standing of those predicates.

8. The Sample Size for the Training Set

Not Applicable. The described studies are not machine learning or AI-based. Therefore, there is no "training set" in the context of data for model development. The product development would involve formulations and material science, not data training.

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

Not Applicable. As there is no training set (as described in point 8), there is no ground truth established for it.

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