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510(k) Data Aggregation
(98 days)
The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.
The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:
- General surgical procedures for electrocoagulation and hemostasis .
- . Relief of minor muscle aches and pain
- . Relief of muscle spasms
- Temporary improvement of local circulation (i.e., blood circulation) .
The AT3™ System delivers RF energy while cooling tissue by conduction. Components and accessories include the handpiece with vibration, return pad, electronic footswitch (optional), cryogen canister, coupling fluid, skin marking paper, and treatment electrodes.
The provided text is a 510(k) Summary for the Alpha Orthopaedics AT3™ System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than describing a specific study with acceptance criteria and detailed performance metrics as one might find for a novel diagnostic or AI-driven device.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this document.
Here's a breakdown of what can be extracted or inferred based on the provided text, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary Statement) |
|---|---|
| Safety: Demonstrated through performance, EMC, and safety testing. | "Performance, EMC, safety, and software testing have been completed." |
| Effectiveness: Demonstrated through performance testing and similar technological characteristics to predicate devices. | "The technological characteristics and the results of the performance data demonstrate that the Alpha Orthopaedics AT3 System is safe and effective..." |
| Technological Characteristics: Similar to predicate devices. | "The technological characteristics of the AT3 System are same as the Thermage ThermaCool NXT System." |
| Intended Use: Matches or is substantially similar to predicate devices. | The stated "Intended Use" aligns with general surgical procedures for electrocoagulation and hemostasis, and with the additional uses (minor muscle aches/pain, muscle spasms, local circulation improvement) likely covered by the predicate devices or deemed appropriate for the technology. |
Missing: Specific quantitative acceptance criteria (e.g., specific thresholds for rise in temperature, lesion size, power output within a certain tolerance), and detailed performance metrics (e.g., actual values for power output, temperature, tissue impedance, or a success rate for a specific clinical outcome). The document only states that testing was "completed" and that the device is "safe and effective."
2. Sample size used for the test set and the data provenance
Missing: The document does not describe a clinical "test set" in the context of a study evaluating clinical performance or an AI algorithm. The performance testing mentioned likely refers to bench testing, engineering verification, and validation, not necessarily patient data. Therefore, sample size and data provenance are not applicable or provided in this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing: This information is not relevant to a 510(k) submission based on substantial equivalence for an electrosurgical device, which primarily relies on engineering and safety testing. No "ground truth" using human expert review, as would be common for diagnostic AI, is mentioned.
4. Adjudication method for the test set
Missing: Not applicable for this type of device and submission.
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
Missing: This information is not applicable. The Alpha Orthopaedics AT3™ System is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool for human readers. There is no mention of AI in the general sense, and specifically no MRMC studies or human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Missing: Not applicable. The device is a physical electrosurgical system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing: No "ground truth" in the clinical sense (like pathology or outcomes data) is described for product performance. The ground truth for this type of device would typically be established by established engineering standards, biophysical principles of RF energy, and comparison to the known performance of predicate devices through bench testing.
8. The sample size for the training set
Missing: Not applicable. The device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Missing: Not applicable. The device is not an AI algorithm requiring a training set.
In summary: The provided 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" of a new electrosurgical device to existing, legally marketed predicate devices. It relies on a comparison of technological characteristics, intended use, and general statements about the completion of performance, EMC, safety, and software testing. It does not contain the kind of detailed study information (specific acceptance criteria, sample sizes, ground truth establishment by experts, MRMC studies, or AI performance metrics) that would be expected for a novel diagnostic device or an AI-driven product.
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