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The Apyx is intended for attaching sutures to ligaments of the pelvic floor.

The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor / suture assembly is deployed to the target site from the cartridge with an applicator. An optional use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing.

The Apyx device is a single use device which is supplied sterile.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format of a clinical or performance study with specific metrics like sensitivity, specificity, or AUC, as these would be associated with diagnostic or AI-powered devices.

However, based on the information provided, here's a breakdown of what can be extracted regarding performance and testing:

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

The document mentions various tests conducted, generally implying that the device met the requirements of these tests to demonstrate safety and effectiveness. Since specific numerical acceptance criteria (e.g., "pull-out strength > X N") and the exact reported performance values are not explicitly stated, I will infer the acceptance as "Met requirements" based on the conclusion of substantial equivalence.

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

• Sample size for test set: The "Cadaver Testing" section does not specify the number of cadavers or the number of anchors tested. It uses general phrasing like "users," "all anchor delivery and retrieval procedures," and "All anchors."
• Data provenance: Not explicitly stated, but cadaver testing implies a controlled laboratory environment. The country of origin of the data is not mentioned. It is prospective testing carried out for regulatory submission.

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

• This information is not provided. The cadaver testing describes the actions of "users" (implying medical professionals) who delivered and retrieved anchors, but doesn't mention independent expert assessment or ground truth establishment in a formalized way for outcomes like accuracy or safety observed during the testing. The "ground truth" here is the observed outcome of the procedure itself (e.g., successful placement, no damage).

4. Adjudication method for the test set

• Not applicable/Not described. The cadaver testing describes qualitative observations of successful delivery, retrieval, and proper fixation. There's no mention of an adjudication process for resolving disagreements between multiple observers, as might be seen in diagnostic studies.

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. This device is a surgical instrument (fixation device), not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness are not relevant or discussed.

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

• No. This device is a manual instrument for surgical use, not an algorithm.

7. The type of ground truth used

• For the cadaver testing, the ground truth was the direct observation of the physical outcome and success of the procedure (e.g., "anchors were accurately delivered," "no damage observed," "properly fixed"). This is akin to direct experimental observation and physical verification rather than consensus, pathology, or outcomes data in a clinical trial.

8. The sample size for the training set

• Not applicable. This device is a physical medical instrument, not a machine learning algorithm, so there is no "training set."

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

• Not applicable, as there is no training set for a physical medical instrument.

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The Apyx One Console is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/J-Plasma handpieces.

The Apyx One Console is an electrosurgical generator that delivers radiofrequency (RF) energy to cut and coagulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. Like the predicate, the Apyx One Console provides standard electrosurgical energy and Helium Plasma energy, with no changes to the intended use, electrosurgical modes, output power waveforms, or maximum power settings. The Apyx One Console is a modified version of the primary predicate device that was cleared under K192867 (Apyx Helium Plasma Generator), with a no change to the intended use.

The Apyx One Console has a Graphical User Interface (GUI). Remote Services will be available using an attached cellular module to assist in troubleshooting the generator in the field, a helium Gas Pressure Transmitter, and two monopolar ports.

The Remote Service module will also provide non-HIPPA data to a cloud data system which will log the various settings of the generator throughout its use.

The Apyx One Console is an electrosurgical generator intended for the delivery of radiofrequency energy and/or helium plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can only be used with dedicated Renuvion/J-Plasma handpieces.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

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

2. Sample sized used for the test set and the data provenance

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. Instead, the performance testing described focuses on engineering verification and validation. Therefore, information regarding sample size and data provenance for a test set (e.g., patient data) is not applicable here as it is not a clinical study in that sense.

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

Not applicable. This evaluation focuses on engineering performance rather than clinical endpoints requiring expert ground truth establishment.

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

Not applicable. This was not a study requiring adjudication of interpretations.

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 device is an electrosurgical generator, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone algorithm performance" is not relevant. The performance evaluation focuses on the engineering safety and effectiveness of the hardware and software in its intended operational context.

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

The "ground truth" for this device's acceptance criteria primarily involved:

• Compliance with established international electrical safety, electromagnetic compatibility, and usability standards.
• Verification against product and performance specifications for electrical functionality, software/firmware operation, and mechanical design.

8. The sample size for the training set

Not applicable. This device, being an electrosurgical generator, does not utilize a "training set" in the context of machine learning.

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

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

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The Apyx is intended for attaching sutures to ligaments of the pelvic floor.

The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor/suture assembly is deployed to the target site from the cartridge with an applicator. An optional retriever can be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx device is a single use device which is supplied sterile.

The provided text describes a 510(k) submission for the Apyx device, which is intended for attaching sutures to ligaments of the pelvic floor. The submission claims substantial equivalence to the predicate device, POP Medical Solutions, NeuGuide (K160569). However, the document does not contain a table of acceptance criteria and reported device performance or information about a specific study proving the device meets acceptance criteria related to efficacy metrics for an AI/ML algorithm.

