(81 days)
Acculis Accu2i pMTA Applicator with SulisVPMTA Generator software release 2.1.0 is indicated for the intraoperative coagulation of soft tissue.
The Acculis Accu2i pMTA (Mk2) Applicator is a surgically invasive, sterile single patient use device that delivers microwave energy for the purpose of the coagulation of soft tissue and represents modifications of the predicate generally to add an intermediate length and reduce system output power range. Based on the modifications within this submission the generator software will also include respective changes to control the output and add multi lingual capabilities.
The Acculis MTA System as a whole includes the (1) Acculis Accu2i pMTA (Mk2) Applicator, (2) Sulis VMMA Generator with ver. 2.1.0 software, (3) Acculis Local Control Station and (4) optional MTA temperature probes. The Acculis Accu2i pMTA (Mk2) Applicator is a surgically invasive, sterile, single patient use device designed to deliver microwave energy for the purpose of the coagulation of soft tissue.
The Acculis Accu2i pMTA (Mk2) Applicator is available in three lengths 14cm (standard); 19cm (intermediate) and 29cm (long). These lengths permit the user to select the appropriate length to reach the target tissue area. The Acculis Accu2i pMTA (Mk2) Applicator incorporates a bespoke connector which interfaces with the SulisVaMTA Generator via the Acculis pMTA Local Control Station (LCS). The LCS, used to control coolant flow to the applicator, is connected to the generator using a microwave coaxial cable and an integrated 12V power supply and data cable.
The SulisVPMTA Generator is controlled via software version 2.1.0.
The provided text is a 510(k) summary for a medical device called the Acculis Accu2i pMTA (Mk2) Applicator with SulisVpMTA Generator software version 2.1.0. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in a typical research format.
Based on the information provided, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy (as one might expect for a diagnostic AI device). Instead, the performance evaluation in this 510(k) is aimed at demonstrating substantial equivalence to a predicate device.
The "acceptance criteria" here are implied by the claim of equivalence: the proposed device's performance must be "equivalent" or "substantially equivalent" to the predicate device's performance across various physical and functional characteristics.
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Equivalent microwave emitting performance | "The microwave emitting performance of the applicator is unchanged from the predicate design." |
| Equivalent coagulation zone shape and size | "The shape and size of the coagulation zones created were analyzed and compared to that of the predicate. ...These tests demonstrate that the performance of the candidate device is equivalent to that of the predicate." |
| Equivalent coolant flow rates | "Bench testing also included verification of coolant flow rates..." (and implicitly found equivalent) |
| Equivalent surface temperature characteristics | "Bench testing also included verification of... surface temperature..." (and implicitly found equivalent) |
| Equivalent interface compatibility | "Bench testing also included verification of... interface compatibility..." (and implicitly found equivalent) |
| Equivalent calorimetry | "Bench testing also included verification of... calorimetry..." (and implicitly found equivalent) |
| Equivalent skin penetration characteristics | "Bench testing also included verification of... skin penetration..." (and implicitly found equivalent) |
| Equivalent dimensional characteristics | "Bench testing also included verification of... dimensional characteristics." (and implicitly found equivalent) |
| Adherence to applicable IEC 60601 standards | "The designed components were individually verified and validated in the course of establishing adherence to the applicable IEC 60601 standards." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for the "test set" in terms of number of cases or patients. It mentions that "Ex-vivo tissue types were used and coagulations conducted at various power and duration settings."
- Data Provenance: The data used for performance characterization was from ex-vivo tissue types. The origin (e.g., country) of these tissues is not specified, nor is whether the data is retrospective or prospective. Given it's ex-vivo, it's typically prospective testing performed in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The performance testing described is focused on physical and thermal properties (coagulation zone size/shape, temperatures, flow rates) and adherence to standards, which do not inherently require human expert consensus for "ground truth" in the way an AI diagnostic algorithm for image interpretation would. The "ground truth" for this device's performance would be the measured physical outcomes in the ex-vivo tissue.
4. Adjudication Method for the Test Set:
This information is not provided. As noted above, the "ground truth" is based on direct measurements of physical parameters rather than expert interpretation, so an adjudication method among experts is not applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing has not been conducted for either the proposed or predicate devices for the purposes of establishing equivalence." This device is a microwave ablation system, not a diagnostic AI system that would typically undergo MRMC studies to evaluate human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The concept of "standalone performance" as it applies to an AI algorithm without human-in-the-loop is not directly applicable to this device. This is a medical instrument (microwave ablation system), not an AI diagnostic algorithm. Its performance is evaluated based on its physical characteristics and ability to coagulate tissue as intended, which are intrinsic to the device's design and function, not an algorithm's interpretation. The generator software (v2.1.0) is primarily for control, multi-language options, and fault symbology, not for independent diagnostic decisions.
7. The Type of Ground Truth Used:
The ground truth used for the performance testing pertains to the physical and thermal effects of microwave energy on tissue. Specifically:
- Measured coagulation zone dimensions (shape and size) in ex-vivo tissue.
- Measured physical parameters such as coolant flow rates, surface temperatures, calorimetry, skin penetration, and dimensional characteristics.
This is closer to physical measurements/benchmarking rather than expert consensus, pathology, or outcomes data in the usual AI context.
8. The Sample Size for the Training Set:
Not applicable/Not provided. This device is a hardware system with control software, not an AI model requiring a "training set" in the machine learning sense. The software version 2.1.0 primarily updates language options, fault symbology, and power control limits, which are likely derived from engineering specifications and safety testing, not statistical training on a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable/Not provided. As there is no "training set" in the AI sense, there is no corresponding "ground truth" for a training set to be established. The ground truth for the device's functional parameters would be established through engineering design, physical laws, and direct measurement of the device's output.
§ 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.