Search Results
Found 25 results
510(k) Data Aggregation
(27 days)
The JAZZ Spinal System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the JAZZ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
The JAZZ Spinal System consists of a variety of shapes and sizes of screws and rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy, unalloyed titanium, or cobalt chrome alloy. Implant components of the system include straight and pre-bent rods, monoaxial and polyaxial screws, reduction screws, domino connectors, crosslinks, dual headed screws and connectors, transverse and sagittal uniplanar screws, favored angle screws, modular screws, iliac screws, along with associated set screws.
The provided FDA 510(k) clearance letter for the JAZZ Spinal System does not describe a study related to AI/algorithm performance for a diagnostic or imaging device. Instead, it details a clearance for a medical implant device (Thoracolumbosacral Pedicle Screw System).
Therefore, I cannot extract the information requested about acceptance criteria, study design, ground truth establishment, or human-in-the-loop performance related to an AI/algorithm. The document focuses on the mechanical performance and material safety of the spinal implant.
Specifically:
- Acceptance Criteria & Reported Performance (Table): Not applicable for an AI/algorithm study based on this document. The document mentions "Performance testing" for the spinal implant, including "static compression bending, static torsion, and dynamic compression bending per ASTM F1717-21, as well as static neutral angle dissociation and static maximum angle dissociation per ASTM F1798-13." However, these are mechanical tests for the implant itself, not metrics for an AI's diagnostic performance.
- Sample size and data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size and ground truth: None of this information is present in the document because it pertains to the validation of a software algorithm or AI, not a spinal implant. The "ground truth" for a spinal implant would be its material properties and mechanical integrity, tested in a lab setting, not clinical annotation by experts.
In summary, the provided document is irrelevant to the prompt's request for details on an AI/algorithm performance study.
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(177 days)
Jazz Classic is a clinical software application that captures images and data from Jazz intraoral xray sensors and various imaging sources (e.g., radiographic devices, digital still/video capture devices, and generic image devices such as scanners). Jazz Classic enables the storage of images, clinical notes, and clinical exam data. Jazz Classic is intended to be used for general populations which includes use for pediatric populations.
It is intended to acquire, display, edit (e.g., resize, enhance), review, print, and distribute images using standard PC hardware. Jazz Classic is intended for diagnostic and non-diagnostic purposes by dental professionals trained to provide dental care.
Jazz Classic is a dental imaging software application that equips trained dental professionals with the tools to capture, process, organize,save, and share diagnostic images of patients. The software operates on standard PC hardware and displays images on the PC's connected display or monitor. Images can be acquired from digital dental imaging devices, including intraoral x-ray sental panoramic and cephalometric scanners, and intraoral cameras. It stores images using lossless compression, and can export them as DICOM, PNG, JPEG, or TIF files. It enables dental practitioners to visualize, and manipulate patient images to assist in case diagnosis, review, and treatment planning to further enhance the diagnostic value of images.
Jazz Classic integrates with client-server practice management software, bridging patient information from the user's existing practice management solutions to be used for scheduling, clinical note-taking, and billing.
Jazz Classic neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by the software but by dentists and other licensed dental professionals.
The provided text includes a 510(k) summary for the Jazz Classic device, a dental imaging software application. The summary outlines the device's intended use, comparison to a predicate device, and a brief description of non-clinical and clinical tests. However, it does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in a quantitative manner.
Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (CLIO/CLIOSOFT, K110886) through technological and indications for use comparisons, and general verification and validation activities.
Here's a breakdown of the available information based on your requests:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The text mentions "verification testing confirmed that the software design requirements have been met" and that "Jazz Classic meets operational and clinical needs to acquire and evaluate dental images safely and effectively based on expert opinion," but no specific quantitative acceptance criteria or corresponding performance metrics are listed in a table format.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "bench testing was performed on Jazz Classic and the predicate device" using "images acquired from scientific phantom targets." It also states "Jazz Imaging also performed a clinical evaluation." However, specific sample sizes (e.g., number of images, number of patients) for either the bench testing or the clinical evaluation are not provided.
- Data Provenance: The document does not specify the country of origin for any data used. The bench testing used "scientific phantom targets," implying synthetic data. The clinical evaluation is mentioned, but whether it was retrospective or prospective is not stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: For the clinical evaluation, it states "Based on expert opinion." The exact number of experts used is not specified.
- Qualifications of Experts: The qualifications of these experts are not provided. It only refers to them as "expert opinion."
4. Adjudication Method for the Test Set:
The document mentions "Based on expert opinion" for the clinical evaluation. This suggests a form of expert review, but the specific adjudication method (e.g., 2+1, 3+1, none) is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is described as a "software only medical device" for imaging management and processing, with diagnosis performed by dental professionals, implying it's a tool, not an AI diagnostic aid.
