Search Results

The Xrecovery 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.

Device Description

The Xrecovery is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently.

The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.

The device is intended to be used with Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are available for the core regions; back, shoulder, hip, and knee and for the extremity region, foot/ankle. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.

The insulated container is filled with ice and water by the user. The water circulates through the cold- compression pad to deliver cold therapy to the application site.

The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional

AI/ML Overview

This document is a 510(k) summary for the Xrecovery (XR-001), a powered inflatable tube massager. The information provided focuses on demonstrating substantial equivalence to a predicate device (Polar Care Wave, K183702), rather than detailing a study that proves the device meets specific acceptance criteria for a new and novel AI-enabled medical device.

Therefore, many of the requested elements for an AI-specific study are not present in this document. This device is a traditional medical device, not an AI-enabled one.

However, I can extract the general acceptance criteria and performance data for this physical medical device and explain why specific AI-related details are missing.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

The document primarily relies on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" are implied by the ability to meet relevant performance standards and demonstrate comparable technological characteristics to the predicate.

Acceptance Criterion (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Table on Page 6)
Intended Use Equivalence:	The Xrecovery's intended use is SE (Substantially Equivalent) to the predicate: "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."
Indications for Use Equivalence:	The Xrecovery's indications for use are SE to the predicate and match the intended use statement.
User Appropriateness:	Intended users are SE (Health Care Professionals and lay users (under prescription)).
Environment Appropriateness:	Intended use environment is SE (Intended for indoor use).
Therapy Modalities:	Offers SE therapies: Cold and Compression (can work together or independently).
Therapy Sessions/Modes:	Supports SE "Manual mode – allows the user to adjust cold and compression settings as directed by a Health Care Professional."
Anatomical Pad Types:	Offers SE various anatomical pads (Knee, Shoulder, Back, Hip, Universal, Foot/Ankle).
Compression Setting Levels:	Two levels available (Low (0-25 mmHg) and Regular (0-52 mmHg)), which is SE to the predicate's 0-50 mmHg range.
Cold Therapy Options:	Available without and with compression (Low and Regular), which is SE.
Therapy Temperature Range:	45°F-60°F, which is SE.
Absence of Heat Therapy:	"Not Available," which is SE.
User Interface:	"Keypad with indicator lights," which is SE.
Operating Fluid:	"Tap Water," which is SE.
Water Cooling Source:	"Ice," which is SE.
Single User Cold Compression Pad:	"Yes," which is SE.
Cold Compression Pad Sterility:	"Non-Sterile," which is SE.
Electrical Safety & EMC Compliance:	Tested and found to comply with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11.
Biocompatibility:	Patient-contacting components tested to ISO 10993-5, ISO 10993-10, and ISO 10993-23. Results demonstrated non-cytotoxic, non-sensitizing, and non-irritating.
Software Verification & Validation:	Conducted as per FDA guidance for "Moderate" level of concern.
General Performance (Bench Testing, Use Life Testing):	"Passed all testing in support of the substantial equivalence determination."

AI-Specific Study Details (Not Applicable for this Device)

The Xrecovery (XR-001) is a physical medical device (Powered Inflatable Tube Massager) that performs cold and compression therapy. It is explicitly described as "AC powered, software controlled." The software controls the pumps and therapy settings but there is no indication it uses AI, machine learning, or performs any diagnostic or predictive functions that would necessitate the in-depth AI-specific study details requested.

Therefore, the following points are not applicable (N/A) based on the provided document:

Sample size used for the test set and the data provenance: N/A as no AI/ML model for diagnostic/predictive tasks is described. The device underwent general performance, electrical safety, biocompatibility, and software V&V testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment for medical imaging or AI diagnostic output is not relevant for this device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: N/A. This is a non-AI therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device's performance relates to its physical parameters (e.g., temperature, pressure, electrical safety, biocompatibility) rather than diagnostic accuracy.
The sample size for the training set: N/A. No AI model is described.
How the ground truth for the training set was established: N/A. No AI model is described.

In summary, the provided FDA 510(k) summary is for a traditional, software-controlled physical therapy device, not an AI-enabled medical device. As such, the study details requested for AI performance are not part of this submission. The "study" described in the document primarily consists of non-clinical bench testing, biocompatibility testing, electrical safety and EMC testing, and software verification and validation, all aimed at demonstrating that the device is as safe and effective as its predicate.

Ask a Question

Ask a specific question about this device

Page 1 of 1