(29 days)
For Jaw Tracking functions of this device:
- Tracks mandibular movement and position .
- . For the diagnosis of functionaldisorderssuch as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion
- Identification of mandibular rest position .
- Identification of interocclusal distance and freeway space .
- . Monitors the position of the jaw in three dimensions
- Represents the spatial position of the mandibular incisal edge relative to the skull .
For electromyographic function of this device:
- Intended for use for muscles of mastication, especially temporalis, masseter, and digastric ●
- . Designed to perform a limited number of functions in dental diagnosis
- For use as a stand alone system for clinical monitoring of up to eight differentmuscles. it is ■ ideally suited for diagnosis and treatment evaluation by recording function of the muscles of the stomatognathic system
- The determination of the degree of relaxation of a particular muscle or muscle group at rest .
- The precise measurement of relative levels of contraction of several muscles during a ■ functional test
For both functions of this device:
- Diagnosis and management of TMJ/MPD disorders, orthodontic patients, denture patients, . and reconstruction patients.
The addition of the feature described in this new Premarket Notification does not expand upon the above indicated uses.
The Model K6-I Diagnostic System is a surface electromyographic device that measures and records electrical potential emanating from muscle (in addition to its ability to track and document mandibular position/range of motion). The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described above and in the Special 510(k).
The provided document is a 510(k) premarket notification letter from the FDA to Myotronics-Noromed, Incorporated, regarding their Model K6-I Diagnostic System. It primarily addresses the substantial equivalence of the device to legally marketed predicates, especially concerning the addition of a Fast Fourier Transformation (FFT) feature to its software.
The document does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria in a quantitative manner. Instead, it focuses on regulatory clearance based on substantial equivalence.
However, based on the information provided, we can infer some aspects and highlight what is missing:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory context and predicate device comparison) | Reported Device Performance (Inferred from substantial equivalence claim) |
|---|---|
| Functional Equivalence: The added Fast Fourier Transformation (FFT) feature should perform its intended function of transforming captured electromyographic data. | The FFT feature in the Model K6-I software has the same technological characteristics as the FFT features found in the predicate devices (ProComp DSP & ProComp, Myosystem 1000 Electromyograph, I-330 Physiological Monitor). |
| Safety and Effectiveness: The device, with the added FFT feature, should be as safe and effective as the predicate devices for its stated indications for use. | The FDA found the device substantially equivalent to legally marketed predicate devices, implying comparable safety and effectiveness for the stated indications. |
| Indications for Use: The device (with FFT) should remain within the indications for use of the predicate devices. | The added feature (FFT) does not expand upon the previously indicated uses for jaw tracking and electromyographic functions. |
Missing Information from the Provided Document:
The following information, as requested in the prompt, is not present in the provided 510(k) letter:
- Sample size used for the test set and the data provenance: The document does not describe a specific test set or its sample size for evaluating the FFT feature.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment for a test set.
- Adjudication method for the test set: Not applicable as no explicit test set or expert evaluation is detailed.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No MRMC study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as a diagnostic system which implies human interpretation. No specific standalone algorithm performance study is described for the FFT feature.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described for a performance study of the FFT feature.
- The sample size for the training set: The document does not describe a training set as it pertains to software algorithms.
- How the ground truth for the training set was established: Not applicable.
Context from the Document:
- Device Name: Model K6-I Diagnostic System
- Added Feature: Fast Fourier Transformation (FFT) of data to the K6-I Software.
- Method of Proof: Substantial Equivalence. The document states that the new FFT feature "has the same technological characteristics as other legally marketed devices described above and in the Special 510(k)." The predicate devices listed are:
- ProComp DSP & ProComp mfg. by Thought Technology
- Myosystem 1000 Electromyograph mfd. by Noraxon
- I-330 Physiological Monitor mfd. by J & J Engineering
- Indications for Use: The device tracks mandibular movement and position for diagnosis of functional disorders (e.g., TMJ/MPD syndrome, muscle tension), identification of mandibular rest position and interocclusal distance. For its electromyographic function, it's intended for use with muscles of mastication (temporalis, masseter, digastric) for clinical monitoring, determining muscle relaxation, and measuring contraction levels during functional tests. The added FFT feature does not expand these indications.
In summary, the provided FDA letter relies on the concept of substantial equivalence to existing, legally marketed predicate devices rather than detailing a specific, quantitative performance study with explicit acceptance criteria, ground truth, and sample sizes for the new FFT feature. The "study" in this context is the comparison made by the manufacturer (Myotronics-Noromed) and reviewed by the FDA to determine that the technical characteristics of the new feature are comparable to those in existing devices.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).