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The Air Pressure Therapy System is intended to temporarily relieve minor muscleaches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Air Pressure Therapy System."

This document does not contain any information about:

• Acceptance criteria
• Device performance results
• Details of a study (e.g., sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations. It also includes the "Indications for Use" statement for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The Air Pressure Therapy System is intended to temporarily relieve minor muscleaches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Not Found

The provided document is an FDA 510(k) clearance letter for the "Air Pressure Therapy System (VU-IPC04B)". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on regulatory compliance, outlining general controls, additional controls for Class II devices, and various regulations such as the Quality System regulation, UDI Rule, and adverse event reporting.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This information would typically be found in the 510(k) submission itself or in a separate study report, which is not part of this FDA clearance letter.

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Air Pressure Therapy System (Model:VU-IPC4M) is intended for home to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Air Pressure Therapy System (Model:VU-IPC4M) consists of air pressure sensor, air pump, sleeves Etc. working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.

The provided document is an FDA 510(k) clearance letter for the Xiamen Weiyou Intelligent Technology Co., Ltd. Air Pressure Therapy System (Model: VU-IPC4M). This letter declares the device substantially equivalent to legally marketed predicate devices.

Crucially, this document is a regulatory clearance and not a detailed study report or clinical trial result. It does not contain information about the specific acceptance criteria for an AI/ML device's performance, nor does it present the results of a study designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.

The "Performance Testing - Clinical" and "Performance Testing - Animal" sections explicitly state "Not Applicable," indicating that the manufacturer did not submit clinical or animal study data to support this 510(k) submission. Therefore, it is impossible to extract the requested information (acceptance criteria, device performance, sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance) for an AI/ML component from this document.

The document focuses on non-clinical performance testing related to the physical device itself and its electrical safety, biocompatibility, and mechanical integrity, as summarized under "Performance Characteristic."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design elements (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth) as they are directly linked to performance evaluation against clinical or diagnostic endpoints, which are not detailed in this regulatory submission.

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The extriCARE® 3000 Negative Pressure Wound Therapy System is intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. It is indicated for the following wound types:

• chronic
• · acute
• · traumatic
• subacute and dehisced wounds
• · partial-thickness burns
• · ulcers (such as diabetic or pressure)
• · flaps and grafts.

The extriCARE® 3000 Negative Pressure Wound Therapy System is intended for use in healthcare facilities.

The extriCARE 3000 Negative Pressure Wound Therapy (NPWT) pump is a portable, rechargeable, battery-powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. The extriCARE 3000 Negative Pressure Wound Therapy (NPWT) is packaged and provided with the following components:

• 1. extriCARE 3000 Negative Pressure Wound Therapy Pump
• 2. extriCARE 3000 100cc Collection Canister

The extriCARE® 3000 Negative Pressure Wound Therapy (NPWT) pump accessories that are included in this 510(k) application and will be commercialized separately are the following:

• 1. extriCARE® 3000 100cc Collection Canister (additional canister replacements)
• 2. extriCARE® 3000 400cc Collection Canister

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a quantitative format for specific clinical outcomes. Instead, it describes various non-clinical tests conducted and states that the device "met all test requirements" or "acceptance criteria established."

Here's a summary of the non-clinical tests and their reported outcomes:

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

The document primarily describes non-clinical bench testing. It does not refer to a "test set" in the context of patient data or clinical trials. Therefore, no sample size for a patient test set or data provenance (country of origin, retrospective/prospective) is provided. The "test sets" referred to are related to the individual non-clinical tests (e.g., electrical safety, EMC).

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

Given that the document focuses on non-clinical testing and does not detail a clinical "test set" with patient data requiring ground truth establishment, this information is not applicable and therefore not provided.

4. Adjudication Method for the Test Set

As no clinical "test set" or ground truth establishment by experts is described, adjudication methods are not applicable and not provided.

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

No, an MRMC comparative effectiveness study is not mentioned or described in the provided document. The submission is for a Negative Pressure Wound Therapy (NPWT) system, which is a medical device, not typically an AI-powered diagnostic tool that would undergo MRMC studies for human reader improvement.

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

No, a standalone algorithm performance study is not applicable as the device is a physical medical device (NPWT pump) and not an algorithm or AI system for diagnostic interpretation.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by adherence to recognized engineering standards (e.g., IEC standards for electrical safety and EMC) and pre-defined performance specifications set by the manufacturer for the device's functionality. This is not "expert consensus, pathology, or outcomes data" in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical NPWT system, not an AI model that would require a "training set" of data.

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

This information is not applicable and not provided for the same reasons as point 8.

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Air Pressure Therapy System VU-IPC04B is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 6 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process. Cycle time and pressure can be adjusted by purpose to avoid any discomfort.

