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The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. 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 spinal level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).

PROW FUSION-L is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-L is provided in different sizes to fit the anatomical needs of a wide variety of patients. PROW FUSION-L is manufactured from titanium alloy per ASTM F136 and Polyetheretherketone per ASTM F 2026. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. PROW FUSION-L is to be filled with autogenous bone graft material.

Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae. The devices require the use of commercially available supplemental spinal fixation systems.

This document describes a 510(k) premarket notification for the "PROW FUSION-L" intervertebral body fusion device. A 510(k) is a submission to the FDA demonstrating that the device is at least as safe and effective as a legally marketed predicate device. This type of submission generally does not require clinical trials with acceptance criteria and statistical performance metrics in the same way a PMA (Premarket Approval) would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and MRMC studies is not applicable to this 510(k) submission.

Instead, the submission relies on the concept of substantial equivalence to a predicate device, demonstrated primarily through mechanical testing.

Here's the summary of what is provided:

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

• Not Applicable. As this is a 510(k) for substantial equivalence, formal acceptance criteria in the context of clinical performance (sensitivity, specificity, etc.) are not presented. The "acceptance" is based on the mechanical test results demonstrating equivalence to the predicate and compliance with relevant ASTM standards.

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

• Test Set Sample Size: Not specified in terms of human subjects or clinical cases. The "test set" here refers to the physical devices subjected to mechanical testing. The number of devices tested for each mechanical test (static and dynamic axial compression, compression-shear, subsidence, expulsion, wear particle assessment) is not explicitly stated.
• Data Provenance: The mechanical testing was conducted to demonstrate substantial equivalence to the predicate device and compliance with ASTM standards. The submission originates from NLT SPINE Ltd. in Kfar-Saba, Israel. The context suggests that the testing was performed in a lab setting rather than involving human data.

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. Ground truth in the context of clinical expert consensus is not relevant for this type of submission focused on mechanical equivalence. The "ground truth" for mechanical testing is adherence to predefined engineering specifications and performance within established ASTM standards.

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

• Not Applicable. Adjudication methods are relevant for clinical studies where expert review is needed for diagnoses or outcomes. This document describes 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:

• Not Applicable. No MRMC or clinical comparative effectiveness study involving human readers or AI is mentioned, as this is a mechanical device, not an imaging or AI diagnostic tool.

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

• Not Applicable. This is a physical intervertebral body fusion device, not an algorithm or AI system.

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

• For the mechanical performance data, the "ground truth" is adherence to established ASTM (American Society for Testing and Materials) standards and demonstrating performance similar to the predicate device. The specific standards cited are ASTM F2077 (for static and dynamic axial compression, static and dynamic compression-shear) and ASTM F2267 (for subsidence).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of a machine learning algorithm for this physical device.

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant.

In summary, the PROW FUSION-L device gained market clearance via a 510(k) submission based on:

• Substantial Equivalence: To several predicate devices including Life Spine, Longbow Spacer System (K133717).
• Mechanical Performance Data: Consisting of static and dynamic axial compression, static and dynamic compression-shear (according to ASTM F2077), subsidence (according to ASTM F2267), and additional expulsion and wear particle assessment testing.
• Compliance with Guidance: Per "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007.

The "study" that proves the device meets the criteria is a set of mechanical tests designed to show that the device performs functionally and structurally equivalent to its predicate.

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PROW FUSION-V is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

PROW FUSION-V is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.

PROW FUSION-V is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-V is provided in different shapes to fit the anatomical needs of a wide variety of patients and can expand to the desired height or the desired lordosis.

Protrusions on the superior and inferior surfaces of each device grip the endplates of the adiacent vertebrae to resist expulsion. The devices require the use of commercially available supplemental spinal fixation systems.

PROW FUSION-V is manufactured from titanium alloy per ASTM F136.

PROW FUSION-V is to be filled with autogenous bone graft material.

The provided document describes a 510(k) premarket notification for a medical device called "PROW FUSION-V." This type of document is a submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission for an intervertebral body fusion device focuses heavily on mechanical testing and material equivalence rather than clinical study results involving human patients or complex AI algorithm performance. The "Performance Data" section explicitly states that mechanical testing (static and dynamic compression, compression-shear, subsidence) was conducted according to ASTM standards and FDA guidance. A cadaveric study was also done.

Therefore, the information required to answer your specific questions relating to AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for training sets, and expert adjudication as would be found in a study validating a diagnostic AI/ML device, is not present in this document.

Based on the provided document, here's what can be inferred about the "acceptance criteria" and "study" for this type of device:

Acceptance Criteria and Device Performance (Based on the document's focus)

Given that this is a 510(k) for an intervertebral body fusion device, the acceptance criteria relate to its mechanical properties and biocompatibility, demonstrating that it functions similarly to predicate devices.

