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The Aquilo Sports CCT1500 System is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The CCT1500 simulates kneading and stroking of tissues by using an inflatable garment.

This submission is for the Aquilo Sports CCT1500 System is a powered inflatable tube massager. It is being submitted as an over the counter device. The device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The CCT1500 simulates kneading and stroking of tissues by using an inflatable garment. The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or integral battery pack. The CCT1500 consists of an air compressor unit with a control system, an inflatable "boot" for the leg, plastic air tubing with a proprietary connector for connecting the device to the boot. The user interface is a front panel display and buttons. The CCT1500 contains an air compressor with a system control that that allows the user to adjust the amount of air coming from the air compressor and going to the individual segments of the inflatable boot. There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.

Here's a breakdown of the acceptance criteria and study information for the Aquilo Sports CCT1500 System, based on the provided FDA 510(k) summary:

This device is a Powered Inflatable Tube Massager (Product Code: IRP) and is classified as a Class II medical device. The 510(k) process is used to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving novel safety and efficacy from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to the predicate device through comparisons of indications for use, technological characteristics, safety features, and performance specifications.

Since this is a GHTF Class B (Class II equivalent) device and the submission focuses on substantial equivalence, the "study" is primarily a comparative analysis against a cleared predicate device, rather than a clinical trial with human subjects or a standalone AI performance study.

1. Table of Acceptance Criteria (Comparisons) and Reported Device Performance

The "acceptance criteria" for a 510(k) submission seeking substantial equivalence are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by comparing various characteristics.

Context of the "Study" and Acceptance

The "study" in this 510(k) submission is not a traditional clinical trial or an AI/ML algorithm validation study. It is a demonstration of substantial equivalence through a detailed comparison to a legally marketed predicate device (Rapid Reboot K182668) and a reference device (NormaTec K160608 for treatment time).

The acceptance criteria are effectively met by demonstrating that:

• The indications for use are identical.
• The technological characteristics are sufficiently similar or that any differences do not raise new questions of safety or effectiveness.
• The performance specifications are comparable or that any differences still maintain safety and effectiveness for the intended use.
• The device complies with relevant recognized consensus standards.

Specific Information Not Applicable or Not Provided in this Document for a 510(k) for this type of device:

Given that this is a 510(k) for a powered inflatable tube massager and relies on substantial equivalence to a mechanically similar predicate, many of the requested items (especially those related to AI/ML or complex clinical studies) are not applicable or typically required to establish substantial equivalence for this specific type of device.

2. Sample size used for the test set and the data provenance: Not applicable in the context of comparative performance for this type of device. The "test" is the comparison against the predicate and compliance with standards.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable for this type of device/submission. Ground truth for a massager is generally its mechanical function, safety, and performance within design specifications, which is verified through bench testing and standards compliance, not expert clinical interpretation of complex data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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/ML diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this massager is established by its physical and mechanical performance (e.g., pressure range, cycle time, safety features) verified through bench testing and compliance with recognized electrical safety and EMC standards (ES 60601-1, IEC 60601-1-2, IEC 60601-1-11). The acceptance criteria are based on this technical performance being comparable to the predicate.
8. The sample size for the training set: Not applicable (not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (not an AI/ML device).

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Intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated area in people who are in good health.

Bio Compression Systems' Sequential Circulators are powered inflatable tube massagers which consist of a segmented pneumatic sleeve ("garment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The sequential inflation of the garment simulates kneading and stroking of tissues with the hands, increasing circulation on the limb worn.

The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch.

The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL).

The device uses the Predicate Device's garments.

The provided text is a 510(k) Pre-market Notification for a medical device (Sequential Circulators) and does not contain information about a study with acceptance criteria and reported device performance in the context of diagnostic accuracy, which would include details about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data for safety and electrical compatibility, and functional verification, rather than a clinical efficacy or diagnostic accuracy study.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in the format of diagnostic metrics (e.g., sensitivity, specificity, AUC) or a study proving those criteria are met. Instead, it lists technical standards and verification testing.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the device itself being tested against technical standards, not a dataset of patient cases.

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 diagnostic accuracy is not relevant here.

4. Adjudication method for the test set: Not applicable.

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 not an AI/diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" for this device's performance relates to compliance with engineering and safety standards, and functional specifications.

8. The sample size for the training set: Not applicable. This is not a machine learning/AI device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Powerpress Recovery Unit is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The Powerpress Recovery Unit simulates kneading and stroking of tissues by using an inflatable garment.

