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Found 22 results
510(k) Data Aggregation
(56 days)
The NanoPress™ 760A-BT pneumatic compression therapy system is indicated for:
- Primary lymphedema
- Secondary lymphedema
- Venous insufficiency
- Venous stasis ulcers
- Dysfunction of the muscle pump
Not Found
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(49 days)
The Ballancer® Platinum is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied. The Ballancer® Platinum System is indicated for: Simulate kneading and stroking of the tissues by use of an inflatable garment. Temporary increase circulation in the areas which the garment is applied Temporary relief of minor muscle aches and pains
The Ballancer® Platinum is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.
The provided text is an FDA 510(k) clearance letter for a medical device called "Ballancer Platinum (1222)." This document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria. It is a regulatory clearance document, not a detailed study report.
Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text because it does not contain this information.
The document primarily focuses on the regulatory aspects of the device, such as:
- Device Name: Ballancer Platinum (1222)
- Regulation Number and Name: 21 CFR 890.5650, Powered Inflatable Tube Massager
- Regulatory Class: Class II
- Product Code: IRP
- Indications for Use: Simulating kneading and stroking, temporary increase circulation, temporary relief of minor muscle aches and pains.
- Type of Use: Over-The-Counter Use
- Regulatory Status: Substantially equivalent to legally marketed predicate devices.
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(108 days)
The Amputee Garment for use with Lympha Press Optimal Plus is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: · Primary Ivmphedema · Secondary Ivmphedema - - · Venous insufficiency - Venous stasis ulcers - · Dysfunction of the muscle pump - · Post mastectomy edema - · Edema following trauma and sports issues - · Post immobilization edema - · Reduction of wound healing time - · Reduction of pain and swelling after injury and surgery - · The device may also be beneficial in the management of Lipoedema
Amputee Garment for use with Lympha Press Optimal Plus
I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "Amputee Garment for use with Lympha Press Optimal Plus." This document describes the device's regulatory clearance and its intended uses, but it does not contain any information about acceptance criteria, a specific study proving device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies (like MRMC or standalone AI performance studies).
Therefore, I cannot provide the requested information based on the input text.
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(76 days)
The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments. The Recovery Pump is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The Recovery Pump simulates kneading and stroking of tissues by using an inflatable garment.
The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments.
The provided text is a 510(k) clearance letter from the FDA for a device called "Recovery Pump, 737R (RPX)." This document explicitly states the regulatory clearance of the device based on substantial equivalence to legally marketed predicate devices.
However, this document does NOT contain information about specific acceptance criteria for a study proving device performance, nor does it describe a study itself.
The letter focuses on:
- Confirming the device's substantial equivalence to predicate devices.
- Stating the intended use/indications for use (found in the enclosure).
- Outlining the general regulatory controls the device must comply with.
Therefore, I cannot extract the requested information from the provided text as it does not contain a description of a performance study with acceptance criteria.
To answer your request, a document detailing device performance testing, such as a summary of safety and effectiveness, clinical study report, or test report, would be required.
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(81 days)
Ballancer® Gold is a pneumatic massage system intended to provide gradient pressure in areas to which the inflatable garment is applied.
The Ballancer Gold is indicated for:
- · Simulate kneading and stroking of the tissues by use of an inflatable garment.
- · Temporary increase circulation in the areas which the garment is applied
- · Temporary relief of minor muscle aches and pains
Ballancer® Gold, Model 1212 is a pneumatic massage system.
This document is an FDA 510(k) clearance letter for the Ballancer® Gold, Model 1212. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to a predicate device and outlines regulatory compliance requirements.
Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory clearance rather than detailed performance study results.
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(216 days)
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:
- Primary lymphedema
- · Secondary lymphedema
- · Venous insufficiency
- · Venous stasis ulcers
- · Dysfunction of the muscle pump
- · Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reducing wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema
The device is intended for hospital, home, and clinic use.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for the "Lympha Press Optimal Plus" device, which is a compressible limb sleeve.
The document discusses the regulatory classification, indications for use, and general controls provisions of the Act that the device must comply with. However, it does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a study proving the device meets acceptance criteria. It also does not mention any multi-reader multi-case studies or standalone algorithm performance.
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(98 days)
The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare professionals, and patients who are under medical supervision, in treating conditions such as:
- · Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
- · Reduction of pain and swelling after injury and surgery
- · Enhancement of venous circulation
- · Prevention of venous stasis
- · Assistance in healing of cutaneous ulcers
- · Reducing edema
- · Treatment of chronic venous insufficiency
The device is intended for hospital, home and clinic use
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Phlebo Press DVT Model 760D" does not contain information about acceptance criteria or a study proving the device meets those criteria.
This document is a standard 510(k) clearance letter, which states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. It briefly mentions the indications for use but does not delve into the specific performance data, clinical trials, or validation studies that would include acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. To answer your question, information from the actual 510(k) submission (which includes performance data, clinical data, and testing protocols) would be needed, not just the clearance letter.
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(89 days)
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:
- Primary lymphedema
- Secondary lymphedema
- · Venous insufficiency
- Venous stasis ulcers
- · Dysfunction of the muscle pump
- Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reduction of wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema
The device is intended for hospital, home, and clinic use.
Lympha Press Optimal Plus Model 912
The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Lympha Press Optimal Plus." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way you've requested.
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and lists the indications for use. It's a regulatory approval document, not a scientific study report.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and study information as they are not present in the provided text.
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(67 days)
The RP Lite 760R is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health.
The RP Lite 760R simulates kneading and stroking of tissues by using an inflatable garment.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "RP Lite 760R". It states that the device is substantially equivalent to legally marketed predicate devices for the indications for use. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The FDA 510(k) clearance process primarily establishes substantial equivalence based on indications for use, technological characteristics, and safety/effectiveness data compared to a predicate device. It does not typically detail the specific performance metrics, acceptance criteria, or the results of the rigorous clinical or technical studies that would be necessary to populate a table like the one requested.
Therefore, I cannot fulfill your request using only the provided text, as the information you're asking for (acceptance criteria, specific study details, sample sizes, ground truth establishment, etc.) is not present in this regulatory clearance letter.
To answer your question, information from a separate submission document (e.g., the 510(k) submission itself, a clinical study report, or a technical performance evaluation document) would be required.
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(111 days)
Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.
The Ballancer 505 System is indicated for:
-
Simulating kneading and stroking of the tissues by use of an inflatable garment
-
Temporary increase circulation in areas which the garment is applied
-
Temporary relief of minor muscle aches and pains
Ballancer® 505 System, Model 1201-AC is a pneumatic massage system.
I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and device performance study details. The text is a letter from the FDA regarding a 510(k) premarket notification for the Ballancer 505 System, Model 1201-AC, and includes its indications for use. It does not include a detailed study report or acceptance criteria for device performance.
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