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The Quadra Bloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.

The Quadra Bloc TENS, Model 101 is a battery powered portable TENS device. The Ouadra Bloc TENS. Model 101 is a prescription device that is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. The device is specifically designed to be small, portable and lightweight so as to not interfere with users movements and/or functions. The electronics unit consists of a housing that contains a battery compartment, display, entry keypad, electronic system, and output channels.

The Quadra Bloc TENS, Model 101 uses four AA alkaline batteries. The display is a single line 16-character alphanumeric display. The entry keypad is used for turning the device on/off, setting parameters on the device, and controlling operation. There are two output channels, designated Left and Right. They have a constant phase relation with each other but are independently set for amplitude. There is a separate two-wire cable for each channel. The electronics consists of a microprocessor (uP) to control and sequence all functions. It also reads the keyboard inputs. Output amplitude and display are under uP control. The electronics also boost the battery voltage to the level required for the stimulation pulse, as well as controls the timing for the pulse width and frequency.

The provided text describes a 510(k) summary for the Quadra Bloc TENS, Model 101 device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with detailed acceptance criteria and performance reports in the comprehensive manner requested in your prompt.

Based on the provided information, I can extract details relevant to a substantial equivalence demonstration, but I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance because this type of detailed clinical study data is generally not part of a 510(k) summary for a TENS device. The 510(k) process for devices like TENS often relies on comparison to predicate devices, electrical safety standards, and performance bench testing rather than extensive clinical efficacy trials.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criteria" in a 510(k) context for this device are that its technological characteristics (e.g., output specifications, intended use, safety) are substantially equivalent to a legally marketed predicate device. This is not a quantitative performance-based acceptance criterion in the way you might find in an AI/imaging device study. Instead, it relies on demonstrating that the new device is as safe and effective as the predicate.
• Reported Device Performance: The document states, "The technological characteristics of the proposed device are substantially equivalent to the identified predicate, Multi-Stim TENS manufactured by Apex Medical Corp. (K973979)." It also mentions, "The output specifications are the same except for minor differences in pulse width range, the number of output modes, net charge per pulse, power supply, maximum phase charge, and maximum power density which do not affect the safety or effectiveness of the device." This indicates that, in the critical performance aspects for a TENS device, the Quadra Bloc TENS is deemed to perform similarly to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: The submission does not describe a clinical "test set" in the context of clinical performance evaluation with human data. The substantial equivalence relies on comparison of technical specifications and intended use to a predicate device.

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 / Not Provided: As there is no clinical "test set" described, there is no mention of experts establishing a ground truth for such a set. The "ground truth" here is essentially the well-established safety and efficacy profile of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided: No clinical test set or adjudication method 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 / Not Provided: This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies with human readers and AI assistance are not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable / Not Provided: This device is a physical medical device (TENS), not an algorithm or AI. Standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Implied Ground Truth: The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the legally marketed predicate device (Multi-Stim TENS, AP-101081T, K973979). The new device is considered safe and effective because its technological characteristics and intended use are substantially equivalent to a device already deemed safe and effective by the FDA.

8. The sample size for the training set

• Not Applicable / Not Provided: This is not an AI device that would have a "training set."

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: See point 8.

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