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The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at either one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies for surgery should be skeletally mature and have had six months of conservative treatment.

The device is not intended to be used as a stand-alone device. For all the above indications the devices must be used with supplemental internal spinal fixation system that have been cleared for use in the lumbar spine, including Pedicle Screw and Hook Systems, and Spinal Plate Systems.

The AxCess® Expandable Interbody System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The AxCess® Expandable Interbody System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate per the patient's anatomical needs. AxCess® Expandable Interbody System implant is to be filled with autogenous bone graft and/or allograft.

The AxCess® Expandable Interbody System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) components per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) components per ASTM F1537.

Here's an analysis of the provided FDA 510(k) summary regarding the AxCess® Expandable Interbody System, based on your requested framework. It's important to note that this document is a summary and often details about specific acceptance criteria and study methodologies, especially for software or AI-driven devices, are abbreviated or not explicitly stated in this format.

Key Observation: The provided document is for a mechanical medical device (intervertebral body fusion device), not a software or AI-driven diagnostic device. Therefore, many of your requested criteria, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "training set size/ground truth," are not applicable to this type of device and are not mentioned in the submission. The acceptance criteria here relate to physical performance and safety, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study referenced is "non-clinical testing" which includes:

• Static and Dynamic Axial Compression per ASTM F2077
• Static and Dynamic Compression Shear per ASTM F2077
• Subsidence per ASTM F2267

The conclusion states that these tests demonstrate "the strength of the AxCess® [is] sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The specific details of the individual test results (e.g., actual load values, fatigue cycles) are not provided in this public summary but would have been part of the full 510(k) submission.

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

• Sample Size: Not explicitly stated. For mechanical testing, the "sample size" refers to the number of devices or components tested. This information is typically found in the full test report, not the summary.
• Data Provenance: Not applicable in the context of clinical data for AI/software devices. The provenance here refers to the materials used (Titanium alloy and Cobalt Chrome alloy) and the application of engineering standards (ASTM). The testing itself is laboratory-based non-clinical testing.

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

• This is not applicable as this is a mechanical device, not an AI/software diagnostic device that requires expert-established ground truth from medical images or clinical data. The "ground truth" for mechanical testing is defined by the ASTM standards and the physical properties of the materials and design.

4. Adjudication method for the test set:

• Not applicable for mechanical device testing. Adjudication typically refers to the process of resolving discrepancies among human readers or between AI and human disagreement in diagnostic studies. Mechanical tests are typically performed to engineering specifications.

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 a mechanical interbody fusion device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device, not an algorithm. The "standalone performance" here would be its mechanical performance without human intervention, which is what the ASTM tests assess.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for this device's performance is established by recognized consensus standards like ASTM F2077 (Static and Dynamic Axial Compression) and ASTM F2267 (Subsidence). These standards define the test methods and performance requirements for intervertebral body fusion devices. The device's performance is compared against the performance of predicate devices tested to the same standards.

8. The sample size for the training set:

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

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

• Not applicable. (See #8)

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The Disc-FX System is intended for use in ablation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine.

The Disc-FX® System is a single-use, disposable kit which is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine. This device originally received requlatory clearance under 510(k) number K052241 with indications for use limited to the lumbar spine. The design of the Disc-FX® System remains unchanged; the purpose of this 510(k) submission is solely to expand the existing indications of use to include both cervical and thoracic applications.

The Disc-FX® System consists of the following components:

1. Trigger Flex® Bipolar System
2. Triager Flex® Depth Stop
3. Surgical guidewires
4. Straight cannula
5. Beveled cannula
6. Tapered dilator
7. Trephine

This document is a 510(k) premarket notification for the Disc-FX System, seeking to expand its indications for use from only the lumbar spine to include cervical and thoracic applications. The submission primarily relies on demonstrating substantial equivalence to a previously cleared version of the Disc-FX System (K052241) and the Arthrocare Coblator IQ™ Perc-D® Spinewand® (K100353).

The document does not contain acceptance criteria or detailed results of a study proving the device meets specific acceptance criteria in the typical format of a clinical performance study with sensitivity, specificity, or similar metrics. The information provided focuses on non-clinical testing to support substantial equivalence for the expanded indications.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/device performance study. The non-clinical testing sections broadly mention "various performance tests including mechanical testing and simulated use tests" and "Comparison of the thermal effect of the subject device on intervertebral tissue as compared to predicate." However, specific numerical acceptance criteria and reported numerical results against those criteria are not provided for these tests in this summary.

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

• Test Set Sample Size: Not applicable. This submission does not describe a clinical performance study with a test set of patient data to evaluate algorithmic performance. The submission uses non-clinical testing (mechanical, simulated use, thermal effect, electrical safety, biocompatibility).
• Data Provenance: Not applicable.

