(259 days)
The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, athletic training settings, and home settings.
Armory Motion is a multimodality software-controlled device designed to provide both a muscle massage and a circulatory thermal therapy.
The Armory Motion is an AC Rechargeable Battery powered device designed to provide cold and intermittent Pneumatic Compression to a treatment site on the user. The device includes a lid with LCD panel, pump and electronics, a reservoir, tubing and a single-patient use, non-sterile, pneumatic air compression joint wrap that can also circulate water (dual bladder), to provide cold thermal therapy in addition to the compression. The Joint wrap can be used to treat the back, elbow, shoulder, foot, ankle, and knee.
The Armory Motion device contains several key parts: A cold-compression pad with a connector hose, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.
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 bladders. The dual 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.
This document, K213097, is a 510(k) premarket notification for a medical device called Armory Motion, which provides cold and compression therapy. The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Breg Polar Care Wave, K183702).
The provided text does not contain detailed acceptance criteria for a study demonstrating detailed device performance against specific metrics using a test set of data with established ground truth. Instead, the "study" demonstrating the device meets acceptance criteria is primarily a comparison with a predicate device and adherence to recognized consensus standards.
The document states:
- "No formal clinical testing was performed on the Armory Motion. The clinical testing is not applicable in this submission."
- "Test results, Risk Analysis, and FMEA analysis show that the new device Armory Motion is safe with no hazard."
- "The new device Armory Motion is designed to comply with relevant safety applicable recognized consensus standards."
- "The output characteristics of Armory Motion are similar to those of predicated device, see Table below."
Given this information, it's clear that a typical "study" proving performance against quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or reader agreement for an AI/diagnostic device (as implied by the detailed questions) was not conducted or presented in this 510(k). The device is a therapeutic device, not a diagnostic one.
However, I can extract the information provided to address your points as best as the document allows, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on technical specifications and safety standards, rather than direct performance metrics against a clinical outcome or diagnostic accuracy.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document establishes "acceptance criteria" through comparison to the predicate device and compliance with recognized standards. Performance is reported through a comparative table.
| Feature / Criteria (Derived from Predicate Comparison) | Acceptance Criteria (Predicate Device K183702) | Reported Device Performance (Armory Motion) | Conclusion |
|---|---|---|---|
| Indications for Use | Treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. Used by/on order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. | Treats post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. Used by a licensed healthcare professional in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings. | Substantially Equivalent |
| Type of Use | Prescription | Prescription | Substantially Equivalent |
| Classification Number | 21 CFR 890.5650; 21 CFR 890.5720 | 21 CFR 890.5650; 21 CFR 890.5720 | Substantially Equivalent |
| Classification Name | Powered Inflatable Tube Massager; Water Circulating hot or cold pack | Powered Inflatable Tube Massager; Water Circulating hot or cold pack | Substantially Equivalent |
| Regulatory Class | Class II | Class II | Substantially Equivalent |
| Product Code | IRP, ILO | IRP, ILO | Substantially Equivalent |
| Classification Panel | Neurological and Physical Medicine | Neurological and Physical Medicine | Substantially Equivalent |
| Therapy | Cold and Compression (work together or independently) | Cold and Compression (work together or independently) | Substantially Equivalent |
| Therapy modes | Manually adjustable mode (cold and two compression settings) | Manually adjustable mode (cold and two compression settings) | Substantially Equivalent |
| Compression Setting | Two levels: Low (0-25 mm Hg), Regular (0-50 mm Hg) | Two levels: Low (0-25 mm Hg), Regular (0-50 mm Hg) | Substantially Equivalent |
| Types of Pads | Various anatomical pads: Knee, Shoulder, Back, Hip, Universal, Foot/Ankle | Various anatomical pads: Knee, Shoulder, Back, calf, Universal/joint, Foot/Ankle | Substantially Equivalent |
| Therapy Temperature Range | 45°F-60°F Cold | 45°F-60°F Cold | Substantially Equivalent |
| Operating fluid and cooling agent | Tap water and Ice | Tap water and Ice | Substantially Equivalent |
| Single User and sterility | Single user and non-sterile | Single user and non-sterile | Substantially Equivalent |
| Line Voltage / Frequency | 100-240 VAC 50/60 HZ | Rechargeable battery and 100-240 VAC 50/60 HZ | Substantially Equivalent |
| Treatment times | Continuous, until turn-off by user | 15, 20, 30, 45 min; compression stops at 30 min max | Substantially Equivalent (despite difference, implies safety/effectiveness maintained) |
| Cooling on/off times | Continuous, until turn-off by user | 15, 20, 30, 45 | Substantially Equivalent (despite difference, implies safety/effectiveness maintained) |
| Pressure Mode | Three | Two compression modes and one cold therapy mode | Substantially Equivalent |
| Power Supply | Power Adapter | 3.7V rechargeable Li-ion Polymer Battery, Power Adapter | Substantially Equivalent |
| Safety Feature | (Implicit: safe operation within parameters) | Malfunction overpressure safety alarm (stops working if pressure >100mmHq, flashes warning) | Enhances safety/Substantially Equivalent |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable as no formal clinical or performance study with a "test set" of data for diagnostic evaluation was performed. The "test set" in this context is the device itself being compared to the predicate device's specifications and standards.
- Data Provenance: Not applicable. The "study" is a technical comparison and demonstration of compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for diagnostic AI (e.g., expert reads, pathology) was not established because no such study was conducted. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the relevant consensus standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process for a test set was performed.
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/diagnostic assistant for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical therapeutic device, not a standalone algorithm. Its performance is inherent in its design and operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) submission is the established safety and performance of the predicate device (Breg Polar Care Wave, K183702) and compliance with recognized consensus standards (listed in the document, e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, etc.).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.