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Elliquence endoscopes are indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.

The Endiscope is an optical and fiber optic based rigid endoscope available with working channels of 2.8 mm, 3.75 mm and 4.3 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the spinal column such as endoscopic assisted discectomy.

The Endiscope Cervical is an optical and fiber optic-based rigid endoscope available with a working channel of 2.2 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the cervical spine.

Elliquence endoscopes may be attached to standard fiber optic light sources, commonly available video adapters and cameras such as Storz, Olympus and Wolf.

The devices are reusable, delivered in non-sterile conditions and available in various designs:

• Outer Diameters from 3.6 mm to 7.0 mm
• Diameter of working channel from 2.2 mm to 4.3 mm
• Working length from 95 mm to 208 mm
• Direction of view: 0%6° (Endiscope Cervical), 30° (Endiscope)
• Viewing angle 80° +/- 5°

The provided document is a 510(k) summary for the Elliquence Endiscope and Endiscope Cervical devices. It describes the device, its intended use, comparison to a predicate device, and non-clinical testing performed. However, it explicitly states, "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

Therefore, I cannot provide information about acceptance criteria or a study proving the device meets them in the context of clinical performance in human subjects from this document. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than performing a new clinical efficacy study with specific performance metrics.

I can, however, extract details about the non-clinical testing that was performed to demonstrate aspects of safety and effectiveness, which could be considered 'acceptance criteria' in a non-clinical sense.

Here's an analysis based on the document's content regarding non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

For non-clinical testing, the concept of a "test set" in the context of device performance in humans or AI algorithms does not directly apply here. These tests are laboratory-based and involve physical devices or materials.

• Sample size: The document does not specify exact sample sizes for each non-clinical test (e.g., how many devices were tested for thermal safety). It generally refers to "the devices" or "greatest challenge devices."
• Data provenance: Not applicable in the sense of human subject data origin. These are laboratory test results.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth in this context typically refers to clinical diagnoses or outcomes. For non-clinical, laboratory-based testing, 'ground truth' is established by the specifications of the standards (e.g., IEC 60601-2-18, ISO 10993-1) themselves, and the expertise lies in the certified laboratories and personnel performing the tests according to those standards.

4. Adjudication Method

Not applicable for non-clinical, laboratory-based testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission explicitly states it did not rely on clinical performance data.

6. Standalone Algorithm Performance Study

Not applicable. This device is an endoscope, not an AI algorithm.

7. Type of Ground Truth Used

For the non-clinical tests: The "ground truth" is adherence to established international and national consensus standards (e.g., IEC 60601-2-18, ISO 10993-1, ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665, EN ISO 17664).

8. Sample Size for the Training Set

Not applicable. This device is an endoscope, not an AI algorithm that requires a training set.

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

Not applicable.

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Orthopedic, arthroscopic, spinal, and neurological

For resection, ablation, and coagulation of soft tissues and hemostasis in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.

Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.

Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma. Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.

Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia

Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

The elliquence Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is a modification to the existing Surgi-Max® / Surgi-Max® Plus (K100390) line of radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. It is designed to enable the performance of monopolar and bipolar functions in conjunction with separatelymarketed electrosurgical accessories and ancillary equipment which have been developed by elliquence for mutually-exclusive use with the Surgi-Max® line of generators.

The Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is the result of an update to internal electrical components of the Surgi-Max® / Surgi-Max® Plus. As a result of this equipment update, device design as it relates to internal electrical system framework was simplified in many respects and overall efficiency was greatly improved upon. This increase in efficiency enabled an increase in the maximum power output of the device from 120W to 170W. Aside from this increase in maximum power output, all other operational aspects of the device were conserved. The only other modifications made to the device were aesthetic in nature.

The modifications enacted do not affect the device's intended use or alter its fundamental scientific technology.

The provided document is a 510(k) summary for the Elliquence Surgi-Max® Ultra, an electrosurgical cutting and coagulation device. The purpose of this submission is to demonstrate substantial equivalence to existing predicate devices, not to present a study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a diagnostic AI would.

Therefore, many of the requested criteria for reporting on an AI/diagnostic device study (like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable to this type of regulatory submission. This submission focuses on engineering testing and comparison to predicate devices to ensure safety and effectiveness.

However, I can extract information related to the acceptance criteria (in terms of performance characteristics and compliance) and the "study" (non-clinical testing) that supports these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate devices and compliance with relevant electrical safety and usability standards. The "reported device performance" is primarily demonstrated through non-clinical testing ensuring it meets these standards and functions similarly to its predicates, with documented improvements/changes.

Study Details (Non-Clinical Testing for Substantial Equivalence)

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

   • Test Set Sample Size: Not applicable in the context of patient data samples. The "test set" here refers to physical testing performed on the device and ex-vivo tissue samples.
   • Data Provenance: Non-clinical (bench) testing. The document explicitly states "ex-vivo bovine tissue" for thermal effect comparison. No geographical or patient-specific provenance is relevant for this type of testing.

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

   • Not applicable. The "ground truth" for electrosurgical device performance is established by engineering specifications, international safety standards (e.g., IEC 60601 series), and documented functional capabilities of the predicate devices. Testing against these standards and comparing to predicate performance does not typically involve expert clinical consensus for "ground truth" in this specific regulatory context.

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

   • Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). This submission relies on objective engineering measurements and comparisons to established standards and predicate device specifications.

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 an electrosurgical generator, not an AI or diagnostic device that involves human readers interpreting cases.

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

   • Not applicable. This device is an electrosurgical unit, not an algorithm, and is intended for use by a human surgeon. Its performance is inherent in its electrical output and tissue interaction, which was assessed via non-clinical testing.

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

   • The "ground truth" for this submission is based on established engineering specifications, international electrical safety and usability standards (e.g., IEC 60601 series, IEC 62366, IEC 62304), and the documented performance characteristics of legally marketed predicate devices. The non-clinical testing verified that the modified device met these engineering and safety benchmarks, and its performance characteristics were comparable or improved (e.g., increased power output) relative to the predicates in a safe manner.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

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

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