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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 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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The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one of 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 retrolisthcsis 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 to provide support for a transforaminal approached surgery

Posterior Lumbar Interbody Fusion (PLIF)

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

The PATHWAY Interbody Fusion Device is made from Polyetheretherketone (PEEK OPTIMA TM) and contain titanium markers. The titanium markers serve a means for the end user of the device to determine the location of the implant intra-operatively and post- operatively.

The device(s) is rectangular in nature and have various widths, lengths, heights and degrees of lordosis (0 Degree and 6 Degree). The devices contain empty space for the practitioner to insert autogenous bone graft. The devices have serrated teeth on the superior and inferior sides to provide anchorage stability to the vertebrae. They are single use devices.

The 0 Degree PLIF has a width of 10 mm, a length of 23 mm, and ranges in height from 7 to 15 mm.

The 6 Degree PLIF is lordotic in nature and has a width of 8 mm, a length of 23 mm, and ranges in height from 7 to 15 mm

The TLIF is a rectangular in nature and has a width of 10 mm, a length of 28 mm, and ranges in height from 7 to 15 mm.

The implants are provided non-sterile and the instruments are provided cleaned, decontaminated and non-sterile. These devices must be sterilized by the user facility.

Here's a breakdown of the acceptance criteria and study information for the Custom Spine, Inc. PATHWAY Intervertebral Body Fusion Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not explicitly mentioned. The submission relies on demonstrating substantial equivalence through material comparison, design specifications, indications for use, and mechanical testing against predicate devices. There is no mention of a clinical "test set" in the context of a prospective or retrospective patient data study for evaluation of algorithm performance.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a pre-market submission for a physical medical device, not an AI/software device evaluated on patient data. The "data" refers to engineering and material testing data, not patient data.

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

• Not applicable. This submission is for a physical orthopedic implant. "Ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here. The ground truth for device performance is based on established engineering standards and comparison to predicate devices.

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

• Not applicable. No expert adjudication of test set results is mentioned for this type of device submission.

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/software device. No MRMC study was conducted.

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

• Not applicable. This is not an AI/software device.

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

• The "ground truth" for this device's performance is derived from:
  • Established ASTM Standards: ASTM F2026 (for PEEK OPTIMA™), ASTM F-136 (for Titanium), ASTM 2077 (for mechanical performance), and ASTM 2267 (for mechanical performance).
  • Performance of Predicate Devices: The device's performance and characteristics (materials, design, indications for use, mechanical properties) were compared to the cleared predicate devices: Spinal Elements Lucent (K071724) and Depuy Acromed™ Stackable Cage™ System (K990148, K001340, K030833). The equivalence to these legally marketed devices serves as the basis for demonstrating safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set of data.

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

• Not applicable. No training set for an algorithm is involved.

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The Onset Medical Pathway™ Balloon Expandable Ureteral Access Sheath is intended to establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Pathway™ Balloon Expandable Ureteral Access Sheath." This type of document does not contain the detailed information requested regarding acceptance criteria and the specifics of a study proving device performance.

510(k) clearance signifies that a device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics, and that it is as safe and effective as the predicate. The FDA review for a 510(k) does not typically involve a new, comprehensive clinical trial for efficacy against specific acceptance criteria in the way a PMA approval might. Instead, it relies on demonstrating equivalence through comparison to existing devices, often including performance testing that is not detailed in the public clearance letter.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily states:

• Device Name: Pathway™ Balloon Expandable Ureteral Access Sheath
• 510(k) Number: K061009
• Indication for Use: To establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.
• Regulatory Class: II
• Product Code: EZN
• Regulation Name: Ureteral dilator
• Predicate Device: The letter states the device is substantially equivalent to legally marketed predicate devices, but does not explicitly name them.

To obtain the detailed study information you're asking for, you would typically need to refer to the 510(k) summary document or the full 510(k) submission to the FDA, which are sometimes publicly available through different FDA databases, but are not part of this clearance letter.

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The PATHWAY- ATS/CHEPS is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.

The PATHWAY- ATS/CHEPS is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as a stimulator for creating sensation and pain stimuli, in the sensory nerves fibers.

The provided document is a 510(k) summary for the PATHWAY- ATS/CHEPS device, which is an evoked response thermal stimulator. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about acceptance criteria and a standalone performance study.

Based on the information available in the provided text, I cannot fully answer all aspects of your request. Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document does not explicitly state specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy targets) nor does it report detailed device performance metrics in comparison to such criteria. The core of a 510(k) submission is to argue substantial equivalence to a predicate device, not necessarily to meet new, independent performance benchmarks documented with extensive clinical study data.

Table of Acceptance Criteria and Reported Device Performance:

Study Details

The document refers to the "Modified Contact Heat-Evoked Potential Stimulator K051448" as the predicate device, implying that the PATHWAY- ATS/CHEPS's equivalence is based on similar technology and intended use. However, it does not describe a new clinical study with detailed performance data for the PATHWAY- ATS/CHEPS itself.

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

• Test Set Sample Size: Not specified. The document does not describe a clinical test set for new performance evaluation. The comparison is primarily based on technological characteristics and intended use.
• Data Provenance: Not applicable, as no new test set data is described. The comparison is based on existing knowledge and documentation for the predicate device.

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

• Number of Experts: Not specified. Not applicable as no new test set or ground truth establishment process is described for performance evaluation.
• Qualifications of Experts: Not specified.

3. Adjudication method for the test set:

• Adjudication Method: Not specified. Not applicable as no new test set requiring adjudication is described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• MRMC Study: No, the document does not indicate that an MRMC comparative effectiveness study was conducted. The device is a stimulator, not an interpretive diagnostic tool that involves human readers interpreting outputs in a comparative manner like AI systems often do.

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

• Standalone Study: Not applicable in the context of this device. The PATHWAY- ATS/CHEPS is a thermal stimulator, not an algorithm-only diagnostic device. Its function is to create stimuli, rather than interpret data from an algorithm.

6. The type of ground truth used:

• Type of Ground Truth: Not applicable. The document focuses on the device's ability to generate specific thermal stimuli for "evaluating the functionality of human pain reception and transmission of sensory pathways," implying its output is a stimulus, not a diagnostic result that requires a "ground truth" for validation in the typical AI sense. The focus is on the stimulator's ability to produce the intended physical effects safely and effectively, similar to the predicate device.

7. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not a machine learning device that requires a training set.

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

• Training Set Ground Truth: Not applicable.

Summary of Limitations based on the Document:

The provided 510(k) summary is designed to demonstrate substantial equivalence to a predicate device for regulatory clearance. It does not include detailed clinical study data, performance metrics against specific acceptance criteria, or information on AI/ML model training or validation often found in submissions for AI-powered diagnostic devices. The device described is a thermal stimulator, which typically undergoes different validation procedures focusing on its ability to generate controlled stimuli safely and effectively, often by comparison to a legally marketed equivalent device.

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The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) is intended to establish a working channel, admitting access to the ureter by way of the urethra and bladder, during endoscopic urological procedures.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Pathway™ Expandable Ureteral Sheath." This document is a regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving device performance based on the provided input. This type of information would typically be found in the 510(k) submission itself, which is a much larger document than this clearance letter.

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