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. As no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

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

No such study is mentioned or described in this document. The submission explicitly states: "Clinical testing was not included in this submission."

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

Not applicable. The device is an electrosurgical system, not an AI algorithm. Its performance is evaluated through non-clinical functional tests.

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

Not applicable. For the non-clinical tests, "ground truth" would relate to engineering specifications, material properties, safety standards, and physiological responses in simulated environments, rather than clinical ground truth diagnoses.

8. The sample size for the training set

Not applicable. The device is a medical instrument (electrosurgical system), not an AI/machine learning algorithm that requires a training set.

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

Not applicable.

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The Cobbra RF Tissue Dissector is intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

The Cobbra™ RF Tissue Dissector is a single-use, sterile, monopolar electrosurgical instrument intended for use exclusively with the elliquence Surgi-Max® Plus radiofrequency generator (510(k) K100390). The basic design of the device is a plastic handpiece, a partially-insulated electrode with an uninsulated, active edge, and a cable and plug. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active edge of the Cobbra™ RF Tissue Dissector's electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation.

The Cobbra™ RF Tissue Dissector is classified as a sterile, surgically-invasive, active device with an intended patient contact period of <1hr (transient). It is composed of 17-4PH medical-grade stainless steel, ABS plastic, PFA, PVC, and copper. The biocompatibility of patient contacting materials has been assured through appropriate testing in accordance with ISO 10993-1.

The Cobbra™ RF Tissue Dissector is individually-packaged and supplied EtO-sterilized for single use. It is available in five models which differ only by the diameter of the electrode: RF-COBB/XS (0.25 in.), RF-COBB/S (0.375 in.), RF-COBB/M (0.5 in.), RF-COBB/L (1.0 in.), and RF-COBB/XL (1.5 in.).

The provided document does not contain information regarding detailed acceptance criteria, the specific study that proves the device meets those criteria, or the detailed aspects of a study typically associated with AI/ML-driven devices. This document is a 510(k) premarket notification for a medical device called the "Cobbra RF Tissue Dissector," which is an electrosurgical cutting and coagulation device.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended use
• Technology/principle of operation
• Materials
• Performance (through non-clinical bench testing)

Here's a breakdown of what is available in the document related to performance and testing, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Various performance tests including mechanical testing, thermal damage measurements, and simulated use tests" were conducted. However, it does not provide a table with specific acceptance criteria (e.g., maximum allowed thermal damage, specific mechanical strength thresholds) or the reported device performance against these criteria.

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

This information is not provided. The testing described is "non-clinical bench testing," which typically involves laboratory conditions rather than human data. There is no mention of "test sets" in the context of patient data, nor country of origin or retrospective/prospective nature.

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

This information is not applicable and therefore not provided. The device is not an AI/ML diagnostic tool that relies on expert interpretation for ground truth.

4. Adjudication Method:

This information is not applicable and therefore not provided.

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

No MRMC study was conducted or reported. The device is an electrosurgical tool, and its effectiveness is not assessed through comparative human reader studies.

6. Standalone (Algorithm only) Performance:

This is not applicable as the device is a physical electrosurgical instrument, not a software algorithm.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/ML validation (e.g., pathology, outcomes data) is not applicable here. The performance is assessed through engineering and biological safety tests. For instance, "thermal damage measurements" would have a physical ground truth related to tissue effects.

8. Sample Size for the Training Set:

This is not applicable as the device is not an AI/ML algorithm that is trained on a dataset.

9. How the Ground Truth for the Training Set was Established:

This is not applicable.

Summary of available information related to performance and testing:

• Acceptance Criteria & Reported Performance: Not explicitly detailed in a table. The document states that "Various performance tests including mechanical testing, thermal damage measurements, and simulated use tests" were performed, along with biocompatibility, electrical safety, EMC, shelf-life, and sterility testing. These tests implicitly have acceptance criteria (e.g., passing results for biocompatibility, meeting electrical safety standards), but the specifics are not enumerated.
• Study Type: Non-clinical bench testing.
• Clinical Testing: The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
• Testing Categories:
  • Mechanical testing
  • Thermal damage measurements
  • Simulated use tests
  • Biocompatibility (in accordance with ISO 10993-1)
  • Electrical safety and electromagnetic compatibility (in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2)
  • Shelf-life determination
  • Sterility validation

The document establishes that the device is "as safe and effective as the predicate devices" based on these non-clinical tests and comparisons of intended use, technological characteristics, and materials.

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The Elliquence Electrodes are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

The elliguence family of electrodes is a collection of monopolar electrodes which are used in association with an electrosurgical generator, elliquence Surgi-Max (K100390). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active tip of the electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coaqulation.

