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510(k) Data Aggregation
(279 days)
The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode and as an adjunct for the treatment of MDD in adolescent patients (age 15-21).
The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS). The Apollo TMS Therapy System is comprised of the following principal components: User Interface, Main Unit (with or without housing), Stimulation Coil, Coil Positioning System. The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system.
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(276 days)
The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).
The Apollo TMS Therapy System is comprised of the following principal components:
- User Interface
- Main Unit (with or without housing)
- Stimulation Coil
- Coil Positioning System
The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system. The observed and documented increase in cortical excitability after high frequency rTMS has been shown to persist beyond the duration of the train of stimulation. For treatment of OCD, the stimulation coil is positioned to the dorsomedial prefrontal cortex (DMPFC).
The provided FDA 510(k) clearance letter and summary for the Apollo TMS Therapy System (K243539) indicate that the device is substantially equivalent to predicate devices. This clearance is based on non-clinical performance data and a comparison to existing cleared devices rather than a de novo clinical comparative effectiveness study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly for the extended indication of Obsessive-Compulsive Disorder (OCD) treatment. The criteria are therefore focused on matching or being demonstrably similar to the predicate device's performance, especially for the OCD treatment parameters, and adhering to recognized safety and performance standards.
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (Apollo TMS Therapy System K243539) |
|---|---|
| Intended Use Equivalence: Identical intended use as predicate devices. | The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). This matches the intended use of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171) for OCD, and the secondary predicate (Apollo TMS Therapy System K232639) for MDD. |
| OCD Treatment Stimulation Parameters Equivalence: Identical brain area, intensity (100% leg MT), frequency (20 Hz), pulse train duration (2 sec), inter-train interval (20 sec), trains per session (50), max no. of pulses (2000), and treatment schedule (5 daily sessions for 5 weeks, 4 daily sessions for 1 week) as the primary predicate device. | Area of brain to be stimulated: DMPFC (Identical to predicate) Stimulation intensity: 100 % of leg MT (Identical to predicate) Stimulation frequency: 20 Hz (Identical to predicate) Pulse train duration: 2 sec (Identical to predicate) Inter-train interval: 20 sec (Identical to predicate) Trains per session: 50 (Identical to predicate) Max no. of pulses: 2000 (Identical to predicate) Treatment schedule: 5 daily sessions for 5 weeks, 4 daily sessions for 1 week (Identical to predicate) |
| Consistent Intensity of Individual Stimuli during OCD Protocol: The intensity of each stimulus during the OCD protocol is equal and kept constant throughout the delivery of the full treatment. | Successfully demonstrated for the subject device. |
| Safety Temperature Limits Adherence: Remaining within recognized safety temperature limits at maximum output. | Remaining within recognized safety temperature limits. (Identical to predicates) |
| Electrical Safety: Conformance to IEC 60601-1. | Conforms to IEC 60601-1. |
| Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2. | Conforms to IEC 60601-1-2. |
| Usability: Conformance to IEC 60601-1-6. | Conforms to IEC 60601-1-6. |
| Software Life Cycle Processes: Conformance to IEC 62304 and FDA guidance for software. | Software verification and validation testing conducted and documented in accordance with IEC 62304 and internal quality procedures. Software documentation considered "basic documentation" (supported by Special Controls Guidance "rTMS Class II"). |
| Risk Management: Application of ISO 14971 and IEC 62304 throughout the product development lifecycle with no new hazards/harms compared to predicates. | Risk assessment applied. Results indicate no new hazards, harms, or safety risks introduced when compared to the predicate devices. |
| Output Stimulation Parameters: Adequately similar output stimulation parameters (amplitude, pulse width, frequency, pulse train duration, ITI range, max # of pulses per session) to enable substantial equivalence determination. | Detailed comparison provided in the summary. While pulse width differs, the output stimulation is considered "adequately similar" to the primary predicate for OCD treatment. Other parameters within acceptable ranges or directly comparable. |
| Stimulation Coil Parameters: Similar coil configuration (figure-of-eight), output waveform (biphasic), E-Field at 1.0 SMT (130 V/m). | All identical to predicates. |
| Coil Positioning System: Comparable in function and method to predicate devices. | Integrated into Head-and-Neck-Support System (HANS), Landmark-Aided Coil Placement, TMS Cap for standardized 10-20-EEG Positioning with Coil Positioning Arm. Considered comparable or improved over predicate. |
2. Sample size used for the test set and the data provenance
The submission does not detail a specific "test set" sample size with patient data for efficacy, as it claims substantial equivalence primarily through non-clinical performance testing and direct comparison of specifications and treatment parameters to already cleared devices.
The "study" relies on:
- Non-clinical performance testing: This would involve engineering and laboratory testing for electrical safety, EMC, usability, temperature, and stimulation intensity, rather than a sample size of patients.
- Leveraged data from prior clearances (K180313 and K232639): This indicates that data from previously cleared versions of the Apollo TMS Therapy System was used as a basis.
- Primary predicate device (HORIZON® 3.0 TMS Therapy System K222171): The effectiveness of the OCD treatment protocol is derived from the established effectiveness of this predicate device, which was itself cleared based on its own clinical or non-clinical data.