6. Standalone (Algorithm Only) Performance:
The document states "Diagnosis is not performed by the software but by dentists and other licensed dental professionals." This indicates that the device is intended to assist human professionals and is not described as a standalone diagnostic algorithm. However, the "bench testing" compared Jazz Classic's "signal-to-noise ratio (SNR) and resolution" to the predicate device, which could be considered a form of standalone technical performance assessment on phantom images. But this is not specifically "algorithm-only diagnostic performance."
7. Type of Ground Truth Used:
- For the bench testing, "scientific phantom targets" were used, implying a known synthetic ground truth for evaluating technical image quality metrics like SNR and resolution.
- For the clinical evaluation, it was "Based on expert opinion," which suggests expert consensus was used as ground truth for assessing "operational and clinical needs." Pathology or outcomes data are not mentioned.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set sample size. This is typical for devices that are primarily image management and processing systems rather than complex AI models that require extensive training data.
9. How Ground Truth for the Training Set Was Established:
Since no training set information is provided, how its ground truth was established is not applicable/not mentioned.
In summary, while the document confirms that Jazz Imaging conducted design verification, bench testing, and a clinical evaluation, it lacks the detailed quantitative information typically found in a robust study proving specific acceptance criteria. The focus is on demonstrating substantial equivalence and general safety/effectiveness through comparison to a predicate device and expert opinion, rather than presenting a detailed performance study against predefined numerical acceptance criteria.
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(88 days)
The JAZZ Spinal System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the JAZZ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.
The JAZZ Spinal System consists of a variety of shapes and rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include straight and pre-bent rods, monoaxial and polyaxial screws (cannulated and non-cannulated), reduction screws, domino connectors, lateral connectors, crosslinks, dual headed screws and connectors, transverse and sagittal uniplanar screws, favored angle screws, modular screws, S2Al screws, along with associated set screws and class I instrumentation.
This document, a 510(k) summary for the JAZZ Spinal System, does not describe the acceptance criteria and study that proves a software device meets acceptance criteria. Instead, it focuses on the mechanical and material performance of a medical device (spinal system) and its substantial equivalence to predicate devices, which is typical for hardware devices.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/software device based on the provided text. The document discusses:
- Acceptance Criteria (Implicit for Hardware): The acceptance criteria are implicitly related to the performance standards set by ASTM F1717 and ASTM F1798 for spinal implants, ensuring the mechanical strength and stability of the system.
- Reported Device Performance: "Bench performance testing was performed including static axial compression, dynamic axial compression, and static torsion per ASTM F1717...; Static Axial grip, Static Nominal Dissociation, and Static Maximum Angle Dissociation per ASTM F1798..."
- Study Type: This is a bench performance testing study, not an AI/software performance study.
- Ground Truth: For this type of device, the "ground truth" is adherence to established engineering standards for mechanical properties.
The other points you raised (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for AI, training set size, and ground truth establishment for training) are all specifically relevant to the evaluation of AI/software medical devices and are not applicable to the content of this 510(k) summary, which concerns a physical spinal implant system.
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(290 days)
Jazz is intended for the labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images, for patients with a known diagnosis of multiple sclerosis (for the multiple sclerosis pipeline) and/or brain metastasis (for the metastasis pipeline), and the production of a radiological report.
Jazz is a Software as a Medical Device (SaMD) consisting of a software intended to be a facilitating tool for the physicians, in the sense of a semi-automatic pipeline for the process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images. "Semi-automatic" refers to the possibility given to the physician to correct the segmentation of the software before saving.
Here's a breakdown of the acceptance criteria and study details for the Jazz device, extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy Experiment 1 (Lesion Segmentation): | All experiments passed the acceptance criteria. |
| - Voxel-wise sensitivity of at least 40% | |
| - Voxel-wise specificity of at least 95% | |
| - Lesion-wise Dice score of at least 0.5 (for both multiple sclerosis high sensitivity and high specificity models) | |
| - Lesion-wise true positive rate of at least 60% (for the high sensitivity model) | |
| - Lesion-wise false negative rate of at most 40% (for the high sensitivity model) | |
| - Lesion-wise false discovery rate of at most 50% (for the high specificity model) | |
| Accuracy Experiment 2 (Anatomy Localization): | All experiments passed the acceptance criteria. |
| - Anatomy localization score of 1 (best) in at least 80% of the cases | |
| - Anatomy localization score of 6 in less than 10% of the lesions | |
| Accuracy Experiment 3 (Coregistration): | All experiments passed the acceptance criteria. |
| - Average quality of the coregistration score larger than 4 (good coregistration) | |
| - Percentage of coregistration score equaling 2 (bad coregistration) or worse smaller than 10% | |
| Reproducibility Experiment: | All experiments passed the acceptance criteria. |
| - Identical number of lesions volume and report generated in a process-reprocess experiment with Jazz |
2. Sample size used for the test set and the data provenance
- Test set sample size: 344 subject datasets.
