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Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

The System 2600 is a three component system consisting of a control unit, inflatable multi-segment leg sleeves, and conduit tubing (4 port) with detachable connections. The control unit is an electro/mechanical device designed to apply a specific degree of pressure to the leg in a precise cycle beginning at the ankle (or lower calf) and continuing sequentially to the thigh. The unit utilizes a software based electronic control system, electro/mechanical compressor, and solenoid operated air inflation control valves. All electrical and mechanical components are contained in a molded plastic housing.

Pressure is generated in the control unit and is transferred to the patient by air inflation of the multisegment leg sleeves. The segments are inflated sequentially to various pressure settings to create a decreasing gradient, distal to proximal, on the lower extremity.

The inflatable multi-segment leg sleeves are designed to be wrapped comfortably around the patient's leg. They consist of multiple air chambers which can be inflated independently. There are four sizes of sleeves offered for use with the system. Two sizes have all four air chambers positioned between the ankle and knee. The other two sizes position two chambers between the ankle and knee and two chambers above the knee on the thigh.

The Jobst System 2600 monitors the sleeve pressure repeatedly during sleeve segment inflation via a pressure transducer. Solenoid activated valves, controlled by the electronic control system, regulate the air pressure in the segment's pressure is controlled by specific solenoid valves and is isolated from the other segments. Segment inflation and cycle timing are based on each segment achieving a preset (non-adjustable) pressure within a maximum allowable time limit. The pressures in each segment are repeatedly monitored and corrected throughout the cycle to ensure the preset pressures are maintained within each segment. After the four segments in the sleeve are inflated in a sequential pressure gradient manner, the solenoid valves open and the air is exhausted. The creation of the gradient sequential condition is dependent on the sequential opening of the solenoid valves and the pressure, monitored by the pressure transducer, in each segment of the sleeve. The pressure setting is fixed and is not user selected.

The provided document describes the K980456 submission for the Jobst Athrombic Pump System 2600. The acceptance criteria and the study proving the device meets them are based on demonstrating substantial equivalence to a predicate device, the Jobst Athrombic Pump System 2500, through bench testing.

Here's the breakdown of the requested information:

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

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

• Sample Size: Not explicitly stated as a numerical sample size of "devices" or "runs." The study was a bench test comparing two systems (System 2600 and System 2500).
• Data Provenance: Retrospective, as it refers to performance data obtained during bench testing of the two systems for comparison. The country of origin is not specified, but the submission is to the U.S. FDA by a company (Beiersdorf - Jobst, Inc.) whose address is in Charlotte, NC, USA.

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. The ground truth was established through direct measurement of physical parameters (pressures and times) during bench testing, not through expert interpretation of data.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. The "ground truth" was objective physical measurements, not subjective evaluations requiring adjudication.

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 mechanical pump system for DVT prevention, not an AI-assisted diagnostic tool requiring human reader studies.

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

• Standalone Performance: Yes, in a sense. The bench testing evaluated the performance of the device (both System 2600 and System 2500) on its own, measuring its output (pressures and timing) against predefined parameters. There is no "human-in-the-loop" component in the operational function of this particular device being evaluated for its core mechanical properties.

7. The type of ground truth used:

• Type of Ground Truth: Objective physical measurements and fixed engineering parameters. The "ground truth" for the comparison was that both systems should produce the same inflation cycle parameters (target pressures, rise times, inflation times, total cycle time) as they use the same controlling parameters and sleeves.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a mechanical system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its engineering design and calibration, likely based on iterative development and testing, rather than a distinct "training set" of data.

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

• How Ground Truth Established for Training Set: Not applicable for an AI training set. For a mechanical device like this, the "ground truth" for its design and calibration would have been established through engineering specifications, biomechanical requirements for DVT prevention (e.g., specific pressure gradients required for effective blood flow), and iterative testing during the development process to ensure the device performs according to these specifications.

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Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)

This submission is being made for a sterile version of the sleeve used for the Jobst Athrombic Pump System 2500. This product is a Class II device and is classified as a compressible limb sleeve under 21 CFR 870.5800. The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs. Both sleeves are made of PVC and are sterilized with ethvlene oxide.

