Search Results

The extriCARE® NPWT foam kit is intended to be used in conjunction with the extriCARE® 2400 NPWT pump. The extriCARE® 2400 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE Negative Pressure Wound Therapy System 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® Negative Pressure Wound Therapy (NPWT) System consists of extriCARE® NPWT Pump, canister, connection tubing, and dressing kit. In operation, the dressing is attached to an extriCARE® Negative Pressure Wound Therapy pump via the tubing. The pump is used to provide the negative pressure to the system. Pressure and mode selections are digitally programmable.

The extriCARE NPWT foam dressing kit is a new accessory to the NPWT system. The foam dressing kit is designed to be an alternative solution to the bandage dressing kit in the original system. The foam dressing kit consists one of each of the following: polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp. The single-use foam dressing kit is packed in Paper/poly peel pouch bag, which is sterilized using ETO. The foam is used to pack the wound.

The extriCARE® NPWT foam dressing kit can be sold alone or as a part of the extriCARE 2400 system. The associated accessories include:

• . Large foam dressing kit
• . Medium foam dressing kit
• . Small foam dressing kit

The provided text describes a 510(k) premarket notification for the extriCARE 2400 NPWT System with extriCARE 2400 NPWT pump and extriCARE NPWT Foam Dressing Kit. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a diagnostic or AI device.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, MRMC studies, standalone performance) are not applicable to the information contained in this document, as it pertains to a medical device approval that is based on demonstrating equivalence rather than a clinical performance study with defined thresholds.

Here's an attempt to extract the relevant information based on your request, with an understanding that the context is a 510(k) submission for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a typical performance study for diagnostic AI. Instead, the "acceptance criteria" are implied by the need for the device's performance to be comparable to or meet the functional requirements of the predicate devices. The performance tests conducted aimed to verify that the device design met its function and performance requirements.

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

The document does not specify a "test set" in the context of diagnostic data, nor does it provide sample sizes for the performance tests mentioned. The testing was conducted on "aged samples" of the device itself (pump and foam dressing kit).
Data provenance (country of origin, retrospective/prospective) is not applicable or provided for this type of device and submission.

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

Not applicable. "Ground truth" in the context of diagnostic accuracy or AI performance is not relevant for this medical device submission, which focuses on functional performance and substantial equivalence.

4. Adjudication Method

Not applicable, as no ground truth for a diagnostic performance test was established.

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

Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical device (pump and dressing kit), not an algorithm or AI system for standalone performance evaluation in the diagnostic sense.

7. Type of Ground Truth Used

Not applicable. As mentioned, the concept of "ground truth" for diagnostic or predictive purposes is not relevant for this device's submission. The "truth" for this submission revolves around the device's functional integrity, safety, and performance characteristics as measured by engineering tests.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device and its accessories, not an AI or machine learning model that requires a training set.

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

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

Ask a specific question about this device

The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE® 3600 Negative Pressure Wound Therapy System 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 grafis.

The system consists of a vacuum pump, canister, tubing, NPWT bandage or NPWT Foam Kits. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage or foam kits. Maximum pressure and continuous mode or intermittent mode selection are digitally programmable. The extriCARE 3600 pump can be sold alone or as a part of the extriCARE 3600 system with extriCARE bandages or foam kits. The extriCARE bandages are an all-in-one wound dressing; with no wound packing required which is cleared in the predicate K110078. The foam kit consists of Polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp, which is included in this submission for review.

The provided 510(k) summary describes a Negative Pressure Wound Therapy (NPWT) system, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML device performance (e.g., sample size for training, expert ground truth, MRMC study, AI improvement effect size) are not applicable to this document.

However, I can extract the information provided regarding the device's acceptance criteria and the studies conducted to demonstrate its performance as a medical device.

Acceptance Criteria and Device Performance for extriCARE® 3600 Negative Pressure Wound Therapy System

Since this is a medical device (Negative Pressure Wound Therapy System) and not an AI/ML algorithm, the acceptance criteria are not typically expressed in terms of metrics like sensitivity, specificity, or AUC, but rather in terms of compliance with functional, safety, and performance standards. The "reported device performance" in this context refers to the successful completion of these tests.