- Data provenance: Not explicitly stated regarding country of origin or whether it's retrospective/prospective. The text only mentions the subjects included "healthy subjects, multiple sclerosis and metastasis patients."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not explicitly stated.
- Qualifications of experts: "gold standard human expert opinion." No further details on specific qualifications (e.g., years of experience, specialty) are provided for the experts who established the ground truth for the test set.
4. Adjudication method for the test set
- Not explicitly stated. The text mentions "gold standard human expert opinion" for ground truth, but doesn't detail how multiple expert opinions (if applicable) were adjudicated.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not conducted to assess how human readers improve with AI assistance. The study focuses on the standalone performance of the Jazz device. The Jazz software is described as a "semi-automatic pipeline" where the physician has the opportunity to review and correct segmentations before the final report. However, the performance data presented is for the device's accuracy and reproducibility against ground truth, not for human reader improvement with the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance data presented primarily reflects standalone (algorithm only) performance against manually labeled ground truth volumes. While the device is "semi-automatic" and allows physician correction, the acceptance criteria are set for the device's algorithmic segmentation and localization capabilities. The phrase "the measured volumes... are validated for accuracy against manually labeled ground truth volumes" supports this. The "neuroradiological confirmation" step in the flowchart implies human review, but the reported performance metrics appear to be for the initial algorithmic output prior to this confirmation.
7. The type of ground truth used
- Expert Consensus / Expert Opinion: The primary ground truth for accuracy experiments was established using "manually labeled ground truth volumes" and "gold standard human expert opinion."
8. The sample size for the training set
- The training set sample size is not specified. The text only states that "Networks were trained using brain images, which were fully segregated from the test set."
9. How the ground truth for the training set was established
- The ground truth for the training set was established "using a gold standard human expert opinion."
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(22 days)
JAZZ Solo sensor is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. It can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images that can be displayed, enhanced, printed, and saved.
The JAZZ Solo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiography images. The JAZZ Solo sensor shall be healthcare operated on by educated are and competent to perform the acquisition of dental intraoral radiographs. The JAZZ Solo sensor can be used either in combination with the provided JAZZ IMAGING positioners, other universal positioningdevices manufactured to facilitate the positioning and alignmentwith an x-ray beam, or it may also be positioned by hand with the assistance of the patient. The JAZZ Solo sensor can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized.
The JAZZ Solo sensor requires a dedicated imaging software package to operate at full potential as a diagnostic imaging device. The imaging software is not included and may need to be purchased separately.
Using a JAZZ Solo sensor is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Furthermore, available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis.
When using the JAZZ Solo sensor and software as a diagnostic aide, clinical experience and a combination of other diagnostic aides should be used to form a diagnosis and should not be solely relied upon for diagnosis.
The JAZZ Solo sensor, Model 10-002, is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional procedures and other diagnostic aides for confirmation.
The JAZZ Solo sensor design uses advanced ergonomic principles with four beveled corners, a moderate profile and a rounded casing providing enhanced comfort for patients. The JAZZ Solo sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned.
The JAZZ Solo sensor has an x-ray imager (CMOS) that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to the JAZZ Solo sensor through the standard USB port. Image analysis software is not part of the submission. For the JAZZ Solo sensor to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer.
Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings. The software of the JAZZ Solo sensor being used is unchanged from the predicate JAZZ SOLO Sensor. Firmware for the JAZZ Solo sensor, which controls basic imager function and readout, has been simplified from the predicate JAZZ SOLO Sensor.
The JAZZ Solo sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis, subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.
