Search Results

Date Cleared

2019-05-15

(76 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

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.

Device Description

The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments.

AI/ML Overview

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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K Number

K190015

Device Name

Ballancer Gold, 1212

Manufacturer

Date Cleared

2019-03-25

(81 days)

Product Code

Regulation Number

Type

Panel

Lympha Press Optimal Plus

Reference & Predicate Devices

N/A

Intended Use

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

Device Description

Ballancer® Gold, Model 1212 is a pneumatic massage system.

AI/ML Overview

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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K Number

K182003

Device Name

Manufacturer

Date Cleared

2019-02-27

(216 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

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.

Device Description

Not Found

AI/ML Overview

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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K Number

K172277

Device Name

Phlebo Press DVT Model

Manufacturer

Lympha Press Optimal Plus

Date Cleared

2017-11-03

(98 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

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

Device Description

Not Found

AI/ML Overview

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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K Number

K170658

Device Name

Manufacturer

Date Cleared

2017-05-31

(89 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

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.

Device Description

Lympha Press Optimal Plus Model 912

AI/ML Overview

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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K Number

K163280

Device Name

RP Lite 760R

Manufacturer

Date Cleared

2017-01-27

(67 days)

Product Code

Regulation Number

Type

Special

Panel

Ballancer 505 System, Model 1201-AC

Reference & Predicate Devices

N/A

Intended Use

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.

Device Description

Not Found

AI/ML Overview

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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K Number

K150269

Device Name

Manufacturer

Date Cleared

2015-05-26

(111 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

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

Device Description

Ballancer® 505 System, Model 1201-AC is a pneumatic massage system.

AI/ML Overview

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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K Number

K142772

Device Name

Phlebo Press DVT 603

Manufacturer

Date Cleared

2014-12-16

(82 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The Phlebo Press DVT 603 is intended for use by medical 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
Reduction of compartmental pressures
The device is intended for hospital, home and clinic use

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Phlebo Press DVT 603". This correspondence primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailing a specific clinical study with acceptance criteria and performance data for the Phlebo Press DVT 603 itself.

Therefore, I cannot directly extract the specific information requested about acceptance criteria and a study proving the device meets those criteria from this FDA letter. The letter confirms a regulatory determination of substantial equivalence, which is a different type of assessment than a detailed clinical performance study.

Typically, such information would be found in a separate clinical study report or a different section of the 510(k) submission that details performance testing.

However, based on the information provided:

I can state that the document does not contain the detailed information required to fill out the table about acceptance criteria and device performance, nor the specifics about sample size, data provenance, ground truth establishment, or clinical study design (MRMC, standalone) for the Phlebo Press DVT 603.

To answer your request, if this were a document that did contain the study details you're looking for, the information would ideally be presented as follows:

Acceptance Criteria and Device Performance Study for [Device Name - Hypothetical Example]

Since the provided document is a 510(k) clearance letter and does not contain the specific study details you've requested regarding acceptance criteria and performance, I will provide a framework of how this information would typically be presented in a suitable document.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
[e.g., Sensitivity]	[e.g., ≥ 90%]	[e.g., 92.5% (95% CI: 90.1-94.4%)]
[e.g., Specificity]	[e.g., ≥ 80%]	[e.g., 85.2% (95% CI: 82.3-87.7%)]
[e.g., Accuracy]	[e.g., ≥ 85%]	[e.g., 88.0% (95% CI: 86.1-89.8%)]
[e.g., Cohen's Kappa]	[e.g., ≥ 0.70]	[e.g., 0.75]
[e.g., Time to Result]	[e.g., ≤ 5 minutes]	[e.g., Average 3.2 minutes]
[e.g., Mechanical Reliability (Cycles)]	[e.g., > 1,000,000 cycles]	[e.g., 1,500,000 cycles without failure]

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

Test Set Sample Size: [Insert number of cases/patients, e.g., 500 cases, 300 patients]
Data Provenance: [e.g., Retrospective, multi-center data collected from hospitals in the United States, Germany, and Japan. OR Prospective, single-center study conducted in the United Kingdom.]

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

Number of Experts: [e.g., 3]
Qualifications of Experts: [e.g., Board-certified Radiologists with 10-20 years of experience in diagnostic imaging, specializing in vascular studies. OR Board-certified Pathologists with 15+ years of experience in histopathology.]

4. Adjudication method for the test set

Adjudication Method: [e.g., 2+1 adjudication (two experts independently review, with a third expert adjudicating discordant cases). OR Majority vote among 3 experts. OR Consensus meeting among all experts.]

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 Done?: [Yes/No]
Effect Size (if Yes): [e.g., "Human readers improved their AUC by an average of 0.08 (from 0.82 to 0.90) when using AI assistance, representing a statistically significant improvement (p

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K Number

K140519

Device Name

RECOVERY PUMP 737R

Manufacturer

MEGO AFEK AC LTD

Date Cleared

2014-06-16

(108 days)

Product Code

Regulation Number

Type

Panel