Study Details:

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

   • Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the context of clinical trials or data-driven algorithm validation. Instead, it mentions "representative samples of the device" for functional, mechanical, EMC, and electrical safety testing. For biocompatibility, "bandage samples and foam kits samples" were tested. No specific number of devices or clinical cases is provided.
   • Data Provenance: The document does not provide information on the country of origin of data or whether tests were retrospective or prospective, as these are not relevant for the type of bench and biocompatibility testing described.

2. 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):

   • This question is not applicable as the document describes a physical medical device undergoing bench and biocompatibility testing, not an AI/ML algorithm requiring expert-labeled ground truth for a test set.

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

   • This question is not applicable for the same reasons as above. Adjudication methods are relevant for resolving discrepancies in expert-labeled ground truth in AI/ML performance studies.

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:

   • This question is not applicable. An MRMC comparative effectiveness study is used for evaluating the impact of AI on human reader performance, which is not relevant for a physical NPWT system.

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

   • This question is not applicable as the document concerns a physical medical device, not a standalone AI algorithm.

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

   • For functional and safety testing, the "ground truth" is adherence to established engineering specifications, international standards (e.g., IEC 60601 series), and biocompatibility standards (ISO-10993). There isn't a "ground truth" in the sense of clinical diagnoses or outcomes data for this type of device submission.

7. The sample size for the training set:

   • This question is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

   • This question is not applicable for the same reason mentioned above.

Ask a specific question about this device

extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

extriCARE® Negative Pressure Wound Therapy Foot Dressing

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the ExtriCARE® Negative Pressure Wound Therapy Foot Dressing, confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and general information but does not detail device performance or studies in the way you have requested.

Ask a specific question about this device

The Cirona™ DVT Prevention Therapy Foot Garment is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

The Cirona™ deep vein thrombosis prevention therapy foot garment is intended to be used with Devon Cirona™ 6100 deep vein thrombosis prevention system (K130571). The Cirona™ deep vein thrombosis prevention foot garment is a pair of single patient reusable soft compression garment(s) (sleeves), that consists of a brushed nylon outer material bonded to a foam inner liner. An inflatable polyvinylchloride (PVC) pressure bladder is encapsulated in an additional foam material. The patient contact material is polyurethane foam and the extension tubing set connects to the garment on one end through quick connectors and to the pump on the other end. It is intended to be used noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition.

The FDA cleared Cirona™ 6100 system (K130571) consists of a pump, a pair of single patient reusable soft compression garment(s) (sleeves), and the extension tubing set for calf and calf-thigh. This submission is for the new Cirona DVT Foot Garment which will be used in conjunction with the Cirona 6100 system. The device will alternatively inflate the two garments and mimic the natural walking pace in order to enhance circulation. The device supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mm Hg is used for all applications. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

Here's a breakdown of the acceptance criteria and study information for the Cirona™ DVT Foot Garment, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides very limited information regarding sample sizes for human subjects or specific details of the "test set" for performance evaluation. The "Sleeve Bladder Burst Test" mentions "all samples," implying a sample size greater than one for that specific bench test.

Data provenance: The tests are described as "bench and laboratory testing," suggesting an in-house, prospective testing environment rather than clinical data. No country of origin for the data is specified, but the submission is to the FDA, implying testing relevant to US regulatory standards.

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

No information is provided regarding the use of human experts or establishing ground truth in the context of the described performance testing. The performance tests appear to be objective, engineering-focused benchmarks rather than clinical evaluations requiring expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The described tests are bench tests with objective pass/fail criteria, not subjective assessments requiring adjudication.

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

No. The document describes bench and laboratory performance testing against specifications, not a clinical comparative effectiveness study involving human readers or AI.

