Search Results
Found 397 results
510(k) Data Aggregation
(122 days)
GT Metabolic Solutions, Inc.
The GT Metabolic MagDI™ System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied.
The GT Metabolic MagDI System is intended for use in adult patients > 21 years.
The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis.
After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.
The provided FDA 510(k) summary (K243359) describes the GT Metabolic MagDI System, a magnetic compression anastomosis system. However, it does not explicitly detail acceptance criteria in a structured table or provide information about a study proving the device meets specific acceptance criteria in the way a clinical trial endpoint analysis would. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K242086) through a summary of performance testing and clinical outcomes.
Here's an attempt to extract the requested information based on the provided text, with explicit notes where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in a table format with corresponding reported device performance values. It discusses performance testing in a narrative form to demonstrate substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in doc) | Reported Device Performance (as described in the document) |
|---|---|---|
| Biocompatibility | Device materials are biocompatible. | "Biocompatibility testing demonstrated the device is biocompatible according to ISO 10993-1." |
| Magnetic Field Safety | Distances from magnets are safe for patients and users with ferromagnetic implants/devices. | "Magnet field strength testing characterized the distances from the magnets are safe for patients and users with ferromagnetic implants, devices, or objects." |
| Separation Force | Magnets maintain adequate separation forces over the use life. | "The Magnets maintain adequate separation forces over the use life." |
| Delivery System Function | Magnets connect and disconnect to the Delivery System over the use life. | "The Magnets connect and disconnect to the Delivery System over the use life." |
| Sterility | Device has a Sterility Assurance Level (SAL) of $10^{-6}$ and maintains sterility through labeled shelf life. | "The MagDI System demonstrates a SAL of $10^{-6}$, a continued sterility through the labeled shelf life of the device, and conforms to ISO 11137-1, ISO 11137-2, and ISO 11137-3." |
| Anastomosis Creation | Successful placement with alignment and creation of patent anastomoses. | "The Magnets were successfully placed in all cases with alignment and created patent anastomoses confirmed by imaging." |
| Device Expulsion | Natural expulsion of the device. | "The device was expelled naturally in most of the subjects reaching the one-month study visit." (One case removed via colonoscopy due to low bowel motility, but after creating a patent anastomosis and natural progression through the small bowel.) |
| Adverse Events | Low incidence/severity of adverse events, particularly serious adverse events (SAE), and no specific anastomotic complications (bleeding, leakage, obstruction). | "Most adverse events were of low grade, Clavien-Dindo Classification I-II and only one serious adverse event (SAE). No cases of internal hernia or bowel obstruction were reported. There were no cases of anastomotic bleeding, leakage, infection, or obstruction and no deaths." (The device performed "as least as safe as the predicate compression anastomosis device.") |
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: The document states, "Clinical testing was conducted in obese patients with or without type 2 diabetes mellitus using the MagDI System for creation of a side-to-side duodeno-ileal anastomosis." It mentions "most of the subjects" for device expulsion but does not provide an explicit numerical sample size for the clinical study. It implies a single study for the clinical data.
- Data Provenance: Not explicitly stated, but the submission is to the U.S. FDA, and a post-market surveillance study is planned for "U.S. patients, representative of the U.S. intended use population." This suggests the clinical data presented might be from the U.S. or a similar regulatory jurisdiction, but it's not confirmed. The study was prospective in nature, as it involved patients using the 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)
This information is not provided in the document. The "ground truth" (e.g., successful anastomosis, patency, adverse events) was likely established by the treating clinicians and study staff based on clinical observation, imaging, and patient outcomes, but the specific number and qualifications of independent experts for ground truth establishment are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
- MRMC Study: No, an MRMC study was not conducted and is not mentioned.
- Effect Size of AI assistance: Not applicable, as this device is a physical medical device (magnetic compression anastomosis system), not an AI-powered diagnostic or assistive tool.
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 a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical performance assessment appears to be based on:
- Outcomes data: Successful placement, alignment, patent anastomoses confirmed by imaging, natural device expulsion, absence of specific adverse events (internal hernia, bowel obstruction, bleeding, leakage, infection, obstruction), and overall safety profile (Clavien-Dindo Classification for AEs).
