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510(k) Data Aggregation
(50 days)
The Model SC-3008 Sequential Circulator 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 device consists of a manual pump (e.g., the user manually adjusts the pressures, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing discrete, segmented inflatable chambers externally applied over the affected extremity. The pump consists of a compressor capable of a maximum pressure of 150mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). . A calibrated dial gauge displays pressure in the range of 0-125mmHg.
As 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. Pressures within the chambers are adjustable - pressure to chambers 1 &2 is controlled by a user-adjusted regulator on the pump. Pressure in chambers 384, 5&6, and 7&8 can be individually lowered from the default factory settings.
Garments are available in 10 sizes, and custom garments are available in variations from these standard sizes; an adapter is available to support bilateral treatment:
Arm - Small | Leg - Small | Leg - Adjustable Small
Arm - Medium | Leg - Medium | Leg - Adjustable Medium
Arm - Large | Leg - Large | Leg - Adjustable Large
Arm - w/ Shoulder | Arm - Custom | Leg - Custom
The provided text is a 510(k) summary for the Model SC-3008 Sequential Circulator, a medical device. It states that "Performance testing was performed and assures that the product meets its specifications." However, it does not provide details on specific acceptance criteria, the results of the performance testing, or the methodology used for the study.
Therefore, many of the requested details about acceptance criteria, study design, and results cannot be extracted from the given text.
Here is what can be inferred from the text:
1. Table of acceptance criteria and reported device performance:
The document states "Performance testing was performed and assures that the product meets its specifications." This implies that there were specifications (acceptance criteria) that the device performance was compared against, and the device met them. However, the specific criteria and actual reported performance values are not provided in the text.
2. Sample size used for the test set and the data provenance:
Not provided. The document does not describe a clinical study with a test set of data. It only mentions "Performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. This device is a sequential circulator, a physical therapy device. The concept of "ground truth" established by experts in the context of image interpretation or diagnostic tools typically does not apply to this type of device's performance testing described here.
4. Adjudication method for the test set:
Not applicable/Not provided. No clinical test set involving expert adjudication 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:
Not applicable. This device is not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a manual pneumatic compression device, not an algorithm. Its performance is inherent in its mechanical operation.
7. The type of ground truth used:
Not provided. Given the nature of the device, "ground truth" for its performance would likely refer to objective measurements of pressure, cycle times, gradient accuracy, and durability against predefined engineering specifications. However, the specific type of ground truth (e.g., direct measurement, simulated conditions, etc.) and its establishment are not described.
8. The sample size for the training set:
Not applicable/Not provided. This is not a machine learning or AI device, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
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(132 days)
The C-Boot™ is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both.
The C-Boot™ is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including:
- Prevention of deep vein thrombosis (DVT)
- Enhancement of blood circulation
- Reduction of post-operative pain and swelling
- Reduction of wound-healing time
- Stasis dermatitis
- Treatment and assist healing of cutaneous ulceration
- Venous stasis ulcers
- Leg ulcers
- Chronic venous insufficiencies
- Reduction of edema
- Prevent pooling of fluids in limbs
- Lymphedema
C-Boot Ltd. introduces a wearable pneumatic compression technology embodied in a therapeutic boot that has the potential to increase treatment efficacy and improve the quality of life for peripheral vascular and lymph distorders patients.
C-Boot's solution integrates the technological advantages of dynamic compression pumps, that enable preset sequential pressure control to individualize treatment regimes, with the mobility benefit of static compression stockings, that activate the calf muscle pump and strengthened the body's natural tendency to enhance lymphatic and venous return.
The device relates to a self-powered compression devices and methods for promoting circulation and therapeutic compression: It is comprising a pump, a plurality of sleeves or limb massager, which utilizes sequential, cyclical pressure, energy or vector forces, to aid circulation in a body part such as the limbs. The inflatable sleeves are filled with air by the pump and transmit massaging movement to the vessel walls whenever the patient wearing the device - walks or transmits body's weight from one leg to another. The pressure generated is a function of the user's body weight and gravitational force. The device provides methods to harness energy generated during movement and weight transfer and uses the energy for compressing to create a massaging effect on the circulation and the muscular-skeletal system.
The C-Boot™ - Lymph and Venous-Insufficiency System's 510(k) summary (K041659) does not contain sufficient information to fill out the requested table and details regarding acceptance criteria and a specific study proving device performance against those criteria.
The document indicates that the C-Boot™ is found substantially equivalent to predicate devices, namely the "WizAir™ Ambulant Pneumatic Compression System" (K002287) and the "Lympha Press®" (K810338). The rationale for substantial equivalence is based on similar technological characteristics and the claim that C-Boot™ functions within the same boundaries of performance as the predicate devices, without raising new safety or effectiveness issues.
However, the submission does not detail specific acceptance criteria for the C-Boot™ itself, nor does it present a study with quantitative results of the C-Boot™'s performance against such criteria. The document states:
- "A series of functional, performance and safety testing, including comparative analysis to Mego-Afek® and WizAir™ - demonstrates that C-Boot™ is substantially equivalent to Mego-Afek® and WizAir™, without raising new safety and/or effectiveness issues." (Page 3, Section 12. Performance Data)
This statement indicates that testing was performed, but it does not provide the results of these tests, any acceptance criteria used, or the methodology (sample size, ground truth, etc.) of these tests. Without this information, the requested table and details cannot be completed.
Therefore, I cannot provide the requested information based on the provided text.
