(15 days)
The Arthro-Surgimat-2000 ECU is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle and wrist joint cavities under optional voice-activation control during arthroscopic procedures. (21 C.F.R. & 888.1100).
The ARTHRO-SURGIMAT-2000 ECU is a high flow arthroscopic pump intended to distend joint cavities. The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the device Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. GmbH. W.O.M. also claims substantial equivalence to the Surgiflator-20 ECU (K981859) and the Linvatec Apex Universal Inrigation System (K933873).
With the exception of the following modifications, the ARTHRO-SURGIMAT-2000 ECU incorporates the same design features and accessories as the Arthro-Surgimat-1500 (K983910):
- A serial interface has been incorporated in the device to allow for surgeon selection of device settings ● utilizing the HERMES Operating Room Control Center (K980787). The external adjustment capability of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Surgiflator-20 ECU (K981859) manufactured by W.O.M. GmbH
- The maximum flow performance of the device has been increased from 1,5 Vmin. to 2 Vmin. The . flow performance of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Apex Universal Irrigation System (K933873) manufactured by Linvatec Corp.
The provided text is a 510(k) Summary for a medical device (arthroscopic pump) and does not contain the specific information required to complete the detailed table and answer the questions related to acceptance criteria, study design, and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances.
This document is for a hardware device, the ARTHRO-SURGIMAT-2000 ECU, an arthroscopic pump. The review process for such a device primarily focuses on demonstrating substantial equivalence to predicate devices in terms of design, materials, and intended use, rather than rigorous performance metric studies or AI algorithm validation.
Therefore, most of the requested information, such as "acceptance criteria and reported device performance" in the context of diagnostic accuracy, "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set details," is not applicable to this type of device submission and is not present in the provided text.
The document states:
- The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the Arthro-Surgimat-1500 (K983910).
- Modifications include:
Essentially, the "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence to predicate devices based on design and performance specifications (flow rate) for a physical pump, along with literature references describing the utility and safety of arthroscopic techniques.
Here's a breakdown of why the requested information is absent and what is available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as diagnostic performance metrics. The implicit acceptance criteria are that the device performs its intended function (fluid distention up to 2 l/min) safely and effectively, and is substantially equivalent to predicate devices.
- Reported Device Performance:
- Maximum flow performance: 2 l/min (increased from 1.5 l/min of the previous version).
- Integration with HERMES Operating Room Control Center for remote setting selection.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a hardware device. No "test set" of data for diagnostic performance was used. The substantial equivalence relies on engineering specifications and comparison to existing devices.
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)
- Not applicable. No ground truth for a diagnostic test was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is not an AI/SaMD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.