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The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

At higher energy levels greater than 62 m./pin, use of the FRF applicator is limited to Skin Types I-IV.

The InMode System with the Fractora3D/3D-90 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis. The device platform is basically constituted on the same system platform as FDA cleared for InMode FRF Applicator (K151273). The InMode System with the Fractora3D/3D-90 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Fractora3D/3D-90 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Fractora3D/3D-90 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Fractora3D/3D-90 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a disposable, single use, 24 electrode pins tip.

Based on the provided text, the device in question is the "InMode System with Fractora3D/3D-90 Applicators," which is an electrosurgical cutting and coagulation device. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a predicate device rather than proving efficacy through clinical trials with specific acceptance criteria as one might see for novel AI/software devices. Therefore, much of the requested information regarding "acceptance criteria" for performance, "ground truth establishment," "expert adjudication," and "multi-reader multi-case studies" is not applicable or explicitly stated in the context of this traditional medical device submission.

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

• AAMI/ANSI 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
• IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
• IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories. |
  | Accuracy and Consistency of RF Output Parameters (Bench Test) | Performance bench tests were performed to measure the accuracy and consistency of the RF output parameters. Results demonstrated that the InMode System complies with design requirements and consists of similar RF output specifications as the predicate device. |
  | Safety and Efficacy for Indicated Use (Animal Study) | A preclinical study on a porcine model evaluated thermal effects and tissue healing. "The animal study results show that the InMode System with the Fractora3D/3D-90 Applicators are safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis." |
  | Biocompatibility of Patient Contact Materials | All device materials which come in direct contact with the patient skin are biocompatible. Reference made to predicate devices: K102461, K082451, K142438, K151019 and K081365 for biocompatibility determination. |
  | Substantial Equivalence to Predicate Device (Performance Specs)| The performance specifications (including RF frequency, pulse duration, and RF energy per pin) of the InMode System were shown to be similar and yielded similar RF energy per pin values to those of the predicate EndyMed Intensif Applicator (K130501). |

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

• Test Set Sample Size:
  • Bench Test: Not explicitly stated how many tests were run, but it refers to "performance bench tests."
  • Animal Study: The study was conducted on a "porcine model." The exact number of animals is not specified, but it refers to a "single RF treatment" per animal at various follow-up times (immediately, 7, 14, and 21 days post-treatment).
  • Clinical Data: "Not Applicable" for this 510(k) submission.
• Data Provenance: The device manufacturer (InMode MD Ltd.) is located in Israel. The studies are described as pre-clinical (animal model) and bench tests. The location where these specific tests were performed is not detailed. The data is retrospective in the sense that it's reported for a 510(k) submission, but the tests themselves would have been performed prospectively as part of validation.

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

• This concept of "ground truth established by experts" is not explicitly applicable or discussed in the context of this traditional device submission for electrocoagulation and hemostasis. The "ground truth" for the animal study would be the histological findings and clinical observations of tissue effect and healing. The expert interpreting these would likely be a veterinary pathologist, but their number and qualifications are not specified in this summary.

4. Adjudication method for the test set

• Not applicable/mentioned. This is typically relevant for diagnostic AI studies where multiple readers might review cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. The document states "Clinical Performance Data: Not Applicable."

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

• This is not an AI/algorithm-driven device. It is a physical electrosurgical device. Therefore, the concept of "standalone performance" of an algorithm is not applicable. The device's performance stands alone in its ability to deliver RF energy as specified.

7. The type of ground truth used

• For the non-clinical studies:
  • Bench Tests: The ground truth is the designed specifications and physical measurements of RF output parameters.
  • Animal Study: The ground truth is histological analysis (tissue changes and healing process) and observation of the gross thermal effects in the porcine model.

8. The sample size for the training set

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

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

• Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment method for one.

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The SJM Confirm " ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias.

The SJM Confirm ICM, Model DM2102, is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The SJM Confirm ICM is a cardiovascular monitoring device used to record and play back. physiological signals.

The provided text for SJM Confirm (DM2102) ICM 5 10(k) Premarket Notification (K133481) indicates that clinical performance testing was performed to demonstrate the device meets the required performance criteria. However, the document does not provide specific acceptance criteria or detailed results of this clinical study. It primarily focuses on asserting substantial equivalence to predicate devices based on technological characteristics and general performance.