- Clinical observation and imaging: To confirm anastomoses patency and device expulsion.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set. The clinical study described in the document served as performance verification for the device in humans.
9. How the ground truth for the training set was established
Not applicable, as this is a physical device and there is no "training set" in the context of AI/ML required.
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(81 days)
Spinal Alignment Solutions, Inc.
The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is indicated for the use with Medtronic CD Horizon™ SOLERA™ Spinal System which is intended for posterior, lumbar and sacral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System consists of pre-bent spinal rods compatible for use with the Medtronic CD Horizon™ SOLERA™ Spinal System. The SAS PI Rod System is manufactured from either titanium alloy or cobalt chrome.
The CD Horizon™ Spinal System consists of a variety of shapes and size of rods, screws, CROSSLINK® Plates, and connecting components which can be rigidly locked into avariety of configurations, with each construct being tailor-made for the individual case.
This looks like a 510(k) clearance letter for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria for AI/software-as-a-medical-device (SaMD).
The provided text discusses a "Spinal Alignment Solutions Pelvic Incidence (PI) Rod System," which appears to be a physical medical device (pre-bent spinal rods) intended for use with an existing spinal system (Medtronic CD Horizon™ SOLERA™ Spinal System). It is not a software-based or AI-driven device.
Therefore, the prompt's request for:
1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established
...are not applicable to the content provided. The document describes a traditional medical device submission, where "Performance Testing" refers to mechanical testing (or the absence thereof, as noted in this case, due to substantial equivalence) rather than clinical performance or AI algorithm validation.
The key statement in the document regarding "Performance Testing" is:
"When used with the Medtronic CD Horizon™ SOLERA™ Spinal System the subject SAS PI Rods have the same fundamental scientific technology, indications for use, intended use, materials, manufacturing processes, and levels of attachment as the predicate CD Horizon™ SOLERA™ Spinal System devices. The subject device does not introduce a new worst case condition and therefore, no additional mechanical testing was performed."
This indicates that the clearance was based on the substantial equivalence principle, asserting that the new device is so similar to an already cleared device that no new performance studies (mechanical or otherwise) were deemed necessary by the FDA. The "acceptance criteria" for a traditional mechanical device would typically involve meeting specific mechanical strength or fatigue standards, but these are not detailed here because the pre-bent rods are considered equivalent to the existing predicate rods.
In summary, as the provided text pertains to a physical medical device (spinal rods) and a 510(k) submission based on substantial equivalence, it does not contain the information requested about acceptance criteria, study design, ground truth, or expert involvement typically associated with the validation of AI/SaMD devices.
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(99 days)
GT Metabolic Solutions, Inc.
The GT Metabolic MagDI System is intended for use in the creation of side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied.
The GT Metabolic MagDI System is intended for use in adult patients > 21years.
The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis.
After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.
The provided text is a 510(k) Summary for the GT Metabolic MagDI System. It describes the device, its intended use, and summarizes performance testing to support its substantial equivalence to a predicate device. However, this document does not contain explicit acceptance criteria or a detailed study proving the device meets specific acceptance criteria with reported performance metrics in a readily extractable format.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on:
- Same intended use and indications for use.
- Same or similar technological characteristics (with specified changes).
- Performance testing (pre-clinical and clinical summaries).
Here's an attempt to answer your questions based on the available information, noting where information is not present in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format. It describes the findings of tests performed, which imply successful outcomes but don't define the pre-established thresholds for those successes.
| Acceptance Criteria (Implied from Text) | Reported Device Performance |
|---|---|
| Biocompatibility ISO 10993-1 | Device demonstrated biocompatibility |
| Magnet field strength safety (ferromagnetic implants/devices) | Magnet field strength characterized, distances safe for patients/users |
| Magnets maintain adequate separation forces | Magnets maintain adequate separation forces over use life |
| Magnets connect and disconnect to Delivery System | Magnets connect and disconnect to Delivery System over use life |
| Patient-contacting materials conform to ISO 10993-1 / FDA Guidance | Patient-contacting materials conform to ISO 10993-1 and FDA Guidance |
| Sterility Assurance Level (SAL) of 10^-6 | MagDI System demonstrates a SAL of 10^-6, continued sterility through shelf life |
| Chronic porcine animal testing | Conducted over 6-week period (details not provided) |
| Clinical performance (anastomosis creation, passage, AEs) | Magnets successfully placed, alignment achieved, device passed naturally. Most adverse events (AEs) low grade (Clavien-Dindo Classification I-II), SAEs resolved without sequelae. No internal hernia, bowel obstruction, anastomotic bleeding, leakage, infection, or deaths. Performed safely and as intended. |
| Compliance with 21 CFR 801 and ISO 15223 | Labeling conforms to 21 CFR 801 and ISO 15223 |
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: The clinical testing summary states, "The Magnets were successfully placed in all cases... and for all subjects reaching the one-month study visit, the device passed naturally as a set of connected Magnets..." This phrasing implies that "all cases" or "all subjects" were monitored, but the exact number of subjects for the clinical test set is not provided in this document.