Data Provenance: Not specified in terms of country of origin or retrospective/prospective for patient data, as direct clinical effectiveness data for the subject device was not required for this 510(k) clearance due to the substantial equivalence claim. The non-clinical testing would have been conducted by the manufacturer (MAG & More GmbH, Germany).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the submission does not describe a clinical study where experts established ground truth for a test set of patient data. The clearance is based on comparison to a predicate device and non-clinical engineering tests.
4. Adjudication method for the test set
This information is not applicable as there was no clinical test set requiring expert 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
This information is not applicable. The Apollo TMS Therapy System is a therapeutic device that directly applies magnetic stimulation, not an imaging analysis or diagnostic AI device that involves "human readers" or AI assistance in interpretation. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an "algorithm only" performance study. The Apollo TMS Therapy System is a hardware device with controlling software. Its performance is always "standalone" in the sense that the device itself (hardware+software) delivers the therapy; there isn't a separate "human-in-the-loop" performance associated with its direct therapeutic action, but rather clinical oversight and operation by a healthcare professional. The software verification and validation are noted, but this is for the control system's reliability, not an "algorithm-only performance" in the diagnostic AI sense.
7. The type of ground truth used
For the effectiveness of the OCD treatment, the "ground truth" is essentially the established clinical efficacy of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171), whose OCD treatment protocol the Apollo TMS Therapy System replicates. The substantial equivalence claim means that because the subject device's treatment parameters are identical and its output stimulation is adequately similar, it can be expected to achieve the same therapeutic effect.
For the safety and performance of the device itself (e.g., electrical safety, temperature limits, consistent stimulus delivery), the "ground truth" is established through adherence to recognized consensus standards (e.g., IEC 60601-1) and successful non-clinical engineering tests.
8. The sample size for the training set
This information is not applicable. The Apollo TMS Therapy System is not an AI/ML device in the sense of requiring a large "training set" of patient data for its primary function. Its software (Stimware) manages protocols and patient data, but it's not "trained" on patient outcomes to learn or adapt therapeutic delivery in an AI sense.
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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(200 days)
ApolloHipX is indicated for use in assisting in Total Hip Replacement in which the use of radiological imaging may be appropriate.
ApolloHipX is a non-invasive intra-operative, image processing software intended to precisely measure the position of total hip replacement (THR) components. The software operates as a near-real time assistive device for THR, measuring component alignment, to assist in precise placement of THR components. The software is intended to be installed on certified hardware (Apollo Station) located outside the patient field. This is accomplished by:
• Transfer of intra-operative 2D imaging of the patient from a capture source e.g. an X-ray machine
• Registration of the 3D pre-operative patient data to the 2D intra-operative patient imaging
• Calculation and display of the component alignment (for final implants as well as intra-operative instruments e.g., broaches and trials) which can be compared to pre-operative target positions.
ApolloHipX is intended to precisely measure the position of THR components by measuring implant positions relative to bone structures identifiable from radiological images and providing information on component alignment.
Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation.The Apollo Station is the physical structure used to host the power supply and contains two user interfaces (monitor and tablet) from which the user can interact with the software applications. It also houses non-surgical Software that manages the user authentication, system access, data transfer of surgical inputs and communication to Corin's cloudhosted ecosystem. The Apollo Station connects to the imaging device intra-operatively to receive the 2D radiological images.
The provided text describes the ApolloHipX device and its clearance (K241808) by the FDA. However, it does not contain detailed information about the acceptance criteria and the specific study findings in the format requested.
The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (JointPoint K160284). While it mentions "Non-Clinical testing conducted to determine substantial equivalence," and lists several studies like "Algorithm Accuracy Study," it does not provide the acceptance criteria table or the detailed study results that prove the device meets these criteria. It also explicitly states "Not Applicable. No clinical testing performed to support substantial equivalence."
Therefore, based solely on the provided text, I cannot complete most of the requested information.
Here's what can be inferred/extracted from the provided text, and what is missing:
Acceptance Criteria and Device Performance:
A table of acceptance criteria and reported device performance is not provided in this document. The document lists "Algorithm Accuracy Study" as one of the non-clinical tests, implying that accuracy was measured, but no specific criteria or results are detailed.
Study Information (Based on available text):
- Sample size used for the test set and the data provenance: Not specified. The document mentions non-clinical tests including "Algorithm Accuracy Study," "Sawbone study," and "Cadaveric evaluation." The specific number of cases/samples in these studies is not provided, nor is the origin of the data (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. No information is given about the experts involved in establishing ground truth for any of the non-clinical studies.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- 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 study was done. The document states, "No clinical testing performed to support substantial equivalence." The device is intended to assist a surgeon ("Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation."), but there's no study described on human performance with/without the device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: An "Algorithm Accuracy Study" was performed, which would be a standalone assessment. However, the results and specific metrics for this study are not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "Algorithm Accuracy Study," the type of ground truth is not specified. Given it's a non-clinical study for a measurement device, it likely involved highly precise measurements from physical models (sawbones or cadavers) or highly accurate imaging, but the exact method isn't detailed.
