(193 days)
The SSIR System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for:
- the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm;
- the temporary increase in local circulation; and / or
- the temporary relaxation of muscle.
The SSIR System is a modern, safe, and easy-to-use devices, which provide continuous heat therapy. The SSIR System consists of a power supply that houses the electronics and controls and treatment module (Velcro Strap Model) that contain the infrared radiating element. The power supply is manufactured from a plastic material that is used in similar products currently in commercial distribution by various medical device companies. The power supply houses a green LED light to indicate when the unit is active.
The Velcro Strap Model is a treatment module comprised of a silicon diode in a black anodized aluminum housing with attached velcro straos. The area of this module that comes in contact with the treatment site is covered with black cotton feit.
The provided text describes a 510(k) premarket notification for the SSIR System, an infrared lamp. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance metrics as would be expected for a novel device or a Premarket Approval (PMA) application. Therefore, much of the requested information regarding "acceptance criteria" and "studies proving the device meets acceptance criteria" in terms of clinical performance, sample sizes for test/training sets, expert adjudication, or MRMC studies is not present in the document.
The document primarily discusses the device's intended use, description, and "testing" in a general sense, noting "functional performance testing and electrical safety testing." It concludes that the device "has the same intended uses, with similar functional and performance characteristics" to predicate devices and "performs as intended and does not raise any new safety or efficacy issues." This language refers to the regulatory standard of substantial equivalence, not a clinical superiority or non-inferiority trial against specific clinical endpoints.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: |
- Temporary relief of minor muscle, joint pain, stiffness, arthritis pain, muscle spasm.
- Temporary increase in local circulation.
- Temporary relaxation of muscle. | The SSIR System "has the same intended uses" as predicate devices. |
| Functional/Performance Characteristics: - Emit energy in the infrared spectrum.
- Provide topical heating to elevate tissue temperature.
- Comply with generally accepted therapeutic heat performance specifications. | "Utilizes infrared diodes to generate topical heating."
"Designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration."
"Performs as intended." |
| Safety: - Electrical safety compliance.
- No new safety issues. | "Electrical safety testing" was performed.
"Does not raise any new safety... issues." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "functional performance testing" and "electrical safety testing" but does not detail the nature of these tests, the number of units tested, or if any human subject testing was part of this.
- Data Provenance: Not specified. It's likely these tests were internal to the manufacturer (Russian-American Technology Associates, Inc. in Alabama, USA), but this is not explicitly stated. The nature of a 510(k) for an infrared lamp typically focuses on engineering and bench testing rather than clinical trials with human participant data of the kind where provenance would be a key detail.
- Retrospective or Prospective: Not applicable, as no clinical study with human subjects is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for this type of device (infrared lamp) in a 510(k) context would be based on engineering specifications and compliance with recognized standards, not expert clinical consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process for a clinical test set is described.
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. The device is an infrared lamp for therapeutic heat, not a diagnostic AI system with "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical therapeutic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the SSIR System's performance in this 510(k) submission appears to be based on:
- Engineering specifications and functional testing: Ensuring the device emits infrared, produces heat, and meets electrical safety standards.
- Regulatory compliance: Adherence to 21 CFR 890.5500 (Infrared lamp classification).
- Existing literature and accepted standards: "producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration." This refers to general scientific understanding and regulatory acceptance of therapeutic heat levels, not specific clinical outcomes data for this particular device.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set."
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.