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The Pathfinder® CR System is an accessory to the Pathfinder Endoscope Overtube, intended to be used with an endoscope to facilitate evacuation of retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older).

It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics and doctors' offices.

The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices. The Pathfinder® CR System consists of the following main components: Suction Adapter (CR, Adapter), Foot Pedal (Suction Controller), Suction Tubing (Tubing).

The provided FDA 510(k) summary for the Neptune Medical Pathfinder® CR System primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, biocompatibility, and non-clinical functional and performance testing. It explicitly states that "No clinical testing was applicable to this submission" and "No animal testing was applicable to this submission." Therefore, the document does not contain information about a study with acceptance criteria of the type requested, which would typically involve human-in-the-loop performance or standalone algorithm performance.

However, based on the provided text, I can infer the "acceptance criteria" are related to successful functional and performance testing and biocompatibility, rather than a clinical performance study with metrics like sensitivity, specificity, or AUC.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document describes several non-clinical functional and performance tests. While specific quantitative acceptance criteria are not explicitly listed in a table format with corresponding reported performance values, the overall conclusion states that the device "successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness."

To provide a table as requested, I'll interpret the successful completion of each test as meeting an implicit acceptance criterion.

Regarding the specific questions about evaluation studies:

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

• Not applicable / Information not provided. This document details non-clinical (bench) testing, not a clinical study involving a test set of patient data.

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

• Not applicable. No expert review of a "test set" to establish ground truth is described, as there was no clinical study.

4. Adjudication method for the test set:

• Not applicable. No clinical 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:

• No. The document explicitly states, "No clinical testing was applicable to this submission." This device is a mechanical system, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

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

• Not applicable. This device is a mechanical system, not an algorithm. The testing described is functional performance testing of the device itself.

7. The type of ground truth used:

• Bench Test Specifications / Engineering Requirements. For the functional tests, the "ground truth" would be the engineering specifications and design requirements against which the device's performance was measured. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set:

• Not applicable. This pertains to algorithm development. This device is a mechanical system.

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

• Not applicable. This pertains to algorithm development. This device is a mechanical system.

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The Pathfinder Endoscope Overtube with Balloon is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder Endoscope Overtube with Balloon device consists of a hollow tube with a balloon at the distal end for use over a flexible gastrointestinal endoscope. The purpose of the balloon is to contact the lumen walls to provide stabilization to the distal end of the overtube within the GI tract. The endoscope is inserted through the proximal end of the device and comes out the distal end. The free space between the overtube and the endoscope is lubricated with water through the irrigation line by connecting to the irrigation/water Luer (female Luer lock fitting) and injecting water. The vacuum line is connected to free space within the device and is completely contained. A source of vacuum must be connected to the barb fitting per the diagram below for the overtube to transition between the flexible and rigid conditions. The balloon line is connected to an extrusion within the device that creates an air pathway from handle to the balloon. An inflation device must be connected to the Luer (male Luer lock fitting) to inflate and/or deflate the balloon. The handle rotator has two positions. The first position connects the device to atmosphere (vent) to stay in the flexible condition. The second position connects the device to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. Balloon inflation and deflation are actuated and controlled by an existing balloon controller unit within the endoscopy suite. The device must be connected to the balloon controller to transition into the inflated and deflated condition.

The provided text does not contain information about a study that proves a device meets acceptance criteria related to AI/algorithm performance.

The document is a 510(k) Premarket Notification from the FDA to Neptune Medical, Inc. for their "Pathfinder Endoscope Overtube with Balloon Device." It describes the device, its intended use, comparison to predicate devices, and summaries of functional and performance bench testing, and biocompatibility testing. It explicitly states:

• "No clinical testing was applicable to this submission."
• The entire submission focuses on a physical medical device, not an AI or algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI-powered device's performance, as the provided text pertains to a traditional medical device not involving AI.

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The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder Endoscope Overtube (Pathfinder) device consists of a flexible overtube that may be connected to vacuum for rigidization. It is used with an endoscope for procedures in the gastrointestinal tract. The handle includes a vacuum line which is connected to free space within the device that is completely contained, forming the vacuumable volume. The handle rotator has two positions: the first connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible position, and the second position connects the vacuumable volume to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to the surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.