- The sample size for the training set: Not specified. The document describes non-clinical tests but does not provide details on the training data used for the algorithm's development.
- How the ground truth for the training set was established: Not specified.
Summary of what is Lacking (and crucial for a complete answer):
The provided FDA 510(k) clearance letter and summary confirm the device's clearance and its intended use as a measurement assistance tool for Total Hip Replacement. However, it explicitly states that no clinical testing was performed. While non-clinical tests like "Algorithm Accuracy Study" are mentioned, the document lacks the specific acceptance criteria, detailed results, sample sizes, ground truth methodology (for both test and training sets), and expert qualifications/adjudication methods that would describe how the device met its performance goals. This information is typically found in the detailed study reports submitted to the FDA, not necessarily in the public 510(k) summary.
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(268 days)
The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).
The Apollo TMS Therapy System is comprised of the following principal components:
- User Interface
- Main Unit (with or without housing)
- Stimulation Coil
- Coil Positioning System
The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil which is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of a coil positioning system. The observed and documented increase in cortical excitability after high frequency (10Hz) rTMS has been shown to persist beyond the duration of the train of stimulation.
This document does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the Apollo TMS Therapy System, demonstrating its substantial equivalence to previously cleared predicate devices for the treatment of Major Depressive Disorder.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on:
- Intended Use and Device Description: The Apollo TMS Therapy System is an electromagnetic device for non-invasive stimulation of the cerebral cortex to treat Major Depressive Disorder.
- Compliance with Standards: Conforms to various ISO and IEC standards for medical devices, electrical safety, usability, software life cycle processes, and risk management.
- Non-Clinical and Clinical Performance Data: States that non-clinical testing was performed according to standards, and comparative testing for additional coils demonstrated substantial equivalence to predicate devices. It specifically mentions that clinical data on the treatment efficacy of the iTBS protocol was already demonstrated in a previous summary (K173620) and that verification testing confirmed constant intensity of individual stimuli.
- Software Verification and Validation: Conducted in accordance with IEC 62304, considered "basic documentation" as software failures are not likely to present high-risk situations.
- Risk Management: Applied throughout the product development life cycle, concluding no new hazards compared to predicate devices.
- Substantial Equivalence: The core of the submission, asserting that the Apollo TMS Therapy System is substantially equivalent to the HORIZON® TMS Therapy System (K182853) and an earlier version of the Apollo TMS Therapy System (K180313). This equivalence is based on identical intended use, indications for use, system components, operational procedures, and treatment protocols (especially iTBS).
- Comparative Table: Provides a detailed comparison of characteristics between the subject device and its predicates, highlighting similarities in indications for use, product code, classification, standard treatment stimulation parameters (e.g., area of brain stimulated, stimulation intensity, frequency, pulse train duration), output stimulation parameters, and coil parameters. It explicitly notes that the performance and clinical effectiveness are substantially equivalent.
In summary, this document is a regulatory submission demonstrating substantial equivalence rather than a clinical study report with specific acceptance criteria and performance data from a clinical trial.
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(27 days)
The Apollo ESG NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI between 30-50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures.
The Apollo REVISE NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with between 30-50 kg/m2 by enabling transoral outlet reduction as a revision to a previous bariatric procedure.
These devices are used to perform gastric remodelling through the placement of anchor-sutures and locking cinch device. The Apollo ESG NXT system is for intended for endoscopic sleeve gastroplasty (ESG) while the Apollo REVISE NXT device is intended for transoral outlet reduction, as a revision to a previous bariatric procedure. The two device systems differ in terms of the number of anchor-sutures and cinches needed to perform ESG and TORe procedures. Both systems are comprised of a Needle Driver Assembly and Anchor Exchange Device, and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.
The Apollo ESG NXT and Apollo REVISE NXT needle driver assembies are designed to be compatible with single channel endoscopes. The endcap assembly of the needle driver is mounted onto the endoscope using polyester medical tape. The external catheter sheath has two working channels through which the Anchor Exchange and other accessories can operate, independent of the endoscope channel. The needle driver assembly also incorporates a pull string feature that, when pulled, allows the physician to further control the retroflexion capabilities of the endoscope.
The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations. A previously cleared Tissue Helix is provided with Apollo ESG NXT while the NXT Tissue Helix Pro is provided with Apollo REVISE NXT. Both instruments are used for manipulating tissue into the suturing window of the needle driver assembly. These devices also include a matching number of anchor-sutures and cinches to perform the gastroplasty or revision procedure.
The NXT Tissue Helix Pro is used to acquire tissue by rotating the device's handle to to gather tissue onto the exposed exposed helix coil. The acquired tissue is then pulled into proximity of the needle body to complete the stitching operation. Tissue is released by rotating the handle in the opposite direction.
The provided document describes a 510(k) premarket notification for the Apollo ESG NXT System and Apollo REVISE NXT System. The study presented here focuses on demonstrating substantial equivalence to a predicate device (DEN210045-Apollo ESG Sx System, Apollo Revise Sx System) rather than proving the device meets acceptance criteria for a new, independent performance claim for an AI/ML-based device.