Therefore, much of the requested information cannot be extracted from the provided text.

Here is what can be inferred and what is missing:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document broadly states the device "meets the required performance criteria" and "performs as intended."
• Reported Device Performance: Not explicitly stated in terms of quantitative metrics. The document concludes that "the SJM Confirm ICM functions to its specifications, performs as intended, and exhibits the appropriate characteristics of an implantable cardiovascular monitoring device."

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

• Sample Size for Test Set: Not specified. The document mentions "clinical performance testing" but does not provide details about the number of patients or cases.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• Not specified. There is no mention of expert review or ground truth establishment in the context of the clinical study described.

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

• Not specified.

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

• The document implies that the SJM Confirm is a standalone cardiac monitoring device rather than an AI-assisted interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described. No such study is mentioned.

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

• The document states "clinical performance testing were performed to demonstrate the SJM Confirm ICM meets the required performance criteria." While it doesn't explicitly use the term "standalone performance," given that it's an "Implantable Cardiac Monitor," its primary function would be continuous, automated monitoring and recording of physiological signals. This suggests the evaluation would focus on the device's ability to accurately detect and record these signals on its own. However, specific metrics are not provided.

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

• Not specified.

8. The sample size for the training set

• Not applicable as this seems to be a hardware device with embedded firmware/software rather than a machine learning algorithm that requires a separate training set. The relevant testing is "Software Verification and System Validation" and "Clinical Study."

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

• Not applicable.

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The SJM Confirm® Implantable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

• patients with clinical syndromes or situations at increased risk of cardiac arrhythmias .
• patients who experience transient symptoms that may suggest a cardiac arrhythmia .

The SJM Confirm® Implantable Cardiac Monitor (MR Conditional) is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100), an external patient activator (Model DM2100A) and a programmer. The programmer is used by the physician to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330).

This document describes the SJM Confirm® Implantable Cardiac Monitor (MR Conditional) (Model DM2100) and its 510(k) submission (K122161). The submission claims substantial equivalence to two predicate devices: the SJM Confirm® ICM Model DM2100 (K081365) and the Medtronic Reveal DX Insertable Cardiac Monitor (K071655).

The submission focuses heavily on the new "MR Conditional" labeling.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or a direct performance table in terms of diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection) for the SJM Confirm® Implantable Cardiac Monitor.

Instead, the "acceptance criteria" for this 510(k) submission appear to be focused on demonstrating:

• Substantial Equivalence: The device is substantially equivalent to the predicate devices in terms of technological characteristics and intended use.
• MRI Compatibility: The device performs safely and effectively in MRI environments.
• Compliance with Predetermined Design and Performance Specifications: As confirmed by verification and validation activities.

Based on the provided text, the "reported device performance" is largely qualitative and focused on meeting these criteria, rather than specific numerical diagnostic performance metrics.

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

The provided text does not describe a clinical test set with human patient data for evaluating arrhythmia detection or diagnostic performance. All listed tests are "nonclinical tests" (bench tests) related to MRI compatibility and product safety/functionality.

• Test Set (for MRI compatibility, electrical safety, biocompatibility): Not applicable in terms of patient data. The "test set" would consist of the device itself and associated components.
• Data Provenance: Not applicable in terms of country of origin or retrospective/prospective clinical study, as these were bench tests.

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

Not applicable. No clinical test set requiring ground truth established by experts is described in the provided nonclinical test summary.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

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 implantable cardiac monitor, not an AI-assisted diagnostic imaging or ECG interpretation system that would involve human readers improving with AI.

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

The device itself is a standalone monitoring system that automatically detects and records ECGs. The document confirms that "verification and validation activities were performed to ensure that the SJM Confirm® ICM devices meet their predetermined design and performance specifications," implying that the device's inherent functional performance (including its algorithms for detection) was tested. However, no specific details about the methodology or results of these "algorithm only" tests are provided beyond the general statement. The focus of this 510(k) is MRI compatibility.

7. The Type of Ground Truth Used

For the nonclinical tests described:

• MRI Compatibility: Ground truth would be defined by the specifications of MRI machines, industry standards (e.g., for heating, force, torque), and post-exposure functional criteria (e.g., does the device still operate to spec?).
• Electrical Safety, Biocompatibility: Ground truth is established by adherence to recognized national and international standards (e.g., ISO-10993-1 for biocompatibility).
• "Predetermined Design and Performance Specifications": The ground truth here is the engineering and functional requirements established during the device's design phase.

