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The Advanced Spinal Mobilization Instrument (ASMI) is for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device is for external use only.

The Advanced Spinal Mobilization Instrument (ASMI) is a handheld electromechanical device intended for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device operates in three distinct modes: introductory, mobilization, and recovery. The system incorporates a handset connected to a console. The handset consists of a metal body containing pistons and two five-port solenoid-operated valves. The console consists of a filter/regulator/filter (FRF) and a metal case which contains a proportional valve and printed circuit board (PCB). The pads, the only patient contact part, are made of silicon. The system is designed for standard connection to a compressed air source. The equipment is failsafe. The power supply is via a transformer with an output of 1.7 A at 12V. In recovery mode, the ASMI transmits a peak force of 50N. In mobilization mode, the pistons act as air springs or cushions and therefore primarily transmit the mobilizing effort applied by the practitioner.

Here's a breakdown of the acceptance criteria and study information for the Advanced Spinal Mobilization Instrument (ASMI), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in the way one might expect for a diagnostic or imaging device. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through functional and technological comparisons rather than performance against pre-defined numerical thresholds.

However, based on the narrative and comparison chart, we can infer the de facto "acceptance criteria" were alignment with the intended use and technological characteristics of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a "test set" or any clinical study involving human subjects or data analysis in the context of typical device performance evaluation (e.g., measuring accuracy, sensitivity, specificity). The submission for the ASMI is a substantial equivalence determination, which relies on demonstrating that the new device is as safe and effective as already legally marketed predicate devices through comparison of technological characteristics.

Therefore, there is:

• No reported sample size for a test set.
• No data provenance (country of origin, retrospective/prospective) for a performance study, as no such study is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no performance study with a test set generating ground truth is described, this information is not applicable and not provided in the document.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

As no test set or performance study is described, an adjudication method is not applicable and not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or appears to have been conducted for this 510(k) submission. The submission relies solely on a direct comparison of the device's technical specifications and intended use against existing predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical instrument for manual interaction by a healthcare professional. Therefore, the concept of a "standalone algorithm" is not applicable. The device's function is inherently human-in-the-loop.

7. Type of Ground Truth Used

No ground truth as typically understood for diagnostic or AI systems (e.g., pathology, outcomes data) was used for this submission. The "ground truth" equivalent in a substantial equivalence filing for a device like this is the established safety and effectiveness of the legally marketed predicate devices. The ASMI's characteristics are compared to these predicates to demonstrate that it functions similarly and, by extension, is equally safe and effective.

8. Sample Size for the Training Set

Since no AI component or machine learning algorithm is described for the ASMI, there is no training set and therefore no sample size for a training set mentioned.

9. How the Ground Truth for the Training Set Was Established

Given that there is no training set for an AI/ML algorithm associated with this device, this question is not applicable.

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