(44 days)
The Game Ready Classic System is intended to treat post-surgical and 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 licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
The Game Ready Classic 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 (under development) .
The Game Ready Classic 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. These protections have been carried forward from the original Game Ready to Game Ready Classic.
The provided text is for a 510(k) premarket notification for the "Game Ready Classic System," a cold/compression therapy system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with specific acceptance criteria related to a new technology's performance.
Therefore, the information requested in the prompt, which typically applies to studies evaluating the performance of a diagnostic or AI-driven device against predefined acceptance criteria, is not present in this 510(k) submission.
Here's a breakdown of why the requested information cannot be provided from this document:
- No new performance claims: The Game Ready Classic System is presented as substantially equivalent to an existing device (Game Ready System, K071050) already on the market. This means the primary evidence presented is a comparison to the predicate, not a performance study against novel acceptance criteria.
- No clinical testing: The document explicitly states: "No clinical testing data are submitted, referenced, or relied on to determine substantial equivalence." This immediately rules out any studies involving human subjects, ground truth establishment, expert review, or MRMC studies.
- Bench testing for specifications: The "Non-Clinical Testing" section mentions "Bench testing was performed at the component and system level. The testing showed that the Game Ready Classic System met its requirements. Design Verification Testing showed that the Game Ready Classic System performed according to specification." This refers to engineering and quality assurance testing against internal specifications, not externally defined acceptance criteria for clinical performance that would typically be described in the context of diagnostic accuracy, sensitivity, or specificity.
In summary, based on the provided 510(k) summary, the following information is not available:
- A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (like sensitivity, specificity, AUC) are discussed in the context of a clinical study.
- Sample size used for the test set and the data provenance: No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment was conducted as there was no clinical study.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (this is a physical therapy device, not an AI algorithm).
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable (no AI training set).
- How the ground truth for the training set was established: Not applicable.
The "study" that proves the device meets "acceptance criteria" in this context is the comparison to the predicate device and the bench testing demonstrating the device meets its own design specifications, indicating substantial equivalence and safety, rather than a clinical performance study against specific acceptance criteria.
§ 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).