- Data Provenance:
- Country of Origin: Not specified in the given text.
- Retrospective or Prospective: "Clinical testing was conducted in obese patients with or without type 2 diabetes mellitus using the MagDI System for creation of a side-to-side duodeno-ileal anastomosis." This describes an active study (prospective).
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)
This information is not provided in the document. The document summarizes clinical outcomes without detailing the mechanism or personnel involved in establishing "ground truth" for those outcomes beyond standard clinical observation and reporting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
- MRMC Study: No, the device is a physical medical device (Magnetic Compression Anastomosis System), not an AI/software device that involves "human readers" interpreting data. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this device's evaluation and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical testing, the "ground truth" seems to be based on:
- Clinical observation/outcomes data: Successful placement, alignment, natural passage of the device, incidence of adverse events (SAEs, internal hernia, bowel obstruction, anastomotic bleeding, leakage, infection, obstruction, deaths), and assessment of patent anastomoses.
- Imaging/surgical observation (implied): To confirm placement and alignment.
8. The sample size for the training set
This information is not provided in the document. The document details a clinical test (performance evaluation) but does not mention a "training set" in the context of device development, which is typically relevant for machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable, as no training set (for an algorithm) is mentioned in the document.
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(70 days)
Bone Solutions, Inc
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine. When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft and or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
The subject devices are a magnesium-based synthetic bone void filler that is moldable, drillable, resorbable, adhesive, radiopaque, and osteoconductive. The subject devices consist of a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction occurs to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.
The provided text is a 510(k) Premarket Notification from the FDA regarding two bone void filler devices, Mg OSTEOREVIVE™ and Mg OSTEOCRETE™. This document primarily outlines the administrative information, device classification, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
The document states: "No clinical data were included in this submission." and focuses on non-clinical testing data leveraged from a previous submission (K234013) to demonstrate substantial equivalence, including chemical composition, physical properties, sterilization, shelf life, and biocompatibility.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and reported device performance (for AI/ML performance).
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
This document pertains to the clearance of a medical device (bone void fillers) based on demonstrating substantial equivalence to existing predicate devices through non-clinical data, not on the performance evaluation of an AI/ML component.
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(301 days)
Peytant Solutions, Inc.
The AMStent® Tracheobronchial Covered Stent System (AMStent® System) is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms in adult patients.
Peytant Solutions, Inc. developed the AMStent® Tracheobronchial Covered Stent System (AMStent System) to provide patency of the tracheobronchial tree in patients suffering from tracheobronchial strictures produced by malignant neoplasms. Like other nitinol devices that are also used for treating tracheobronchial strictures produced by malignant neoplasms, the AMStent System consists of a self-expanding metallic stent (SEMS) that has a covering material over the interstices of the stent is provided preloaded on a delivery catheter (Figure 1). The difference is that the AMStent covering is made from human-sourced decellularized amniotic membrane (DCAM), while the existing stents utilize synthetic cover materials (e.g., polyurethane, ePTFE, or silicone).
The AMStent is an open-cell, self-expanding, nitinol stent (10mm diameter x 40mm length) with a DCAM cover that is attached to the stent with polyethylene terephthalate (PET) sutures. The AMStent is preloaded on a flexible, "pull-back," AMStent delivery catheter. The AMStent delivery catheter is positioned in the tracheobronchial stricture with the assistance of a standard 0.035" guidewire, that is not provided with the AMStent System, under bronchoscopic and / or fluoroscopic visualization. Radiopaque markers are located on each end of the AMStent and on the distal end of the AMStent delivery catheter to facilitate placement.
