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Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound are diagnostic ultrasound systems designed to be used for general pelvic imaging. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. Measurements and calculations of the organ, muscle, and tissue structures can be recorded.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound utilize the ultrasound probes, cable and host software application used in Interson USB Ultrasound Probe System. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a self contained portable, multiplemode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and video recording.

User-customized parameter settings for the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a B-Mode ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, and calculate angles. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound supports the Cine function (capable of storing up to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device Interson USB Ultrasound Probe System, K070907.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound interfaces with the Interson USB Ultrasound Probe System software to collect the ultrasound images, measurements, and calculations. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound allows for the entry of patient information and generates reports from the recorded ultrasound images, measurements, and calculations.

The provided text describes a 510(k) premarket notification for the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound systems. It asserts their substantial equivalence to a predicate device, the Interson USB Ultrasound Probe System (K070907). The document focuses on demonstrating this equivalence rather than presenting an independent study with new acceptance criteria and performance data for the device. Therefore, a direct table of acceptance criteria and reported device performance with specific values cannot be compiled from the provided text as the application relies on the predicate's established performance.

However, based on the provided text, we can infer the basis for acceptance and the type of study conducted to demonstrate this.

Here’s a breakdown of the requested information, derived from the document's content:

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

The provided document does not list specific, quantitative acceptance criteria for the subject devices, nor does it present new performance data for them. Instead, the acceptance criterion is substantial equivalence to an existing predicate device (Interson USB Ultrasound Probe System, K070907). The reported device performance is implicitly considered to be equivalent to that of the predicate device based on similar technological characteristics and a subset of clinical applications.

• Same technological characteristics (materials, measurements, principle of operation, transducer probe design, acoustic output limits).
• Same intended use (Diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications).
• Similar safety and effectiveness features. | Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound:
• Materials: TPX brand Polymethyle Pentene (PMP) for lens; Ertalyte brand Polyetheylene Terephthalate (PET-P), Delrin for housing. (Identical to predicate)
• Measurements: Distance (mm), Circumference (mm), Area (mm²), Angle (degree). (Identical to predicate)
• Principle of Operation: Apply high voltage bursts to Piezoelectric material in the transducer and detect the reflected echo to construct 2D images for diagnostic purposes. (Identical to predicate)
• Transducer Probe Design: Mechanical sector ultrasound imaging probe that connects directly to host computer via USB. Host computer forms real-time ultrasonic images without additional electronics. (Identical to predicate)
• Acoustic Output Limits: SPTA.3 94 mW/cm² (Max), MI 1.9 (Max). (Identical to predicate)
• Clinical Applications: Subset of predicate's applications (Abdomen, OB/GYN, Urology). (Considered safe and effective as they are within the predicate's cleared range).
• Report:
  • Morpheus®/Pathway®: Multiple page report displaying up to 10 user selectable images, user notes, printed on standard 8 1/2" X 11" paper. (Enhanced functionality compared to predicate, but the underlying images and data are the same).
  • QuickScan®: Single page report displaying a single image, printed on 80mm thermal printer paper. (Condensed report compared to predicate, but underlying data is the same). |

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

No new test set or data provenance details are reported for the subject device. The submission relies on the existing clearance of the predicate device (Interson USB Ultrasound Probe System, K070907). The specific studies and data used for the predicate device's clearance are not detailed in this document.

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

Not applicable. No new test set or ground truth establishment process is described for the subject device. The substantial equivalence argument relies on the predicate device's prior clearance.

4. Adjudication method for the test set

Not applicable. No new test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool to improve human reader performance. No MRMC study was conducted or referenced for the subject device.

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

Not applicable. The device is a diagnostic ultrasound system intended for use by a human operator, not an autonomous algorithm. The document emphasizes that the device functions identically to the predicate in how it generates images.

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

The type of ground truth for verifying the performance of the predicate device (and therefore implicitly the subject device) for diagnostic ultrasound imaging would typically involve comparison to other established imaging modalities, clinical findings, or expert interpretation. However, the current document does not specify the ground truth used for the predicate's original clearance.