Therefore, many of the requested elements pertaining to an AI/ML device's acceptance criteria, performance study design (e.g., ground truth establishment, MRMC studies, standalone performance), and expert input are not applicable to this submission, as the fundamental claim is one of equivalence based on similar design, materials, and intended use as a physical medical device.
However, I can extract the information relevant to what types of testing were performed to show this equivalence and where "acceptance criteria were met."
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance (as demonstrated for Substantial Equivalence)
| Criteria Category | Acceptance Criteria (Implied by equivalence to predicate & regulatory standards) | Reported Device Performance (Summary from submission) |
|---|---|---|
| Functional/Performance | Expected to perform similarly to predicate (e.g., suture drag, tensile strength, torque load, tissue acquisition reliability, endoscope compatibility, functional durability). | - Suture Drag Testing: Performed.\n- Tensile Testing: Performed.\n- Torque Load Testing: Performed.\n- Endoscope Compatibility: Tested and confirmed for single-channel endoscopes with OD range 8.8-9.8 mm (same as predicate).\n- Sterility: Tested.\n- Reliability: Performed.\n- Bond Strength: Performed.\n- Tissue Acquisition Reliability: NXT Tissue Helix Pro specifically tested.\n- Functional Durability: Validated to perform 8 stitches for each of 8 sutures (same as predicate).\n- "MaxFlex" Feature: Integrated into the needle driver, providing enhanced retroflexion control (new feature, demonstrated to function).\n- Endoscope Attachment Method: Updated method and materials, tested for functionality.\n- Design/Material Modifications: New materials and design changes implemented to improve durability and manufacturability, validated through testing. |
| Biocompatibility | Meet ISO 10933-1 requirements for risk category. | - Biocompatibility Testing: Performed per ISO 10933-1 (cytotoxicity, irritation, skin sensitization, systemic toxicity, material-mediated pyrogenicity) on "OverStitch devices" (presumably refers to the subject devices, as they are part of the OverStitch family and use similar components/materials) – Same as Predicate. |
| Shelf Life | Established shelf life. | - Shelf Life: Established as 1 year (predicate was 3 years, so this is a difference, but acceptable). |
| Sterilization | Validated sterilization method. | - Sterilization Method: EO (Ethylene Oxide) – Same as Predicate. |
| Packaging Integrity | Maintain sterile barrier and protect device during transport/storage. | - Packaging Integrity: Confirmed by repeating testing in accordance with ASTM F2096-11, ASTM F1980-21, ASTM D4169-22, and ASTM F88/F88M-21. |
| MR Compatibility | Safe for use in specific MR environments. | - MR Compatibility: Safe with 1.5 and 3 T MR scanners with spatial field gradient of 2500 Gauss/cm (extrapolated or less) and SAR of 2.0 W/kg for 15 minutes of continuous scanning – Same as Predicate. |
| Clinical Performance (Leveraged) | Demonstrate equivalent weight loss outcomes and adverse event profiles to the predicate, with proper training. | - Leverages clinical data from the DEN210045 predicate. The ESG and outlet revision procedures performed with these new devices are stated to be "the same (same implant placements and the same implants)". "There is reasonable assurance that the weight loss and adverse events will be the equivalent to the predicate." |
Here's an analysis of the requested elements:
-
A table of acceptance criteria and the reported device performance
- See table above. The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate device and adherence to relevant standards for biocompatibility, sterility, etc. The "reported device performance" is a summary of the non-clinical testing performed.
-
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the bench or functional testing (e.g., number of devices tested for tensile strength, torque, etc.). It states: "Appropriate product testing was performed... All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility."
- The document primarily relies on non-clinical (bench and ex vivo) testing for the current device and leverages existing clinical data from the predicate device (DEN210045).
- Data Provenance: The new testing is likely proprietary, conducted at Boston Scientific facilities or their chosen testing labs. No information is given about the country of origin for the data itself. The clinical data is leveraged from the predicate's De Novo clearance, which would have had its own clinical study details (not provided in this 510(k) summary).
-
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 is a physical medical device submission, not an AI/ML diagnostic or image analysis device. There is no concept of "ground truth" established by experts in the context of image interpretation or diagnosis for this device's performance claims. The "ground truth" for the device's function (e.g., successful suturing, material integrity) is established through engineering and performance testing against specifications.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, this is not an AI/ML or diagnostic study requiring human expert adjudication of output.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted diagnostic or image analysis device, so no MRMC studies were performed. The device is a surgical/endoscopic suturing system.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not have an "algorithm only" or a "human-in-the-loop" component in the context of AI/ML performance. Its standalone performance refers to its mechanical and functional reliability as a physical instrument.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing: The "ground truth" refers to the established engineering specifications and validated test methods (e.g., a specific tensile strength must be met, a specific number of stitches must be capable of being performed successfully).
- For the clinical performance: The document states "These devices, which use the De Novo clearance devices as predicates, leverage the clinical data presented in that De Novo." This implies that the 'ground truth' for clinical efficacy (weight loss) and safety (adverse events) for the predicate device would have been established through its own clinical trials, likely using patient outcomes data. The current submission argues that because the new device performs the "same procedures" with "same implant placements and the same implants," the clinical data from the predicate is applicable.