Air Pressure Therapy System intermittent pneumatic compression could be used in family for improving blood circulation in the treated area, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.

This document is a 510(k) premarket notification for a medical device called "Air Pressure Therapy System: VU-IPC04B". The FDA has determined the device is substantially equivalent to a legally marketed predicate device, "NormaTec Pulse and NormaTec Pulse Pro (K160608)".

Based on the provided text, the device in question is a Powered Inflatable Tube Massager (Product Code IRP), which falls under Class II medical devices.

Here's an analysis of the acceptance criteria and study proving the device meets them, according to the document:

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

The document directly states: "Performance testing - clinical: Not Applicable." and "Performance testing - animal: Not Applicable." This indicates that for this specific type of device and its indications for use, no clinical or animal performance studies were required by the FDA or provided by the manufacturer to demonstrate meeting acceptance criteria for its therapeutic claims (temporary relief of muscle aches/pains, increased circulation).

Instead, the substantial equivalence hinges on:

• Indications for Use: The subject device's indications for use are identical to the predicate device.
• Technological Characteristics: The core technology (compressor and valve system for sequential inflation) is the same.
• Non-clinical Performance Data: This is where the "acceptance criteria" lie in this context, focusing on safety and technical specifications rather than direct clinical efficacy.

Here's a table summarizing the relevant "performance characteristics" and acceptance based on this document:

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

• Sample Size: Not applicable. No clinical or animal test set data was used for performance validation as per the document. The substantial equivalence is based on comparison to a predicate device and engineering/bench testing against recognized standards.
• Data Provenance: Not applicable.

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

• Not applicable. No expert-adjudicated test set was used for performance assessment in this 510(k).

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

• Not applicable.

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 an Air Pressure Therapy System, not an AI-powered diagnostic or assistive technology for human readers.

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

• Not applicable. The device is not an algorithm; it's a physical medical device.

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

• The "ground truth" for this 510(k) relies on the established safety and effectiveness of the legally marketed predicate device (NormaTec Pulse and NormaTec Pulse Pro), combined with compliance to recognized international and national electrical, safety, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993 series) through non-clinical (bench) testing. There is no "ground truth" derived from patient outcomes or expert consensus for this specific device's clinical performance, as clinical studies were deemed unnecessary for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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Air Pressure Therapy System VU-IPC06 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 8 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process. Cycle time and pressure can be adjusted by purpose to avoid any discomfort.

Air Pressure Therapy System intermittent pneumatic compression could be used in family for improving blood circulation in treated areas, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.

The provided text is a 510(k) summary for the "Air Pressure Therapy System: VU-IPC06". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a clinical study proving its own independent performance against acceptance criteria.

The submission explicitly states:

• "Performance Testing - Clinical: NOT Applicable." (Page 4)
• "Performance Testing - Animal: NOT Applicable." (Page 4)

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Instead, it relies on a comparison to a predicate device (NormaTec Pulse and NormaTec Pulse Pro, K160608) to establish substantial equivalence.

The table below summarizes what could be considered acceptance criteria based on standard compliance and a comparison of the subject device's performance to its predicate. However, it's crucial to understand these are not acceptance criteria from an independent performance study of the subject device but rather a demonstration of similarity to a cleared device.

Summary of Device Comparison (No Independent Performance Study Provided)

1. Table of Acceptance Criteria and Reported Device Performance

Since no independent performance study is reported for the subject device against acceptance criteria, the table below reflects a comparison to the predicate device, which is the basis for its 510(k) clearance. The "acceptance criteria" here implicitly refer to being "as safe and effective" as the predicate.

Note: The differences identified (e.g., treatment time, specific modes of compression) are evaluated to ensure they do not raise adversely impact or safety and effectiveness compared to the predicate, rather than meeting specific performance thresholds for the device itself.

2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable, as no clinical performance study on a test set (human subjects or patient data) was conducted or reported for the substantially equivalent device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable, as no clinical performance study was conducted.

4. Adjudication Method for the Test Set:
Not applicable, as no clinical performance study was conducted.

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 not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device (air pressure therapy system), not an algorithm or software-only device.

7. The type of ground truth used:
Not applicable, as no clinical performance study was conducted. The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate device based on its prior clearance and generally accepted standards for this type of device.

8. The sample size for the training set:
Not applicable, as no algorithm training or performance study was conducted or reported.

9. How the ground truth for the training set was established:
Not applicable, as no algorithm training or performance study was conducted or reported.

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The device is air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The system consists of an air pump, leg sleeves and hoses working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; one sleeve has 4 compression chambers. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. This software is to control the timing and the pressure reflected by the sensor, it cycles the airflow to reach the function of cycling compression of body parts.

