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The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

The Isolator Synergy EnCompass Clamp and Guide System (OLH, OSH, GPM100) is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH), each with an accessory Glidepath Magnetic Guide (GPM100). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The clamp features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. When activated, the generator delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch connected to the generator. The Guide is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The guide has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the clamp jaws inside the jaw magnet cups.

The provided FDA 510(k) clearance letter and summary for the AtriCure Isolator® Synergy™ EnCompass Clamp and Guide System (K252056) describe modifications to an existing device, rather than a novel device requiring extensive clinical or AI-based performance studies. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device through bench testing and non-clinical performance evaluations, rather than establishing performance against specific diagnostic accuracy or clinical outcome metrics.

The document primarily focuses on ensuring the device modifications do not negatively impact the safety and effectiveness compared to the predicate device. As such, there is no mention of AI integration, MRMC studies, or extensive human reader performance evaluations typically associated with AI/CADe devices.

Here's the breakdown of the information as requested, tailored to what is provided in this specific 510(k) summary:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the AtriCure Isolator® Synergy™ EnCompass Clamp and Guide System (K252056)

The acceptance criteria and supporting studies for this device are designed to demonstrate substantial equivalence to its predicate device (Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System, K210477) following minor design and manufacturing changes. The focus is on ensuring the updated device maintains the same safety and effectiveness profile.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for minor modifications, the "acceptance criteria" are implied by the specific performance tests conducted to show that the modified device performs similarly to the predicate and meets relevant safety standards. The reported device performance indicates that the device met these implicit criteria.

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

• Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., number of clamps tested for mechanical properties, number of cadavers for usability). It refers to "bovine tissue" for ex vivo ablation and "cadaver lab" for usability. Given the nature of a 510(k) for minor device modifications, this level of detail regarding sample size for bench testing is typical.
• Data Provenance: The studies are primarily bench testing and laboratory-based non-clinical performance studies.
  • Ex vivo ablation: "bovine tissue"
  • Usability testing: "cadaver lab"
  • Biocompatibility: In vitro and some in vivo tests (implied by ISO 10993 standards, typically not human data unless specified).
  • Sterilization: Tests conducted at Steris Isomedix Operation (Spartanburg, SC).
  • Retrospective/Prospective: Not applicable as these are laboratory and bench studies for device changes, not clinical data from patients.
  • Country of Origin of Data: Not explicitly stated for all tests, but given the manufacturer (AtriCure, Inc., Ohio, USA) and sterilization vendor location (Spartanburg, SC, USA), the direct tests were likely conducted in the USA.

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

This type of information is generally not applicable to a 510(k) submission for minor device modifications based on bench and non-clinical testing. "Ground truth" in this context refers to established scientific and engineering principles, and performance standards (e.g., ISO, IEC). For the usability study, "participants" are mentioned, implying a group of users (likely surgeons or clinical personnel) who operated the device in a simulated environment, but their number and specific qualifications beyond being "users" are not detailed.

4. Adjudication Method for the Test Set

Not applicable. As these are technical, mechanical, and biological tests, "adjudication" in the sense of expert review for ambiguous cases (like in diagnostic image interpretation studies) is not relevant. The results are objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of a diagnostic aid (e.g., AI in image interpretation) on human reader performance. The Isolator® Synergy™ EnCompass Clamp and Guide System is an electrosurgical instrument, not a diagnostic device, and the modifications are minor, so such a study would not be relevant or required.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device does not incorporate an AI algorithm or software that operates independently to produce a diagnostic or analytical output. All testing pertains to the physical and functional performance of the medical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted is based on:

• Regulatory Standards: Compliance with recognized standards like ISO 10993 (Biocompatibility), IEC 60601 (Electrical Safety), and ANSI/AAMI/ISO 11135 (Sterilization).
• Engineering Specifications: Predetermined design life, mechanical limits (e.g., force, jaw aperture), and functional requirements for the device.
• Established Medical Practice: The ability to create "transmural lesions" in tissue (ex vivo), reflecting the intended therapeutic effect.
• Predicate Device Performance: The underlying "ground truth" for demonstrating substantial equivalence is often the proven safety and effectiveness of the legally marketed predicate device. The new device must perform in a "substantially equivalent manner" in relevant aspects.

8. The Sample Size for the Training Set

Not applicable. This device is a physical electrosurgical clamp and guide system, not an AI/ML-driven software device that requires a "training set" of data.

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

Not applicable, for the same reason as point 8.

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The Isolator linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU/ASB or MAG in Ablation mode.

