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The Therasage™ Heating Pad is intended to provide topical heating to the user indicated for (a) the temporary relief of minor muscle and joint pain and stiffness: (b) the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains, and sprains, and minor muscular back pain; (c) muscular relaxation; and (d) the temporary increase of local circulation where applied.

The Therasage™ Heating Pad provides infrared heat to different areas of the consumer's body. The Pad consists of an outer application cover enhanced with precious stones. The Pad's cover is fabricated of faux leather and a standard polyfiber fabric blend.

The Therasage Heating Pad is a medical device designed to provide topical heating to the user. The study provided in the document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria through a clinical or performance study. Therefore, detailed information on acceptance criteria and a study proving those criteria are met is not explicitly available in the provided text in the way a traditional clinical trial report would present it.

However, based on the provided text, we can infer the "acceptance criteria" were primarily demonstrating conformity to safety standards and functional equivalence to predicate devices through nonclinical testing and comparison of technological characteristics.

Here's an attempt to structure the information based on your request, with the understanding that direct "acceptance criteria" are not numerically stated and the "study" is primarily a nonclinical comparison and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

• Same intended uses and similar indications.
• Similar technological characteristics (function, design, materials, power source, usage environment, anatomical usage, sterility, environmental compatibility).
• Similar target populations.
• No new questions of safety or effectiveness raised by technological, aesthetic, or ancillary differences. | The Therasage Heating Pad is described as "substantially similar" to the Thermotex Heat Therapy Systems (K092589) and the BIO-MAT 2000 (K072534).
• Function: Distributes far infrared heat to user (same as predicates).
• Design: Small blanket design with jade stones (similar to predicate blanket/mat designs).
• Intended for OTC use: Yes (same as predicates).
• Non-biologic, non-sterile, non-single-use, no drug/biologic content, not implanted: All "No" (same as predicates).
• Uses software: Yes (same as predicates).
• Material: Primarily polyurethane (exterior) and cotton padding (interior) – different from predicates but deemed not to raise new safety/effectiveness questions.
• Electrical Safety: Based upon standards of IEC60601-1, IEC 60601-1-2 (predicates' undisclosed but original approval required compliance with then-applicable standards).
• Power Source: Electrical Current, 100-120v, 5 amps, 45-480w, 50/60 Hz (similar to predicates, varying wattage).
• Where Used: Home, Office, or similar locations (same as predicates).
• Energy Delivered: $35+^{\circ}C$ to $60.5+^{\circ}C$ (within range of predicates).
• Standards Met: ISO 14971, IEC 60601-1, IEC 60601-1-2, ISO 10993/G95-1, ISO 10993-18 (predicates' undisclosed but original approval required compliance).
• FDA Product Code: ILY (same as predicates).
• Target Populations: Persons over 10; persons who are not infants, invalids, unconscious, sleeping, or with poor circulation (similar to predicates).
• Anatomical Usage: Any exterior locations where the application of heat would be helpful (same as predicates).
• Biocompatibility: Testing through NAMSA completed pursuant to ISO 10993-18 (predicates' methods undisclosed but original approval assumed compliance).
• Sterility: None (external use only) (same as predicates).
• Compatibility with Environment: Fully compatible with an inside environment (same as predicates).
• Duration of Use: Personal preference (similar to predicate).
• Max Temp on Skin: 41°C (predicates undisclosed, but within expected therapeutic range).
• Maximum Time Setting: 6 hours (predicates undisclosed).
• Time Setting Intervals: 15 minutes (predicates undisclosed).
• Sizes: Various (14"x20" to 72"x70") (similar to predicates).
• Method of Generating FIR Heat: Electrical wiring and heating element (similar to predicates).
• Safety Features: Auto shut-off on timer; heat sensor for potential overheating; surge protector built into device (similar to predicate features). |
  | Performance Data / Nonclinical Testing:
• Functionality
• Performance
• Safety
• Durability
• Relative Emissivity and Energy Density
• Flammability
• Electromagnetic Compatibility
• Product Risk Evaluation
• General Electrical Safety | The Therasage Heating Pad:
• "functioned as intended and passed all manufacturing tests, including tests for functionability, performance, safety, and durability."
• Passed "routine evaluations during manufacturing and conformance to established standards."
• Results reflect "substantial equivalence with the performance of the two cited predicate devices" from testing for:
  • Relative Emissivity and Energy Density
  • Flammability
  • Electromagnetic Compatibility
  • Product Risk Evaluation
  • General Electrical Safety |

Detailed breakdown of the study information as per your request:

2. Sample size used for the test set and the data provenance
The submission describes nonclinical laboratory bench testing rather than a human clinical test set. The "samples" would refer to the manufactured devices tested.

• Sample Size for Test Set: Not explicitly stated as a number of units. The text refers to "the Pad's performance," "the subject device," and "all manufacturing tests," implying testing was conducted on samples representing the device.
• Data Provenance: Not explicitly stated (e.g., country of origin) but would be from the manufacturer's internal testing labs or contracted testing facilities (e.g., NAMSA for biocompatibility). The tests are entirely retrospective in the sense that they were conducted upon completion of the device design and manufacturing to demonstrate compliance for submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this 510(k) submission. The "ground truth" for the nonclinical tests (e.g., electrical safety, temperature output) is based on established engineering standards and measurements, not expert consensus from human observation. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.

4. Adjudication method for the test set
Not applicable. Nonclinical tests are typically evaluated against predefined specifications or standards by qualified technicians/engineers, not adjudicated by a panel of experts.

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 a heating pad, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an "algorithm only" component in the sense of AI or image interpretation. Its "software" (implied by the "does device use software?" answer) refers to its control interface (LCD screen showing temperature/time, power, fault detection), which is part of the integrated device's functionality, not a standalone algorithm being evaluated. The device's performance is inherently "standalone" in that it functions without human real-time intervention beyond initial settings.

7. The type of ground truth used
For the nonclinical tests:

• Established engineering and safety standards: Such as IEC60601-1, IEC 60601-1-2, ISO 14971, ISO 10993/G95-1, ISO 10993-18.
• Performance specifications: Manufacturer-defined limits for factors like temperature output, emissivity, flammability, and electromagnetic compatibility.
• Predicate device characteristics: The characteristics and approved performance of the Thermotex Heat Therapy Systems (K092589) and the BIO-MAT 2000 (K072534) served as the benchmark for demonstrating substantial equivalence.

8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device or its submission, as it is not a machine learning or AI-based product.

9. How the ground truth for the training set was established
Not applicable, as there is no training set.

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