The provided text describes the AMStent® Tracheobronchial Covered Stent System, a medical device, and its regulatory information, but does not contain information about an AI-powered device or a study demonstrating its performance against acceptance criteria in the context of an AI/human reader comparison.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer questions about sample sizes, ground truth establishment for a test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or training set details in the context of an AI device.
The document details the non-clinical/bench studies performed for the AMStent® System to demonstrate its safety and effectiveness, which are standard for a medical device of this type. It highlights:
- Biocompatibility: Testing based on ISO 10993-1 demonstrated that patient-contacting materials are biocompatible.
- Shelf-Life: Demonstrated continued intended function over a minimum of 90 days.
- MR Compatibility: Tested per ASTM standards, resulting in an "MR Conditional" label with specific parameters (translational attraction 2 degrees, max temperature rise 3.1℃, artifact 5mm).
- Packaging: Engineering bench testing confirmed packaging integrity.
- Performance/Bench Testing: Included stent deployment, compression and recoil, expansion force, dimensional, fatigue, corrosion, and puncture tests of the DCAM cover. These tests were deemed satisfactory to show the device performs as intended and is safe for use.
- Human Tissue Controls: Detailed process for obtaining and preparing human tissue (DCAM) according to 21 CFR 1271 and CGTP requirements, with risk control measures, material characterization, and lot release.
- Animal Studies: Two GLP-compliant large animal studies (one chronic (average 92 days) and one acute) evaluated in-vivo safety, implantability, migration, systemic effects, removability, and usability. Both met success criteria and supported safety and performance claims. The chronic study showed less stent migration, mucus accumulation, occlusion, and fewer obstructive granulomas compared to a control device, though for a small sample size.
- Clinical Information: Explicitly states "Not applicable. Validation of the AMStent System did not require clinical evaluation in human subjects."
Summary of what the document does provide regarding acceptance criteria and studies (non-AI related):
The document outlines Special Controls (effectively regulatory acceptance criteria) that the device must meet, and then describes the studies that demonstrate compliance.
Special Controls (Acceptance Criteria):
- Human tissue characterization and infection control measures:
- Donor eligibility assessment (screening, testing for communicable diseases).
- Testing of all donor tissue for specific communicable disease agents (HIV, Hepatitis B/C, Treponema pallidum).
- Material sourcing from registered facilities following specific procedures (environmental monitoring, decellularization, viral inactivation, nucleic acid removal, distinct ID code, quarantine).
- Material characterization demonstrating consistent meeting of final product specifications.
- Non-clinical performance testing:
- Deployment testing (accuracy, repeatability).
- Compression and expansion forces.
- Dimensional testing.
- Fatigue and corrosion testing.
- MR environment compatibility.
- Animal performance testing:
- Chronic study to evaluate device migration, occlusion, and granuloma formation.
- Biocompatibility: Demonstrated.
- Labeling: Must include MR compatibility, device/procedure-related complications, summary of bench/in-vivo testing duration, functionality limited to demonstrated performance, and shelf-life.
- Sterility: Performance data must demonstrate sterility of patient-contacting components.
- Shelf-life: Performance data must support continued sterility, package integrity, tissue integrity, and device functionality over the identified shelf life.
Studies and Reported Performance (Demonstrating Compliance with Special Controls):
The text does not present performance in a structured table against specific quantitative acceptance criteria for each special control, but rather states that the studies "demonstrated" or "met" the objectives.