The Isolator linear pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Isolator Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The Isolator Transpolar Pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

The Isolator Linear Pen (MLP1) utilizes radiofrequency (RF) energy from a RF generator to create lines of ablation on cardiac tissue. The MLP1 device is comprised of an end effector, shaft, handle, and cable. This end effector consists of one pair of ablation electrodes separated with insulating material, with the electrodes used for the pacing and sensing functions. When the Isolator linear pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Isolator Transpolar Pen (MAX1, MAX5) is a hand-held, single use bipolar surgical instrument intended for the ablation of cardiac tissue and for use by trained surgeons only. It is composed of a handpiece with a bipolar electrode configuration at its distal end with integral cable and is powered by a radiofrequency (RF) generator. When the Transpolar pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Coolrail Linear Pen (MCR1) is a hand-held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by a radiofrequency (RF) generator. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar RF energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.

The Isolator Synergy Clamps (EMR2, EML2) are single-patient use, electrosurgical instruments designed for use with a radiofrequency (RF) generator and are indicated to ablate cardiac tissue. When activated, the ASU delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the AtriCure Isolator Synergy Clamp. The Operator controls the application of this RF energy by pressing the Footswitch. The AtriCure Isolator Synergy Clamps feature two pairs of opposing dual electrodes, an in-line handle with syringe-type grip handle/ actuation and button release mechanisms.

The Isolator Synergy EnCompass Clamps (OLH, OSH) are a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms. The clamps utilize bipolar energy generated from a radiofrequency (RF) generator.

The Isolator Synergy Access Clamp (EMT1) is a handheld, single use, bipolar radiofrequency (RF) surgical instrument intended for the ablation of cardiac tissue. EMT1 is part of the AtriCure Bipolar (Transpolar) System which includes an accessory instrument guide (Glidepath Tape). The EMT1 clamp is connected via an integral cable to a radiofrequency (RF) generator.

The ASU/ASB Generator is the original RF energy source for the cleared handpieces listed above. The ASU/ASB Generator will continue to be available for use and is unchanged from the original clearances.

The Multifunctional Ablation Generator (MAG) is an alternate RF energy source to the currently cleared ASU/ASB generator for each handpiece system above. The MAG RF generator is a portable reusable device that produces and delivers monopolar and bipolar RF energy at 460 kHz. It provides a pass-thru to an external sense and pace system (feature relates to the Pen devices). The MAG consists of several circuit boards, power supplies, a power entry module, a footswitch interface, and an LCD display with an integrated touchscreen. Like the ASU/ASB generator, the main function of the MAG is to deliver and control of voltage and current output to the selected handpiece. Upon reaching a predetermined threshold (voltage and/or current relationship or a preset time), the RF generator will provide visual and audible indications to signal the end of the ablation cycle and decrease the energy level until RF is stopped or the time limit is reached. A footswitch and a Start-Stop button on the touchscreen are included in the system to start and stop RF ablation. The output of the MAG generator is designed to be equivalent to the ASU/ASB generator when connected to each handpiece listed above.

This looks like a 510(k) summary for a medical device called the AtriCure RF Pen and Clamp Handpieces, which are electrosurgical devices intended to ablate cardiac tissue. The summary is primarily aimed at demonstrating substantial equivalence to previously cleared predicate devices, with the main change being the addition of an alternative radiofrequency (RF) generator, the Multifunctional Ablation Generator (MAG).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for performance metrics. Instead, the entire submission hinges on demonstrating equivalence to predicate devices. The "reported device performance" is the finding that the system with the MAG generator is "equivalent" to the system with the predicate ASU/ASB generator.

The tables (Table 2 to Table 7) list various technological characteristics for each specific device (Isolator Synergy Clamps EMR2 & EML2, Isolator Synergy Access System EMT1, EnCompass OLH/OSH, Isolator Transpolar Pen MAX1/5, and Multifunctional Linear Pen MLP1, Coolrail Linear Pen MCR1). For almost all features, the comparison is "Same," meaning the proposed device/system feature is identical to the current/predicate device.

The key "acceptance criteria" here implicitly are:

• Identical Intended Use: The proposed device must have the same intended use as the predicate device (verified in row 3 of each table, with minor language adjustments noted as "Equivalent - Adjusted language to align with AtriCure's other RF devices" but indicating no change in core intent).
• Equivalent RF Generator Performance: The MAG generator must demonstrate equivalent RF energy output, algorithms, frequency, and duration to the ASU/ASB generator (verified in rows 13-15 or 14-17 of each table, marked as "Equivalent" for the generator itself, and "Same" for algorithm, frequency, and duration).
• No Change in Handpiece Design: The single-use handpieces themselves must be unchanged from the predicate systems.
• Conformance to Standards: The device must meet recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• Packaging, Sterilization, Biocompatibility: These aspects must remain the same and meet relevant standards (ISO 10993 for biocompatibility, 10-6 SAL for sterility assurance).
• System Performance Equivalence: Bench testing and ex-vivo lesion equivalency testing must confirm that system performance with the MAG generator is equivalent to performance with the ASU/ASB generator.