Absence of Information for AI/ML Device Validation Questions:

The following information is not available in the provided document, as it pertains to the validation of AI/ML algorithms, which is not the subject of this 510(k) for an intervertebral body fusion device.

2. Sample sizes used for the test set and the data provenance: Not applicable to this type of mechanical and cadaveric testing. No "test set" in the context of an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a spinal implant is defined by its mechanical properties and successful implantation in cadavers, not expert interpretation of diagnostic images.
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 device is not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, ground truth is largely defined by engineering standards (e.g., ASTM F2077, ASTM F2267 for mechanical properties) and anatomical/surgical considerations (evaluated in cadaveric study). It is not "expert consensus, pathology, or outcomes data" in the typical AI/ML sense.
8. The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a physical medical device (spinal implant) and its regulatory submission (510(k)) primarily relies on non-clinical (mechanical and cadaveric) testing to demonstrate substantial equivalence, rather than clinical studies or AI/ML algorithm validation. Therefore, most of your specific questions related to AI/ML device validation cannot be answered from this text.

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The PROW FUSION Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through SI in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of 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 spinal level(s).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle 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 PROW FUSION device.

The PROW FUSION intervertebral body fusion device must be inserted using a transforaminal approach.

The PROW FUSION Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use PROW FUSION implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the PROW FUSION Delivery System) used for its implantation. The implant is made from PEEK and titanium alloy. The implant features 4 PEEK mid segments and titanium end segments has coarse surface on the superior and inferior surfaces and are attached with titanium pins.

The PROW FUSION intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by PEEK strip is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.

This document is a 510(k) Summary for the PROW FUSION intervertebral body fusion device. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, much of the requested information regarding acceptance criteria, specific study design details, ground truth establishment, expert involvement, and reader studies is not typically found in this type of regulatory submission.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a formal table of acceptance criteria with specific quantitative thresholds or a direct report of the device's performance against such criteria. The "Performance Data" section broadly states that "Performance testing, including static axial compression testing per ASTM F2077, cadaver testing, and deployment force testing demonstrated that the PROW FUSION is substantially equivalent to its predicate PROW FUSION (K130254)."

The acceptance criterion, by inference, is that the device demonstrates substantial equivalence in its performance characteristics to the predicate device (K130254). The reported "performance" is that this substantial equivalence was demonstrated through the stated tests.

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

The document does not specify the sample sizes (e.g., number of test articles, cadavers) used for the static axial compression testing, cadaver testing, or deployment force testing. It also does not state the provenance of any data (e.g., country of origin, retrospective/prospective). This level of detail is usually found in the full technical report, not the 510(k) summary.

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

Since this is a mechanical device performance test, the concept of "ground truth" and "experts" as in clinical or interpretive studies (e.g., radiologists) is not applicable. The "ground truth" for mechanical testing is derived from the objective physical measurements and engineering specifications, often interpreted against established standards (like ASTM F2077).

4. Adjudication Method for the Test Set

Not applicable for mechanical performance testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms where human readers interpret results, and the document describes an intervertebral body fusion device.

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

This device is not an algorithm, so this question is not applicable. The performance testing conducted (static axial compression, cadaver testing, deployment force) can be considered "standalone" in the sense that it assesses the device's physical properties and function without human intervention in its operation during the test, but it is not "algorithm only" performance.

7. The Type of Ground Truth Used

For the performance testing:

• Static axial compression testing: The ground truth is established by the specified mechanical properties and failure criteria outlined in the ASTM F2077 standard, and comparison to the predicate device's performance under the same standard.
• Cadaver testing: The ground truth would be based on the observed mechanical stability, insertion characteristics, or other defined metrics within the cadaveric model, compared to the predicate.
• Deployment force testing: The ground truth would be the measured forces and comparison to predicate or specified engineering targets.

8. The Sample Size for the Training Set

This device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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 Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative 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 spinal level(s).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle 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 Prow Fusion device.

The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.

The Prow Fusion Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use Prow Fusion implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the Prow Fusion Delivery System) used for its implantation. The implant is made from PEEK-OPTIMA® LT1 & LT2 and titanium alloy. The implant features 4 PEEK-OPTIMA® LT1 mid segments and titanium end segments. The segments has coarse surface on the superior and inferior surfaces and are attached with titanium pins.

The Prow Fusion intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by PEEK-OPTIMA® LT2 strip. The PEEK-OPTIMA® LT2 strip is used to pull the distal seament proximally to form a ring-shaped, closed-configuration implant in the disc space.