The provided document describes a Special 510(k) submission for modifications to the Pathfinder Endoscope Overtube, specifically the addition of new sizes and a change in material durometer for the vacuum and irrigation line. This is NOT a typical AI/ML medical device submission, and therefore, many of the requested fields related to AI/ML performance, ground truth, and expert evaluation are not applicable.

Here's the breakdown of the information that can be extracted from the provided text, and where it indicates non-applicability for AI/ML specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a device modification submission for physical characteristics (sizes, material), the "acceptance criteria" are related to the functional and performance testing of the physical properties of the device, rather than a quantifiable performance metric like sensitivity or specificity for an AI algorithm. The document states that the "line extension was the subject of extensive testing under applicable design control requirements."

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

The document mentions "extensive testing" but does not provide specific sample sizes for each type of functional and performance testing (e.g., how many devices were tested for lubricity, how many cycles for rigidization).

• Sample Size (Test Set): Not specified in the provided summary.
• Data Provenance: The testing appears to be bench testing (laboratory-based) as stated in section 1.10: "the modified Pathfinder Endoscope Overtube has been shown to be safe through bench testing." This is not retrospective or prospective clinical data.

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

This question is not applicable as this submission is for a physical medical device (endoscope overtube) and not an AI/ML device that requires human interpretation for ground truth.

4. Adjudication method for the test set

This question is not applicable for the same reason as 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

This question is not applicable as this is not an AI-assisted device requiring human interpretation of results. No MRMC study was conducted.

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

This question is not applicable as this is not an AI algorithm.

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

This question is not applicable as there is no "ground truth" in the context of an AI algorithm's performance. The "truth" for this device modification is adherence to design specifications and successful functional performance as measured by engineering tests.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device, and therefore, there is no "training set."

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

This question is not applicable as there is no "training set" and no "ground truth" in the AI/ML context.

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The Pathfinder Endoscope Cap is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

The Pathfinder Endoscope Cap is single-use distal attachment for endoscopes. It is an aid to endoscopic visualization and treatment in the gastrointestinal (GI) tract. The Pathfinder Endoscope Cap consists of a single piece of Pebax® in a symmetrical, tapering shape for placement on the distal tip of an endoscope. It is a short, transparent tube with an attaching portion used to connect the cap to an applicable endoscope, a distal portion that tapers into a narrower diameter opening, and a side hole for drainage to prevent fluids lodging on the surface of the endoscope. The device is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection in the GI tract.

The Pathfinder Endoscope Cap has the following physical and performance characteristics:

• Sterilized by ethylene oxide
• For single use
• Tapering distal tip
• Soft stop (tactile indicator of correct depth position)
• Compatible with endoscopes with 11.7 mm outer diameter distal ends, such as the Olympus PCF-H180A and PCF-H190
• Compatible with the Pathfinder Endoscope Overtube, which is intended for use with the same size endoscopes.

The provided text describes the 510(k) premarket notification for the "Pathfinder Endoscope Cap" and its substantial equivalence comparison to a predicate device. However, it does not include the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or reader improvement with AI.

The document focuses on the Pathfinder Endoscope Cap's physical characteristics, materials, and a comparison with a predicate device based on general technological and performance criteria. It also mentions mechanical testing and biocompatibility testing.

Here's a breakdown of what is and is not in the provided text, structured as requested:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the text. The document states that the device underwent "mechanical testing" and "biocompatibility evaluation," but it does not list specific acceptance criteria (e.g., minimum tensile strength, maximum tracking force) or the quantitative results from these tests. It only lists the types of tests performed.

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

This information is not provided in the text. The document mentions "mechanical testing" and "biocompatibility evaluation" but gives no details about the sample sizes used for these tests or the origin of any data.

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

This information is not provided in the text. The device is a physical endoscope cap, not an AI or diagnostic tool that would typically involve expert ground truth for performance evaluation in the context of medical image analysis.

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

This information is not provided in the text. Similar to point 3, this type of method is relevant for expert-based evaluation of diagnostic or AI performance, which is not described for this physical device.

