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The SOPRO 670 irrigation pump is a arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures that may only be used by qualified physicians

The SOPR0 670 irrigation pump is a peristaltic pump system designed to automatically provide and control distension and irrigation of the operative site during arthroscopic procedures and fluid irrigation of the operative site during laparoscopic procedures using sterile fluids. The pump is used in conjunction with specific tubing sets designed for arthroscopic procedures.
The Arthroscopy Pump SOPRO 670 is a microprocessor controlled pump system designed to provide liquid distension and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. The Arthroscopy SOPRO 670 consists of the following main components: housing, power supply, roller wheel, pump head, a servo-motor, various setting keys and display elements. The device is to be used with special designed irrigation and suction tubings and a foot-remote control. A constant performed redundant pressure measurement controls the conformity of the actual pressure in the joint cavity with the pre-set nominal pressure.

The provided text describes a 510(k) summary for the SOPRO 670 Arthroscopic Pump, focusing on its substantial equivalence to a predicate device rather than a de novo clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested elements for a study proving acceptance criteria cannot be directly extracted from this document, as this type of submission relies on demonstrating similarity to an already cleared device.

However, based on the information provided, here's what can be inferred or stated about the acceptance criteria and the "study" (in this context, the declaration of compliance and substantial equivalence):

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SOPRO 670 Arthroscopic Pump are implicitly based on its substantial equivalence to the predicate device, the Future Medical Systems FMS DUO (K954465), and compliance with relevant safety standards.

Regarding the study proving the device meets the acceptance criteria:

The "study" in this context is the 510(k) submission itself, which primarily relies on a comparative analysis and declarations of compliance with recognized standards, rather than a new clinical trial or performance study generating novel data.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. No specific test set of patients or data from a prospective study is mentioned for evaluating the performance of the SOPRO 670 Arthroscopic Pump against a predefined acceptance criterion in vivo. The submission relies on the established safety and effectiveness of the predicate device and the new device's compliance with engineering standards.
   • Data Provenance: Not applicable for a clinical test set from this document. The data provenance is primarily from engineering tests to ensure compliance with standards (IEC 601-1, UL60601-1) and comparison with the specifications of the predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. As there's no clinical test set for ground truth establishment in this type of submission, no experts were used in this manner. The ground truth for regulatory clearance in a 510(k) is the established safety and effectiveness of the predicate device and the compliance with recognized standards by the new device.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable, as there was no test set requiring multi-reader adjudication.

4. 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:

   • No. This is a medical device (an arthroscopic pump), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI performance metrics are not relevant or performed for this submission.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable, as this is a medical device (pump) and not an algorithm or AI. The device operates as intended by a qualified physician.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for regulatory clearance of the SOPRO 670 Arthroscopic Pump, in the context of this 510(k) submission, is based on:
     • Predicate Device Performance: The established safety and effectiveness of the FMS DUO (K954465).
     • Compliance with Recognized Standards: Verification through engineering testing and documentation that the SOPRO 670 meets standards such as IEC 601-1 and UL60601-1.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the machine learning sense for this medical device submission. The device's design and engineering are based on established principles of peristaltic pumps and medical device safety/performance.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this device.

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