(77 days)
The Game Ready System combines cold and compression therapies. It is intended to treat post-surgical acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
The Game Ready System is comprised of the following components: Control Unit, with AC Adapter (to convert line power to DC input power), Connector Hose (connects Control Unit to Wrap), Wrap (Heat Exchanger + Sleeve), Optional Carry Bag, Optional Battery Pack. The Game Ready System is a DC-powered device that provides intermittent compression and controlled cold therapy by controlling fluid flow and air pressure through a Wrap that is specially designed for a specific body part or location (e.g., shoulder, elbow, knee, ankle, back). A Wrap is comprised of a Sleeve (the outer covering for the Heat Exchanger) and a Heat Exchanger. Cooling is provided by circulating ice water from the Control Unit through the Connector Hose to the Wrap. Compression is provided by an intermittent-cycling pneumatic pump that pumps air from the Control Unit through the Connector Hose to the Wrap. The user can adjust the amount of compression, the amount of cooling, and the treatment time. The Control Unit software is designed to protect both the user and the Control Unit from harm by shutting off the system and sounding an alarm if there is insufficient fluid flow or in case of an over-pressure or under-pressure situation. The software detects other. less-serious error conditions and sounds a warning beep to alert the user, so that the error condition can be corrected. The Game Ready System is available in two configurations: the Game Ready Professional Therapy System (P/N 550100) and the Pre-Programmed Game Ready Professional Therapy System (P/N 550350)
The provided text is a 510(k) Summary for the Game Ready System. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through clinical studies in the same way a novel high-risk device might.
Therefore, many of the requested elements about acceptance criteria, sample sizes, expert ground truth, adjudication, and comparative effectiveness studies are not applicable or not present in this type of document for this specific device.
However, I can extract the information that is available and clarify what is not.
Game Ready System 510(k) Summary Analysis
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific quantitative acceptance criteria or detailed device performance metrics typically found in clinical trials for novel devices. The basis for clearance is "substantial equivalence" to predicate devices, focusing on design, function, and intended use.
The document states:
- "Design Verification Testing showed that the Game Ready System performed according to specification."
- "Bench testing was performed at both the sub-assembly and assembly level. The testing showed that the Game Ready System met its requirements."
However, the specific "specifications" or "requirements" (e.g., target temperature range, compression pressure accuracy, cycle times) are not detailed in this summary.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/not provided. This submission relies on "Bench testing" and "Design Verification Testing" to demonstrate that the device itself performs as expected, not on a test set of patient data.
- Data Provenance: Not applicable. No clinical data or patient data was used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No expert ground truth was established for a test set, as no clinical testing data was used.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method was used for a test set, as no clinical testing data was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The document explicitly states: "No clinical testing data are submitted, referenced, or relied on to determine substantial equivalence." Therefore, no effect size for human readers with or without AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical cold/compression therapy system, not an AI algorithm. Its performance is related to its mechanical and electrical functions, not algorithmic output on data.
7. Type of Ground Truth Used
- This concept is not applicable in the context of this 510(k) Summary. The "truth" being established is that the device functions as designed and is substantially equivalent to existing legally marketed devices, based on bench testing of its physical properties and performance against its own specifications, not against a clinical "ground truth."
8. Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of Device-Specific Information from the Text:
- Device Name: Game Ready System (Game Ready Professional Therapy System, Pre-Programmed Game Ready Professional Therapy System)
- Intended Use: To treat post-surgical acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. To be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
- Components: Control Unit (with AC Adapter), Connector Hose, Wrap (Heat Exchanger + Sleeve), Optional Carry Bag, Optional Battery Pack.
- Functionality: DC-powered, provides intermittent compression and controlled cold therapy by controlling fluid flow and air pressure through a Wrap. User can adjust compression, cooling, and treatment time. Software includes safety shut-offs for insufficient fluid flow, over/under-pressure, and warning beeps for less serious errors.
- Predicate Devices: CRYOPress (K951769) and Polar Care 500 (K961855).
- Basis for Clearance: Substantial Equivalence to predicate devices in design, function, and indications for use/intended use, supported by non-clinical bench testing and design verification testing. No clinical testing was performed or relied upon.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).