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HPR45i electrosurgical electrode is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures. The device is a prescription use (Rx) device.

HPR45i is a monopolar electrosurgical electrode intended to remove tissue and control bleeding using radio frequency electrical current. It is a prescription use device which is intended to be used by a licensed doctors or specialist in the healthcare facility/ hospital.

The HPR45i is supplied sterile (Sterilized by EO Sterilization) and is not intended to be reused. It consists of 3 different parts such as HPR45i handle, output cable and stainless-steel tube. The stainless-steel tube is insulated over most of its exposed length, and it is connected to the stainless steel (AISI316L) tip at the end. The material of insulation is PTFE. The stainless steel (AISI316L) tip and PTFE insulation are the direct patient contacting parts of the device. It is an external communicating device with limited duration (

The provided text is a 510(k) summary for the HPR45i electrosurgical electrode. It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical and a lack of clinical study data.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria in a table format with corresponding device performance metrics for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are met by demonstrating compliance with recognized standards and passing various non-clinical performance tests.

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

The provided document describes non-clinical performance tests only. It does not refer to a "test set" in the context of clinical data or diagnostic accuracy. Therefore, there is no information on:

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

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

Since no clinical "test set" was used for diagnostic accuracy, there is no information on the number or qualifications of experts used to establish ground truth. The non-clinical tests rely on established engineering and safety standards.

4. Adjudication Method for the Test Set

As no clinical "test set" was used for diagnostic accuracy, there is no information on any adjudication method.

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 MRMC comparative effectiveness study was done or reported. The device is an electrosurgical electrode, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. This device is a medical instrument used by a human surgeon, not an independent algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" implicitly refers to:

• Compliance with international and FDA-recognized consensus standards: such as IEC 60601-2-2, IEC 60601-1, IEC 60601-1-2, and various ISO 10993 standards.
• Engineering specifications and validated processes: for electrosurgical unit performance, component testing, and sterilization.

There is no clinical ground truth (e.g., expert consensus, pathology, outcomes data) presented as no clinical studies were performed.

8. The Sample Size for the Training Set

Not Applicable. This device is an electrosurgical electrode and does not involve machine learning algorithms that require a "training set."

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

Not Applicable. (See point 8).

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THE MED RF 4000 SYSTEM IS INTENDED FOR THE EPILATION AND FOR THE TREATMENT OF LOWER LIMB SPIDER VEIN OR TELANGECTASIA BY THERMOCOAGULATION.

The MedRF4000 consists of the following parts: The generator, The pedal, The output cable, The neutral electrode cable (optional), The needle holder. The following consumables can be used with the MedRF4000: The Ballet needles, The neutral electrode (optional).

The provided text is a 510(k) summary for the MED RF4000 device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (EVRF) based on technological characteristics and performance testing.

However, the document does not contain the level of detail requested for acceptance criteria, study design, or ground truth establishment that would be typical for an AI/ML device or a device requiring specific performance metrics for regulatory clearance. The MED RF4000 is an electrosurgical cutting and coagulation device, and its clearance seems to rely more on demonstrating functional equivalence to a predicate device and compliance with electrical safety standards, rather than clinical performance metrics in the way an AI diagnostic device would.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for "acceptance" in the sense of accuracy, sensitivity, specificity, etc., as one would expect for a diagnostic AI device. Instead, the "acceptance" seems to be based on demonstrating similar effect on tissue and compliance with electrical safety standards.
• Reported Device Performance:
  • Comparison of output signal of EVRF (predicate) and MedRF4000 (subject device) on pork tissue.
  • Result: "results indicate the EVRF (predicate device) and the MedRF4000 (subject device) with and without neutral electrode have equivalent effect."
  • The document implies that the acceptance criterion is "equivalent effect" to the predicate device, especially regarding the neutral electrode connection.

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

• Test Set Sample Size: Not explicitly stated. The "test set" appears to be pork tissue, not human patient data.
• Data Provenance: Pork tissue (laboratory setting). This is a pre-clinical, non-human study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's likely assessed by engineers or technicians given the nature of the test (output signal and tissue effect).
• Ground Truth Establishment: The "ground truth" seems to be the observed "effect" on pork tissue, which is compared to the predicate device's effect. It's not a diagnostic "truth" requiring expert consensus.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/specified. The comparison of tissue effects likely involved direct observation or measurement in a laboratory setting, not reviewer adjudication as for diagnostic imaging.

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, an MRMC study was not done. This device is not an AI-assisted diagnostic tool for human readers. It's an electrosurgical device for treatment.

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

• Not applicable in the context of typical AI/ML standalone performance. The device is a "standalone" electrosurgical generator in that it operates independently, but its performance isn't evaluated as an algorithm's diagnostic accuracy. The performance testing was on its physical output on tissue.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for the performance testing was the observed "effect" of the radiofrequency energy on pork tissue, aiming for equivalence with the predicate device. This is a technical, physical effect, not clinical pathology or outcomes directly.

8. The sample size for the training set

• Not applicable. This device does not use machine learning in a way that requires a "training set" for model development. Its software manages impulse duration, power, and delay, but this is fixed programming, not learned behavior.

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

• Not applicable, as there is no "training set" in the AI/ML sense.

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• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Clench® Compression Staple is an implant for use in bone fixation and reconstructive surgical procedures for the management of bone fractures. The implant is designed to provide constant compression over a bone fracture site. Implants are made from Nickel-Titanium Alloy per ASTM F2063 and range in size from 7mm to 20mm wide with two equal length legs ranging from 5mm to 20mm long.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Clench Compression Staple, formatted as requested.

Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, rather than clinical efficacy studies often seen with AI/clinical decision support devices. Therefore, many of the requested categories related to human-in-the-loop performance, expert consensus on ground truth for clinical cases, and multi-reader multi-case studies are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Clench Compression Staple are based on demonstrating mechanical performance equivalent to or better than predicate devices, and conformance to recognized industry standards. The reported performance refers to the device meeting these established standards.

Study Details:

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

   • The document does not specify a "test set" in terms of clinical data or patient cases. The testing conducted was mechanical (bench testing) of the device itself.
   • The sample size for each mechanical test (static axial pull-out, static four-point bending, dynamic four-point bending, corrosion susceptibility, transformation temperature) is not explicitly stated in this summary but would have been defined by the ASTM standards and validated through the testing.
   • Data provenance is from bench testing of the manufactured device.

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

   • Not applicable. Ground truth for mechanical testing is established by the specified ASTM standards and measurement protocols, not by expert medical opinion. Engineers and lab technicians conduct and interpret these tests according to the standards.

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

   • Not applicable. This type of adjudication is typically used for clinical image interpretation or expert consensus on patient outcomes, not for mechanical bench testing.

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 device is a bone staple, an orthopedic implant, not an AI or diagnostic imaging device. Therefore, an MRMC study is not relevant or performed.

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

   • Not applicable. This is a physical medical device (implant), not an algorithm or software. Standalone performance is evaluated through the mechanical and material tests described.

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

   • For the mechanical and material testing, the "ground truth" is defined by the established performance criteria and methodologies within the relevant ASTM standards (ASTM F564-10, ASTM F2129, ASTM F2082). These standards define how the device should behave under specific conditions.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing processes are refined through engineering principles, not machine learning training.

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

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

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The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

The EVRF has 2 major parts: 1) the generator and 2) the needle. The generator creates the impulse. The impulse can be set at between in 0.1 second increments. The combination of these two settings means that highly accurate doses of energy can be delivered. The system utilizes a current of 4MHz .The power and impulse values are accurately maintained by a microprocessor and displayed on a LCD screen. The values can be digitally adjusted. The ultra-fine needle (Product Code KCW) has a diameter of 0.075 mm allowing for accurate operation and is protected by a specific isolating sheath. The vessel is thermocoagulated without damaging the epidermis and surrounding tissue. Needles are nickel. In case of a nickel allergy, gold needles are also available. The needles are disposable and can be used for a complete session. The combination of the generator and insulated needle allows for a very precise amount of energy to be delivered to exactly the right place.

The provided document is a 510(k) summary for the EVRF System. It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or effectiveness beyond establishing substantial equivalence to a predicate device.

The 510(k) submission process is primarily to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove clinical efficacy through a comprehensive clinical trial with specific performance metrics and acceptance criteria.

However, based on the provided text, here’s an extraction of relevant details and an explanation of why a full table of acceptance criteria and a study proving their fulfillment isn't present in this type of document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify "acceptance criteria" in the sense of predefined performance targets for clinical outcomes (e.g., success rates, complication rates, or specific measurements of improvement). Instead, it focuses on demonstrating substantial equivalence to the predicate device, the Veinwave TC3000. The comparison table highlights that the key technological characteristics are identical or highly similar, suggesting that if the predicate device performs acceptably, then the new device, being substantially equivalent, should also perform acceptably.

Important Note: The "Acceptance Criteria" and "Reported Device Performance" in the table above are largely implied by the substantial equivalence argument within a 510(k) summary. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, not necessarily meeting specific clinical efficacy metrics.

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

The document mentions "Comparison bench testing was performed" for the device. This testing focused on comparing output power and pulse settings between the EVRF System and the predicate device.

• Sample Size for Test Set: Not explicitly stated for the bench testing. It would typically involve multiple measurements to confirm consistency and accuracy of the device's output.
• Data Provenance: The bench testing was presumably conducted by F Care Systems NV or a contracted lab. The document does not specify country of origin for bench testing data beyond the sponsor's location (Belgium). This was retrospective testing performed on the device to support its 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable. The 510(k) summary does not mention a clinical study that required expert-established ground truth for a test set. The comparison was primarily technical between the new device and a predicate.
• Qualifications of Experts: Not applicable for this type of submission.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication.

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

• MRMC Study: No, a MRMC comparative effectiveness study was not done or reported in this 510(k) submission. The submission relies on substantial equivalence regarding technological characteristics and indications for use.
• Effect Size with AI vs. without AI Assistance: Not applicable, as this device is an electrosurgical device and not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

6. Standalone Performance Study (Algorithm Only):

• Standalone Study: No, this is not an algorithm-only device. It is a physical electrosurgical system. The concept of "standalone performance" as typically applied to algorithms for diagnostics does not directly apply here. The "standalone" performance that was assessed was the device's ability to accurately control and deliver energy, which was evaluated via bench testing.

7. Type of Ground Truth Used:

For the bench testing, the "ground truth" was likely instrumentation standards and measurements of electrical output (power, frequency, pulse duration). The device's output measurements were compared to its specified settings and to the known characteristics of the predicate device. There was no "clinical" ground truth like pathology or outcomes data presented to support a standalone clinical efficacy claim. The ground truth for the overall submission is implicitly that the predicate device is safe and effective when used as labeled.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is an electrosurgical hardware system, not a machine learning algorithm that requires a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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