-
The sample size for the training set
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set."
-
How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no AI/ML training set for this device.
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(92 days)
ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty.
Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system.
ApolloKnee is compatible with the following implant systems:
- · Apex Knee™ System.
- · Unity Knee™ System.
ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.
ApolloKnee™ (formerly OMNBotics) is a robotic-assisted stereotaxic surgery system that aids the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee replacement (TKR). ApolloKnee is composed of eight sub-systems that integrate to form the ApolloKnee system. Four of these sub-components (Station, Tracking System, Communication Module and Nonsurgical Application) form the main structure of Corin's core platform for robotic or computer assisted surgeries. This core platform is referred to as "Apollo". Future Corin technologies are intended to be developed on the basis of the Apollo core platform. ApolloKnee is one such technology built upon the Apollo common platform. ApolloKnee includes four system specific sub-components (Apollo Robot, BalanceBot, TKR Instruments and ApolloKnee Software),
ApolloKnee is an evolution of the former OMNIBotics Knee System. ApolloKnee is the first launched under Corin Ltd following acquisition of the OMNIBotics' prior manufacturer OMNIlife Science. ApolloKnee differs from OMNIBotics Knee System (as previously marketed under K200888) in branding (for commercial reasons), as well as redesigns of the station and software, and introduction of additional surgical instrumentation, namely the BalanceBot Pre-Resection Paddles, Tibial Cutting Guide and V-Array.
This document, a 510(k) Summary for the ApolloKnee device, details the premarket notification to the FDA. However, it does not contain the specific information required to answer your prompt about acceptance criteria and a study proving the device meets them.
The sections you've highlighted (Non-Clinical Testing, Conclusion) mention "Accuracy testing per custom protocols and ASTM F2554-22" and "surgeon user validation studies (cadaver evaluations)." While these indicate testing was performed, the document does not provide the acceptance criteria or detailed results of these studies.
Therefore, I cannot provide the requested information from this document. It lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Information on MRMC studies or effect sizes.
- Standalone performance data.
- Specific type of ground truth used.
- Sample size for training sets.
- How ground truth for training was established.
This document primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, and general non-clinical testing categories, rather than presenting a detailed clinical or performance study report with specific acceptance criteria and detailed outcomes.
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(90 days)
APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
APOLLO ADVANTAGE Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151 and ASTM D6319. The proposed device is non-sterile and powder free.
This document is primarily concerned with the 510(k) premarket notification for APOLLO ADVANTAGE Nitrile Examination Gloves, asserting its substantial equivalence to a predicate device. It details acceptance criteria and performance data for various physical and biocompatibility characteristics of the gloves.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): | Length (mm): |
| S: ≥220 | S: 221-238mm | ||
| M/L/XL: ≥230 | M: 232-251mm; L: 232-243mm; XL: 234-250mm | ||
| Width (mm): | Width (mm): | ||
| S: 80 ± 10 | S: 80-89mm | ||
| M: 95 ± 10 | M: 94-104mm | ||
| L: 110 ± 10 | L: 102-111mm | ||
| XL: 120 ± 10 | XL: 111-122mm | ||
| Thickness (mm): | Thickness (mm): | ||
| Finger: ≥0.05 | Finger: S: 0.11-0.15mm; M: 0.11-0.15mm; L: 0.11-0.14mm; XL: 0.11-0.16mm | ||
| Palm: ≥0.05 | Palm: S: 0.08mm; M: 0.08mm; L: 0.08mm; XL: 0.08mm | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 (Acceptable Quality Limit) | 0 glove water leakage found |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 <2.0mg | 0.14-0.21mg |
| ASTM D6319 | Physical Properties (Before Aging) | Tensile Strength: ≥14Mpa | 34.1-39.0Mpa |
| Ultimate Elongation: ≥500% | 520.808%-637.854% | ||
| ASTM D6319 | Physical Properties (After Aging) | Tensile Strength: ≥14Mpa | 32.0-37.0Mpa |
| Ultimate Elongation: ≥500% | 463.000-562.586% | ||
| ISO 10993-11 | Biocompatibility: Acute Systemic Toxicity | Non-acute systemic toxicity under the conditions of the study. | The test article showed no evidence of causing acute system toxicity under the conditions of the study. |
| ISO 10993-10 | Biocompatibility: Skin Irritation | Non-irritating under the conditions of the study. | The test article has no skin irritation under the conditions of the study. |
| ISO 10993-10 | Biocompatibility: Dermal Sensitization | Non-sensitizing under the conditions of the study. | The test article showed no evidence of causing delayed dermal contact sensitization under the conditions of the study. |
2. Sample size used for the test set and the data provenance:
The document doesn't explicitly state specific sample sizes for each test. Instead, it refers to compliance with established ASTM and ISO standards for medical devices and biocompatibility. These standards typically define acceptable sampling plans. The data provenance is not explicitly mentioned, but given the manufacturer (Dell Corning Corporation) with an address in South Carolina, USA, and an Asia Co., Ltd in Wuhan, China, and the nature of the tests, it's likely conducted in a controlled laboratory setting by or for the manufacturer. The tests are non-clinical (laboratory-based) rather than retrospective or prospective patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in a way that is applicable to human expert review. For these types of device performance tests (physical properties, watertightness, powder content, biocompatibility), the "ground truth" is established by the specifications and methodologies outlined in the referenced international standards (ASTM and ISO). The testing would be performed by qualified laboratory personnel following these validated procedures, not typically by human experts reviewing results for subjective interpretation.