8. The sample size for the training set

Not applicable. This document describes an ultrasound imaging device, not an AI/machine learning system that requires a training set.

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

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

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The PATHWAY ELIF device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s).

The PATHWAY ELIF device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY ELIF device(s).

The PATHWAY ELIF device can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

The PATHWAY ELIF implant features three prescribed lordotic angle / height positions and is available in two lengths for posterior lumbar fusion. It allows lordotic adaptability and height restoration to meet patient anatomy. It is comprised of upper and lower expandable surfaces preassembled with a posterior height maintenance component. The device can be expanded to fixed configurations of 0°, 8°, and 16° positions. Each position after 0° provides approximately 2mm of additional mid-body height increase. The superior and inferior surfaces of all components are coated with plasma sprayed titanium to provide a roughened finish.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the PATHWAY ELIF device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with specific numerical targets. Instead, it refers to compliance with established ASTM standards for intervertebral body fusion devices. The reported device performance is that the PATHWAY ELIF System demonstrated "equivalent performance to the predicate" by successfully passing these tests.

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

The document does not specify the exact sample sizes used for each mechanical test (static/dynamic compression, subsidence, expulsion). Instead, it states that "Testing was performed in accordance with the following standard(s):" and lists several ASTM standards. These standards typically define minimum sample sizes for such tests.

The document mentions a "cadaver study" for usability and functionality, but the sample size for this study is not provided.

The provenance of the data is retrospective, as it describes tests conducted to demonstrate the device's characteristics. No information on the country of origin for the data is provided, but given the US FDA submission, it's presumed to be from tests conducted by or on behalf of Custom Spine, Incorporated.

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

This information is not applicable to the supplied document. The "ground truth" for this medical device submission is established through objective engineering and material testing standards (ASTM standards), rather than expert consensus on medical images or clinical outcomes. The evaluation is based on whether the device meets pre-defined mechanical and material specifications.

4. Adjudication Method for the Test Set:

This information is not applicable. The assessment is based on quantifiable engineering test results and adherence to material specifications, not on human interpretation that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The PATHWAY ELIF is an intervertebral body fusion device (an implant), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable for the same reason as point 5. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for this device is based on:

• Engineering Standards: Compliance with recognized ASTM standards (e.g., F2077, F2267) for mechanical performance (static/dynamic compression, subsidence, expulsion).
• Material Specifications: Adherence to defined material standards for Titanium alloy (ISO 5832-3, ASTM F136) and coating properties (e.g., ASTM F1580, F1854).
• Cadaveric Demonstration: For usability and functionality, a cadaver study provided empirical evidence.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not an AI model that requires a "training set." The development would involve engineering design, finite element analysis, and physical prototyping, but not a data training set in the AI sense.

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

This information is not applicable, as there is no "training set" in the context of this physical medical device.

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The PATHWAY AVID intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have Grade I Spondylolisthesis at involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s).

The device is intended to be used with supplemental fixation systems that have been cleared for the lumbosacral spine (i.e. posterior pedicle screws and rod systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted from a transforaminal approach (TLIF).

The proposed modification subject device is to be provided to the users in one of two configurations: the predicate device containing PEEK Optima LT1with titanium hinges and linkages (Ti-6Al-4V, ASTM F136) or the proposed PEEK Optima LT1 with MP35N (Co-Cr-Ni-Mo Alloy, ASTM F562).

Here's an analysis of the provided text regarding the acceptance criteria and study for the PATHWAY AVID device, conforming to your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This document is a 510(k) summary for a modification to an existing device. The acceptance criteria and performance data are primarily focused on demonstrating substantial equivalence to the predicate device, rather than proving de novo clinical efficacy or specific accuracy metrics.

Here's a breakdown of the other requested information based on the provided text. Many of these points are not applicable or explicitly stated in a 510(k) summary for a device modification, which focuses on engineering and material equivalence:

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices tested, but implied to be sufficient for mechanical and corrosion testing. Specific numbers of units are not provided.
• Data Provenance: Not specified. Standard practice for such tests is in a laboratory setting.
• Retrospective or Prospective: Not applicable for engineering bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The "ground truth" for these tests are objective measurements based on engineering standards (tensile strength, corrosion). No human experts are used to interpret the results in the same way as they would for medical images.