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

The document does not specify a numerical sample size for "test sets" in the traditional sense of clinical or statistically powered performance studies. The testing described is primarily bench testing and ex-vivo lesion equivalency testing.

• Sample Size: Not explicitly stated as a number of devices or data points from a large population. It mentions "System testing with each handpiece" which implies a representative number of each device type was tested.
• Data Provenance: The data provenance is from "Bench testing" and "ex-vivo lesion equivalency testing." This indicates the testing was done in a laboratory setting, likely on animal tissue or synthetic models, not human subjects. There is no mention of country of origin for the data, but given the company is US-based and seeking FDA clearance, the testing would generally align with US regulatory expectations and likely performed in the US or by a recognized international testing facility. The data is retrospective in the sense that it's performed to support a pre-market notification, not a prospective clinical trial.

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

This information is not provided in the document. For bench and ex-vivo testing, "ground truth" might be established by direct physical measurements or comparisons to established baselines, rather than expert interpretation of complex data like medical images. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of bench and ex-vivo performance testing described. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving human interpretation or subjective assessments where multiple experts need to agree on a "ground truth" diagnosis or outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is critical for evaluating the impact of AI or new technologies on human reader performance, typically in diagnostic imaging. The device described is an electrosurgical device, and the focus of this submission is on the equivalence of a new power generator, not on changing human diagnostic performance.

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

The specific context of "standalone algorithm performance" as it relates to AI is not directly applicable here. The "algorithm" referenced (Algorithm G, B, C, L in the tables) refers to the proprietary algorithms within the RF generator controlling power output based on tissue impedance.

However, the bench testing and ex-vivo lesion equivalency testing essentially represent standalone performance of the device's ability to ablate tissue. These tests evaluate the device's technical capabilities (e.g., power output characteristics, lesion depth/quality) without human intervention beyond operating the device according to its instructions. The equivalence was demonstrated by comparing the MAG generator's performance in these standalone bench tests to the ASU/ASB generator's performance.

7. The Type of Ground Truth Used

For the bench and ex-vivo testing, the "ground truth" would be established through direct physical measurement and characterization of the ablations. This could involve:

• Physical measurements: Lesion dimensions (depth, width), temperature profiles.
• Histopathology: For ex-vivo tissue, microscopic examination to confirm lesion extent and cellular changes (though not explicitly stated, this is standard for lesion equivalency).
• Electrical measurements: Characterizing RF power output, frequency, and current delivery under various load conditions.

8. The Sample Size for the Training Set

This information is not applicable as the document describes an electrosurgical device system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "proprietary algorithm which senses tissue impedance" within the generator would have been developed and refined through engineering processes and testing, not a machine learning training paradigm of external data.

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

This information is not applicable for the same reasons as point 8.

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For In Vitro Diagnostic Use.

The Rheonix STI TriPlex™ Assay, as performed on the Rheonix Encompass MDx® Workstation, is an automated DNA extraction and multiplex PCR amplification test system intended for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), and/or Neisseria gonorrhoeae (NG), and/or Trichomonas vaginalis (TV) in male urine specimens collected with the Rheonix Urine Specimen Collection Kit. The test is indicated to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and trichomoniasis in asymptomatic male individuals.

The Rheonix Encompass MDx® Workstation and the Rheonix STT TriPlex™ Assay are comprised of an instrument with associated hardware and accessories, disposable microfluidic CARD cartridges, master mixes and reagent components used to extract, amplify, and detect DNA using end point PCR. In addition, all male urine specimens in this system must be collected using the Rheonix Urine Specimen Collection Kit. The process is fully automated with the user intervention required only for loading and unloading the samples and disposable assay components. The Rheonix Encompass MDx Workstation's software automatically interprets test results which may be called as POS (positive), NEG (negative), or IND (indeterminate) for each of the assay's three targets. In addition, if the instrument encounters an error during the performance of the assay, it will report an ERR code. If either an IND or ERR code results, the same specimen should be reanalyzed for the presence of the target for which the indeterminate or error code occurred. Each assay has a built-in process control that assures that the individual steps of the entire process occurred properly. The user may also include external positive and/or negative controls to monitor the assay performance.

The Rheonix STI TriPlex Assay, performed on the Rheonix Encompass MDx Workstation, is an automated DNA extraction and multiplex PCR amplification test system for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in male urine specimens.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the clinical performance (sensitivity and specificity) against a Patient Infection Status (PIS) derived from FDA-cleared Nucleic Acid Amplification Tests (NAATs). While explicit "acceptance criteria" are not listed as pass/fail values, the reported performance metrics serve as the demonstration that the device is fit for its intended use. For the purpose of this response, I will list the observed clinical performance as the "reported device performance," which implicitly met the FDA's criteria for substantial equivalence.