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

No. The device is a physical medical device (compression garment) and does not involve an algorithm in the sense of AI. The performance testing is for the physical attributes and functionality of the device itself.

7. The Type of Ground Truth Used

The ground truth for the performance tests is based on the device's own specifications (e.g., 40mmHg pressure, 12-second inflation, structural integrity). This is a form of objective engineering specification compliance rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied, as this device is not an AI/machine learning product requiring training data.

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

Not applicable, as there is no training set.

Ask a specific question about this device

The Cirona™ 6100 system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

The Cirona™ 6100 deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition. The Cirona'''' 6100 system consists of a pump, a pair of single patient reusable soft compression garment(s) (sleeves), and the extension tubing set for calf and calf-thigh. The device will alternatively inflate the two garments and mimic the natural walking pace in order to enhance circulation. The device supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mm Hg is used for both the calf and calf-thigh treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

The provided 510(k) summary describes a pneumatic compression device (Cirona™ 6100) for deep vein thrombosis prevention. The study conducted for this device is focused on showing its substantial equivalence to predicate devices through performance testing, rather than a clinical study evaluating its effectiveness in patients.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device's performance testing is primarily based on functional standards and safety. The acceptance criteria are essentially that the device passes specific bench and laboratory tests, ensuring it meets its specifications and conforms to relevant safety standards.

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

The document does not explicitly state a specific "test set" in terms of patient data. The testing described is bench and laboratory testing of the device itself.

• Sample Size for Test Set: Not specified for individual tests, but implies a sample sufficient to perform the listed performance tests (e.g., "all sleeves tested" for the bladder burst test).
• Data Provenance: Not applicable as it's not a clinical study with patient data. The data is generated from engineering/performance testing of the device hardware and software.

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

Not applicable. The ground truth for engineering and performance tests is typically established by engineering specifications, regulatory standards, and established test protocols, not by clinical experts.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert opinions. The performance tests yield objective results (pass/fail, measurements against specifications).

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

No. There is no mention of an MRMC comparative effectiveness study, nor would it be relevant for this type of device (a pneumatic compression system) seeking 510(k) clearance based on substantial equivalence to predicate devices through performance testing. The purpose of this submission is to show the device functions safely and effectively as intended, not to compare its efficacy against a control arm in a clinical setting or to evaluate human reader performance with or without AI.

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

Not applicable. This device is a hardware-based medical device, not an AI/algorithm-based diagnostic or assistive system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is derived from:

• Engineering Specifications: The design and operating parameters the device is intended to meet (e.g., 40mmHg pressure, 12-second inflation, 48-second relaxation).
• Regulatory Standards: Conformance to recognized international and national standards for medical electrical equipment, risk management, and biological evaluation (e.g., IEC 60601-1, ISO 14971, ISO 10993 series).
• Predicate Device Characteristics: Ensuring the Cirona™ 6100 has "very similar components" and "very similar principles of operation" to its predicates.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" in the context of an algorithm.

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

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

Ask a specific question about this device

The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

• Lymphedema -
• Venous stasis ulcers -
• Venous insufficiency -
• Peripheral edema -
  The device is intended for both home and hospital use.

The CircuFlow™ 5150 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow™ 5150 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within in the first chamber can be programmed, with each successive chamber having its pressure be 7% less than the previous chamber.

This document describes the acceptance criteria and the study conducted for the Devon Medical Products, Inc. CircuFlow™ 5150 Sequential Compression Device.

1. Acceptance Criteria and Reported Device Performance:

The provided document lists several performance tests that were conducted. While the acceptance criteria (i.e., the specific thresholds the device needed to meet) are not explicitly stated in numerical terms within the document, the "Reported Device Performance" is implied by the statement "Bench and laboratory testing was performed and assures that the product meets its specifications." This suggests that all tests were passed successfully according to internal specifications.

