(276 days)
The VSTAAR is a mechanical device intended to be used by chiropractors, medical doctors and other licensed health care professions for the external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization.
The VSTAAR AdjusteR is a mechanical device used by chiropractors, medical and other licensed health care professionals for the external analysis and adjustment of the human spinal column, and for soft tissue and musculoskeletal mobilization. The graphical user interface is mouse driven. All of the screens are easy to find and easy to understand. Navigating from screen to screen is quick and intuitive.
The provided text describes a 510(k) premarket notification for the VSTAAR AdjusteR device, seeking substantial equivalence to existing predicate devices. The submission focuses on non-clinical performance data and electrical safety testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the VSTAAR AdjusteR in terms of performance metrics like sensitivity, specificity, or accuracy, which are common for diagnostic or AI-driven devices. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical testing.
The performance reported is primarily confirmation of meeting design specifications and intended uses, with electrical safety and electromagnetic compatibility being verified against international standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to device specifications | The performance data records documents that the VSTAAR AdjusteR device met its stated requirements and design specifications as intended. |
| Conformance to intended uses | Validation testing... to confirm the device met its intended uses and requirements. |
| Electrical Safety (IEC 60601-1) | Tested in conformance with IEC 60601-1 / EN 60601-1 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995), by Intertek, Twinsburg, OH. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Tested in conformance with IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, by a Keystone Compliance, New Castle, PA. |
| Similar Technological Characteristics to Predicates (Implicit) | As demonstrated by the "PRODUCT COMPARISON TABLE" on page 8, the VSTAAR AdjusteR has similar IFU, power source, force settings, applicator tip velocity, pulse rate, range of displacement, duration of force, max count of impulses to predicate devices, with differences in method of delivering thrust force, patient-contacting material, and sensor within handheld device noted to not adversely affect safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "significant verification and validation testing" and "performance data records". However, it does not specify any sample sizes for a test set, nor does it refer to patient data or its provenance (country of origin, retrospective/prospective). The testing described is non-clinical, focusing on device performance specifications and safety standards.
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)
This information is not applicable and not provided in the document. The testing described is non-clinical laboratory testing, not human subject or diagnostic performance studies that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As above, the testing is non-clinical and does not involve subjective assessment requiring adjudication.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device, VSTAAR AdjusteR, is a mechanical adjusting instrument, not an AI or imaging device that would typically leverage such studies to evaluate human reader improvement with AI assistance. The document is entirely focused on the mechanical and electrical safety/performance of the device itself, not its impact on human diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the VSTAAR AdjusteR as described. The device is a mechanical instrument used by healthcare professionals. It is not an algorithm, nor an AI system capable of "standalone" performance in the sense of a diagnostic or assistive software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance and safety testing, the "ground truth" would be the established engineering specifications, test procedures, and international standards (e.g., IEC 60601-1, IEC 60601-1-2) that the device was tested against. The document does not describe any studies involving expert consensus, pathology, or outcomes data, as these are typically associated with clinical efficacy or diagnostic accuracy studies, which are not detailed here.
8. The sample size for the training set
This information is not applicable and not provided. The VSTAAR AdjusteR is a mechanical device, not a machine learning or AI model, thus it does not have a "training set" in that context.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reasons stated in point 8.
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