| Acceptance Criteria Category (Special Control) | Reported Device Performance/Study Findings |
|---|---|
| 1. Human Tissue Characterization and Infection Control | - Material Characterization & Lot Release: DCAM composition characterized via tests (Mechanical Strength, Nucleic Acids/Cell Debris, Collagen Quality/Type/Content, Visual Quality, Manufacturing Residuals). Results demonstrated processing consistency and ability to meet final product specifications. |
- Human Tissue Controls: Process for obtaining/preparing human tissue (DCAM) follows 21 CFR 1271 and CGTP requirements. Risk control measures include donor screening/testing, terminal sterilization. |
| 2. Non-clinical Performance Testing | - Performance/Bench Testing: Included stent deployment, compression and recoil, expansion force, dimensional, fatigue, corrosion tests, and puncture testing of DCAM cover. Specific testing for nitinol (corrosion, Ni ion release) performed. "Testing was satisfactory to show the device performs as intended and is safe for use." - MR Compatibility: Tested per ASTM F2052-15, F2213-06, F2119-07 at 1.5T/3T. "MR Conditional" (Translational attraction 2 degrees, max temp rise 3.1℃, artifact 5mm). |
| 3. Animal Performance Testing | - Animal Studies: Two GLP-compliant studies. Chronic study (avg. 92 days): Evaluated safety, implantability, migration, systemic effects, usability. Met success criteria. Showed "less stent migration, less mucus accumulation and occlusion, and fewer obstructive granulomas relative to a marketed stent" (small sample size). Acute study: Evaluated safety, implantability, removability, usability. Met success criteria. |
| 4. Biocompatibility | - Biocompatibility: Tested based on ISO 10993-1. "Results of all biological tests demonstrated that the patient contacting materials...are biocompatible." |
| 6. Sterility | - Sterility Testing: Implied as part of shelf-life testing and manufacturing controls. "Performance data must demonstrate the sterility of patient-contacting components." (No direct results provided beyond this general statement). |
| 7. Shelf-life | - Shelf-Life: "All testing...has demonstrated continued intended function over a minimum of 90 days." Current shelf life established at 90 days. "Performance data must support the shelf-life by demonstrating continued sterility, package integrity, tissue integrity, and device functionality." |
Since the request is about an AI device's acceptance criteria and study, and the provided text describes a physical medical device (a stent) with no mention of AI, I must state that the vast majority of the requested information is not applicable based on the provided input.
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(28 days)
Qpix Solutions Inc
X Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
X Sensor is a digital intraoral sensor which acquires digital intra-oral images. X Sensor acquires intra oral images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. X Sensor includes the firmware for the sensor and the previously cleared imaging software "ExDent-I".
The provided text is a 510(k) summary for the X Sensor, a digital dental intraoral sensor. It describes the device's technical characteristics, intended use, and its comparison to a predicate device (EzSensor XHD). However, this document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving the device meets these criteria in the context of AI/ML performance.
Specifically, the document focuses on regulatory clearance for a medical device (an X-ray sensor) based on hardware and image quality performance relative to a predicate device, as well as electrical, mechanical, and software safety. It does not mention any AI/ML components or studies evaluating AI/ML performance.
Therefore, many parts of your request, such as those related to AI/ML specific acceptance criteria, sample sizes for AI/ML test and training sets, expert adjudication, MRMC studies, or standalone algorithm performance, cannot be answered from the provided text.
However, I can extract information related to the device's general performance testing and comparison to the predicate device, which serves as a form of "acceptance" for medical device clearance.
Here's what can be extracted and how it relates to your request, with a clear indication of what information is not present:
Acceptance Criteria and Device Performance (General Device Performance)
Based on the document, the "acceptance criteria" appear to be meeting or exceeding the performance of the predicate device (EzSensor XHD) in key technical metrics and demonstrating adequate image quality for diagnostic use.
| Acceptance Criterion (Implicit) | Reported Device Performance (X Sensor) |
|---|---|
| Image Quality (General) | "The performance test result indicates that the X Sensor intra oral sensor performed equally to the EzSensor XHD, the predicated device, as both sensors have the same pixel pitch, thereby providing the same maximum line-pair resolution." |
| "The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively." | |
| "The image quality in terms of contrast and resolution are overall similar for the X sensor, the proposed new device and EzSensor XHD, the predicate device." | |
| "There are no observable radiographic findings and no quality issues with intra oral diagnostic images provided by both sensors." | |
| "The proposed device produces overall better definition and grayscale of bony and soft tissue images." | |
| "In conclusion, both the proposed new device and the predicate device produced radiographic images with adequate quality for intra oral diagnosis in terms of resolution and anatomic details." | |
| Detective Quantum Efficiency (DQE) (6 lp/mm) | 0.258 (Better than predicate's 0.204) |
| Modulation Transfer Function (MTF) (3 lp/mm) | 0.889 (Better than predicate's 0.685) |
| Noise Power Spectrum (NPS) | Demonstrated better performance outcome than predicate. (Specific value not provided) |
| Maximum Resolution (lp/mm) | 33.8 (Same as predicate due to same pixel pitch) |
| Electrical Safety (IEC 60601-1 Series) | Compliance demonstrated. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliance demonstrated. |
| Software Function (FDA Guidance) | Development followed "Content of Premarket Submissions for Device Software Functions." Provides "basic level of documentation for the firmware." |
| Cybersecurity (FDA Guidance) | Development, documentation, and testing followed "Cybersecurity in Medical Devices..." guidance. |
| Pediatric Information (FDA Guidance) | Development followed "Pediatric Information for X-ray Imaging Device Premarket Notifications" guidance. |
| Mechanical Durability (Drop & Vibration, etc.) | Performed, risks analyzed and mitigated (e.g., stainless-steel frame, soft silicon exterior for USB connector). |
Study Information (Based on Available Text)
-
Sample size used for the test set and the data provenance:
- The document states "The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively."