4. Adjudication method for the test set:
Not applicable in the context of this type of device testing. The results are quantitative measurements against objective criteria defined by the standards. There is no subjective interpretation requiring adjudication among 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:
Not applicable. This is a medical device clearance for examination gloves, not an AI-assisted diagnostic or imaging device. There are no "human readers" or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (examination gloves), not an algorithm or software.
7. The type of ground truth used:
The ground truth for these tests is based on established international and national standards and specifications:
- ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
- ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
The device's performance is compared against the quantified acceptance criteria outlined in these standards.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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(106 days)
The Apollo Knotless Suture Anchors are intended for use in soft tissue to bone fixation in areas such as the shoulder, elbow, knee, hip, wrist, hand, foot, and ankle.
The Apollo Knotless Suture Anchors are made from PEEK (Zeniva ZA-500 and Zeniva ZA-600) per ASTM F2026. The Anchors are provided loaded on individual inserters with and without integrated sutures made of ultra-high molecular weight polyethylene (UHMWPE), sterile, for single use only.
This document is a 510(k) Summary for the Maruho Medical Apollo Knotless Suture Anchor. It details the device, its intended use, and a comparison to predicate devices, but it does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic or AI/machine learning device.
Instead, this document describes a medical device (a suture anchor) and its substantial equivalence to previously cleared predicate devices. The "performance testing" mentioned is related to the physical characteristics of the suture anchor (e.g., pullout strength, fatigue) and material biocompatibility, not diagnostic performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/ML-driven device.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because this document is not about an AI/ML-enabled medical device or a diagnostic tool with performance metrics typically associated with such criteria.
The information provided is about a physical implantable medical device and its mechanical/physical performance.
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(402 days)
Apollo duet(RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
Apollo Duet has RF handpiece attached to the main body, and consists of an electrode cable and a power adapter. This equipment has RF mode, which is the main function, RF mode is a mode in which Radio-frequency is output in a bipolar method. An RF handpiece is used, and a high frequency is output through 4ea RF handpiece electrodes. In addition, the RF handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 45 C
The provided text describes the regulatory clearance of a medical device called "Apollo Duet" (Model: APD-4000) by the FDA. It does not contain information about a study that proves the device meets specific acceptance criteria related to its performance in terms of effectiveness for its intended use.
The document focuses on demonstrating substantial equivalence to a predicate device (InMode RF Pro System) based on technical, safety, and operational characteristics, rather than a clinical effectiveness study with defined acceptance criteria for efficacy.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The information requested regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets is not present in the provided text.
Here's what can be extracted regarding testing and related safety:
Acceptance Criteria and Study Information (Based on provided text)
The document outlines safety and performance bench testing and adherence to international standards to demonstrate substantial equivalence and safety, rather than effectiveness acceptance criteria for its therapeutic claims (relief of muscle aches, spasm, and improved blood circulation).
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied Safety/Technical) | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety (IEC 60601-1:2005, AMD1:2012) | Complies with standard |
| Electromagnetic Compatibility (IEC 60601-1-2:2014) | Complies with standard |
| High Frequency Surgical Equipment Safety (IEC 60601-2-2:2017) | Complies with standard |
| Nerve & Muscle Stimulators Safety (IEC 60601-2-10:2012/A1:2016) | Complies with standard |
| Risk Management (ISO 14971:2019) | Risk management recorded |
| Usability (IEC 60601-1-6:2010 + A1:2013) | Usability documented |
| Biocompatibility (ISO 10993-1) (Electrode: SUS 304, LED Display: PC (SR3108FM)) | Materials are biocompatible for intact skin, limited contact (<24 hours) |
| RF Ablation Thermal Effects (Ex-vivo testing) | Performed to compare thermal effects with predicate device |
| Skin Temperature Measurement | Measured with thermographic camera; output automatically turns off if skin temperature exceeds 45°C |
2. Sample size used for the test set and the data provenance:
- RF Ablation Thermal Effects (Ex-vivo testing): Not specified (type of tissue: porcine abdominal skin).
- Skin temperature measurement: 6 healthy volunteers (3 light skin, 3 dark skin). Data provenance: Not specified (implied to be from the manufacturer, WEERO Co., Republic of Korea). This appears to be a prospective safety test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not specified in the document. The tests seem to be objective measurements (e.g., temperature, compliance with standards) rather than expert-derived ground truth for performance.
4. Adjudication method for the test set:
Not applicable/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:
No MRMC study was done, as this is not an AI-assisted diagnostic device, but an electrosurgical cutting and coagulation device and accessories.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not directly applicable in the context of typical AI standalone performance. The device itself is a standalone medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For safety/technical testing, the "ground truth" is compliance with established international standards (e.g., IEC 60601 series, ISO 14971) and objective measurements (e.g., temperature thresholds). For ex-vivo testing, direct measurement of thermal effects on tissue.