The provided text is related to a 510(k) submission for a sterile version of a limb sleeve used with the Jobst Athrombic Pump System 2500. This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, a 510(k) submission, especially for this type of device, does not typically involve a "study that proves the device meets acceptance criteria" in the way one might expect for a novel diagnostic AI algorithm. The goal of a 510(k) for a device like this is to show it is substantially equivalent to a predicate device, not necessarily to independently prove its efficacy through a clinical trial with specific performance metrics and corresponding acceptance criteria.

The 510(k) summary provided states:

• "The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use."
• "Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs."
• "The Jobst Athrombic Pump System 2500 with the non-sterile sleeves has been on the market since 1994 and has proven to be safe and effective in that time. The sterile version is being offered for situations where sterile product is preferred."

Given this context, the request for "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format typically applied to AI performance metrics (like sensitivity, specificity, accuracy) is not directly applicable to this document. The "proof" here is the argument for substantial equivalence, primarily based on the predicate device's established safety and effectiveness, and the material/operational similarity of the new sterile sleeve.

Therefore, many of the requested fields about AI-specific study details (sample size for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth types) cannot be filled from this document because it describes a different type of regulatory submission and device evaluation.

However, I can extract information related to the device and its intended use, framed within the context of substantial equivalence.

Acceptance Criteria and Device Performance (as inferred from the 510(k) process for this device type):

• Both sleeves are made of PVC.
• Sterilized with ethylene oxide. |
  | 3. Safety and Effectiveness Equivalence: Device must be as safe and effective as the predicate device. | - The non-sterile version has "proven to be safe and effective" since 1994.
• The sterile version is technologically equivalent, implying similar safety and effectiveness. |
  | 4. Performance (Mechanism of Action) Equivalence: Device achieves its therapeutic effect in a similar manner to the predicate. | "Accomplished by intermittent compression of the muscles in the lower limbs." (Identical to predicate) |
  | 5. Sterility: The sterile version must achieve and maintain sterility. | "Sterilized with ethylene oxide." (Implicitly meets sterility requirements for a sterile product, though specific validation data is not in the summary). |

Study Details (Not applicable in the context of an AI study, but addressing what is relevant to the K970922 submission):

This 510(k) submission for a sterile limb sleeve is for a Class II medical device (a physical device, not an AI algorithm). The "study" isn't a traditional clinical trial with a test set and ground truth in the AI sense, but rather a demonstration of substantial equivalence.

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

   • N/A. This is not an AI algorithm and such a "test set" as typically defined for AI performance evaluation was not used. The submission relies on establishing substantial equivalence to a predicate device. The predicate device's long-standing market presence (since 1994 for the non-sterile version) serves as a form of "proven safety and effectiveness."

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):

   • N/A. Ground truth in the context of expert consensus for AI performance is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (Kendall Healthcare Product's sterile sleeve/SCD compression system) and the existing non-sterile version of the Jobst Athrombic Pump System 2500.

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

   • N/A. Not applicable for this type of device and submission.

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:

   • N/A. This is a physical medical device, not an AI system.

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

   • N/A. This is a physical medical device.

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

   • The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device and the existing non-sterile version of the device based on its market history and regulatory clearance. This effectively functions as "outcomes data" over time, demonstrating its intended therapeutic effect and safety profile.

7. The sample size for the training set:

   • N/A. This is not an AI algorithm.

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

   • N/A. This is not an AI algorithm.

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used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremittles. This is accomplished by intermittent compression of the muscles in the calf and thigh.

upgrade of the Jobst Athrombic Pump System 2000 to the System 2100. It also covers the use of thigh length sleeves with the System 2100. This device is classified as a compressible limb sleeve under 21 CFR 870.5800.

This document is a 510(k) summary for a medical device called the "Jobst Athrombic Pump System 2100." It primarily focuses on demonstrating substantial equivalence to a previously cleared device (System 2000) and another marketed device (Flowtron DVT/thigh sleeve system).

Unfortunately, the provided text does not contain the detailed information necessary to answer most of your questions regarding acceptance criteria and a study proving device performance as you've outlined. This type of 510(k) summary typically focuses on substantial equivalence arguments rather than detailed performance studies with acceptance criteria, sample sizes, ground truth establishment, or expert involvement for AI-driven devices.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

• Cannot be provided. The document states that the System 2100 "is substantially equivalent" to existing devices and "has proven effective for several years." It does not provide specific acceptance criteria (e.g., minimum effectiveness rates, sensitivity/specificity targets) or report quantified device performance metrics against such criteria.