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

• Test Set Sample Size:
  • CT and NG: 1606 evaluable male subjects.
  • TV: 1585 evaluable male subjects (out of 1586, one excluded due to invalid test result).
• Data Provenance:
  • Country of Origin: United States. Specimens were collected at 8 geographically distinct sites in the US.
  • Retrospective or Prospective: Prospective. The study enrolled both symptomatic and asymptomatic subjects, and one first-catch urine specimen was collected from each subject.

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

The ground truth, referred to as "Patient Infection Status (PIS)," was established by multiple FDA-cleared Nucleic Acid Amplification Tests (NAATs), not individual human experts. The document does not specify the number or qualifications of experts involved in running these comparator NAATs or interpreting their results beyond the described adjudication method. It implies that these were standard laboratory procedures using cleared devices.

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

The adjudication method used to establish the Patient Infection Status (PIS) for the test set was a 2+1 method:

• For each target (CT, NG, TV), up to three different FDA cleared NAATs were used.
• If the first two NAATs yielded concordant results (both positive or both negative), the PIS was defined accordingly.
• If the first two NAATs were not concordant, a third "tie-breaker" test was used. The PIS was then determined based on the majority rule (2 out of 3 results being either positive or negative).

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:

This device is an automated in vitro diagnostic (IVD) assay for nucleic acid detection, not an AI-assisted imaging device that involves human "readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not applicable and not performed. The device itself provides an automated interpretation (Positive, Negative, Indeterminate, or Error).

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

Yes, a standalone performance study was done. The entire premise of the clinical performance evaluation (Tables 15-17) is a direct comparison of the Rheonix STI TriPlex Assay's automated results (Positive, Negative) against the established Patient Infection Status (PIS). There is no mention of a human-in-the-loop component for the Rheonix system's result interpretation. The workstation's software automatically interprets test results.

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

The ground truth used was molecular diagnostic consensus derived from multiple FDA-cleared Nucleic Acid Amplification Tests (NAATs). This is a common and accepted method for establishing ground truth in diagnostic studies for infectious diseases, as NAATs are highly sensitive and specific.

8. The sample size for the training set:

The document does not explicitly specify a "training set" for the clinical performance evaluation in the context of device clearance. Instead, it describes analytical and clinical performance studies demonstrating the device's capability. For an IVD like this, "training" typically refers to the development and optimization phase using internal validation data rather than a distinct, reported "training set" from a pivotal clinical trial. No sample size for a separate training set is provided in this submission summary.

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

As noted above, a distinct "training set" with ground truth established in the same manner as a clinical test set is not typically described for IVD device submissions in this way. The analytical performance characteristics (e.g., Limit of Detection, Inclusivity, Specificity, Interference, Carry-over) are established using contrived samples with known concentrations of target organisms and potential interfering substances, which serve as a form of "ground truth" for ensuring the assay's fundamental analytical capabilities during its development and internal validation. The clinical study then validates these capabilities in real-world patient samples against the PIS.

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The AtriCure Isolator Synergy EnCompass Clamp and Guide system is intended to ablate cardiac tissue during surgery.

The CLAMP is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms. The GUIDE is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The GUIDE has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the CLAMP jaws inside the jaw magnet cups.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as per your request:

Based on the provided FDA 510(k) summary for the AtriCure Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System (K210477), the device described is an electrosurgical cutting and coagulation device, not an AI/ML-based diagnostic device. Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sensitivity, specificity, human-in-the-loop performance, expert ground truth for image data, MRMC studies, effect size of AI assistance, training set details) are not applicable or not provided in this type of submission for this medical device.

This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here refer to the pre-established benchmarks for these engineering and performance tests, rather than clinical efficacy metrics for a diagnostic algorithm.

Here's a breakdown of the available information:

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

The document states: "The Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared Isolator Synergy Dual Electrode Clamp (EMR2/EML2)." However, the specific numerical acceptance criteria for each test and the precise reported device performance against those criteria are not detailed in this summary. The summary only lists the types of tests performed.

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

• Sample Size for Test Set: Not specified for any of the individual tests. This type of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The tests are "bench testing" and "Ex vivo Ablation Comparison Testing," and a "GLP Animal Study." This indicates laboratory and animal testing, not human patient data. Therefore, country of origin is not applicable in the same way as with clinical data. The studies are prospective in nature, as they involve testing the new device.

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. This device is an electrosurgical clamp, not a diagnostic imaging device requiring expert interpretation for ground truth. Ground truth for these engineering tests would be established through physical measurements, chemical analyses, and biological observations (in the animal study/biocompatibility).