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 provided in the text. The device is a physical endoscope cap, not an AI system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and not mentioned.

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

This information is not provided in the text. As noted, this is a physical device, not an algorithm.

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

This information is not provided in the text. Given the device is a physical cap, typical "ground truth" as applied to diagnostic or AI performance evaluation (e.g., pathology, expert consensus) would not be relevant. The "ground truth" for its performance would likely be engineering specifications and functional testing results (e.g., does it fit correctly, does it maintain integrity during use), but these specific details are not elaborated.

8. The sample size for the training set:

This information is not provided in the text. Since this is not an AI device, there is no "training set."

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

This information is not provided in the text. As above, this is not an AI device, so this concept is not applicable.

Summary of available information regarding the "study" for the Pathfinder Endoscope Cap:

The document describes the following types of testing that were performed:

• Mechanical Testing:
  • Dimensional and visual testing
  • Cap tracking force (through compatible overtube)
  • Cap tensile strength with tape
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and relevant standards.
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Systemic Toxicity

The stated conclusion (Section 1.10) is: "The enclosed biocompatibility and performance testing results demonstrate that the subject device is safe and effective for its intended use and substantially equivalent to the predicate."

However, the specific quantitative results of these tests and the acceptance criteria that those results met are not detailed in the provided FDA letters and summary. This document primarily serves as a notification of a 510(k) clearance and outlines the general characteristics and comparison to a predicate device, rather than a detailed study report.

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The Pathfinder™ Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder™ Endoscope Overtube (Pathfinder™) device consists of a flexible overtube that may be connected to vacuum for rigidization via an attached stopcock and is used with an endoscope for procedures in the gastrointestinal tract. The stopcock is connected to the vacuum line which is connected to free space within the device and is completely contained, forming the vacuumable volume. The stopcock has two positions: the first position connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible condition, and the second position connects the device to a source of vacuum to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.

This document is a 510(k) premarket notification for a medical device called the Pathfinder™ Endoscope Overtube. It does not describe a study involving an AI-based medical device, nor does it include information on acceptance criteria for such a device.

The document focuses on demonstrating substantial equivalence to a predicate device (KMS Medical EndoGuide) primarily through:

• Comparison of technological characteristics: This involves comparing the design, materials, intended use, and other features of the new device to the predicate.
• Non-clinical performance data: This typically includes biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) and mechanical testing (simulated use, lubricity, insufflation, insertion/removal, steering, navigation, rigidization/de-rigidization, endoscope compatibility).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria for an AI-based device and the study proving it meets them. The document does not contain any of the following:

• Table of acceptance criteria and reported device performance for an AI device.
• Sample size used for an AI test set or data provenance.
• Number of experts or their qualifications for establishing ground truth for an AI test set.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used for an AI algorithm.
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

The provided text is solely for a traditional medical device (an endoscope overtube) and its regulatory clearance process, not for an AI/ML-based diagnostic or therapeutic device.

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When intended for pedicle screw fixation from T1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

The existing, commercially available Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System ("PathFinder NXT System") consists of various screws, rods and associated accessories and is intended to provide temporary stabilization following surgery to fuse the spine. The PathFinder NXT screws are polyaxial cannulated designs with a range of spinal rod lengths. The PathFinder NXT System allows the surgeon to place polyaxial pedicle screws either through an open or mini-open procedure. The percutaneous insertion rods are for minimally invasive procedures. The PathFinder NXT System is designed to aid in the surgical correction of several types of spinal conditions and intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass.

Additionally, the PathFinder NXT System includes instrumentation to facilitate the implantation of the PathFinder NXT implants.

The provided document describes the acceptance criteria and the study conducted for the Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System to demonstrate its substantial equivalence to predicate devices, rather than an AI/ML device. Therefore, many of the requested fields, such as those pertaining to AI/ML specific studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth for training set) are not applicable to this submission.

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to legally marketed predicate devices in terms of design, materials, function, and intended use. The study focuses on performance testing to confirm this equivalence.