The Jazz Solo sensor is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. It produces digital images that can be displayed, enhanced, printed, and saved.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Predicate Device (JAZZ SOLO Sensor) Performance | New Device (JAZZ Solo sensor) Performance | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Explanation of Meeting Criteria (via improvement for new device) |
|---|---|---|---|---|
| Image Quality Parameters | ||||
| Dynamic Range | 4096:1 | 16384:1 | At least equivalent to 4096:1 | Meets/Exceeds: The new device has a significantly better dynamic range (4x improvement). |
| MTF (Modulation Transfer Function) | Not explicitly stated but implied by overall image quality | Assessed to be "substantially better" | At least equivalent to predicate | Meets/Exceeds: The new device's MTF is reported as "substantially better," which implies it meets and exceeds the predicate's performance. |
| SNR (Signal-to-Noise Ratio) | Not explicitly stated but implied by overall image quality | Assessed to be "substantially better" | At least equivalent to predicate | Meets/Exceeds: The new device's SNR is reported as "substantially better," which implies it meets and exceeds the predicate's performance. |
| Usable x-ray Dose Range | Not explicitly stated but implied by overall image quality | Assessed to be "substantially better" | At least equivalent to predicate | Meets/Exceeds: The new device's usable x-ray dose range is reported as "substantially better," which implies it meets and exceeds the predicate's performance. |
| X-Ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm | 20+ visible lp/mm | Meets: Identical to the predicate. |
| Imager Resolution | 1936 x 1460 pixels (2.7 M Pixels) | 1936 x 1460 pixels (2.7 M Pixels) | 1936 x 1460 pixels (2.7 M Pixels) | Meets: Identical to the predicate. |
| Pixel Size | 18 μm | 18 μm | 18 μm | Meets: Identical to the predicate. |
| Technical Characteristics | ||||
| Technology | CCD | CMOS | Functionally equivalent to CCD for dental imaging | Meets: While the underlying technology changed (CCD to CMOS), the clinical performance in terms of image quality and diagnostic utility is deemed substantially equivalent, and better, as per the comparison. |
| Interface to PC | USB 2.0, Type A Plug | USB 2.0, Type A Plug | USB 2.0, Type A Plug | Meets: Identical to the predicate. |
| Operating System | Windows 7, 8 or 10 (32 or 64 Bit) | Windows 7, 8 or 10 (32 or 64 Bit) | Windows 7, 8 or 10 (32 or 64 Bit) | Meets: Identical to the predicate. |
| Electrical Rating | DC 5V, 350 mA max | DC 5V, 350 mA max | DC 5V, 350 mA max | Meets: Identical to the predicate. |
| Power Consumption | 1.4 Watts Max | 0.7 Watts Max | Less than or equal to 1.4 Watts Max | Meets/Exceeds: The new device has lower power consumption. |
| Safety and Biocompatibility | ||||
| Sterilization | Not suitable for sterilization | Not suitable for sterilization | Not suitable for sterilization | Meets: Identical to the predicate. |
| Housing | IPx7 Equivalent ISO 10993 Biocompatible | IPx7 Equivalent ISO 10993 Biocompatible | IPx7 Equivalent ISO 10993 Biocompatible | Meets: Identical to the predicate. |
| Standards Compliance | N/A (implied by predicate clearance) | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, ISO 10993-1, ISO 14971, IEC 62304 | All relevant safety and performance standards | Meets: The device was tested and found compliant with a comprehensive set of recognized safety and performance standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states: "Clinical images were provided. These clinical images were not necessary to establish substantial equivalence based on the modifications to the device (note that the x-ray detector technology is similar to predicate). These clinical images provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
- Sample Size: The exact sample size for the clinical images used as "further evidence" is not specified in the provided text.
- Data Provenance: The provenance of the clinical images (e.g., country of origin, retrospective or prospective nature) is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts used or their qualifications for establishing ground truth for any test set. The review primarily relies on laboratory performance data and a comparison to a predicate device.
4. Adjudication Method for the Test Set:
- The document does not specify any adjudication method for a test set. This suggests that a formal, multi-reader, adjudication-based study for diagnostic accuracy was not the primary method for demonstrating substantial equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A formal MRMC comparative effectiveness study, where human readers with AI assistance are compared to human readers without AI assistance, was not performed or reported in this submission. The device (JAZZ Solo sensor) is a digital x-ray sensor, not an AI-powered diagnostic tool. The submission states, "Image analysis software is not part of the submission."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Since the device is a digital x-ray sensor and "image analysis software is not part of the submission," a standalone performance study of an algorithm was not conducted as part of this submission. The device itself is solely for image acquisition.
7. Type of Ground Truth Used:
- The primary method for demonstrating substantial equivalence was through laboratory performance data focusing on physical characteristics (Dynamic Range, MTF, SNR, X-Ray Resolution) and technical specifications, compared to a legally marketed predicate device.
- "Clinical images" were provided as "further evidence" that the "complete system works as intended," but details about how ground truth was established for these clinical images (e.g., expert consensus, pathology, outcomes data) are not provided.
8. Sample Size for the Training Set:
- Since this submission is for a digital x-ray sensor, not an AI algorithm, there is no concept of a training set in the traditional machine learning sense. The device captures images, it does not learn from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- As there is no training set for an AI algorithm, this question is not applicable.
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(192 days)
The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve.