Powerpress Recovery Unit is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components.
Pneumatic Manual / Analog Pump.
Limb Sleeve or garment composes of 4 chambers
Powerpress Recovery Unit enables different treatment pressure (30 ~ 100mmHg). 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 chamber 2, 3 & 4 are individually lowered according to the default factory setting.
Gradient: appx 7%, example: Foot 60mmHg – Ankle 56mmHg – Calf 52mmHg - Thigh 48mmHg Cycle Time: Inflation 36 sec / Deflation 24 sec Inflation time each chamber : 1st chamber(foot) – 36 sec, 2nd chamber(ankle) – 27 sec, 3rd chamber(calf) - 18 sec, 4th chamber(thigh) - 9 sec
A calibrated dial gauge displays pressure in the range of 0 ~ 160 mmHg

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Powerpress Recovery Unit." This type of document is for demonstrating substantial equivalence to a previously cleared device, not typically for proving clinical efficacy or meeting specific performance acceptance criteria through the kind of study structure you've described for an AI/ML device.

Therefore, the information you've requested regarding acceptance criteria, study design for proving device performance (like sample size, number of experts, adjudication, MRMC, standalone performance, ground truth establishment for training and test sets), is not present in this document.

Here's why and what information is available:

The FDA's 510(k) pathway (as indicated by the K202044 number) is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves:

• Comparing Indications for Use: Are they the same or very similar?
• Comparing Technological Characteristics: How does the new device work compared to the predicate? Are any differences significant enough to raise new questions of safety or effectiveness?
• Performance Testing: This usually refers to bench testing (like electrical safety, electromagnetic compatibility, usability, etc.) to ensure the device performs as intended and is safe, but typically not clinical studies designed to show therapeutic efficacy or diagnostic accuracy against a ground truth in the way you've outlined for AI/ML performance.

Specifically, regarding your questions in the context of this document:

• 1. A table of acceptance criteria and the reported device performance: This document does not contain such a table for clinical performance. It presents a "Substantial Equivalence Comparison Table" (Section K) that lists characteristics of the subject device and the predicate device to argue for equivalence. The "performance" mentioned (O. Conclusion) refers to "specifications / performance and compliance with international standards," which points to the bench testing listed in Section N.
• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. No clinical ground truth establishment is described.
• 4. Adjudication method ... for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This type of study is common for diagnostic AI tools, but this device is a therapeutic massager.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical massager, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable. This device does not use an AI/ML model that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide related to performance and justification:

• Benchmark Testing (Section N): The device was tested against recognized standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11) and a skin sensitization test (ISO 10993). These are the "performance tests" for this type of device, focusing on safety and basic function, not clinical outcomes for aches/pains or circulation.
• Claim of Equivalence for Pressure Range (Section J): The device has a pressure range of 30-100 mmHg, while the predicate has 20-80 mmHg. To address this difference, the applicant explicitly points to other FDA-cleared devices (Recovery Pump 737R and NormaTec Pulse/Pulse Pro) which have overlapping or higher pressure ranges (20-100 mmHg and 30-110 mmHg respectively) and are also Over-The-Counter (OTC). This is their evidence that the different pressure range "raises no new questions of safety and effectiveness."
• No Clinical Testing (Section N): The document explicitly states: "Clinical: No clinical testing was performed."

In summary: The provided FDA document pertains to a physical medical device (a powered inflatable tube massager) seeking 510(k) clearance based on substantial equivalence. It does not involve AI/ML, and therefore, the detailed study design and acceptance criteria for algorithm performance you are asking about are not relevant to this specific submission and are not present in the text. The "acceptance criteria" for this device are its ability to meet electrical and usability safety standards and to demonstrate substantial equivalence to a predicate device in its intended use and technological characteristics.

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The NormaTec PCD-T and NormaTec PCD-B are intended to apply pressure to the extremities to treat:

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 to prevent:

Deep Vein Thrombosis

The NormaTec PCD-T and PCD-B are designed to provide noninvasive air compression therapy for the treatment of lymphedema, venous insufficiency, other edemas, and venous stasis ulceration and to prevent deep venous thrombosis.

They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.

The NormaTec PCD-T and PCD-B consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.

The inflatable leg and arm "appliances" and the plastic air tubing are of the same general design and constructions as those cleared in the predicate NormaTec PCD (K013436) the materials are identical. The hip appliance is identical to that in NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608 and uses identical materials. Additionally, the air compressor, valve control are similar to the predicate NormaTec PCD (and are identical to the NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608)

The user interface on the PCD-T model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the PCD-B model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.

