Search Results

The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra Therapy Spectra A1000 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra A1000 is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle pain and/or the temporary relaxation of muscle.

The Spectra A1000 System houses multiple photo energy devices. The photo devices consist of 4 dual [infrared and RED visible] lasers combined with a cluster of 8 visible RED LED's, and 8 Infrared LED's and a yellow indicator lamp.

The Spectra A1000 Laser Therapy Device consists of a docking unit, a USB and laser port, a key port and a key. The laser and light therapy releases radiation with wing wavelengths, all of which fall within the infrared range as defined in 21 CFR 890.5500.

The provided text is a 510(k) Summary for the Spectra Therapy Spectra A1000 Laser Device. It details the device's name, sponsor, predicate device, description, intended use, and substantial equivalence to a legally marketed predicate device.

However, the document does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy, or reader performance). Instead, the submission focuses on demonstrating substantial equivalence primarily through technological characteristics and safety testing (Tissue Temperature and electrical safety and EMC/EMI testing).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth, expert opinions, or MRMC studies because this information is not present in the provided 510(k) summary. These types of studies and criteria are typically associated with devices that have a more complex diagnostic or therapeutic function requiring performance validation against a defined clinical outcome or expert diagnosis, which is not the primary focus of this submission for an infrared lamp for topical heating.

The relevant sections of the document explicitly state that:

• "Tissue Temperature and electrical safety and EMC/EMI testing have been performed demonstrating that the Spectra A1000 Laser Device is safe and effective for its intended use." This points to safety and basic functionality testing, not performance criteria like sensitivity or reader improvement.
• The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." Substantial equivalence in this context is based on comparing the device's technological characteristics and intended use to a predicate, not necessarily on a new clinical study proving performance against defined acceptance criteria for a diagnostic or complex therapeutic claim.

Ask a specific question about this device