- Specific sample size for the clinical images reviewed is NOT provided.
- Data provenance (country of origin, retrospective/prospective) is NOT provided. Given it's a 510(k) for a device like an X-ray sensor, the "test set" likely refers to physical images generated during bench testing and some limited clinical image capture, rather than a large dataset for AI/ML validation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively."
- The number of experts and their qualifications are NOT specified. This phrasing suggests a qualitative human review of generated images to ensure diagnostic utility.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method is NOT specified. The review appeared to be a comparative assessment of image quality.
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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 performed or discussed. This device is an X-ray sensor, not an AI-assisted diagnostic tool in the sense of an algorithm interpreting images for a human. It provides the images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is NOT applicable. The "device" is the sensor itself, which captures images. There is no mention of an algorithm that performs standalone diagnostic interpretations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the image quality assessment, the "ground truth" seems to be clinical utility/diagnostic adequacy as judged by human review of images generated by both the new device and the predicate device. Quantitative metrics (DQE, MTF, NPS) also served as objective performance measures.
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The sample size for the training set:
- NOT applicable/NOT provided. This document describes a medical device, an X-ray sensor, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The "training" for such a device would be its engineering and design optimization.
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How the ground truth for the training set was established:
- NOT applicable/NOT provided. As above, there's no mention of a machine learning training set or associated ground truth.
Summary of Limitations:
The provided document is a regulatory submission for an X-ray sensor. It focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, image quality, and regulatory compliance (electrical safety, EMC, software documentation, cybersecurity). It does not describe an AI/ML diagnostic algorithm or any studies related to its performance, and therefore cannot answer the specific questions posed about AI/ML acceptance criteria and validation.
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(83 days)
Myocardial Solutions, Inc.
MyoStrain® software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart. A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis.
The Myocardial Solutions Myostrain is software that runs on Windows-based operating systems to view and analyze SENC MR images of the heart in DICOM format. MyoStrain quantifies regional and global cardiac from SENC images by implementing the SENC processing methods. With a friendly graphic user interface, users are able to analyze SENC MR images and obtain fast and reproducible measurements of myocardial strain, ejection fraction, and volumes. Measurements are collected and presented on screen as a report showing values as colors and numbers, and this report can be printed or exported in digital format.
The provided text does not contain the acceptance criteria or details of a study that proves MyoStrain (6.0) meets specific performance criteria.
The document is a 510(k) summary for the device MyoStrain (6.0). In such submissions, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide a detailed clinical or performance study report with specific acceptance criteria and results.
While the document mentions "PERFORMANCE TESTING" and "Software Verification and Validation Testing," it states that these were "conducted, and documentation was provided as recommended by FDA's Guidance..." It does not present the actual results, acceptance criteria, or study details within this summary.
Therefore, I cannot provide the requested information from the given text.
To confirm, none of the specific details requested below are present in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not provided.
- Adjudication method: Not provided.
- Multi Reader Multi Case (MRMC) comparative effectiveness study details: Not provided.
- Standalone (algorithm-only) performance details: Not provided.
- Type of ground truth used: Not provided.
- Sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
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(98 days)
GT Metabolic Solutions, Inc.
The GT Metabolic MagDI System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied.
The GT Metabolic MagDI System is intended for use in adult patients > 21 vears.