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

The document does not explicitly state the sample size used for each performance test. It mentions "Bench and laboratory testing," which typically refers to controlled testing environments rather than clinical trials with human subjects. The data provenance is laboratory-based testing. There is no indication of country of origin of data or whether it was retrospective or prospective in the sense of patient data.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

Not applicable. This device is a medical instrument (sequential compression device), and its performance testing as described focuses on engineering specifications rather than diagnostic interpretation requiring expert human ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As the testing focuses on engineering performance rather than human interpretation, an adjudication method for a test set is not relevant.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (sequential compression device), not an AI algorithm for diagnostic interpretation. Therefore, assessing how human readers improve with or without AI assistance is not relevant.

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

Yes, a standalone study was effectively done. The performance tests described (e.g., Pressure Accuracy Test, Cycle Time Test) assess the device's intrinsic mechanical and electronic performance without human intervention in its operational function beyond initiation and setting parameters (which are part of its intended use). The device is designed to operate independently based on its programming and mechanics to deliver compression therapy.

7. Type of Ground Truth Used:

The ground truth for the performance tests was based on engineering specifications and established measurement standards. For example, the "Pressure Accuracy Test" would likely compare the device's output pressure to a high-precision reference pressure gauge, and "Cycle Time Test" would measure the actual cycle duration against programmed or target times.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical/electronic medical device, not an AI or machine learning model that requires a training set in the conventional sense. Its "training" is in its design, engineering, and manufacturing processes, rather than data-driven learning.

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

Not applicable, as there is no training set in the context of an AI/ML model for this device. The device's operational parameters and performance targets are established through engineering design, clinical requirements for such devices, and regulatory standards.

Ask a specific question about this device

The CircuFlow 5208 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema
  The device is intended for home and hospital use.

The CircuFlow 5208 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5208 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into garments chambers, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within each chamber can be programmed and individual chambers can be skipped or the pressure decreased in the case of a wound.

The provided document describes a 510(k) summary for the CircuFlow 5208 Sequential Compression Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria related to a disease outcome. Therefore, the information provided primarily pertains to performance testing designed to ensure the device operates according to its specifications and is safe, rather than a study proving clinical effectiveness against defined acceptance criteria for a medical outcome.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests but does not explicitly state quantitative acceptance criteria or their corresponding reported device performance values. The general statement is that "Bench and laboratory testing was performed and assures that the product meets its specifications."

• Leakage Current Test: Performed. (Implicitly met standards, but no data provided.) |
  | Pressure Control | - Pressure Calibration for Pressure Sensor: Performed. (Implicitly met specifications, but no data provided.)
• Pressure Gradient Performance: Performed. (Implicitly met specifications, but no data provided.) |
  | Timing Accuracy | - Inflation & Deflation Time Performance: Performed. (Implicitly met specifications, but no data provided.)
• Treatment Time Performance: Performed. (Implicitly met specifications, but no data provided.) |
  | Biocompatibility | - ISO 10993-5 (in vitro cytotoxicity): Conforms to standard.
• ISO 10993-10 (irritation and delayed-type hypersensitivity): Conforms to standard. |
  | Risk Management | - ISO 14971 (risk management): Conforms to standard. |
  | General Safety & Performance | - IEC 60601-1 / AAMI ES 60601-1 (general requirements for basic safety and essential performance): Conforms to standards. |
  | Electromagnetic Compatibility | - IEC 60601-1-2 (collateral standard for EMC): Conforms to standard. |

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

The document describes bench and laboratory testing, not a clinical study on human subjects. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) and sample size for human subjects does not apply. The tests mentioned are likely conducted on a limited number of device units in a controlled lab environment.

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

This question is not applicable as the testing described is technical product performance testing, not a study requiring expert clinical ground truth assessment on a test set.

4. Adjudication Method for the Test Set:

Not applicable, as this was not a clinical study requiring human adjudications.

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 medical device, not an AI diagnostic or assistive tool, and no MRMC study was conducted or referenced.

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

Not applicable. This is a physical medical device, not an algorithm. The device operates independently according to its programmed functions.