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

• Not applicable. This concept pertains to human interpretation/review, not objective engineering tests.

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 medical device (intervertebral body fusion device), not an AI/software device. MRMC studies are not relevant here.

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

• No. This is a physical medical device, not an algorithm.

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

• Ground Truth: For mechanical testing, the ground truth is defined by the objective physical properties and performance under specific force/environmental conditions. For corrosion testing, the ground truth is determined by electrochemical measurements according to ASTM F 2129-08 standards.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device. The "training set" concept is not relevant.

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

• Not applicable. This is not an AI/machine learning device.

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The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device.

The PATHWAY device can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provide support to the spine for a posterior surgery.

The proposed modification to the PATHWAY Intervertebral Body Fusion Devices (PLIF and TLIF) is to The proposed mountedion with the currently cleared titanium (Ti-6Al-4V) markers.

The provided text is a 510(k) summary for a medical device called "PATHWAY Intervertebral Body Fusion Device." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

The document explicitly states: "Performance Data was originally performed on the PATHWAY Device (K080281). The proposed changes do not impact the mechanical performance of the device." This indicates that the current submission (K111774) is for a modification that does not require new performance data or a new study, but rather relies on the performance data of the previously cleared predicate device (K080281).

Therefore, I cannot provide the requested information from the given text.

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When used as an intervertebral body fusion device, the Custom Spine PATHWAY ACIF is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Custom Spine ACIF.

When used as a vertebral body replacement, the Custom Spine PATHWAY ACIF is intended for use in the thoracic and/or throcolumbar spine (TI-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft.

For all indications, the device is intended to be used with supplemental fixation systems that have been cleared for use in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).

The PATHWAY ACIF is a cervical interbody fusion active as identification markers for the (Polyetheretherketone). The device continues of the implant both intra-operatively and postoperatively.

The device is trapezoidal in nature and is provided in various heights ranging from 5 mm to 12 mm and a The device is trapezondan in hatale and is pro naiss a central cavity which is to be packed with width of 15 mm, and 13 mm in length This abouts of Indusis (0 Degree and 7 Degree and 7 Degree). The superior autograft. This device is provided in various degrees of lordos autograft. This device is provided in the resist implant migration/displacement.
and inferior surfaces have serrated teeth to help resist implant migration/displacement.

The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The product is provided clean and "non-sterile".

The provided text describes the "PATHWAY ACIF" intervertebral body fusion device and its regulatory clearance (510(k) K092904). However, it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance, nor any AI/ML components for which such a study would be relevant.

The "Performance Data" section explicitly states:

The PATHWAY ACIF device was tested in accordance with ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Websited by Jan ASTM F2077-03 "Test Method For Intervertebral Body Fusion Devices". The data are located in Section 19 of this submission, "Bench Testing". The data demonstrate that the device is capable of performing in accordance with its intended use.

This indicates bench testing (mechanical testing) was performed to demonstrate the device's physical performance, not a clinical study or an AI/ML performance study. Therefore, most of the requested information regarding AI/ML study design (sample sizes, ground truth, experts, MRMC, standalone performance) is not applicable or available in this document.

Here's a breakdown of the information that can be extracted, and where the requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only mentions "mechanical support" and "resistant to migration/displacement" as performance goals, and refers to industry standards for testing. Specific acceptance criteria values (e.g., maximum allowable subsidence, specific load magnitudes) and quantitative performance results are not provided in this summary.

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

• Not applicable for AI/ML performance study. The device underwent mechanical bench testing, not a clinical test set with data provenance in the context of AI/ML.

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 clinical images or data interpretation by experts is not relevant to mechanical bench testing of an intervertebral fusion device.

4. Adjudication method for the test set

• Not applicable. This applies to expert review of clinical data, not mechanical testing.

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 device is a physical implant, not an AI/ML diagnostic or assistive tool for human readers.