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the type of testing performed for this device.

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 a surgical instrument, 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 not an AI algorithm.

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

The "ground truth" for this type of device is established through:

• Engineering specifications and measurements (e.g., clamp force, electrical resistance, temperature).
• Ex vivo and in vivo (animal study) observations of ablation lesion quality and tissue response.
• Standardized biocompatibility tests to assess material interactions with biological systems.
• Accelerated aging for shelf life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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The Encompass™ 15 Channel Head Coil is intended to be used in conjunction with a Magnetic Resorance Scanner for the MR examination of the human brain just before, during, and at the end of brain surgery. The Encompass™ 15 Channel Head Coil can also be used as a standard diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). When used with magnetic resonance imaging systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Qfix and NORAS MRI products GmbH have jointly developed a head coil designed to enable MRI for diagnosis and to inform additional clinical actions, the Encompass™ 15 Channel Head Coil, 3T. The Encompass 15 Channel Head Coil is a diagnostic imaging device for use in 3T environments for obtaining diagnostic MR images to be used to inform procedures which use MR imaging to guide interventional procedures and other treatments. The Encompass™ 15 Channel Head Coil has been specifically designed to interface with the Encompass™ SRS Immobilization System (cleared with K152321 December 4, 2015).

The Encompass™ 15 Channel Head Coil is a ridged receive only coil featuring a 7 Channel Top Coil, an 8 Channel Bottom Coil, and an optional mirror holder. Imaging is performed with a 15-Channel "phased array" co-developed by Qfix and NORAS and manufactured by NORAS. The coils are mounted in a rigid Coil Frame and connection to the MRI is managed by the applicable MRI software. The Encompass™ 15 Channel MRI Head Coil has been designed for use with Siemens Healthineers MAGNETOM 3T systems e.g. MAGNETOM Skyra.

Encompass™ 15 Channel Head Coil has been optimized for use with the Encompass™ SRS Immobilization System. The use of the Encompass™ 15 Channel Head Coil together with the Encompass™ SRS Immobilization System allows immobilization of the patient while obtaining diagnostic MR images to be used to inform procedures which use MR imaging to guide interventional procedures and other treatments.

This FDA 510(k) summary describes the Qfix Encompass™ 15 Channel Head Coil, 3T, which is an MRI head coil. The document primarily focuses on demonstrating substantial equivalence to a predicate device (NORAS OR Head Coil 3T) through non-clinical performance and safety testing. It does not present an independent study with acceptance criteria involving specific performance metrics like sensitivity, specificity, or AUC for an AI/device's diagnostic accuracy.

Therefore, many of the requested elements for an AI/device performance study (like test set sample size, expert ground truth, effect size with AI assistance, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary.

However, based on the provided text, I can infer the general acceptance criteria and describe the general study approach used to demonstrate substantial equivalence for this type of medical device (an MRI coil).

Here's the breakdown:

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

For an MRI coil, "acceptance criteria" and "reported device performance" are typically framed around safety and technical imaging performance, often compared to a predicate device, rather than diagnostic accuracy metrics.

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

• Sample Size: Not applicable in the context of an "AI/device test set." This document describes testing for an MRI coil. The "test set" would primarily refer to technical performance measurements on imaging systems. There's no mention of a defined "test set" of patient images or specific clinical cases for evaluating diagnostic accuracy in the way an AI algorithm would be evaluated.
• Data Provenance: Not applicable for a typical AI/device test set. The performance data comes from non-clinical bench testing conducted by Qfix and NORAS. It indicates testing on "3T Siemens Healthineers MAGNETOM MRI scanners."

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

• Not applicable. No expert review for establishing ground truth on a 'test set' of patient data for diagnostic accuracy is mentioned. The "interpretation by a trained physician" is mentioned in the Indications for Use, which is standard for diagnostic imaging, but this is not part of a study to establish ground truth for algorithm performance.

4. Adjudication method for the test set

• Not applicable. No adjudication method is mentioned as there's no diagnostic accuracy study described involving a test set and experts.

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 comparative effectiveness study was not performed. This document is for an MRI head coil, not an AI-powered diagnostic device, so AI assistance is not a component.

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

• Not applicable. This device is an MRI head coil, not an algorithm. Its performance is inherent to its physical design and interaction with the MRI scanner. It does not perform a standalone diagnostic function akin to an algorithm.

7. The type of ground truth used

• For an MRI coil, "ground truth" relates to the accuracy and quality of the image acquisition, not diagnostic findings from patient cases. The "ground truth" (or reference standard) in this context would be:
  • Engineering specifications and standards: Adherence to NEMA standards for MRI performance (e.g., SNR, uniformity).
  • Safety standards: Compliance with IEC 60601-1 series and ISO 14971.
  • Predicate device performance: Functional equivalence and demonstrated improvements over the NORAS OR Head Coil 3T.

