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The UltrAblator Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Areas of application include knee, shoulder, ankle, wrist and elbow arthroscopic procedures.

The UltrAblator Electrode is a sterile, single-use monopolar electrode that is connected to an electrosurgical generator via an electrosurgical pencil. The modification to the UltrAblator Electrode described in this 510(k) is a change to the insulation material. This modification does not affect the indications for use, operational instructions, performance specifications or labeling.

The provided text is a 510(k) Summary of Safety and Effectiveness for the UltrAblator Electrode. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way one might find for a novel diagnostic or AI-based device.

Here's a breakdown of the information requested, based on the provided text, and where gaps exist due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the form of a table. Instead, it makes a general claim:

Since this is a modification to an existing device (a change in insulation material), the focus is on maintaining the established safety and effectiveness of the existing device. There aren't new performance claims that require specific, quantifiable acceptance criteria to be met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test set or the data provenance. It only mentions "performance testing."

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)

This information is not applicable and is not provided. The device is an electrosurgical electrode, and its "performance testing" would likely involve engineering and biocompatibility evaluations, not ground truth established by medical experts in the context of diagnostic interpretation.

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

This information is not applicable and is not provided. Adjudication methods are typically relevant for studies involving subjective interpretation, often in diagnostic imaging or clinical trials, which is not the nature of this submission.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices. The UltrAblator Electrode is a surgical tool, not a diagnostic AI.

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

This information is not applicable. The device is a physical surgical electrode, not an algorithm.

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

This information is not provided. Based on the nature of the device (electrosurgical electrode), "ground truth" would likely relate to engineering specifications (e.g., insulation integrity, electrical performance) or biocompatibility testing results rather than clinical diagnoses.

8. The sample size for the training set

This information is not applicable and is not provided. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable and is not provided. There is no training set for this type of device.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The document states, "Performance testing has been conducted to show that the new design does not raise any new issues regarding safety and effectiveness." (Page 2). It also emphasizes that the modification (change to insulation material) "does not affect the indications for use, operational instructions, performance specifications or labeling" (Page 2).

This implies that the study conducted was a benchtop or laboratory performance test aimed at confirming that the new insulation material does not negatively impact the established performance and safety characteristics of the original UltrAblator Electrode. Specifically, the study would have focused on ensuring that the new insulation material maintained:

• Electrical isolation properties: To ensure safe and effective energy delivery without leakage or unintended arcing.
• Biocompatibility: To ensure the material is safe for contact with human tissue.
• Mechanical integrity: To ensure the insulation remains intact during use.
• Thermal properties: To ensure proper heat dissipation and prevent overheating.

The study's primary objective was to demonstrate substantial equivalence to the predicate device, meaning it performs similarly and presents similar safety and effectiveness profiles. The nature of the device (a surgical electrode with a material change) means the "study" would be a series of engineering and material science tests, not a clinical trial or an AI validation study.

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The UltrAblator™ Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:
Knee

1. Meniscectomy
2. Lateral Release
3. Chondroplasty
4. Synovectomy
5. ACL Debridement
6. Plica Removal
7. Meniscal Cystectomy
   Ankle
8. Fracture Debridement
9. Excision of Scar Tissue
10. Synovectomy
11. Chondroplasty
    Wrist
12. Synovectomy
13. Cartilage Debridement
14. Fracture Debridement
    Shoulder
15. Labral Tear Resection
16. Synovectomy
17. Excision of Scar Tissue
18. Acromioplasty
19. Bursectomy
20. Subacromial Decompression
21. Chondroplasty
    Elbow
22. Synovectomy
23. Tendon Debridement
24. Chondroplasty

The UltrAblator™ Electrode is a monopolar electrode which will be packaged individually or in a kit containing an UltrAblator™ Electrode, ConMed electrosurgical pencil, and a ConMed electrosurgical dispersive pad. The electrode is connected to an electrosurgical generator via the ConMed electrosurgical pencil. The device is inserted into the joint. Upon activation of the generator, the tip of the device electrosurgically ablates and coagulates tissue.
The UltrAblator™ Electrode is a modification of Linvatec's Ablator Electrode which received FDA clearance under 510(k)# K983652 on March 23, 1999. The electrode will be made available in a range of sizes from 2.4" to 6.3" inches in working length, and in three angles, 0°, 30°, & 90°. The insulating material will be changed from polyolefin shrink to Vitek powder coat.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific performance criteria.

The document is a 510(k) premarket notification for a medical device (UltrAblator™ Electrode) seeking clearance from the FDA based on substantial equivalence to a predicate device. This type of submission typically focuses on ensuring safety and efficacy through comparison to an already marketed device, rather than through a detailed study proving performance against explicit acceptance criteria.

Here's what the document does provide and why the requested information is absent:

1. Acceptance Criteria and Reported Device Performance: Not present. The document describes the device, its intended use, materials, manufacturing processes (sterilization, packaging), and identifies a predicate device (Linvatec's Ablator Electrode, K983652). It also mentions "Engineering testing will be performed per ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993" for tests like Dielectric Withstand, Voltage Withstand, Run Test, and Resection Effectiveness Test, but it does not provide the acceptance criteria for these tests nor the results that demonstrate the new device meets them. It merely states that the protocols are included in an exhibit (which is not provided in the input text).

2. Sample size used for the test set and the data provenance: Not present. Since no performance study is detailed, there's no mention of a test set, its sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. This information would be relevant for clinical performance studies, which are explicitly stated as "not required" for this submission.

4. Adjudication method: Not present, for the same reasons as point 3.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not present. This type of study is more common for diagnostic imaging AI systems to assess human reader improvement with AI assistance, which is not applicable to this electrosurgical electrode.

6. Standalone (algorithm only without human-in-the-loop performance) study: Not present. This is a physical electrosurgical device, not an algorithm.

7. Type of ground truth used: Not applicable, as there's no clinical performance study involving ground truth.

8. Sample size for the training set: Not applicable, as there's no AI/algorithm being trained.

9. How the ground truth for the training set was established: Not applicable, as there's no AI/algorithm being trained.

In summary, the provided document is a 510(k) notification focused on demonstrating substantial equivalence, not a detailed performance study with explicit acceptance criteria and results for the device's functional performance. It references engineering tests and biocompatibility tests but does not include the results or specific acceptance criteria within the provided text.

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