The JAZZ Suction Valve is intended to control the suction (aspiration of air and fluids) of a FUIFILM gastrointestinal endoscope during endoscopy procedures.
The JAZZ Air/Water Valve is intended to control air of a FUJIFILM gastrointestinal endoscope for insufflations and water delivery (for distal lens cleaning) during endoscopy procedures.
The JAZZ Forceps Valve is intended to facilitate passage of an endotherapy device, to prevent a leak or backflow of air and/or fluids, and to enable the suction function of a FUJIFILM gastrointestinal endoscope.
The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, Air/Water Valve, and Forceps Valve. These devices are intended for single-use and are supplied sterile, eliminating the need for manual cleaning and reprocessing. These valves are designed to the corresponding port of a FUJIFILM G7 gastrointestinal endoscope. The air/water valve can be activated to control air and water flow, while the suction valve can be activated to aspirate excess fluids or other debris. The forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support thesuction function.
The provided text describes the JAZZ Disposable Valve Kit, a medical device for use with FUJIFILM gastrointestinal endoscopes. The document is a 510(k) summary submitted to the FDA, asserting substantial equivalence to predicate devices based on performance data.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide explicit "acceptance criteria" in a quantitative format with thresholds for each test. Instead, it states that "The subject devices met performance specifications in the following additional non-clinical tests." and "Bench testing demonstrates that the subject device is as safe and effective as the predicate devices." Implied acceptance is that the device performs functionally and safely, similar to the predicate devices.
| Performance Test (Implied Acceptance Criteria: Met Specifications/Safe and Effective) | Reported Device Performance |
|---|---|
| Biocompatibility | Met consensus standards (ISO 10993-1, 10993-5, 10993-7, 10993-10) and FDA guidance. |
| Sterility | Met consensus standards (ISO 11135, ISO 11607-1). |
| JAZZ Air/Water Valve - Backflow Prevention | Validated for efficiency in preventing backflow to proximal irrigation system as defined by FDA Guidance. |
| Spring Force Testing | Performed; met performance specifications (implied by overall conclusion). |
| Suction Valve - Suction pressure | Met performance specifications. |
| Suction Valve - Tightness | Met performance specifications. |
| Suction Valve - Functional life | Met performance specifications. |
| Suction Valve - Compatibility with endoscope | Met performance specifications. |
| Air/Water Valve - Insufflation pressure | Met performance specifications. |
| Air/Water Valve - Flushing pressure | Met performance specifications. |
| Air/Water Valve - Tightness | Met performance specifications. |
| Air/Water Valve - Functional life | Met performance specifications. |
| Air/Water Valve - Compatibility with endoscope | Met performance specifications. |
| Forceps Valve - Tightness | Met performance specifications. |
| Forceps Valve - Compatibility with endoscope | Met performance specifications. |
| Forceps Valve - Compatibility with endoscopic instruments | Met performance specifications. |
| Forceps Valve - Ease of use | Met performance specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and validation studies. It does not specify the sample sizes (e.g., number of valves tested for each parameter) used for these tests. The data provenance is not explicitly stated beyond being "bench testing" and "validation" which implies a controlled laboratory environment. There is no indication of clinical data, animal studies, or human subject data. Therefore, the data can be considered prospective in the sense that the tests were conducted specifically for this submission. The "country of origin of the data" is not stated, but the manufacturer is FUJIFILM medwork GmbH (Germany).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not describe any studies involving human experts to establish "ground truth." The performance evaluations are based on non-clinical tests (bench testing) against established standards and internal specifications to demonstrate functional performance and safety.
4. Adjudication Method for the Test Set:
Not applicable, as no studies involving human interpretation or subjective adjudication are mentioned. The testing involves objective measurements rather than expert consensus on a "ground truth" derived from images or clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The JAZZ Disposable Valve Kit is an accessory for an endoscope, and its evaluation focuses on mechanical and functional performance, sterility, and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This question is not applicable to the JAZZ Disposable Valve Kit. This device is a mechanical accessory, not an algorithm or AI-driven system. Its performance is inherent in its physical and functional design, not in a standalone algorithm's output.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation can be considered the established consensus standards (ISO standards), FDA guidance documents, and internal performance specifications for medical devices of this type. For example, for sterility, the ground truth is that the device must meet the requirements of ISO 11135 and 11607-1. For backflow prevention, the ground truth is compliance with the FDA guidance. For functional aspects like suction pressure or tightness, the ground truth would be predetermined functional thresholds defined by the manufacturer or industry standards.