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

• No, a standalone AI/ML performance study was not done. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

• For mechanical performance: The "ground truth" for the device's performance relies on the established engineering standards and requirements outlined in ASTM F2267-04 and ASTM F2077-03, and the physical measurements obtained during bench testing. There is no biological or expert consensus 'ground truth' in the clinical sense for this type of testing as described.

8. The sample size for the training set

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

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

• Not applicable. This device is not an AI/ML algorithm, so there is no training set or associated ground truth establishment process.

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The PATHWAY Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device.

The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.

The PATHWAY AVID Intervertebral Body Fusion Device is made from PEEK Optima. The device is made from multiple PEEK segments. The segments are serrated on the superior and inferior surfaces. The PEEK segments are attached with titanium pins and have a titanium linkage that attaches the segments. This pins and the linkage provide the means to form into its final articulated shape.

The titanium alloy pins serve as markers providing visual aid in determining the location of the implant both intra and postoperatively.

The articulated device foot print ranges from 8 mm through 14 mm in height, 20mm in width and 35 mm in length.

The implants are non-sterile and instruments are provided clean and non-sterile. These devices are to be sterilized by the user facility.

The provided text describes a medical device, the PATHWAY AVID Intervertebral Body Fusion Device, and its 510(k) summary for FDA clearance. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of AI/ML performance.

The "Performance Data" section states: "Performance data per ASTM 2077 and ASTM 2267 and compared to the predicate devices. In addition, cadaver testing demonstrated the PATHWAY AVID is substantially equivalent to its predicates, as it was shown that the device can be used as intended by the intended user population per its labeling following a standard training program."

This indicates physical performance testing and comparison to predicate devices, and cadaver testing for surgical use, but it does not involve any AI/ML components, acceptance criteria tables, or studies with a test set, ground truth experts, or training sets as requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance from the provided text.

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The Pathway PVTM Atherectomy System is intended for use in atherectorny of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity perspheral arteries ≥30 mm in diameter It 1s not intended for use in coronary, carotid, iliac or renal vasculature

The Jetstream™ Pathway PVTM Atherectorny System (hereafter "Jetstream System") is an atherectomy catheter system designed with an expandable cutting tip for use in debulking and treating vascular disease in the peripheral vasculature Separate lumens within the Catheter allow for continuous aspiration and infusion during Excised tissue, thrombus, and fluid are aspirated from the peripheral device use treatment site through ports in the Catheter tip to a collection bag located on the Console The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure

The Jetstream System consists of two primary components (1) a Jetstream Catheter and Control Pod and (2) a PV Console, which are packaged separately Each of these system components is described generally as follows

• Jetstream Catheter and Control Pod: A sterile, single-use unit consisting of an . electrically driven Jetstream Catheter and Control Pod The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities The Control Pod provides a user interface with keypad controls The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double-pouched tray
• PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status The Console mounts on a standard I V stand and remains outside the sterile field during the procedure

Here's an analysis of the provided text regarding the Jetstream™ Pathway PVT™ Atherectomy System, focusing on acceptance criteria and study information.

It's important to note that this document is a 510(k) Summary, which typically provides a high-level overview to demonstrate substantial equivalence to a predicate device. It doesn't usually contain the detailed study protocols, raw data, or comprehensive statistical analysis found in a full clinical trial report.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on bench testing to support the expanded indications for use and demonstrates substantial equivalence to predicate devices.

The key reported performance is the "expanded indications for use," which now includes the ability "to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3.0 mm in diameter." The implicit acceptance criterion is that the device is safe and effective for this expanded indication, as demonstrated through bench testing and comparison to predicates.

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

The document does not mention a clinical test set sample size or clinical data provenance (e.g., country of origin, retrospective/prospective). The evidence provided is based on "bench testing." Bench testing typically involves laboratory experiments on models or excised tissue, not human subjects.

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

Since the study described is "bench testing" rather than a clinical study evaluating diagnostic accuracy or expert interpretation, the concept of "ground truth for a test set" established by experts does not apply in the traditional sense. Bench testing would likely involve engineers and technicians evaluating mechanical performance, material properties, and the device's ability to perform its intended function in a controlled environment.