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

• Cannot be provided. The document does not describe a new performance study with a test set. It relies on the established effectiveness of predicate devices.

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

• Cannot be provided. No new test set or ground truth establishment is described.

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

• Cannot be provided. Not applicable as no new test set is described.

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

• Cannot be provided. This device is a mechanical pump system, not an AI-driven diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Cannot be provided. Not applicable; this is a mechanical device, not an algorithm.

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

• Cannot be provided directly. The document implies that the ground truth for the predicate devices' effectiveness for "preventing deep vein thrombosis and pulmonary embolism" would be clinical outcomes data (i.e., whether DVT/PE actually occurred). However, it doesn't specify how this was measured or established in detail for those predicate devices.

8. The sample size for the training set

• Cannot be provided. This is not an AI/machine learning device, so there is no "training set."

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

• Cannot be provided. Not applicable.

Summary of what the document does provide:

• Device Name: Jobst Athrombic Pump System 2100
• Device Classification: Compressible limb sleeve (21 CFR 870.5800)
• Indications for Use: To help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremities.
• Mode of Operation: Intermittent compression of the muscles in the calf and thigh.
• Predicate Devices:
  • Jobst Athrombic Pump System 2000 (for pump console)
  • Flowtron DVT/thigh sleeve system (for use with thigh length sleeves and overall system comparison)
• Argument for Equivalence: Minor modifications from System 2000, and similar operation/indications to Flowtron DVT/thigh sleeve system, both of which have "proven effective for several years."

For detailed performance data, acceptance criteria, and specific study designs, one would typically need to consult the full 510(k) submission, clinical study reports (if any were required beyond reliance on predicate device performance), or peer-reviewed publications associated with the device or its predicates. A 510(k) summary is designed to be a high-level overview.

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The Elvarex garments are equivalent to the preamendment Jobst-Custom garments which are used for the same indications.

Consequently, they can be used to treat the same indications, i.e. CVI, edema, lymphedema, phlebitis and vascular malformations. The contraindications for the two products are also the same, i.e. significant arterial insufficiency, cutaneous infections. dermatitis in the acute phase. wet dermatosis and conditions in which venous and lymphatic return is not desired.

While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the Elvarex garments are flat knit using yarns made of nylon, natural rubber latex, cotton and spandex and then sewn together. Both products use the specific measurements for a patient and calculate the final garment dimensions using the LaPlace formula. Compression is provided for both products by large elastic yarns that act circumferentially on the limb. The gradient compression present with both products helps to force fluid into the deep venous system and in the return of Ivmphatic fluid.

The provided text is a 510(k) summary for a medical device (Elvarex compression garments). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting scientific studies with specific acceptance criteria, performance metrics, and detailed study methodologies as would be found in a clinical trial report for a novel medical device.

Therefore, many of the requested categories of information cannot be extracted from this document, as they are not present.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The acceptance criteria seem to be based on demonstrating "substantial equivalence" to the predicate device in materials, mode of action, and indications for use, and a history of safe use.
• Reported Device Performance: The document states: "Elvarex has been on the market for several years in Europe and has an established track record. There have also been no reports of serious injury resulting from its use during the three year period assessed." This is a qualitative statement about safety, not a quantitative performance metric.

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

• Sample Size: Not specified. The "three-year period assessed" refers to a retrospective review of safety reporting in Europe, not a formal study with a defined sample size for a test set.
• Data Provenance: European market data (retrospective safety reporting).

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. There was no "test set" in the sense of a diagnostic or performance test that required expert ground truth establishment as typically understood in medical device studies. The assessment was based on market history and safety reporting.

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

• Not applicable. There was no test set requiring expert adjudication.

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 compression garment, not an imaging or diagnostic AI device.

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

• Not applicable. This is a compression garment, not an algorithm.

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

• The "ground truth" for the claims of safety and effectiveness appears to be derived from the "established track record" of the device in Europe and the lack of "serious injury reports" over a three-year period. This can be considered a form of retrospective outcomes data or post-market surveillance data regarding safety.

8. The sample size for the training set

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

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

• Not applicable. Not a machine learning or AI device.

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