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

For the performance testing, the "ground truth" would be established engineering and safety standards (e.g., IEC 60601-1, ISO 10993) and the device's own internal design specifications. The tests verify that the device's performance aligns with these predefined technical requirements.

8. The sample size for the training set:

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not described here.

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

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

Ask a specific question about this device

The ArterioFlow 7500 is intended as an adjunctive therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

• Amputations (minor) .
• Angioplasty/stent failure .
• Arteriopathic wounds .
• Graft failure .
• Intermittent claudication .
• Ischemia .
• Night Pain .
• Rest Pain .
• Small vessel disease .
• Ulcers .
  The device is intended for home and hospital use.

The ArterioFlow 7500 is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complication of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The device for consists of a pump, inflatable garments, and tubing. In operation, the device is attached via tubing to garments containing inflatable chambers applied externally and bilaterally over the feet and calves. Maximum pressure and treatment times are digitally programmable. Quick connector fitting on the tubing prevent accidental and incorrect orientations. Garments are available in anatomical designs including a single inflation chamber for the foot and a single inflation chamber for the calf. Garments are non-sterile, intended for single patient use and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners allow for easy application and adopting a variety of sizes.

The provided document describes a 510(k) premarket notification for the "ArterioFlow 7500 Sequential Compression Device." This device is a sequential compression device used to improve blood circulation in the lower extremities. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria for an AI/ML device or a new type of therapeutic device.

Therefore, many of the requested points from the prompt (related to AI performance, ground truth, expert adjudication, MRMC studies, sample sizes for training/test sets, etc.) are not applicable to this type of medical device submission. The device is a physical medical device (pump, garments, tubing) and its performance is assessed through bench and laboratory testing against specifications, not through an AI model's predictive accuracy.

Here's the information that can be extracted relevant to the prompt, with explanations for why other points are not present:

Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:
The document states, "Bench and laboratory testing was performed and assures that the product meets its specifications." This indicates that the performance tests listed (PQ-03 to PQ-07) were conducted as part of this bench and laboratory testing.

Non-Applicable or Unknown Information (based on the provided text)

Since this is not an AI/ML device or a diagnostic device requiring clinical accuracy studies, the following information is not present or relevant in this 510(k) summary:

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. "Test set" refers to data for evaluating an algorithm, which is not relevant here. The testing involved physical device performance. The sample size for bench/laboratory tests of physical parts is not specified, but it would typically be a limited number of devices or components tested to engineering specifications.
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 an AI algorithm is not relevant here. Device specifications (e.g., pressure, cycle time, tensile strength) are engineering parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication of expert opinions is relevant as there's no clinical "ground truth" being established by experts for algorithmic performance.
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 does not involve human readers interpreting data with or without AI assistance. It is a therapeutic physical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device like this is its engineering specifications and its ability to meet those during manufacturing and operation, confirmed by bench testing.
8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established: Not applicable. No training set is involved.

Ask a specific question about this device

The CircuFlow 5200 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

• Lymphedema -
• -Venous stasis ulcers
• Venous insufficiency -
• • Peripheral edema
    The device is intended for home and hospital use.

The CircuFlow 5200 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5200 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into garments chambers, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within each chamber can be programmed and individual chambers can be skipped or the pressure decreased in the case of a wound.

The provided text describes a 510(k) premarket notification for the CircuFlow 5200 Sequential Compression Device. This submission focuses on establishing substantial equivalence to existing predicate devices through bench and laboratory testing. It does not present a clinical study or performance data in the way typically seen for AI/ML-driven medical devices.

Therefore, many of the requested categories for AI/ML study details (e.g., sample size for test sets, expert consensus, MRMC studies, ground truth for training data) are not applicable to this submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission defines "Performance Testing" as a set of bench and laboratory tests to assure the product meets its specifications and is substantially similar to predicate devices. Specific acceptance criteria values are not explicitly stated in the provided text, nor are specific quantitative performance results for each test. The document generally states that "Bench and laboratory testing was performed and assures that the product meets its specifications."