Here's a summary based on the provided text, with "N/A" for fields not relevant to this type of medical device submission:

1. Table of acceptance criteria and the reported device performance

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 for specific tests (e.g., number of screws, rods tested). The document mentions "components of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System" were reviewed and tested.
• Data Provenance: Not specified, but generally, bench and cadaver lab testing for FDA submissions are conducted by manufacturers or contracted labs, likely within the United States or other regulated regions. The nature of the tests (bench, cadaver) is inherently prospective within a controlled lab environment.

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. This is a physical device and not an AI/ML system requiring expert-derived ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to engineering standards and functional performance. However, cadaver lab testing would involve surgical experts for evaluation. The qualifications of these experts are not detailed.

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

• Not applicable. This is not an AI/ML system requiring adjudication of interpretations. Performance is measured against engineering standards and functional requirements.

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

• Not applicable. This is not an AI/ML system.

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

• Not applicable. This is not an AI/ML system. The device itself is a "standalone" surgical implant system.

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

• The "ground truth" for this medical device's performance testing is based on:
  • Engineering Standards: Adherence to established ASTM F1717 and F1798 standards for mechanical performance.
  • Biocompatibility Standards: Ensuring materials meet medical-grade biocompatibility requirements.
  • Functional Equivalence: Demonstrating that changes to the device (e.g., instrument design, labeling) do not negatively impact the intended function or safety when compared to predicate devices, including evaluation in cadaver labs for human factors.

8. The sample size for the training set

• Not applicable. This is not an AI/ML system that uses a training set.

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

• Not applicable. This is not an AI/ML system.

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The SpeedLock Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot

reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedLock Knotless Fixation System is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of soft tissue to bone.

The SpeedLock consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter, which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized. Both the anchor and inserter are designed for single use only.

The SpeedLock System also includes associated instruments for implanting the anchor into bone.

The design modifications include aligning the shape and size of the windows at the distal end of the anchor and adding a flat surface to the internal crossbar against which the anchor plug may rest once deployed. The modifications do not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the devices cleared indications for use.

The provided text is a 510(k) summary for the ArthroCare® Corporation SpeedLock® Knotless Fixation System. This document outlines a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might for a diagnostic AI algorithm.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission, as it concerns a physical bone fixation device, not a diagnostic AI or software.

However, I can extract information related to product performance and testing where available.

Acceptance Criteria and Device Performance (ArthroCare® Corporation SpeedLock® Knotless Fixation System)

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study referenced is a Design Verification testing program.

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

• Sample Size: Not specified quantitatively in the document. The testing involved "Insertion strength and pull-out strength testing."
• Data Provenance: The testing was conducted in a simulated bone substrate. This indicates a bench-top, in-vitro (non-human/animal) lab setting. The country of origin for the data is not specified but implicitly refers to the testing performed by ArthroCare Corporation.
• Retrospective/Prospective: Not applicable, as this was laboratory testing of a physical device.

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

• Not Applicable. This submission is for a physical medical device (bone anchor) and its performance in mechanical tests, not a diagnostic AI algorithm requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No. This is a hardware device; MRMC studies are relevant for software/AI interpretation where human readers are involved.

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

• Not Applicable. This is a hardware device; "standalone performance" generally refers to AI algorithm performance without human intervention. The testing described is of the physical device itself.

7. The type of ground truth used:

• For the mechanical tests (insertion strength, pull-out strength), the "ground truth" would be the measured mechanical properties against pre-defined engineering specifications or performance standards. The document refers to "design, performance, and safety specifications."

8. The sample size for the training set:

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

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

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

Summary of the Study:

The study involved Design Verification testing for the modified SpeedLock® Knotless Fixation System. This testing specifically included:

• Evaluation to demonstrate that the modifications did not alter the device's intended use or performance.
• Insertion strength testing in a simulated bone substrate.
• Pull-out strength testing in a simulated bone substrate.

The purpose of these tests was to demonstrate that the modified device continues to meet its pre-established design, performance, and safety specifications and that its mechanical properties remain substantially equivalent to its predicate device. The submission states that "All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling." No clinical or animal data were included in this submission, indicating reliance solely on non-clinical, bench-top testing.