The MagDI System is comprised of two (2) GT Metabolic DI Magnet ("Magnet") devices delivered sequentially with a minimally invasive GT Metabolic Delivery System ("Delivery System"). Class I magnetic surgical instruments (GT Metabolic Laparoscopic Positioning Device: FDA Listing #D512834) are used to position the Magnets to the target anastomosis locations in the duodenum and ileum and connect the two Magnets. The device provides a method for the creation of a round (oval/circular) compression anastomosis.
After a period of approximately 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.
The MagDI System components (Magnets and Delivery System), as shown in Figures 1 and 2 below, are provided sterile and are for single use.
Acceptance Criteria and Device Performance Study for MagDI System
1. Table of Acceptance Criteria and Reported Device Performance
The clinical study's primary endpoint focused on feasibility and performance. The acceptance criteria were:
| Protocol Feasibility/Performance Criteria | Acceptance Criteria (target) | Reported Device Performance |
|---|---|---|
| Placement of the device with ≥90% alignment of Magnets | Successfully placed in all subjects | 49 (100%) |
| Passage of the device without invasive re-intervention | Passage without re-intervention | 49 (100%) |
| Creation of a patent anastomosis confirmed radiologically | Confirmed radiologically | 49 (100%) |
Note: The document also details extensive pre-clinical (bench and animal) testing with their own acceptance criteria, all of which were reported as "Pass." For brevity, only the clinical performance acceptance criteria are included in this table.
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size: 49 subjects.
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Data Provenance: The data was collected from a multi-center, open-label, two-stage clinical study (MAGNET Study, GTM-001 / NCT05322122). The study was conducted retrospectively (based on the date of data closure) across four centers in:
- Belgium
- Canada
- Republic of Georgia
- Spain
The study involved follow-up durations of 3, 6, 9, and 12 months, indicating a prospective data collection approach from the start of the study, even though the report itself is a summary of already collected data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish all aspects of clinical ground truth for the test set. However, for radiological confirmation of patent anastomoses, it can be inferred that qualified radiologists were involved. For surgical assessments and adverse event adjudication, surgeons and other medical professionals at the study sites were involved.
4. Adjudication Method for the Test Set
The document does not explicitly describe a specific adjudication method like "2+1" or "3+1" for establishing ground truth for the test set outcomes. However, safety outcomes, specifically the relationship of adverse events to the study device and procedure, were classified as "Possible, Probable, Definite, or Indeterminate" by clinicians. Events assessed as "probable or definite" were categorized as "Related" for causality in the report. This implies an internal adjudication process based on clinical assessment at the study sites.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned for the MagDI System. The device's primary clinical study did not compare its performance against human readers with or without AI assistance. The study design focused on the feasibility and safety of the device itself.
6. Standalone (Algorithm Only) Performance Study
The MagDI System does not contain software, as explicitly stated in the document. Therefore, a standalone (algorithm only) performance study was not applicable and not performed. The device is a mechanical system.
7. Type of Ground Truth Used
The ground truth for the clinical effectiveness endpoints was primarily based on:
- Radiological confirmation: To confirm the creation of a patent anastomosis.
- Direct observation/Clinical assessment: For device placement, alignment, and natural passage.
- Clinical assessment/Medical records: For the incidence and severity of adverse events, hospital stay, and device expulsion time.
8. Sample Size for the Training Set
The clinical study (MAGNET Study) served as the primary data for evaluating the device's performance related to its indications for use. There is no mention of a separate "training set" in the context of machine learning, as the device does not employ AI/machine learning. The 49 subjects in the clinical study are effectively the "test set" for regulatory evaluation.
9. How Ground Truth for the Training Set Was Established
As the device does not use AI/machine learning and thus has no "training set" in that context, this question is not applicable. The clinical study data was collected and evaluated as described in point 7.
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(256 days)
LSI SOLUTIONS, Inc.
The Mi-CHORD System is indicated for the replacement of adult mitral chordae tendineae with the patient on cardiopulmonary bypass, with the heart either arrested or fibrillating, and the surgical field under direct visualization.
Direct visualization, in this context, requires that the surgeon is able to see the heart and target tissues in a bloodless field, with or without assistance from an operating telescope or videoscopy.