8. The Sample Size for the Training Set:
Not applicable. As a physical medical device (valve kit), there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are developed based on engineering principles and regulatory requirements, not through data training.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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(88 days)
The JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ Systems may also be used in conjunction with other medical implants made of titanium alloy or Cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
JAZZ PF enables the passing of a JAZZ braid around or through the upper spinous process. The main difference with the JAZZ regular connector is that in the subject device the braid is locked horizontally, that is, along the spine axis, instead of vertically. On each side of the instrumented levels, a JAZZ PF connector is implanted on the union rod below the upper pedicle screw. A JAZZ braid is passed and locked through a 1st connector, above or through the spinous process and back through the second connector on the other side. The slack that can exist in the band is removed using the JAZZ PF Band Reducer (Enrouleur Instrument) without applying any tension in the band and the 2nd connector is locked. By doing so, flexion is controlled which helps in the primary stabilization of the levels where fusion has to be achieved.
The provided text describes a medical device, JAZZ PF, and its substantial equivalence determination by the FDA. However, it does not include detailed information regarding "acceptance criteria" for a study in the context of device performance, nor does it present a study that rigorously proves the device meets specific acceptance criteria in a quantitative sense as might be expected for an AI/CADe device.
Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices. This means the device is considered safe and effective because its technological characteristics and intended use are similar to those of devices already legally marketed. The performance data mentioned is for mechanical durability testing, not for diagnostic or analytical performance against ground truth.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's what can be provided based on the text:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the primary "acceptance criterion" for this type of device (spinal implant) in a 510(k) submission is typically demonstrating mechanical durability and safety comparable to predicate devices. The study mentioned is a mechanical test.
| Acceptance Criteria (Inferred from 510(k) context for spinal implants) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Withstand dynamic compression loading for a specified number of cycles. | JAZZ PF constructs passed 5 million cycles at a load of 600N. |
| Demonstrate sufficient rationale for sterilization, cleaning, and biocompatibility. | Detailed rationales were provided to demonstrate why the device did not constitute a new worst-case in terms of sterilization, cleaning and biocompatibility. |
| Substantial equivalence to predicate device. | Concluded as substantially equivalent based on similar intended uses, indications, technological characteristics, and principles of operation, and performance data. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as "test set" in the context of an analytical or diagnostic study. For the dynamic compression testing, the number of devices or constructs tested is not specified, only that "JAZZ PF constructs passed."
- Data Provenance: Not applicable in the context of clinical data for AI/CADe. The performance data is from mechanical testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of a diagnostic or analytical AI study (e.g., expert consensus on medical images) is not relevant for this device's mechanical performance testing.
4. Adjudication method for the test set
Not applicable. There's no adjudication process mentioned for a mechanical test.
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. This is a spinal implant, not an AI/CADe device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a spinal implant, not an algorithm.
7. The type of ground truth used
Not applicable in the context of an AI/CADe device. The "ground truth" for the mechanical test is adherence to engineering specifications for load and cycles.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Study from Text:
The JAZZ PF is a temporary spinal implant for stabilization during fusion and fracture repair. Its approval (K191217) was based on demonstrating substantial equivalence to existing predicate devices (NuVasive VersaTie System - K173117 and JAZZ System - K182771). The key performance data provided in the submission was a dynamic compression test where JAZZ PF constructs "passed 5 million cycles at a load of 600N," indicating its mechanical durability. The submission also addressed sterilization, cleaning, and biocompatibility by providing rationales that the device did not constitute a new worst-case compared to predicates. The document does not describe a study involving human readers, AI algorithms, or clinical performance against a diagnostic ground truth.
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(46 days)
The Jazz Systems are temporary implants to be used in orthopedic surgery. The Jazz Systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
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- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
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- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
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- Spinal degenerative surgery, as an adjunct to spinal fusions.
The Jazz Systems may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium-molybdenum allov whenever "wiring" may help secure the attachment of other implants.
The Jazz Systems consists of the following components: JAZZ Connector, JAZZ Claw Connector, JAZZ Claw hooks, JAZZ Lock Connector, various rods, and JAZZ Braid (a.k.a. Band) with buckle. The JAZZ Band is inserted into various JAZZ connectors and is used to attach them to the spine.
This document is a 510(k) summary for the JAZZ Passer Band. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study against specific acceptance criteria for a novel device. Therefore, much of the requested information (like expert-established ground truth, MRMC studies, or training set details) is not applicable or not provided in the given text.