8. The sample size for the training set

• Not applicable. This device is hardware (an MRI coil), not an AI 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 an AI algorithm.

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The Encompass™ SRS Headframe provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. repositioning, and immobilization. The Encompass™ SRS Headframe allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Qfix, has made a modification to its previously cleared Encompass™ SRS Immobilization System (cleared in K152321). In this modified variant of the Encompass™ SRS Immobilization System, the essential geometry of the head portion of the Encompass™ SRS Standalone Device is isolated to create a separate attachment which can be affixed to patient positioning devices that accept S-type thermoplastic masks, such as Qfix's Portrait™ Intracranial, Head and Neck Device (a device for use with S-type thermoplastics). Ofix intends to initially market the subject device for use with the Encompass™ SRS Fibreplast® System with optional IntegraBite™ (also cleared in K152321) and its devices which share a hole pattern and geometry with its Portrait™ Intracranial, Head and Neck Device. Examples of such devices include the kVue™ Portrait™ Intracranial. Head and Neck Insert and the Symphony® Portrait™ Transfer Device (cleared in K160627). This creates a flexible solution for a variety of imaging and radiotherapy treatment applications using stereotactic radiosurgery, such as radiation oncology and the treatment of noncancerous conditions and malformations such as trigeminal neuralgia.

The provided text is a 510(k) summary for the Qfix Encompass™ SRS Headframe, a medical device for patient immobilization during radiation therapy. It claims substantial equivalence to a previously cleared predicate device rather than presenting a novel AI/software-as-a-medical-device (SaMD) study. Therefore, the information typically requested about AI/SaMD acceptance criteria, test set details, expert ground truth, MRMC studies, and training set information is not present in this document.

However, I can extract information related to the device's performance claims and general testing.

Here's a breakdown of what can be extracted based on the provided text, and what cannot be extracted because it's not an AI/SaMD submission:

Acceptance Criteria and Device Performance (General Device Performance):

The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance data in the typical sense of a SaMD validation study. Instead, it makes a general claim about performance relative to its predicate device.

• Verification of hardware specifications
• Accuracy validation via motion studies
• Ease of use/ergonomics assessments
• Verification of aluminum equivalence
• Verification of compatibility with optical tracking systems |

Information NOT available in the provided text (typical for AI/SaMD studies):

2. Sample size used for the test set and the data provenance: Not applicable to this device type and submission. The document mentions "testing using healthy volunteers" for non-clinical bench testing but does not specify a sample size for these volunteers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical immobilization device is typically established through direct measurement (e.g., motion studies, calibration) rather than expert interpretation of images or data.
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: Not applicable, as this is not an AI-assisted device for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, ground truth for accuracy claims would be based on physical measurements (e.g., displacement measurements during motion studies) rather than expert interpretation or pathological findings.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary of Device and Study Type:

This 510(k) submission is for a physical medical device (Encompass™ SRS Headframe) used for patient immobilization during radiation therapy. The submission relies on demonstrating substantial equivalence to a previously cleared predicate device (Encompass™ SRS Immobilization System, K152321). Therefore, the "study" described is primarily non-clinical bench testing and testing with healthy volunteers to ensure the modified device maintains the performance characteristics (e.g., sub-millimetric accuracy, compatibility) and safety profile of the predicate device, rather than a clinical trial or AI/SaMD validation study with diagnostic endpoints.

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ENCOMPASS Eagle 3D is intended to acquire two-dimensional digital panoramic and cephalometric radiographies, and multi-field of view 3D computed tomography images of dento-maxillo-facial region for the purpose of advanced diagnosis at the direction of qualified dental healthcare professionals

The ENCOMPASS Eagle 3D is a complete 3-in-1 system for dental imaging capable of make Tomography, Digital Panoramic Profiles and Digital Cephalometric Profiles. The machine uses a CCD sensor technology with the traditional scintillator technologies and auto image processing that speeds up the diagnostic and improves the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).

The provided text describes the ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-ray device and its substantial equivalence to a predicate device (PREXION 3D ECLIPSE). However, it does not detail a study with specific acceptance criteria and reported device performance in the way a clinical performance study for an AI/ML SaMD would.

Instead, the document focuses on demonstrating substantial equivalence based on technical specifications and performance testing against the predicate device, a common approach for traditional medical devices like X-ray systems.