The information provided is primarily related to the mechanical and biocompatibility testing of the Apyx device as a medical instrument, not an AI/ML system. Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving an AI/ML device meets them, as those details are not present in the provided text.

Based on the available text, I can only extract general performance data categories and a cadaver study description for the mechanical device as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML device. It lists general performance data categories for the Apyx medical device (a mechanical fixation device), along with a summary of cadaver testing.

The subsequent questions (2-9) are specifically tailored to the evaluation of an AI/ML-based medical device. Since the provided document describes a mechanical medical instrument (Apyx) and not an AI/ML product, these questions are not applicable to the information given. The text does not mention any AI/ML components, software algorithms, or their performance evaluation. Therefore, I cannot answer questions 2 through 9 based on the provided input.

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The Apyx Helium Plasma Generators (owned by Apyx Medical) are indicated for delivery of radiofrequency energy and/ or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/ J-Plasma handpieces.

The Apyx Helium Plasma Generator is an electrosurqical device that delivers radiofrequency (RF) energy to cut and coaqulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. Like the predicate, the Apyx Helium Plasma Generator provides standard electrosurgical energy and Helium Plasma energy, and there are no changes to the intended use, performance specifications, electrosurgical modes, output power waveforms or maximum power settings. Essentially, the Apyx Helium Plasma Generator is a combination of a standard electrosurgical generator and a Helium Plasma generator.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and A1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance)
• AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests)
• AAMI/ANSI/IEC-60601-2-2:2017 (Medical electrical equipment - Part 2-2: Particular requirements of basic safety and essential performance of high-frequency surgical equipment) |
  | Electromagnetic Compatibility (EMC) | Complies with:
• AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests)
• IEC60601-1-2 (electromagnetic compatibility) |
  | Electrical Performance | The electrical functionality of the generator was verified to meet performance specification requirements. |
  | Software Functionality | The system and Field Programmable Gate Array (FPGA) perform as intended and according to the product specifications. |
  | Mechanical Design | The mechanical design meets the product and performance requirements. |

Summary of the Study:

The provided document describes a 510(k) premarket notification for the Apyx Helium Plasma Generator. This notification seeks to demonstrate substantial equivalence to a previously cleared predicate device (K170188, Bovie Ultimate® Gen 2 Electrosurgical Generator). The study involved bench and software verification and validation testing to confirm the modified device's safety and effectiveness.

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

The document does not specify a numerical sample size for the test set. The tests describe "Electrical Verification," "Software Verification & Validation," and "Mechanical Verification," which are typically performed on a limited number of manufactured units or system components, rather than a large clinical "test set" in the sense of patient data.

The data provenance is retrospective, as the study primarily compares the modified device to a previously cleared predicate and leverages existing regulatory standards. The testing itself would have been conducted in a controlled laboratory or engineering environment, rather than using patient data from a specific country of origin.

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

This information is not provided in the document. The type of testing described (electrical, software, mechanical verification) typically relies on engineering and regulatory standards rather than expert clinical consensus to establish "ground truth" for the device's functional and safety characteristics.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the type of testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic decisions. Here, the "truth" is determined by adherence to established engineering and safety standards.

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

No, an MRMC comparative effectiveness study was not done. The study described is not a clinical trial evaluating human reader performance with or without AI assistance. It's a regulatory submission demonstrating the substantial equivalence of an electrosurgical device through engineering and software verification.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This concept is not directly applicable to this device. The Apyx Helium Plasma Generator is a physical medical device that delivers energy for surgical procedures. It does not operate as an "algorithm only" or an AI system that provides diagnostic output without human intervention in the loop. Its performance is evaluated based on its technical specifications and safety conformity, regardless of human interaction methods.

7. Type of Ground Truth Used

The "ground truth" used in this submission is implicitly based on established international and national standards for medical electrical equipment (e.g., IEC 60601 series). Compliance with these standards, along with the device's documented performance against its own product specifications, forms the basis of its "truth" for safety and effectiveness in the context of substantial equivalence. There is no mention of pathology, expert consensus (in a clinical sense), or outcomes data being used to establish ground truth for the device itself in this specific regulatory context.

8. Sample Size for the Training Set

This information is not applicable/not provided. The device in question is an electrosurgical generator, which is a hardware device with embedded software. It is not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a "training set" of data in the conventional sense. The software verification and validation are against predefined specifications, not learned from a dataset.

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

This information is not applicable/not provided for the same reasons mentioned in point 8.

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The Apyx Plasma/RF Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation of soft tissue during open surgical procedures. The Apyx Plasma/RF Handpiece is compatible with the Electrosurgical Generators, BVX-200H and BVX-200P, owned by Apyx Medical.

The Apyx Plasma/RF Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation.

The Apyx Plasma/RF Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).

The provided text describes the performance data for the Apyx Plasma/RF Handpiece (K191542) to demonstrate its substantial equivalence to predicate devices, focusing on non-clinical testing.

Here's the breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

This section synthesizes the various tests and their outcomes as presented in the document.

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