The elliquence electrodes are composed of SUS 303 stainless steel, ABS plastic, TEFLON heat shrink tubing, tungsten, brass alloys, and PFA. The basic design of the electrodes consists of an insulated shaft with an uninsulated active tip.

All elliquence electrodes share the same materials, design principle, and operating principle, but are available in various shaft and tip configurations in order to satisfy different user preferences. There are eight shaft form "families" which vary in length (1.9 cm to 60 cm), shape (straight, angled, bayonet, and curved), diameter (1/16" and 3/32"), and malleability: (1) FlexTrode Malleable Electrodes, (2) Depth Gauge FlexTrodes, (3) Clear-Vu Bayonet Electrodes, (4) Empire microlncision Needle Electrodes, (5) MicroFibre Electrode, (6) Standard Electrode, (7) Medical Electrode, and (8) Surg-e Tip Electrode. The electrode tips are available in three fundamental configurations: (1) loop (round loop, diamond loop, and triangle loop), (2) ball, and (3) blade (fine wire, needle, and spatula).

This document describes the 510(k) premarket notification for Elliquence Electrodes. However, it does not describe a study related to an AI/ML device that has acceptance criteria and performance data in the way requested in the prompt.

The document discusses:

• Device: Elliquence Electrodes, intended for electrosurgical cutting and coagulation.
• Regulatory Pathway: 510(k) substantial equivalence to predicate devices.
• Testing: Primarily non-clinical bench tests (Hipot, Drop, Pull, Lateral heat spread, Bend tests), Biocompatibility (ISO 10993), Electrical Safety (IEC 60601 series), and Sterilization/Shelf Life (ISO 11135-1, ISO 11137-1).
• Key finding: "Clinical testing was not performed for the elliquence electrodes. The elliquence electrodes do not differ from the predicate devices in fundamental scientific technology or intended use."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets it in the context of an AI/ML device, a test set, expert ground truth, MRMC studies, or training sets, because this document describes a traditional medical device (electrosurgical electrodes) and not an AI/ML-driven diagnostic or assistive device. The "acceptance criteria" here are related to engineering performance, biocompatibility, and electrical safety, not diagnostic performance metrics like sensitivity, specificity, or AUC.

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The Meddusa Bipolar System is a single-use product designed for and intended to be used exclusively with Surgi-Max® RF Generators (510(k) K100390). For optimal performance the Surgi-Max® Plus generator (510(k) K100390) is recommended.

The Meddusa™ Bipolar System is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Laryngeal coagulation, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

The Meddusa Bipolar System is a disposable device manufacturer of medical grade Stainless Steel, ABS plastic and TEFLON heat shrink tubing. The category of contact as classified by ISO 10993-1:2003 are that the device is an (1) External Communicating Device, (2) Contact Area: Tissue, Bone, Dentin, (3) Contact Duration <24 hrs.

The Meddusa Bipolar System is classified as Sterile, Surgically Invasive, Active Device, with intended patient contact for a period for <1hr (Transient).

The Meddusa Bipolar System is intended to be used with the elliguence Surgi-Max Plus Radiofrequency generator (510(k) K100390). The Surgi-Max emits high frequency, lowtemperature radiowaves which is directed to the Meddusa Bipolar System tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The timevarying voltage produced by the electrical power source vields a predetermined electrosurgical effect, such as tissue cutting or coagulation.

The Meddusa Bipolar System is an electrosurgical device. The provided text, a 510(k) summary, outlines its substantial equivalence to predicate devices, rather than detailing specific acceptance criteria and a study proving the device meets them in the traditional sense of a clinical trial with predefined performance metrics. The submission focuses on demonstrating safety and effectiveness through comparisons of physical and performance characteristics with existing devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria are not explicitly stated in the document, as this is a 510(k) summary focused on substantial equivalence. Instead, the performance is evaluated by demonstrating similarity to predicate devices in terms of thermal effects and safety.

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

• Sample Size for Test Set: Not explicitly stated as a numerical value for a "test set" in the context of a clinical trial. The testing was done on ex vivo tissue, specifically liver, kidney, and muscle tissue. The quantity or number of samples of these tissues is not quantified.
• Data Provenance: The data is from bench tests using ex vivo tissue. The country of origin of this tissue or the testing location is not specified, but it can be inferred to be part of the manufacturer's testing process. The study is retrospective in the sense that it's laboratory testing on prepared samples, not observations from a live patient study.