The provided document is a 510(k) summary for the NormaTec PCD-T and NormaTec PCD-B devices. This type of regulatory submission seeks to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for device performance studies, sample sizes for test sets, expert-established ground truth, MRMC studies, standalone performance, training set details) is generally not part of a 510(k) submission unless the device introduces new technology or indications for use that differ significantly from the predicate.

In this specific document, the manufacturer relies on a comparison to a predicate device (NormaTec PCD, K013436) and a reference device (NormaTec Pulse and Pulse Pro, K160608) to establish substantial equivalence. Performance testing mentioned is primarily bench testing and compliance with electrical safety and electromagnetic compatibility standards.

Here's an analysis based on the provided text, addressing your questions where information is available:

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

The document does not explicitly state quantitative acceptance criteria for device performance studies in the way you might expect for a novel device proving efficacy. Instead, the "performance" is largely demonstrated by showing substantial equivalence to the predicate device and compliance with relevant safety standards.

The closest we get to "reported device performance" in relation to acceptance criteria is the statement under "Performance Testing": "The device has been tested to ensure that it all requirements have been met, this includes:

• Testing of all controls
• Testing of all indicators
• Testing of battery state indicators
• Testing of performance
• Testing of hazard mitigations"

However, no specific performance metrics (e.g., pressure accuracy, cycle timing accuracy with defined thresholds) or the results against them are provided in this summary. The "acceptance criteria" here implicitly refers to the device functioning as intended and matching the performance characteristics of the predicate, as well as meeting the requirements of the standards listed.

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 applicable/not provided. The performance testing described is bench testing, not a study involving human subjects or collected data sets in the typical sense.
• Data Provenance: Not applicable/not provided.

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

Not applicable/not provided. "Ground truth" is typically established in clinical or diagnostic studies. For these devices, the "ground truth" for demonstrating substantial equivalence is the predicate device's established safety and performance.

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

Not applicable/not provided. No clinical test set requiring 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/not provided. This is not an AI-enabled diagnostic device, and no MRMC study was conducted.

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

Not applicable/not provided. This is a physical medical device (compressible limb sleeve), not an algorithm or AI.

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

Not applicable. For this 510(k) submission, the "ground truth" for regulatory clearance is the substantial equivalence to the predicate device, which has already been deemed safe and effective for its intended uses. The performance testing focuses on ensuring the new device operates similarly and meets safety standards.

8. The sample size for the training set

Not applicable/not provided. This is a physical device, not a machine learning model.

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

Not applicable/not provided.

Summary of what was included and relevant for a 510(k) submission:

• Predicate Device Comparison Table (Pages 7-8): This is the core of the substantial equivalence argument. It directly compares the new devices (PCD-T and PCD-B) to the predicate device (PCD K013436) across several attributes, including:

  • Indications for Use (Identical)
  • Contraindications (Identical)
  • Prescriptive (Identical)
  • Power Source (New devices have optional integrated battery)
  • Software/Firmware/Microprocessor Control (Same control technology)
  • Technology (Identical compressor and valve system)
  • Compliance with Voluntary Standards (New devices comply with updated standards and a home use standard)
  • Device Pressure range (Identical)
  • Treatment Time (New devices have added ability to time treatment)
  • Inflation/deflation cycle type (Identical)
  • Appliance contact surface material (Identical)
  • Number of Inflatable appliance segments (Identical)
  • Weight and Dimensions (Similar, new devices are lighter/smaller)
  • Housing Materials and Constructions (Similar)
  • Patient contact (Identical)
  • Appliances (New devices use leg/arm appliances from K013436 and hip appliance from K160608)

• Performance Testing (Page 9):

  • Bench Testing: Described as ensuring "all requirements have been met," including controls, indicators, battery state, overall performance, and hazard mitigations. No specific quantitative criteria or results are provided in this summary.
  • Standards Compliance:
    • AAMI / ANSI ES60601-1:2005 (Medical electrical equipment - basic safety and essential performance)
    • IEC 60601-1-2: 2007 (Electromagnetic Compatibility)
    • IEC 60601-1-11: 2010 (Home healthcare environment)

• No Animal Testing or Clinical Testing was performed.

The conclusion explicitly states "The NormaTec PCD-T and PCD-B are substantially equivalent to the predicates in: indications for use, contraindications, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness." This statement, along with the detailed comparison table and standards compliance, forms the basis of the "proof" that the device meets the implicit acceptance criteria for a 510(k) clearance.

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