(117 days)
The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
The AT2 System utilizes monopolar radiofrequency energy for coagulation and to induce tissue changes in dermatologic and general surgical procedures. It consists of a RF generator, cooling module, handpiece, and sterile disposable single-patient use treatment electrodes. It uses accessories including coupling fluid, return pad, coolant canister, and skin marking paper. The AT2 System applies to specific areas of the body radiofrequency energy while cooling the surface of the tissue in contact with the treatment electrode and uses dielectric as the method of applying radiofrequency via the treatment electrode. This submission adds treatment electrodes that have electrode patient contact surface area of 0.25cm² and 1.50cm².
This document, K120527, is a 510(k) summary for the Alpha Orthopaedics AT2 System. It's a submission for an electrosurgical device and largely focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study demonstrating new performance criteria for this specific submission.
Therefore, many of the typical elements expected in a clinical study for a diagnostic AI device (like acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details) are not present in this type of regulatory submission.
The submission aims to show that the new variations of the AT2 System (with specific electrode sizes) are as safe and effective as previously cleared versions and other legally marketed predicate devices, primarily through technological characteristic comparisons and non-clinical testing.
Here's a breakdown of the information that can be extracted, and an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the context of this 510(k) submission as it's not a clinical study to prove new performance criteria. The submission aims to demonstrate substantial equivalence based on technological characteristics and existing performance of the predicate devices.
The "performance" described leans towards the device's operational principles and safety testing, not diagnostic accuracy.
| Feature | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (as described for Substantial Equivalence) |
|---|---|---|
| Intended Use | Same as predicate devices: Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. | The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis (matches predicate). |
| Operational Principle | Same as predicate devices: Delivers RF energy while cooling the surface of tissue. | The system delivers RF energy while cooling the surface of the tissue in contact with the treatment electrode (identical to predicate). |
| Modes | Same as predicate devices: Monopolar/Bipolar. | Monopolar/Bipolar (identical to predicate). |
| Capacitive/Inductive | Same as predicate devices: Capacitive. | Capacitive (identical to predicate). |
| Operating Frequency | Same as predicate devices: 6 MHz. | 6 MHz (identical to predicate). |
| Treatment Electrodes | Same properties as predicate devices: Sterile, disposable, single patient use. | Sterile, disposable, single patient use. This submission adds 0.25cm² and 1.50cm² electrodes, implying these new sizes maintain the same safety/effectiveness characteristics as existing ones. |
| Tuning | Same as predicate devices: Built-in RF Generator tuning, automated, software-controlled. | Tuning function built into RF Generator and automated Process is software controlled (identical to predicate). |
| Safety | Meets general safety standards and performance of predicate devices. | Biocompatibility, EMC, safety, and bench tests have been completed. (Details of these tests are not provided in the summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission doesn't describe a clinical "test set" in the sense of a dataset used to evaluate diagnostic performance. The evaluation is primarily based on technological comparison, bench testing, and biocompatibility.
- Data Provenance: Not applicable for a clinical test set. The data presented relates to the device's design, operational principles, and results of non-clinical bench testing. No country of origin for clinical data is mentioned because no clinical data is presented for performance evaluation. The submission refers to the predicate devices (K031046 and K082956) as the basis for established safety and effectiveness. The study's design is "retrospective" in the sense that it relies on previously accepted devices and standards, but it's not a retrospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. No clinical test set requiring expert ground truth is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set 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
- MRMC Study: No. This device is an electrosurgical tool, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers interpreting images or data. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a hardware-based electrosurgical system. It doesn't rely on an "algorithm only" performance evaluation in the way an AI diagnostic tool would. Its performance is tied directly to its physical operation and the energy delivery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of this 510(k). The "truth" being established is that the device, with its new electrode sizes, is substantially equivalent in safety and effectiveness to the predicate devices, based on a comparison of technological characteristics and non-clinical testing (biocompatibility, EMC, safety, bench tests).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.