The provided document, K130254, is a 510(k) premarket notification for the NLT SPINE Prow Fusion device. This document focuses on demonstrating substantial equivalence to a predicate device (NLT Prow Fusion K112359) rather than establishing new clinical effectiveness or safety through extensive clinical trials. Therefore, the information provided primarily pertains to bench testing to prove similar performance characteristics to its predicate, not a study involving human subjects or AI.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance data in the typical sense of a clinical study demonstrating efficacy. Instead, it relies on demonstrating substantial equivalence through mechanical and performance testing. The acceptance criterion is essentially that the Prow Fusion performs equivalently to its predicate device (K112359).

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

• Sample Size: The document does not specify a "test set" in the context of clinical data or human subjects. The performance testing refers to bench testing of the device components. The sample sizes for each type of mechanical test (Static Compression, Dynamic Compression, etc.) are not provided in this document. These would typically be detailed in separate test reports referenced or summarized.
• Data Provenance: The data provenance is from bench testing conducted by NLT SPINE. There is no information about country of origin for any human data, as no human data is presented for performance evaluation. The tests followed ASTM F2077 and ASTM F2267 standards, implying industry-standard testing methodologies.

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

Not applicable. This is a 510(k) submission for a medical implant based on substantial equivalence and bench testing, not a study involving human image interpretation or diagnostic performance where expert ground truth would be established.

4. Adjudication Method for the Test Set

Not applicable, as no human-read test set requiring adjudication is mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a modified intervertebral body fusion device, relying on bench testing to demonstrate substantial equivalence to a predicate device, not a clinical study involving human readers or AI assistance.

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

Not applicable. This is not a submission for an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the validated mechanical properties and performance characteristics of the predicate device (K112359), as established through its own prior testing and regulatory clearance. The current device's performance is compared against these established benchmarks through bench testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no training set mentioned.

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The Prow Fusion is intended to be used for spinal fusion.

The Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through 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 spinal level(s).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle 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 Prow Fusion device.

The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.

The Prow Fusion Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use Prow Fusion implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the Prow Fusion Delivery System) used for its implantation. The implant is made from PEEK enriched with carbon fibers (CFPEEK) and titanium alloy. The implant features multiple CFPEEK mid segments and titanium end segments. The segments are serrated on the superior and inferior surfaces and are attached with titanium pins.

The Prow Fusion intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by ultra high molecular weight poly ethylene (UHMWPE) suture. The suture is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.

The NLT SPINE Prow Fusion device is an intervertebral body fusion device. The acceptance criteria and the study that proves the device meets the acceptance criteria are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each mechanical test (ASTM F2077, F2267, expulsion, wear testing). These are typically laboratory studies, and the provenance would be laboratory-generated data, not human patient data, unless explicitly stated otherwise.

For the cadaver testing, the sample size is also not specified. Cadaver testing is a prospective evaluation of device usability. The geographic origin of the cadavers or the testing facility is not provided.

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

This information is not provided in the document. For mechanical testing, the "ground truth" is defined by the ASTM standards themselves and the test results obtained. For cadaver testing, the "ground truth" (that the device can be used as intended) would be established by the observations and assessments of the performing surgeons or evaluators, whose specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided. For mechanical testing, adjudication typically involves adherence to standard operating procedures and data analysis. For cadaver testing, the method of assessing "can be used as intended" is not described, so an adjudication method is not specified.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and mechanical testing, not through a human-in-the-loop study comparing human reader performance with and without AI assistance.

6. If a Standalone Performance Study Was Done:

Yes, standalone performance (algorithm only performance, in this context, refers to the device's mechanical and functional performance independent of a specific human-in-the-loop clinical trial) was done. The ASTM F2077 and F2267 tests, expulsion, and wear testing evaluate the device's inherent mechanical properties and durability.

7. The Type of Ground Truth Used:

• Mechanical Performance Tests (ASTM F2077, F2267, expulsion, wear): The ground truth is based on engineering principles and established industry standards for intervertebral body fusion devices, with "acceptance" being defined by meeting requirements comparable to predicate devices.
• Cadaver Testing: The ground truth is based on the functional demonstration of the device's intended use by the intended user population, verifying that the device can be properly implanted and functions as expected in a simulated surgical environment.

8. The Sample Size for the Training Set:

This information is not applicable. This device is not an AI/ML (Artificial Intelligence/Machine Learning) device requiring a "training set" in the conventional sense. The "training" for this device would refer to the standard engineering design and iterative testing processes, not a dataset for an algorithm.

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

This information is not applicable, as there is no "training set" in the AI/ML context for this device. The design and validation of the device rely on engineering principles, material science, and established biomechanical testing methods.

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