8. The sample size for the training set:
Not applicable. This device does not appear to involve machine learning models that require a training set.
9. How the ground truth for the training set was established:
Not applicable.
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(285 days)
The APOLLO ESG and ESG SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI 30 -50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures.
The APOLLO REVISE and REVISE SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI 30 - 50 kg/m² by enabling transoral outlet reduction as a revision to a previous bariatric procedure.
Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic procedure that involves the creation of plications in the stomach to reduce stomach volume. The plications form a sleeve, which reduces stomach capacity and slows gastric emptying.
Patients having previous Roux-en-Y gastric bypass bariatric surgery may experience dilation of the gastrojejunostomy outlet and the gastric pouch, followed by weight gain. This can be addressed by reducing the diameter of the gastric outlet by suturing. This procedure is often referred to as Transoral Outlet Reduction (TORe).
The APOLLO ESG and APOLLO REVISE Systems are designed to accomplish ESG and TORe, respectively, using a dual channel scope. The APOLLO ESG SX and APOLLO REVISE SX Systems are designed to accomplish ESG and TORe. respectively, using a single channel endoscope. The systems function by delivering the suture to the targeted area to create full thickness bites when approximating soft tissue.
The device components are:
- The OverStitch (SX) Handle is comprised of a needle driver assembly and anchor exchange.
- The Tissue Helix enables the user to manipulate and position tissue before and after suturing.
- The Suture Anchor consists of a polypropylene suture attached to a metal piece.
- The Cinch device is a plastic component that simultaneously cuts the suture and clamps onto the suture.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Summary
The document describes two main categories of performance testing: Non-Clinical/Bench Studies and Clinical Studies. The acceptance criteria and reported performance for the non-clinical studies are directly provided in Table 3. The clinical performance is evaluated against the primary effectiveness and safety endpoints of the MERIT Trial.
1. Table of Acceptance Criteria and Reported Device Performance
Non-Clinical/Bench Studies
| Test | Test Methods | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|---|
| Durability of APOLLO Systems | (b)(4) suture passes done during simulated use on synthetic tissue with a thickness of (b)(4) | APOLLO System can deliver 64 suture passes | Pass |
| Durability of Tissue Helix | (b)(4) iterations of grabbing and retracting synthetic tissue to demonstrate that the tip did not dull and the helix was not adversely affected such that it could not engage or release the tissue | Complete at least 64 tissue acquisitions | Pass |
| Magnetic Resonance Imaging (MRI) compatibility of implanted suture - Displacement force | Testing was conducted in accordance with ASTM F2052-02: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment. Previous testing leveraged from prior marketing submissions K171886 and K191439 | MRI compatibility labeling must be supported by testing. To be considered MRI conditional, displacement forces should not have the potential to damage the tissue where the device is placed | Sutures are MRI conditional |
| APOLLO Systems Design verification | (b)(4) | • System can be passed through the working channel of an endoscope and can be manipulated within the endoscope • System allows for a 360-degree full range of motion on the endoscope • System can be passed through the working channel of an endoscope and can be visualized by the endoscope • System can be pre-loaded with an anchor-suture prior to passing the device endoscopically • System can be reloaded with a needle and suture endoscopically • System can obtain tissue to pass suture through tissue • Tissue Helix can be advanced up to collar and retracted into the endoscope without failure • System can deliver a suture through various tissue • Anchor-suture assembly placement can be visually confirmed endoscopically • System can secure a suture through the working channels of an endoscope • The Cinch attachment strength, for all suture types, shall maintain a minimum suture retention force of 2.4 lbf. | Pass |
| Polypropylene suture verification | Test (Missing details in table) | • Suture-needle attachment (b)(4) • Tensile Strength (b)(4) (b)(4) • Suture diameter (b)(4) (b)(4) | • The tensile strength for the Anchor to the Suture in a T-tag configuration must be ≥ 1.10 kgf • The average knot-pull tensile strength of the Suture must be ≥ 1.44 kgf • The average Suture diameter must be between 0.300 mm and 0.339 mm. • The force required to pull 6 inches of suture through the endoscope (or Anchor Exchange Channel for SX (Missing details in table) |
| MRI compatibility of implanted suture - Magnetically induced heating | ASTM F2182-02a: Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging | MRI compatibility labeling must be supported by testing. To be considered MRI conditional, temperature increases should not damage tissues when patients are scanned as outlined in the labeling | Sutures are MRI conditional |
| MRI compatibility of implanted suture - Artifact assessment | ASTM F2119-01: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants | MRI compatibility labeling must be supported by testing. To be considered MRI conditional (Missing details in table) | Sutures are MRI conditional |
Clinical Studies (MERIT Trial)
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance (Results) |
|---|---|
| Primary Effectiveness: Percentage of subjects who were responders to treatment at 52 weeks follow-up, where response was defined as achieving ≥10% Total Body Weight Loss (%TBWL). | Completers Rate: 44/68 (64.7%) in Treatment group vs. 4/89 (4.5%) in Control group. LOCF Rate: 48/77 (62.3%) in Treatment group vs. 5/110 (4.5%) in Control group. Difference in %TBWL: Mean %TBWL at 52 weeks was 13.86% ± 8.06% for Treatment subjects vs. 0.76% ± 4.97% for Control subjects. Difference of 13.10% (95% CI: 10.89%, 15.30%). |
| Primary Safety: Percentage of subjects having device and procedure related adverse events with Clavien-Dindo Grade III or higher at 52 weeks following ESG treatment. | Completers Rate: 3/131 (2.3%) with upper limit of 1-sided 95% CI of 6.5%. Imputation (Best Case): 3/150 (2.0%) with upper limit of 1-sided 95% CI of 5.7%. Imputation (Worst Case): 22/150 (14.7%) with upper limit of 1-sided 95% CI of 21.4%. |
2. Sample Size and Data Provenance
Test Set (Clinical Study - MERIT Trial):
- Sample Size:
- Randomized: 209 subjects (85 Treatment, 124 Control).