Here's an analysis based on the provided input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from the study's perspective) | Reported Device Performance |
|---|---|
| Mechanical Strength (Static Tensile Testing) | The JAZZ Passer Band's changes were assessed via static tensile testing to evaluate the strength of the hole at the band extremity. |
| No new or different issues of safety or effectiveness | Performance data demonstrated that the modified JAZZ Passer Band is as safe and effective as the predicate JAZZ Band. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "static tensile testing," which inherently involves a test set of physical devices. However, the specific sample size (e.g., number of JAZZ Passer Bands tested) is not provided.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. Given it's a 510(k) submission, the testing would generally be conducted by the manufacturer (Implanet, S.A., based in France) or a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this submission. The "ground truth" for mechanical testing is typically based on engineering specifications and material properties, not expert clinical consensus.
4. Adjudication Method for the Test Set
This is not applicable. Mechanical testing results are objectively measured and do not require an adjudication method like clinical assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or imaging interpretation devices. The JAZZ Passer Band is a physical orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not relevant for a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on engineering specifications and established mechanical testing standards for medical implants. The specific and detailed acceptance criteria for the static tensile testing (e.g., passing a certain load threshold without failure) are not explicitly detailed in this summary but would be part of the full submission.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" of data in the context of this physical device's mechanical performance testing.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set.
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(92 days)
JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
The JAZZ Systems consists of the following components: JAZZ Connector, JAZZ Claw Connector, JAZZ Claw hooks, JAZZ Lock Connector, various rods, and JAZZ Braid (a.k.a. Band) with buckle. The JAZZ Band is inserted into various JAZZ connectors and is used to attach them to the spine.
The provided document is a 510(k) summary for a medical device (JAZZ System, including JAZZ Band) and does not contain the level of detail required to answer all parts of your request regarding acceptance criteria and a detailed study proving device performance in the context of an Artificial Intelligence (AI) or machine learning device. This document describes a traditional medical device (a temporary implant for orthopedic surgery) and its regulatory clearance process, not an AI/ML powered medical device.
Therefore, for aspects related to AI/ML device evaluation (like sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance of an algorithm, and training set details), the information is not applicable as the JAZZ System is a physical implant, not a software-based diagnostic or predictive tool.
However, I can extract the relevant information regarding the performance data provided for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Equivalent to predicate (assessed per ISO 10993) |
| Mechanical Performance | Equivalent to predicate (assessed via static tensile testing) |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical implant, and the performance assessment described is based on testing the physical properties of the device, not a classification or prediction task on a "test set" of data in the AI/ML sense. Data for biocompatibility and mechanical testing would involve a certain number of test samples of the device and testing materials, but these are not disclosed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML devices is not relevant here. Biocompatibility and mechanical performance are assessed through laboratory testing against established standards and engineering principles.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For biocompatibility, the ground truth would be adherence to the ISO 10993 standard. For mechanical performance, the ground truth would be demonstrating equivalent or superior strength and integrity compared to the previously cleared predicate device, based on established engineering specifications and static tensile testing protocols.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Additional Information from the Document:
- Device Name: JAZZ System, including JAZZ Band
- Purpose of 510(k): To modify the JAZZ Band component. Minor changes were made to the ultrasonic welding of the braid and the design of the metal buckle.
- Predicate Devices: Implanet's JAZZ System (K151740), Implanet's JAZZ Systems (K162764), Implanet's JAZZ Lock (K153348).
- Conclusion: The modified JAZZ Band is as safe and effective as the predicate JAZZ Braid. The JAZZ Band has the same intended uses and indications, and similar technological characteristics and principles of operation as its predicate device. Performance data (biocompatibility and mechanical performance) demonstrate that the modified JAZZ Band is substantially equivalent.
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(113 days)
The JAZZ SOLO digital sensor is intended to acquire dental intra-oral radiographic images. It can be operated by trained dental professionals for patients receiving intraoral x-ray examinations for diagnostic purposes.
The JAZZ SOLO Digital Sensor, Model 10-001, is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital xray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional procedures and other diagnostic aides for confirmation.
The JAZZ SOLO Digial Sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned.
The JAZZ SOLO Digital Sensor has an x-ray imager (CCD) that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to the JAZZ SOLO Digital Sensor through the standard USB port. Image analysis software is not part of the submission. For the Jazz Solo Digital Sensor to be used in a dental practice, an optional image analysis software will be necessary. Only with imaqe analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files and printed out on a suitable printer.
The JAZZ SOLO Digital Sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies and abnormal conditions. Inadequate images may result in mis-diagnosis, subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.
The provided document is a 510(k) summary for the JAZZ SOLO Sensor, seeking substantial equivalence to a predicate device (DEXIS Digital Sensor). The document describes the device, its intended use, and a comparison with the predicate device, but it does not include a study or acceptance criteria related to a device's performance in meeting acceptance criteria for diagnostic capability.