4. Adjudication Method for the Test Set

As there's no clinical test set with human interpretation, an adjudication method for test set ground truth is not applicable.

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

No, an MRMC comparative effectiveness study is not mentioned or implied. The study described is bench testing, not a clinical study involving human readers.

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

This device is an atherectomy system, a physical medical device. It is not an algorithm or AI system, so the concept of "standalone (algorithm only)" performance is not applicable.

7. The Type of Ground Truth Used

For the "bench testing" mentioned, the "ground truth" would be established by controlled experimental conditions and measurements. For example, if testing the ability to remove thrombus, the "ground truth" would be the known amount of simulated thrombus placed in a model, and the performance would be measured by the amount removed. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The Sample Size for the Training Set

This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" sample size is not applicable.

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

As this is a physical device, not an AI/ML model, the concept of establishing ground truth for a "training set" is not applicable.

Summary of Findings from the 510(k) Summary:

The 510(k) summary for the Jetstream™ Pathway PVT™ Atherectomy System primarily relies on demonstrating substantial equivalence to predicate devices and provides evidence through bench testing to support its expanded indications for use. It does not contain information about clinical studies involving human subjects, reader performance, or AI/ML model evaluation. Therefore, many of the requested details regarding sample sizes, expert ground truth, and training data are not present in this type of regulatory document for this category of device.

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The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Pathway PV Atherectomy System is an atherectomy catheter system designed with an expandable cutting tip for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through ports in the Catheter tip to a collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

The Pathway PV Atherectorny System consists of two primary components: (1) a Catheter and Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:

• Catheter and Control Pod: A sterile, single-use unit consisting of an electrically . driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double-pouched tray.
• A reusable compact Console, with two (2) peristaltic pumps for . Console: aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

This 510(k) is for the same device with modifications to the Console to add a check of the Control Pod's parameter settings at the time of device use.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary (K082664) for the Jetstream™ Pathway PVT™ Atherectomy System does not contain explicit acceptance criteria or details of a study proving the device meets specific performance criteria in the way you might expect for an AI/algorithm-based device.

Instead, this 510(k) is for a modification to an existing, already cleared device (K081328, K082186). The primary claim for this submission is substantial equivalence to the predicate device.

The document states:

• "This 510(k) is for the same device with modifications to the Console to add a check of the Control Pod's parameter settings at the time of device use."
• "The Pathway PV Atherectomy System is substantially equivalent to the specified predicate device. The device has the identical indications for use and the same technological characteristics. Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k) for the Pathway PV Atherectomy System."

This indicates that the "study" was focused on demonstrating the safety and effectiveness of the modification (the Console's parameter check) through bench testing, rather than a full-scale clinical performance study with predefined acceptance criteria for a new device.

Therefore, for many of your requested points, the answer is that the information is not applicable or not provided in this type of 510(k) submission, which focuses on substantial equivalence for a physical device modification.

Detailed Breakdown of Requested Information:

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

   • Not provided. The document does not list quantitative acceptance criteria or specific performance metrics. The "performance" demonstrated was that the modified console's parameter check maintained the safety and effectiveness established by the predicate device through bench testing.

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

   • Not applicable / Not provided. Since the study involved bench testing for a physical modification, there isn't a "test set" of patient data in the typical sense for algorithms.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not provided. Ground truth, in the context of expert review of images or clinical outcomes, is not relevant for this type of bench testing study for a physical device modification.

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

   • Not applicable. See point 3.

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 device is a physical atherectomy system, not an AI/algorithm for image analysis or diagnosis. Therefore, an MRMC study is not relevant.

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

   • No. This is a physical medical device, not an algorithm.

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

   • Not applicable / Not provided. For the bench testing mentioned, "ground truth" would likely relate to engineering specifications, mechanical performance, or functional checks, rather than clinical ground truth types. The document only states "Bench testing was completed and provided to support the safety and effectiveness of the modifications."

8. The sample size for the training set

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

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

   • Not applicable. See point 8.