8. The Sample Size for the Training Set

Not applicable. The device is not described as an AI/machine learning system requiring a training set in the conventional sense. Its "algorithms" for arrhythmia detection would have been developed through traditional embedded software engineering.

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

Not applicable. As there's no described AI/machine learning training set.

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The SJM Confirm® Implantable Cardiac Monitor is indicated for monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, shortness of breath, and patients who are at risk for other cardiac arrhythmias.

The SJM Confirm® Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100) and the external patient activator (Model DM2100A). The third component is the programmer the physician uses to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330).

This 510(k) premarket notification (K122090) from St. Jude Medical, CRMD, for the SJM Confirm® Implantable Cardiac Monitor (Model DM2100) describes a change to an existing device, specifically the use of an alternate collector cell battery. The submission uses substantial equivalence to a legally marketed predicate device (SJM Confirm® Implantable Cardiac Monitor System, K081365).

The provided text does not include acceptance criteria for the device's performance in detecting or diagnosing arrhythmias, nor does it detail a study proving such performance specific to this 510(k) submission. Instead, the core of this submission focuses on demonstrating that the new battery component does not negatively impact the device's existing performance, which was presumably established in the predicate device's original clearance.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted directly from this document.

Here's a breakdown of the information that can be extracted or inferred based on the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This 510(k) is about a component change. The acceptance criteria are implicitly that the device, with the new battery, performs identically to the predicate device in all relevant aspects (electrical performance, safety, sterilization, etc.). The reported performance is a summary statement that this equivalence has been confirmed through testing.

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

• Sample Size for Test Set: The document mentions "Device testing (documented in 60041954, Attachment 3) and component level testing (documented in QTR40008803, Attachment 4)." However, it does not specify the sample size of devices or components used for these tests. The testing would have been conducted on a representative sample of devices containing the new battery.
• Data Provenance: The testing was conducted by St. Jude Medical, CRMD. Given it's a premarket submission, the testing would be considered prospective in the context of validating the new battery component. The country of origin of the data is not specified but is inferred to be from St. Jude Medical's internal testing.

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

• Not Applicable / Not Provided: This submission focuses on engineering and component-level performance validation post-battery change, not on diagnostic accuracy against a clinical ground truth. Therefore, there's no mention of experts establishing a ground truth for clinical performance.

4. Adjudication method for the test set

• Not Applicable / Not Provided: As explained above, this submission does not involve clinical performance assessment requiring ground truth adjudication.

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 device is an implantable cardiac monitor with diagnostic capabilities (detecting arrhythmias), but the submission focuses on a battery change, not on an AI algorithm or human reader interaction. Therefore, no MRMC study, AI component, or effect size is discussed.

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

• Not Applicable: This submission relates to the hardware component change of an existing implantable cardiac monitor, not a standalone algorithm. The device itself performs sensing and EGM storage as part of its diagnostic function, but the approval here is for the battery, not a new or modified detection algorithm.

7. The type of ground truth used

• Engineering Specifications and Existing Device Performance: For this 510(k), the "ground truth" for the battery change is that the device with the new battery must meet the established engineering specifications for the original device and exhibit performance equivalent to the device with the original battery. This would involve electrical performance metrics, mechanical integrity, and other product and system specifications established for the predicate device. There is no clinical "ground truth" (like pathology or outcomes data) established in this document for the purpose of demonstrating diagnostic accuracy.

8. The sample size for the training set

• Not Applicable / Not Provided: As this submission is about a hardware component change, there is no "training set" in the context of an algorithm.

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

• Not Applicable / Not Provided: As there is no training set for an algorithm in this submission, this question is not applicable.

Summary of Device Performance Study:

The study described is an internal engineering and component-level validation. It involved:

• Device testing: Documented in St. Jude Medical record 60041954, Attachment 3.
• Component level testing: Documented in St. Jude Medical record QTR40008803, Attachment 4.

The conclusion of these tests was that the alternate collector cell battery "has no effects on the device performance." No further details on methodologies, specific results, or quantitative metrics are provided in this summary. The focus is on demonstrating equivalence to the predicate device, not on re-proving the predicate device's efficacy.

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