Here's a breakdown of the information that is available, formatted to address your request as much as possible, along with explanations of why some requested information is not present:

Acceptance Criteria and Device Performance for ENCOMPASS Eagle 3D

The device is an X-ray system, and its "performance" is primarily assessed by comparing its technical specifications and image quality characteristics (like MTF and DQE) to those of a legally marketed predicate device. The underlying acceptance criterion is that the new device should be substantially equivalent to the predicate device in terms of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

For an X-ray device, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with relevant electrical, mechanical, environmental, and radiation safety standards, as well as key imaging performance metrics (e.g., resolution, noise). The "reported device performance" is then how the new device measures up against these (often implicitly defined by the predicate's performance).

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

The document states: "In accordance with the FDA guidance document on Solid State X-Ray Imaging Devices, clinical images were acquired with both the new device and the predicate device."

• Sample Size: The exact number of clinical images or cases used is not specified.
• Data Provenance: The country of origin and whether the data was retrospective or prospective are not specified. It is implied to be prospective data collection for the purpose of the submission since images were "acquired with both the new device and the predicate device" for comparison.

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

• Number of Experts: "a licensed dentist" assessed the clinical images. This implies one expert.
• Qualifications of Experts: "a licensed dentist." No further details on experience or specialization are provided in this summary.

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

• Given that only "a licensed dentist" performed the comparison, there was no adjudication method (like 2+1 or 3+1 consensus) in the traditional sense, as there was only one reviewer.

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. This device is an X-ray imaging system, not an AI/ML-driven diagnostic software. The comparison was primarily on the physical and imaging characteristics of the hardware and the quality of the images produced, rather than reader performance with or without AI assistance.

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

• No standalone algorithm performance study was done. This is a hardware device for image acquisition, not a software algorithm.

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

• For the clinical image comparison, the "ground truth" was implicitly established by the judgment of a single licensed dentist who compared images from the new device and the predicate device for diagnostic ability, sharpness, and quality. This is a form of expert assessment or expert-generated truth. There's no mention of pathology or outcomes data being used for this comparison.
• For the technical performance metrics (MTF, DQE), the "ground truth" comes from standard physical measurements using phantoms and calibrated equipment.

8. The sample size for the training set

• Not applicable / Not specified. This device is an X-ray imaging system, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The device is trained/calibrated during manufacturing and installation processes, but this is distinct from an AI model's training data.

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

• Not applicable / Not specified. As explained above, there isn't a "training set" in the AI/ML sense for this hardware device.

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The Encompass™ SRS Immobilization System provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. a pationing and immobilization. The Encompass™ SRS Immobilization System allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

The Encompass™ SRS Immobilization System is a highly advanced, non-invasive immobilization solution designed for precisely targeted brain, head and neck treatments. The Encompass™ SRS Immobilization System consists of a posterior support of either a Fibreplast™ thermoplastic mask, or a Moldcare cushion which rests on a contoured surface. The Encompass™ SRS Immobilization System features the IntegraBite™, which reduces motion allowing for maximum dose to the tumor while minimizing radiation delivered to the surrounding healthy tissue. The Integrated Shim System™ enables quick and seamless 0.5 mm height adjustments of the thermoplastic mask for a fully customizable patient setup. The Encompass™ SRS Immobilization System is designed to optimize workflow efficiencies and improve patient outcomes.

The provided text describes the Encompass™ SRS Immobilization System and its performance studies to support its substantial equivalence to a predicate device. However, it does not explicitly define "acceptance criteria" in the way one might expect for a diagnostic or AI-driven medical device (e.g., sensitivity, specificity thresholds). Instead, the performance studies assess immobilization and workflow.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, I will infer them from the "verification, validation and safety requirements" and the "conclusions" of the studies.

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

• Sample Size for Test Set:
  • Motion Studies: Healthy volunteers (number not specified).
  • Intrafractionation Studies: Not specified, but conducted "at a clinical site."
  • Workflow Studies: Not specified.
• Data Provenance: The text does not explicitly state the country of origin. The motion studies were conducted on "healthy volunteers," implying a prospective study. The intrafractionation studies were conducted "at a clinical site," also suggesting prospective data collection.

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 diagnostic accuracy for this immobilization system. The "ground truth" for immobilization performance appears to be directly measured via tracking systems. For workflow studies, the assessment is observational.

4. Adjudication Method for the Test Set

Not applicable. The performance studies described involve direct measurement of physical parameters (motion, time), not subjective interpretation requiring adjudication among experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an immobilization system, not a diagnostic imaging interpretation tool where human readers and AI would be compared. The study focused on the physical performance of the device itself.

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

Not applicable. The device is a physical immobilization system, not an algorithm. Its performance is inherent in its design and physical properties, tested in conjunction with human interaction (mask formation, patient use).