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(66 days)
The NormaTec PCD is intended to be used to apply pressure to the extremities. The NormaTec PCD is indicated for use in the treatment of: Lymphedema and other edematous conditions, including Congenital lymphedema (Millroy's disease, lymphedema praecox, and lymphedema tarda) Post-mastectomy lymphedema Post-infection lymphedema Post-traumatic lymphedema Post-surgical lymphedema Post-radiation-treatment lymphedema Venous insufficiency Venous stasis ulceration and the prevention of: Deep Vein Thrombosis
The NormaTec PCD is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics. Both NormaTec's PCD and its predicates are intended to apply pressure to the extremities to treat edematous states like lymphedema, and to prevent deep vein thrombosis. NormaTec's PCD has very similar components as its predicate devices and very similar principles of operation. Each device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, control of pressure applied cyclically and simultaneous treatment of two limbs, if necessary. Like the predicates, pressure is pulsed to the affected limb for a specified period of time, followed by a rest period, according to the physician's prescription.
The NormaTec PCD is a noninvasive pneumatic compression device.
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Acceptance Criteria and Reported Device Performance:
Test Type Acceptance Criteria Reported Device Performance Electromagnetic Interference Not specified "functioned as intended" Burst Testing Not specified "functioned as intended" Safety Testing Not specified "functioned as intended" Quality Assurance Testing Not specified "functioned as intended" -
Sample Size and Data Provenance:
- No specific sample size for a test set is mentioned. The document only states that the device "underwent electromagnetic interference testing, burst testing, safety testing and quality assurance testing."
- Data provenance is not specified. The studies were likely conducted internally by NormaTec, Inc.
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Number of Experts and Qualifications for Ground Truth:
- Not applicable. The document describes engineering and safety tests, not clinical studies involving expert interpretation of medical data.
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Adjudication Method:
- Not applicable. This was not a study requiring adjudication of expert opinions.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned. The submission focuses on substantial equivalence to predicate devices and basic engineering/safety performance.
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Standalone Performance Study:
- The "Performance Data" section describes direct testing of the device itself ("The NormaTec PCD underwent..."). This can be considered a standalone assessment of the device's basic operational performance and safety characteristics.
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Type of Ground Truth Used:
- The "ground truth" for the engineering and safety tests would have been predefined engineering specifications, safety standards, and functional requirements for pneumatic compression devices. For instance, "burst testing" implies a standard for pressure resistance.
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Sample Size for Training Set:
- Not applicable. This is not a machine learning or AI-based device, so there is no training set mentioned.
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How Ground Truth for Training Set was Established:
- Not applicable, as there is no training set for this device.
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(56 days)
The Lympha Press Plus device is intended for treatment of lymphatic disorders, venous disorders, post- mastectomy lymph-edema and dysfunction of the "Muscle Pump".
The Lympha Press Plus Device is a programmable sequential compression therapy device with compression garments for the treatment of lymphatic and venous disorders. The Lympha Press Plus device consists of a main console and compression garments. The main console contains an air compressor that is regulated by a mechanical air pressure regulator. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments containing up to 12 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.
Acceptance Criteria and Device Performance Study for the Lympha Press Plus Device
This document describes the acceptance criteria and the study that proves the Lympha Press Plus device meets these criteria, based on the provided FDA 510(k) summary.
Evaluation Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria, statistical analysis, and performance metrics as typically found in a clinical trial report for novel devices. Therefore, the information below is derived from the context of substantial equivalence and assumes that the "acceptance criteria" for a 510(k) submission are met by showing similar technological characteristics and intended use to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit for 510(k)) | Reported Device Performance (as per 510(k) justification) |
|---|---|---|
| Intended Use | Device is intended for specific medical conditions. | "Treatment of Lymphatic Disorders, Venous Disorders, Postmastectomy Lymphedema and Dysfunction of the 'Muscle Pump'." |
| Technological Characteristics | Mechanism of action, overall design, materials, mode of operation, and performance characteristics are similar to predicate devices. | "The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Lympha Press Plus device are substantially equivalent to the predicate devices cited above." |
| Safety and Effectiveness | Device is as safe and effective as the predicate devices for its intended use. | Demonstrated by substantial equivalence to legally marketed predicate devices (Lympha Press, Jobst Extremity Pump, Sequential Circulator). The FDA's issuance of a substantial equivalence determination signifies this. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe a specific clinical test set, corresponding sample size, or data provenance (e.g., country of origin, retrospective/prospective). 510(k) submissions for substantial equivalence often rely on comparative analysis of technical specifications, existing clinical data for predicate devices, and sometimes bench testing, rather than a new clinical trial with a "test set" in the context of AI/diagnostic algorithm validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no specific test set or clinical study described in detail, there is no information about experts used to establish ground truth. Substantial equivalence for this type of device typically relies on regulatory review of technical specifications and comparison to predicate devices, not expert consensus on a diagnostic outcome.
4. Adjudication Method for the Test Set
Given the lack of a defined test set for a clinical study, no adjudication method is described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric. The Lympha Press Plus is a therapeutic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Lympha Press Plus is a mechanical therapeutic device, not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" implicitly refers to the established safety and effectiveness of the legally marketed predicate devices (Lympha Press, Jobst Extremity Pump, and Sequential Circulator). The Lympha Press Plus device claims substantial equivalence to these devices, meaning its
"ground truth" for regulatory approval is based on its similarity to products already proven safe and effective through their own regulatory pathways (which could have included clinical trials, post-market surveillance, or pre-amendment status).
8. The Sample Size for the Training Set
The Lympha Press Plus device is a mechanical therapeutic device, not an AI/machine learning model. Therefore, the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a "training set" does not apply to this device.
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