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

• Sample Size for Test Set: Not applicable. This was bench and laboratory testing, not a clinical study with patient data.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. Ground truth for clinical cases was not established as this was not a clinical study.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.

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

• MRMC Study: No. This device is a sequential compression device, not an AI/ML diagnostic or assistive tool for human readers.

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

• Standalone Performance: Not applicable. This device is a physical medical device (pneumatic compression) and does not involve an AI algorithm with standalone performance metrics.

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

• Type of Ground Truth: For the "Performance Testing" section, the "ground truth" would be the engineering specifications and recognized electrical/mechanical safety standards (e.g., IEC 60601-1-1, IEC 60601-1-2, UL 60601-1). The device's performance was measured against these predefined engineering and safety requirements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning, therefore, there is no "training set."

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

• Ground Truth for Training Set: Not applicable.

Summary Explanation:

The K101523 submission for the CircuFlow 5200 is a 510(k) premarket notification for a physical medical device. The focus is on demonstrating substantial equivalence to already legally marketed predicate devices, primarily through bench and laboratory performance testing against engineering specifications and relevant safety standards. It is not an AI/ML device submission, and therefore, the structured questions regarding clinical studies, data provenance, expert labeling, and AI performance metrics are not relevant to this document. The "study" proving the device meets acceptance criteria consists of the listed "Performance Tests" performed in a "bench and laboratory" setting, ensuring the device functions according to its design specifications and electrical safety standards.

Ask a specific question about this device

The CircuFlow 5100 Sequential Compression Device is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.

The CircuFlow 5100 is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components:

• Pneumatic manual pump
• Limb sleeve or garment composes of 4 chambers
  The CircuFlow 5100 enables different treatment pressures (0-120mmHg) and treatment times (30 minutes to continue) that should be used according to physician prescription. When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable -pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chambers 2, 3 & 4 are individually lowered according to the default factory settings. A calibrated dial gauge displays pressure in the range of 0-200 mmHg. Garments are available in 8 sizes, and custom garments are available in variations from standard sizes.

The provided text describes a 510(k) premarket notification for the CircuFlow 5100 Sequential Compression Device. This submission primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics, intended use, and performance testing, rather than detailed clinical study outcomes to prove specific acceptance criteria met by the device.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a separate table with specific metrics (e.g., pressure output within X mmHg tolerance, cycle time within Y% of target) for various performance aspects. Instead, it lists various "Performance Testing" categories that were performed to assure the product meets its specifications. The specific results of these tests and the acceptance criteria they were measured against are not provided in this summary.

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

The document mentions "Bench and laboratory testing was performed," but it does not specify any sample sizes for these tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as these were likely internal lab tests on device prototypes or components. There is no indication of human subject data being used for this submission.

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

Given that the performance testing described is "Bench and laboratory testing," there is no mention of "experts" or "ground truth" being established in the context of clinical scenarios, image interpretation, or disease diagnosis. The ground truth for these tests would be the established engineering standards or internal specifications against which the device's physical and electrical performance was measured.

4. Adjudication Method for the Test Set

As the performance testing consists of bench and laboratory tests, the concept of an adjudication method (like 2+1 or 3+1 for expert review) is not applicable. The results of these tests would likely be objective measurements taken by testing personnel.

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

No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission focused on demonstrating substantial equivalence through technical characteristics and bench testing, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.

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

The device described, the CircuFlow 5100, is a sequential pneumatic compression device, a hardware medical device. There is no mention of any algorithms or AI components that would require standalone performance testing (without human-in-the-loop).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench and laboratory performance tests, the "ground truth" would be the engineering specifications, established physical limits, and relevant standards (e.g., IEC 60601-1-1, ISO 10993) against which the device's performance was measured. There is no mention of ground truth based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Since there is no mention of any AI components or algorithms in the CircuFlow 5100, there is no training set and therefore no sample size for a training set.

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

As there is no training set, this question is not applicable.

Ask a specific question about this device