Instead, the submission focuses on demonstrating substantial equivalence through technical comparisons and compliance with general safety and performance standards. Specifically, it states:
- "Clinical images were provided. These clinical images were not necessary to establish substantial equivalence based on the modifications to the device (note that the x-ray detector technology is similar to predicate). These clinical images provide further evidence in addition to the laboratory performance data to show that the complete system works as intended." (Page 9)
- It also notes that the predicate's proprietary software prevents raw image generation for scientific evaluation of MTF and DQE.
Therefore, many of the requested details about acceptance criteria and a study proving diagnostic capability cannot be extracted from this document, as such a study is explicitly stated as not necessary for this 510(k) pathway.
However, based on the information available, here's what can be provided:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative diagnostic acceptance criteria for the JAZZ SOLO Sensor. The submission relies on demonstrating substantial equivalence to the predicate device (DEXIS Digital Sensor) based on technical characteristics and general safety standards, rather than proving diagnostic performance against specific clinical metrics.
The comparison table provided focuses on technical specifications to establish substantial equivalence:
| Characteristic | Predicate: DEXIS Digital Sensor | JAZZ SOLO Digital Sens (Reported Performance) | Acceptance Criteria (Implicit for Substantial Equivalence) |
|---|---|---|---|
| Indication for Use | To acquire dental intra-oral radiography images for diagnostic purposes by trained dental professionals. | To acquire dental intra-oral radiographic images for diagnostic purposes by trained dental professionals. | Substantially equivalent to predicate. |
| Intended Use | Indirect converting x-ray detector, generates digital images for dental intra-oral applications. | USB-driven digital sensor, acquires dental intra-oral radiography images. | Substantially equivalent to predicate. |
| Sensor Exterior Size | 38.95 mm x 29.75 mm | 39.1 mm x 30 mm | Comparable to predicate. |
| Sensor Imaging Size | 32.99 mm x 25.82 mm | 34.85 mm x 26.28 mm | Comparable to predicate. |
| Overall Imaging Area | 820 mm² | 873 mm² | Comparable to predicate. |
| Pixel Size | 19.5 µm | 18 µm | Comparable to predicate. |
| Imager Resolution | 1692 by 1324 pixels | 1936 x 1460 pixels | Comparable to predicate. |
| X-Ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm | ≥ 20 visible lp/mm (Explicit matching of predicate) |
| Dynamic Range | 16,384:1 | 4096:1 | Comparable to predicate (though numerically different, deemed substantially equivalent) |
| Technology | CMOS | CCD | Comparable/functionally equivalent to predicate despite different underlying technology (CMOS vs CCD) |
| Scintillator Technology | Cesium Iodide | Cesium Iodide | Explicitly matching predicate. |
| Interface to PC | USB 2.0, Type A Plug | USB 2.0, Type A Plug | Explicitly matching predicate. |
| Cable Length | 2.8 m | 72" Nominal | Comparable to predicate. |
| Operating System | Windows XP, Vista | Windows 7, 8, 10 | Compatible with current systems. |
| Power Consumption | 1.4 Watts Max | 1.4 Watts Max | Explicitly matching predicate. |
| Sterilization | Not suitable for sterilization | Not suitable for sterilization | Explicitly matching predicate. |
| Housing | IP68, ISO 10993 Biocompatible | IPx7 Equivalent ISO 10993 Biocompatible | Equivalent to predicate. |
| Electrical Rating | DC 5V, 350 mA max | DC 5V, 350 mA max | Explicitly matching predicate. |
Note: The "Acceptance Criteria" column reflects what the manufacturer is implicitly or explicitly claiming as acceptable for substantial equivalence, i.e., being similar enough to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Clinical images were provided. These clinical images were not necessary to establish substantial equivalence based on the modifications to the device... These clinical images provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/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)
Information not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information not provided.
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 done for this submission. The device is a digital X-ray sensor, not an AI-powered diagnostic tool. The document explicitly states that "Image analysis software is not part of the submission." and "Only with image analysis software can acquired images be optimized for specific diagnostic tasks..." (page 4).
- Effect Size: Not applicable, as no such study was performed or needed for this type of device submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is a digital X-ray sensor, a hardware device for image acquisition, not an algorithm. The document explicitly states that "image analysis software is not part of the submission." (page 4).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information not provided. For this 510(k) submission, the ground truth for substantial equivalence was primarily based on technical specifications and functional equivalence to the predicate device, not diagnostic accuracy against pathology or outcomes data.
8. The sample size for the training set
Not applicable. This is a hardware device (digital X-ray sensor), not an AI algorithm requiring a training set for diagnostic purposes.
9. How the ground truth for the training set was established
Not applicable, as no training set was used for an AI algorithm.
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