- Modified Intent-to-Treat (mITT) Population: 187 subjects (77 Treatment, 110 Control) after exclusions.
- Completers Population (52 weeks for effectiveness): 157 subjects (68 Treatment, 89 Control).
- Safety Population: 150 subjects (77 initial Treatment + 73 cross-over Control subjects who underwent ESG).
- Data Provenance: Prospective, randomized, multicenter study conducted across 9 U.S. sites.
Training Set (Not explicitly tested for AI, but for clinical evidence):
- The document primarily describes a clinical trial (MERIT), real-world registry data, peer-reviewed literature, and post-market surveillance. It does not mention a distinct "training set" in the context of an AI model. The data serves as the evidence base for the device's overall safety and effectiveness.
- Sample Size (Clinical Evidence Base):
- MERIT Trial: As above, up to 187 subjects (mITT) for effectiveness and 150 subjects for safety.
- Real-World Registry (AGA partnership): 80 subjects for ESG, 39 subjects for TORe.
- Ongoing Registry (private practice): 295 subjects for ESG (169 with 6-month data, 116 with 12-month data); 201 subjects for TORe (89 with 6-month data, 30 with 12-month data).
- Peer-Reviewed Literature: Selected articles from PubMed search ("endoscopic sleeve gastroplasty" OR "transoral outlet reduction") and 9 additional relevant articles.
3. Number of Experts and Qualifications for Ground Truth for Test Set:
- The document describes a clinical trial measuring objective outcomes like weight loss and adverse events. It does not mention the use of experts to establish a "ground truth" for interpretations of images or complex data as would be typical for an AI device. The ground truth for weight loss is objective measurement, and for adverse events, it's clinical diagnosis and Clavien-Dindo grading.
- Medical professionals (gastroenterologists or surgeons) performed the procedures and managed patient care, thus indirectly contributing to the data collection that forms the "ground truth" of patient outcomes. Adverse event classification by Clavien-Dindo grading implies expert medical judgment.
4. Adjudication Method for the Test Set:
- For adverse events, the document states: "All adverse events were recorded." and "The three adverse events rated Clavien-Dindo Grade III or higher were as follows..." This implies that adverse events were classified and graded, likely by clinical investigators, according to the Clavien-Dindo classification system.
- There's no explicit mention of an independent adjudication committee for the clinical outcomes or adverse events in the MERIT trial data presented, beyond the standard clinical trial procedures (e.g., source data verification, monitoring).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed. This study evaluates the device itself (an endoscopic suturing system), not an AI algorithm assisting human readers. The clinical study compares device use plus lifestyle intervention vs. lifestyle intervention alone.
6. Standalone (Algorithm Only) Performance:
- No, this is a physical medical device, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The device's performance is demonstrated in the context of its use by trained clinicians.
7. Type of Ground Truth Used:
- For the clinical study (MERIT Trial), the ground truth for effectiveness was based on objective measurements of patient outcomes:
- Weight loss: Measured %Total Body Weight Loss (%TBWL) and %Excess Weight Loss (%EWL).
- BMI change: Measured change in Body Mass Index.
- For safety, the ground truth was based on clinical diagnosis and classification of adverse events using the Clavien-Dindo grading system.
- For non-clinical/bench studies, the ground truth was based on engineering specifications and quantifiable performance metrics (e.g., number of suture passes, tissue acquisitions, tensile strength, MRI compatibility testing).
8. Sample Size for the Training Set:
- As noted in point 2, the document describes a clinical trial and other forms of "real-world" and literature evidence. There is no mention of a distinct "training set" for an AI algorithm. The training for device use is for human clinicians.
9. How the Ground Truth for the Training Set was Established:
- Since there's no AI training set involved, this question is not directly applicable.
- For the training of clinicians, the document states: "APOLLO ESG, ESG SX, REVISE and REVISE SX Systems should only be used by gastroenterologists and surgeons who have undergone specific training by the device manufacturer." This implies the "training" refers to physician training on the use of the device itself. The "ground truth" for this training would be the proper procedural steps and techniques established by the manufacturer and medical consensus for safe and effective use.
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