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The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Pathway PV Atherectomy System is an atherectomy catheter system designed with an expandable cutting tip for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through ports in the Catheter tip to a collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. The Pathway PV Atherectomy System consists of two primary components: (I) a Catheter and Control Pod and (2) a Console, which are packaged separately.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information:

Analysis of Acceptance Criteria and Study Information for Pathway PV Atherectomy System (K082186)

The provided 510(k) summary for the Pathway PV Atherectomy System (K082186) focuses on demonstrating substantial equivalence to a predicate device after modifications to improve manufacturability, ergonomics, and ease of use. It explicitly states that the device has "identical indications for use and the same technological characteristics" as its predicate.

Crucially, this 510(k) summary does not detail specific acceptance criteria for performance, nor does it describe a clinical study or a standalone algorithm performance study with a test set, ground truth, or expert involvement. The documentation primarily relies on bench and laboratory testing to support the safety and effectiveness of the modifications to the device.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document.

The document states: "Bench and laboratory testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k) for the Pathway PV Atherectomy System." However, it does not specify what parameters were tested, what the acceptance criteria for those tests were, or the quantitative results of those tests. These details would typically be found in the comprehensive testing reports submitted to the FDA, but they are not part of this summary.

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

Not available concerning clinical data or a test set for performance assessment.

The "bench and laboratory testing" mentioned would have involved a certain number of test units or trials, but the sample sizes for these engineering tests are not disclosed. There is no mention of a clinical "test set" in terms of patient data.

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

Not applicable/available.

Since there is no described clinical "test set" and no ground truth establishment process involving expert review for performance, this information is not provided. The 510(k) pathway for this device focused on demonstrating equivalence through engineering modifications, not on a new clinical efficacy study.

4. Adjudication Method for the Test Set

Not applicable/available.

No test set for performance requiring adjudication is mentioned.

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

No, an MRMC comparative effectiveness study was not done.

This type of study is relevant for diagnostic imaging AI devices, comparing human performance with and without AI assistance. The Pathway PV Atherectomy System is a mechanical atherectomy device, not a diagnostic AI system, so an MRMC study would not be applicable or expected.

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

No, a standalone algorithm performance study was not done.

The device is an electromechanical system for atherectomy, not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

Not applicable/available.

Without a clinical or diagnostic performance study described, there is no mention of ground truth types (e.g., pathology, outcomes data, expert consensus). The "ground truth" for the engineering changes would have been the established performance specifications of the predicate device and relevant industry standards.

8. The Sample Size for the Training Set

Not applicable/available.

The device is not an AI/ML system that utilizes a training set in the conventional sense.

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

Not applicable/available.

As the device is not an AI/ML system, there is no training set or associated ground truth establishment process.

Summary Limitations:

The provided 510(k) summary is typical for a device with minor modifications where substantial equivalence is demonstrated primarily through engineering verification and validation (bench and lab testing) rather than new clinical trials. It confirms that the modifications did not alter the safety, effectiveness, or indications for use compared to the predicate device. Therefore, the detailed information requested about clinical acceptance criteria, expert reviews, and AI-specific study designs is not within the scope of this particular document.

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The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Pathway PV Atherectomy System consists of two primary components: {1} a PV Catheter and Control Pod and (2) a PV Console, which are packaged separately. Each of these system components is described generally as follows:

• PV Catheter and Control Pod: A sterile, single-use unit consisting of an . electrically driven PV Catheter and Control Pod. The PV Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls and LED indicators for device operational status. The unit, its electrical connectors, tubing. and aspirant collection bag are packaged in a double pouched tray.
• Console: A reusable compact PV Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
  The Pathway PV Atherectomy System is compatible with 8F sheaths and exchange length (300cm or longer) 0.014" diameter guidewires.

The provided text is a Fragmented 510(k) Summary. It includes general device information, predicate device comparison, and FDA's substantial equivalence letter for the Pathway PV™ Atherectomy System. However, it does not contain specific details about acceptance criteria or a study that proves the device meets such criteria.

The document states that "Performance testing of the Pathway PV Atherectomy System included in vitro performance, biocompatibility, packaging, sterilization, electrical/EMC, animal, and clinical study." but does not provide results for these studies or define specific acceptance criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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