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

There is no mention of "experts" establishing ground truth in the context of radiologists or similar medical professionals for image interpretation. This device is not an imaging device that requires interpretation. The "ground truth" for the thermal effect would have been established through direct measurement and observation by the engineering or scientific personnel conducting the bench tests. No specific number or qualifications of these individuals are provided.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical trial with human observers or an "adjudication method" in the traditional sense. The performance data comes from direct measurements and observations during bench testing.

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. The Meddusa Bipolar System is an electrosurgical device, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant or performed.

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

Not applicable. This is a hardware medical device used by a physician, not an algorithm. The "standalone performance" is essentially the device's physical and functional performance during the bench tests, which were conducted without direct human control of the outcome metrics, but rather under controlled experimental conditions.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would be:

• Direct Physical Measurements/Observations: For thermal damage (width and depth of thermally damaged zones), temperature profiles, and peak temperatures. These are objective measurements rather than subjective interpretations or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."

9. 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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Orthopedic, arthroscopic, spinal, and neurosurgical
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels 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 turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, 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, submucosal palatal shrinkage, traditional uvulopalatop!asty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

The SurgiMax / SurgiMax Plus is a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device can be used with monopolar or bipolar devices. The energy is used for cutting, coagulation, and hemostasis.

The SurgiMax / SurgiMax Plus Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status.

Power level for each mode is indicated by front panel digital displays; which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.

This device is designed to comply with international safety standards including applicable IEC series electrical safety standards.

The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions including short and open for monopolar mode.

Three output waveforms are provided:

CW CUT - Continuous wave output with average power equal to the maximum with no deliberate modulation.

CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 75 Hz rate.

HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 75 Hz rate.

The provided 510(k) summary for the Elliquence SurgiMax / SurgiMax Plus electrosurgical unit does not contain the information requested in your prompt regarding acceptance criteria and a detailed study proving performance.

This document is a marketing submission to the FDA demonstrating "substantial equivalence" to a predicate device, not a report of an original clinical or performance study with acceptance criteria.

Here's a breakdown of why the requested information is absent and what is provided:

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

• Absent. The document does not define specific acceptance criteria for performance such as accuracy, sensitivity, or specificity, as it's not a diagnostic device. For an electrosurgical unit, performance is typically measured by output power, frequency, and waveform consistency. These specifications are provided in a table within the document (see "Output Characteristics:") but without explicit acceptance criteria or a formal performance study against them. Instead, it states the device "complies with IEC 60601-2-2."

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

• Absent. No test set or associated data is described. The submission relies on "non-clinical testing and comparison between the subject device and predicate device" to demonstrate equivalent performance, which generally involves engineering bench testing rather than a clinical "test set" in the sense of patient data.

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/Absent. Since there is no described test set involving patient data, there would be no ground truth established by medical experts for diagnostic purposes.

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

• Not applicable/Absent. No test set necessitating adjudication is mentioned.

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/Absent. This device is an electrosurgical unit, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not part of this submission.

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

• Not applicable/Absent. Again, this is an electrosurgical unit, not an algorithm or AI.

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

• Not applicable/Absent. No "ground truth" for diagnostic purposes is relevant to this device. Performance is instead confirmed through engineering compliance and comparison to the predicate device's specifications.

8. The sample size for the training set

• Not applicable/Absent. This is not an AI/machine learning device, so there is no training set mentioned.

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

• Not applicable/Absent. As above, no training set.

What the document does provide regarding performance and equivalence:

• Predicate Device Comparison: The core of this 510(k) submission is to demonstrate "substantial equivalence" to a previously cleared device, the Ellman SurgiMax (K061174). The document explicitly states: "The subject device and predicate device have identical indications for use, waveforms, functionality with bipolar and monopolar devices, frequency, maximum power, weight, and power adjustment. The electronics and software in the subject device is the same identical electronics and software in the predicate device. The outputs and performance characteristics are identical as the electronics and software have not changed."
• Compliance with Standards: It states that the "Ellman SurgiMax / SurgiMax Plus complies with IEC 60601-2-2." This international standard specifies general requirements for basic safety and essential performance of electrosurgical equipment. Compliance with such a standard serves as a key piece of performance evidence for this type of device.
• Non-Clinical Testing: The document vaguely mentions "Non-clinical testing and comparison between the subject device and predicate device demonstrate equivalent performance." This typically refers to bench testing of electrical outputs, power delivery, safety features, etc., against the device's own specifications and the predicate's known performance, but no details of these tests (e.g., sample sizes, specific measurements, acceptance criteria) are provided in this summary.

In summary, for a device like an electrosurgical unit seeking 510(k) clearance, the "study" demonstrating it meets acceptance criteria often involves compliance with applicable recognized standards and benchtop engineering testing to prove that its specifications (like power output, frequency, and waveform) match those of a legally marketed predicate device, rather than a clinical study with patients and expert-adjudicated ground truth.

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