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DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode.

DELPHI System is a bipolar, high radiofrequency electrosurgical device designed for coagulation and ablation of tissue and hemostasis during arthroscopic surgery. DELPHI system consists of DELPHI II (Generator), power cable, Mode Footswitch, output Footswitch, DELPHI PLUS (Electrodes) and DISCORE (Electrode). The DELPHI II is an electrically isolated radiofrequency generator designed to deliver power for soft tissue ablation (vaporization) and coagulation procedures in arthroscopic surgery. The DELPHI II offers the operator the flexibility to choose from a range of functional modes using the front panel set-up options. These modes include PETTIE MODE and GRANDE MODE for tissue ablation and coagulation. DELPHI PLUS and DISCORE bipolar electrode is a foot-controlled sterile, single-use electrosurgical electrode intended to deliver radiofrequency energy for coagulation and ablation of tissue and hemostasis during arthroscopic surgery in conjunction with DELPHI System.

This FDA 510(k) clearance letter and summary for the DELPHI System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to its clinical performance.

The document focuses on demonstrating substantial equivalence to a predicate device based primarily on technical characteristics and safety/EMC standards. It explicitly states: "No clinical studies were considered for this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical performance, as it is not present in the provided text.

However, I can extract information related to the technical comparisons and safety testing that were used to establish substantial equivalence.

Here's what can be extracted based on the provided text, categorized as much as possible according to your request, but with the caveat that it does not cover clinical performance:

No Acceptance Criteria or Study for Clinical Performance Found

The provided FDA 510(k) clearance letter and summary does not include any acceptance criteria or details of a study that proves the device meets clinical performance requirements. The document explicitly states: "No clinical studies were considered for this submission."

The clearance is based on demonstrating substantial equivalence to a predicate device through comparison of technical specifications, safety standards compliance, and electromagnetic compatibility.

Key Information Extracted from the Document (Technical & Safety Focus):

Since clinical performance acceptance criteria and studies are absent, the following addresses the safety and technical aspects that were evaluated for substantial equivalence:

1. Table of Acceptance Criteria (Technical/Safety) and Reported Device Performance

Notes on "Similar" points:

• ¹ The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance.
• ² The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance.
• ³ The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance.
• ⁸ Sterilization method differs (EO gas vs Radiation) but is stated to "not affect the efficacy or safety or the devices" as both are for single-use products.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set for Clinical Performance: Not applicable, as "No clinical studies were considered for this submission."
• Test Set for Technical/Safety (e.g., EMC, Electrical Safety): The document does not specify a "sample size" in the traditional sense for these tests. The tests were performed on the DELPHI System itself.
• Data Provenance: Not specified for the technical/safety tests beyond stating they were performed by the manufacturer in accordance with FDA recognized standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. No clinical ground truth was established as no clinical studies were performed or considered. The "ground truth" for substantial equivalence was based on direct comparison of technical specifications against the predicate device and compliance with established technical and safety standards (IEC, ISO).

4. Adjudication Method for the Test Set

• Not applicable. No clinical adjudication was performed as no clinical studies were considered. Technical differences were evaluated by the manufacturer for their impact on safety and effectiveness (e.g., "The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance.").

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not done, as "No clinical studies were considered for this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The DELPHI System is an electrosurgical device, not an AI/algorithm-only device for diagnosis or interpretation. Its performance is inherent to its physical operation. Therefore, this question is not directly applicable in the context of this device type, and no "standalone" performance study in the sense of an algorithm was conducted. The performance was assessed through technical testing and comparison to existing devices.

7. The Type of Ground Truth Used

• For the purpose of this 510(k) submission, the "ground truth" was established by compliance with recognized international standards (e.g., ANSI AAMI ES60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 14971) for electrical safety and EMC, and direct comparison of technical specifications (e.g., output voltage, frequency, types of protection) to the legally marketed predicate device. No clinical, pathology, or outcomes data ground truth was used for this submission.

8. The Sample Size for the Training Set

• Not Applicable. This device is an electrosurgical system, not a machine learning or AI-driven system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set.

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