The provided text describes a 510(k) premarket notification for the "Pressure Therapy System PT1003". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a predetermined set of acceptance criteria for a novel AI/imaging device. As such, many of the requested categories for AI/imaging device studies (like MRMC studies, effect size of AI assistance, expert qualifications, sample provenance, training sets, etc.) are not applicable or not provided in this regulatory submission.

However, I can extract information related to the performance characteristics, safety testing, and how the device's adherence to standards and safety was demonstrated.

Here's a breakdown of the available information:

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

The document doesn't explicitly state "acceptance criteria" in the format typically used for AI/imaging performance metrics (e.g., sensitivity, specificity, AUC). Instead, it demonstrates compliance with recognized medical device standards and functional tests to ensure safety and performance comparable to legally marketed predicate devices.

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

This document does not describe a test set in the context of clinical data for AI/imaging performance. The testing performed consists of bench testing and electrical/biocompatibility safety evaluations on the device itself. Therefore, concepts like "sample size" for a data set or "data provenance" (country of origin, retrospective/prospective) are not applicable. The tests were performed on the "PT1003" device following defined procedures.

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

Not applicable. "Ground truth" for AI/imaging interpretation is not relevant for this type of device (a powered inflatable tube massager). The evaluation focuses on engineering, safety, and functional performance.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 not an AI/imaging device.

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

Not applicable. This is not an AI/imaging device. The "standalone" performance here refers to the device's functional and safety performance in isolation, which was indeed assessed through the listed standards and function tests.

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

The "ground truth" for this device's evaluation is primarily established by regulatory standards (e.g., IEC, ISO, AAMI ANSI ES) and the functional and safety performance of legally marketed predicate devices. The device is deemed safe and effective if it meets these standards and its performance characteristics (like pressure range, cycle time) are comparable to or safely within the established parameters of already cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/imaging device, and therefore does not involve a "training set" in the machine learning sense.

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

Not applicable. As above, no training set for AI was used.

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The device is indicated for use by medical professionals and patient at home, who are under medical supervision, in treating many conditions, such as: Primary lymph edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymph edema.

The system consists of an air pump, leg sleeves and hoses working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; one sleeve has 4 compression chambers. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. This software is to control the timing and the pressure reflected by the sensor, it cycles the airflow to reach the function of cycling compression of body parts.

The provided text is a 510(k) Pre-market Notification for the "Pressure Therapy System PT1003", which seems to be a medical device. This document focuses on demonstrating substantial equivalence to a predicate device (PT1002), rather than providing detailed acceptance criteria and a study design for a new, AI-powered diagnostic device.

Therefore, the information required to answer your specific questions about AI/ML device acceptance criteria and a study proving performance (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) is not present in the provided document.

The document discusses:

• Device Description: A pneumatic compression system (PT1003) for treating conditions like lymphedema and venous insufficiencies.
• Predicate Device: PT1002, an earlier version by the same manufacturer.
• Substantial Equivalence: The primary goal of the 510(k) submission is to show that PT1003 is substantially equivalent to PT1002 in terms of intended use, indications, and technological characteristics.
• Minor Differences: Changes in appearance and PCB components (microprocessors, touch keys) are noted, with the manufacturer asserting these changes do not affect safety or performance.
• Performance Characteristics: Mentions adherence to various safety standards (AAMI ANSI ES 60601-1, IEC 60601-1-2, ISO10993-5, ISO 10993-10) and general "function tests" (min/max air pressure, electric current, airflow, noise level, modes A and B). It states that test results are "almost same" as the predicate device.

Without the specific details about AI/ML components and their performance evaluation, I cannot generate the table or answer the questions related to AI device acceptance criteria and study proving its performance.

The document's "Performance characteristic" section is very general and does not provide:

• Specific Acceptance Criteria (quantitative thresholds for performance metrics).
• Detailed Study Design: e.g., how the "function tests" were conducted, the sample size of devices tested, the number of measurements taken, or the statistical methods used to compare results between PT1003 and PT1002.
• Ground Truth Establishment: For a simple physical therapy device evaluating pressure and airflow, "ground truth" would likely be derived from calibrated measurement instruments, not expert consensus or pathology, and these details are not provided.

In summary, the provided text describes a traditional medical device 510(k) submission, not an AI/ML powered device, and therefore lacks the information needed to answer your questions about AI device validation.

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The device is indicated for use by medical professionals and patient at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, edema following trauma and sport injuries, post immobilization edema, venous insufficiencies, lymphedema.

The system consists of an air pump, leg sleeves and hoses working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; one sleeve has 4 compression chambers. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. This software is to control the timing and the pressure reflected by the sensor, it cycles the airflow to reach the function of cycling compression of body parts.

The provided document is a 510(k) Premarket Notification for a medical device (Pressure Therapy System, K161907). It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through the kind of study described in your request.