7. The Type of Ground Truth Used

• Motion Studies: Direct measurement of motion using tracking systems.
• Intrafractionation Studies: Direct measurement of intrafractionation motion, likely using external tracking or imaging.
• Workflow Studies: Timed observations of the mask-making process.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

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

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For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.

The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine with CCD sensor is a complete system for dental imaging capable of Digital Panoramic Profiles and Digital Cephalometric Profiles. The machines use a sensor CCD sensor technology with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current). ONLY THE SENSOR HAS CHANGED.

The provided text describes the ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD sensor. Based on the information, here's a description of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

The device sought substantial equivalence to its predicate device (K110371, Encompass made for Panoramic Corp.). The acceptance criteria appear to be focused on achieving comparable diagnostic quality, sharpness, and overall image quality to the predicate device, as well as meeting relevant safety and performance standards.

Table of Acceptance Criteria and Reported Device Performance:

Overall Result: "All test results were satisfactory." and the clinical summary states the images were found to have comparable diagnostic quality, sharpness, and overall quality.

Study Details:

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

   • Sample Size: Not explicitly stated. The text only mentions "the predicate and new device pan and ceph images."
   • Data Provenance: Not specified. It does not mention the country of origin of the data, nor whether the data was retrospective or prospective.

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

   • Number of Experts: "a licensed dentist" (singular).
   • Qualifications of Experts: A "licensed dentist." No further details on experience level (e.g., years of experience, specialization) are provided.

3. Adjudication method for the test set:

   • Adjudication Method: Not specified. With only one expert reviewing, there was no adjudication process (like 2+1 or 3+1 consensus). The assessment was based on a single licensed dentist's review.

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:

   • MRMC Study: No, an MRMC study was not done. The evaluation involved a single licensed dentist comparing images from the new device and the predicate device, not assessing human reader performance with or without AI assistance. This device is an X-ray machine with a new sensor, not an AI-assisted diagnostic tool.

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

   • Standalone Performance: Not applicable in the context of an X-ray imaging device itself. The device produces images for human interpretation. The "resolution figures" and technical performance tests (safety, EMC, X-ray standards) could be considered standalone performance metrics for the device's technical capabilities, but not a standalone diagnostic "algorithm" performance.

6. The type of ground truth used:

   • Ground Truth Type: Expert opinion/consensus. In this case, it was the opinion of a single "licensed dentist" who evaluated the diagnostic quality, sharpness, and overall quality of the images. There is no mention of pathology or outcomes data being used as ground truth.

7. The sample size for the training set:

   • Sample Size: Not applicable. The device is an X-ray machine with a new sensor, not a machine learning model that requires a "training set" in the conventional sense. The "auto image processing" mentioned is likely built-in firmware/software rather than a continually learning AI.

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

   • Ground Truth Establishment: Not applicable, as there is no mention of a training set for a machine learning model.

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The Encompass® 10/12 Hip Stem is intended for use in total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis
2. Previously failed surgery
3. Proximal femoral neck fractures or dislocation
4. Idiopathic avascular necrosis of the femoral head
5. Non-union of proximal femoral neck fractures
6. Treatment of fractures that are unmanageable using other forms of therapy
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis

The Encompass® 10/12 Hip Stem is a one-piece, straight femoral stem, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stem is manufactured from wrought titanium alloy Ti-6Al-4V EU per ASTM F136. The proximal portion of the stem is subsequently plasma-sprayed with Commercially Pure Titanium per ASTM F1580. The stem has a neck with a 10/12 trunnion taper for modular attachment to femoral heads. To accommodate various patient anatomies, the stem is offered with and without collars and in a variety of sizes, including the following ranges: lengths (115-143mm), horizontal offsets (32-46mm), and vertical offsets (29-36mm), with a resection angle of 130°, and neck angle of 132°.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The document does not report any clinical studies or human test subjects. The performance testing was non-clinical (mechanical testing of the device itself).
• Data Provenance: Not applicable. All testing mentioned is non-clinical laboratory testing.

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

• Not applicable. As no clinical studies were performed, there was no human test set requiring expert adjudication for ground truth. The "ground truth" for non-clinical performance testing is based on established engineering standards (ISO).

4. Adjudication Method for the Test Set

• Not applicable. No clinical studies were performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hip stem prosthesis, not an AI or imaging-based diagnostic tool that would typically involve human readers.

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

• Not applicable. This device is a medical implant, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.

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

• For the non-clinical performance studies, the "ground truth" is established by adherence to internationally recognized engineering and medical device standards (e.g., ISO 7206-6, ISO 7206-4, ISO 21535). These standards define acceptable performance parameters for hip stem prostheses.

8. The Sample Size for the Training Set

• Not applicable. As no clinical studies or AI/algorithm development are reported, there is no "training set." The device is a physical implant.

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

• Not applicable. There is no training set.

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