The Mi-CHORD™ System, shown in Figure 1, is a sterile, single use system, including the Mi-STITCH™ suturing device with its loaded LS-5™ expanded polytetrafluoro-ethylene (ePTFE) suture (Figure 2) and the Mi-KNOT™ device with its loaded Mi-KNOT™ titanium fastener (Figure 3).
The provided text describes a medical device (Mi-CHORD System) and its non-clinical and clinical performance data. However, it does not describe an AI/ML-based device, nor does it contain information about "acceptance criteria" in the context of an AI/ML study, or any "study that proves the device meets the acceptance criteria" in that context.
The document primarily focuses on:
- Device Description: The physical components and their functionality (Mi-STITCH and Mi-KNOT devices, ePTFE suture, titanium fastener).
- Nonclinical/Bench Studies: Biocompatibility, shelf life/sterility, and various engineering bench tests demonstrating mechanical performance, reliability, durability, and material properties. These are traditional engineering and material science tests for a physical medical device.
- Clinical Information: A single-center, single-cohort feasibility study conducted outside the United States (OUS) with 12 patients, focusing on operative times, echocardiographic outcomes, adverse events, and mortality in mitral valve repair.
- Regulatory Aspects: De Novo classification request, indications for use, risks to health, and special controls.
Since the prompt asks for information related to an AI/ML device's acceptance criteria and studies (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details), the provided text does not contain the information requested in points 2-9 of your prompt. It describes the validation of a physical surgical device, not a classification algorithm or AI system.
Therefore, I cannot fulfill the request as presented, as the necessary information for an AI/ML device's acceptance criteria and proving study is absent from the provided text.
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(28 days)
EndoGastric Solutions, Inc.
The EndoGastric Solutions EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single-use, sterile system consisting of an all-mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile by ethylene oxide (EO). The delivery device is limited contact and materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon.
The permanent contact, implantable SerosaFuse tissue fasteners are constructed of injection molded polypropylene and are of a strength equivalent to 3-0 suture. The SerosaFuse Implantable Fastener Cartridge is dual-lever containing 20 fasteners in each lever, and is designed to be removable. Each fastener consists of a leading leg, interconnecting web and trailing leg. The fastener's unique design allows it to be loaded onto a stylet, passed into and down a small delivery lumen of the device and subsequently delivered through apposed tissue surfaces in the GI tract. When deployed in tissue, the fastener serves as a suture-like implantable.
The system is used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The EsophyX Z+ device deploys the SerosaFuse fastener during an endoscopic procedure. A separate commercial endoscope operating independently down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. The EsophyX Z+ device is capable of transoral tissue approximation, ligation, and full thickness plication in the GI tract. The process essentially mimics the standard surgical technique of grasping tissue and apposing/approximating the tissue, piercing, and suturing the tissue fold. Each of these steps is controlled at the device proximal end, though plication, ligation and gastroesophageal valve formation is accomplished at the distal end of the device.
The provided text describes a 510(k) premarket notification for the EsophyX Z+ Device with SerosaFuse Fasteners and Accessories. The submission claims substantial equivalence to a predicate device, the EsophyX Z Device (K172811).
Crucially, this document does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria, particularly in the context of an AI/ML powered device. The document explicitly states: "This 510(k) submission primarily proposes changes to the instructions for use and other device labeling."
The "Performance Data" section only mentions "Non-clinical testing" including "Labeling verification" and "Benchtop performance testing," which are not clinical studies for efficacy. It concludes that "In all instances, the EsophyX Z+ device functioned as intended and demonstrated passing results." This refers to engineering and functional performance, not clinical outcome or comparative effectiveness against a defined set of clinical acceptance criteria.
Therefore, since the provided text does not contain the information required to answer the prompt (as it is not for an AI/ML device and does not detail a clinical study with acceptance criteria for device performance as a diagnostic or therapeutic tool), I must state that the information is not present in the given document.
The prompt asks for details typically found in submissions for AI/ML devices or devices requiring clinical performance data against specific endpoints (e.g., sensitivity, specificity, clinical outcome measures). This 510(k) submission focuses on a mechanical device demonstrating substantial equivalence through non-clinical testing of its functional similarities and minor labeling changes compared to a cleared predicate.
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