The document discusses the device's technical characteristics and how they compare to a predicate device. It also lists the standards a performance test was conducted against to demonstrate safety and effectiveness. However, it does not include the detailed type of study you're asking about (e.g., a multi-reader multi-case clinical study with performance metrics like sensitivity/specificity, specific acceptance criteria for diagnostic performance, or extensive details on ground truth establishment from a clinical dataset).

Here's a breakdown of what the document does provide in relation to your request, and what it does not provide:

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

• What's explicitly stated: The document lists standards that the device was tested against. This implies that meeting these standards served as "acceptance criteria" for safety and basic operational performance.
  • IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
  • IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)
  • ISO10993-5 (Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity)
  • ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
• Reported Device Performance: The document states, "The Pt1002 pressure therapy system has been tested and met the following standards." It does not provide specific performance values (e.g., specific pressure accuracy tolerances, cycle time deviations) against quantified acceptance criteria. Instead, it concludes that the device "has substantially equivalent technological and performance characteristics" to the predicate device and "is as safe and effective as the predicate device."
• Missing from your request: There are no specific numerical acceptance criteria for diagnostic accuracy or clinical effectiveness (e.g., sensitivity, specificity for detecting a condition) because this is a physical therapy device, not a diagnostic AI.

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

• Not Applicable/Not Provided: This document describes a submission for a physical therapy device. The testing mentioned (compliance with IEC and ISO standards) would typically involve engineering tests on the device itself and biocompatibility tests on materials, not clinical trials with "test sets" of patient data in the way an AI diagnostic device would. Therefore, sample size for a "test set" and data provenance from patient data are not detailed, as they are not relevant to this type of device submission as described.

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/Not Provided: Ground truth by experts is relevant for diagnostic AI devices, clinical studies, or performance evaluations that require expert interpretation of data (e.g., images, physiological signals). For this physical therapy device, compliance with technical safety and biocompatibility standards does not involve expert-established ground truth in this manner.

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

• Not Applicable/Not Provided: As noted, this type of submission for a physical therapy device focuses on engineering and biocompatibility standards, not the adjudication of clinical outcomes or diagnostic interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No: This is not a diagnostic AI device, and therefore, an MRMC study is not relevant or mentioned.

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

• Not Applicable: This is a physical therapy device, not an algorithm, so the concept of standalone performance does not apply in the context of AI without human-in-the-loop.

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

• Not Applicable/Implicit: For the standards listed, the "ground truth" would be the defined specifications and methodologies within those standards (e.g., a specific electrical resistance value, a specific biocompatibility response under defined lab conditions). This is not "expert consensus" or "pathology" in the clinical sense.

8. The sample size for the training set

• Not Applicable/Not Provided: This is not an AI/machine learning device that requires a "training set" of data.

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

• Not Applicable/Not Provided: As it's not an AI/machine learning device, the concept of establishing ground truth for a training set does not apply.

In summary:

This 510(k) submission for the "Pressure Therapy System" focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and confirming compliance with recognized safety, electromagnetic compatibility, and biocompatibility standards. It does not provide the detailed performance study information with clinical acceptance criteria, test set, ground truth, or expert involvement that would be expected for a diagnostic device or an AI-powered system as detailed in your request.

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The ABThera Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. The Intended Use of this system is in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

The therapy system consists of a therapy unit which delivers negative pressure through a tubing set to the dressing which is placed into the open abdomen. Controls within the therapy unit monitor delivery of negative pressure and provide safety alarms. The dressing manifolds negative pressure from the therapy unit and protects abdominal contents. A canister collects wound fluids removed under negative pressure.

The document describes the ABThera Open Abdomen Negative Pressure Therapy System. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text only mentions "laboratory tests" for functional equivalence. It does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for this kind of device.

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

This information is not applicable to the provided document. The device in question is a medical therapy system (Negative Pressure Wound Therapy System), not an AI/imaging diagnostic device that would require expert consensus for ground truth. The evaluation focused on the physical performance of the system against predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

A MRMC comparative effectiveness study was not done as this is not an AI/imaging diagnostic device intended to be used by human readers for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study in the context of AI algorithms was not done. The "standalone" performance here would refer to the device's ability to maintain negative pressure and remove fluid, which was evaluated in laboratory tests without direct human intervention in the continuous therapy delivery, but the evaluation itself was conducted by human operators.

7. Type of Ground Truth Used

The ground truth used for the functional equivalence tests was the performance of legally marketed predicate devices. The new device's performance (negative pressure delivery and fluid removal) was compared against these established devices in laboratory settings to demonstrate equivalence.

8. Sample Size for the Training Set

This information is not applicable as this device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable as this device does not involve a "training set."

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