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The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:

• Hip capsule repair
• Acetabular labrum reattachment

The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The SpeedLock HIP is a knotless fixation device: surgical knots are not necessary for the fixation of suture to tissue.

The SpeedLock HIP consists of two primary parts: a PEEK bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The SpeedLock HIP Knotless Fixation System consists of the 3.4 mm SpeedLock HIP anchor and associated instruments for implanting the anchor into bone.

The provided text describes the SpeedLock® HIP Knotless Fixation Implant, a bone anchor device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing, rather than an AI/ML device. Therefore, a direct response to some of the AI/ML-specific questions (like sample sizes for training/test sets, expert adjudication methods, MRMC studies, or multi-reader multi-case studies) is not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria for various mechanical tests. Instead, it broadly states that the device "meets all design, performance, and safety specifications" and that the "test results demonstrate... substantial equivalence" to predicate devices. The study performed was a comparative bench test.

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

The document mentions "side by side bench testing" but does not specify the sample size (number of devices tested) for the proposed device or the predicate devices.

• Sample Size: Not specified.
• Data Provenance: The testing was "in vitro" using a "simulated human bone substrate." This indicates laboratory bench testing, not human data.

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

This question is not applicable as the study involved mechanical bench testing of a physical device, not an AI/ML algorithm requiring expert interpretation of data or images to establish ground truth.

4. Adjudication Method for the Test Set

This question is not applicable for a mechanical bench test. The "ground truth" (or reference standard) for mechanical properties would be derived from the testing equipment and established engineering principles, not expert consensus or adjudication.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a physical medical device (bone anchor), not an AI/ML software.

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

This question is not applicable as the submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was established through mechanical testing data (static and cyclic fatigue testing) against pre-defined engineering and performance specifications, and in comparison to the performance of predicate devices. This is based on objective measurements from laboratory equipment, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable. There is no training set mentioned or implied, as this is not an AI/ML device.

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

This question is not applicable, as there is no training set for an AI/ML device.

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When intended for pedicle screw fixation from T1 -S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion.

As pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

The existing, commercially available Zimmer Spine PathFinder NXT® system consists of various screws, rods and associated accessories and is intended to provide temporary stabilization following surgery to fuse the spine. PathFinder NXT screws are polyaxial cannulated designs with a range of spinal rod lengths. PathFinder NXT allows the surgeon to place polyaxial pedicle screws either through an open or mini-open procedure. PathFinder NXT is designed to aid in the surgical correction of several types of spinal conditions and intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass. Additionally, the PathFinder NXT MIS System includes instrumentation to facilitate the implantation of the PathFinder NXT implants. The prior 510(k) for the PathFinder NXT MIS System included both Class I 510(k) exempt instrumentation and those instruments considered to the implant. PathFinder NXT was cleared via 510(k) #K100845 on 21 September 2010.

The Fixed Percutaneous Rod Holder accessory that is the subject of this premarket notification instrument is intended for use with the PathFinder NXT® Pedicle Screw System. This instrument is designed specifically for use with the rod implant component of the PathFinder NXT® Pedicle Screw System and, is considered an accessory to the implant. The Fixed Percutaneous Rod Holder holds and inserts a rod percutaneously through the extender sleeves which are positioned on the implanted screw head.

This 510(k) summary describes a modification to an existing medical device, the PathFinder NXT® Minimally Invasive Pedicle Screw System, specifically an accessory called the Fixed Percutaneous Rod Holder. The submission focuses on demonstrating substantial equivalence to the predicate device, not on proving de novo clinical effectiveness of the entire system.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not describe a clinical study with a "test set" in the traditional sense of patient data. The "tests" performed were engineering design verification tests on the device itself. Therefore, the concepts of "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" are not applicable to this type of submission.

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

There were no human experts used to establish ground truth for a test set of patient data, as this was a device modification and engineering verification testing. The "ground truth" for the performance was established by the physical testing against engineering specifications and comparison to the predicate device. Therefore, this information is not applicable.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring human interpretation or labeling, an adjudication method is not applicable. The "adjudication" in this context would be the internal engineering and regulatory review process by Zimmer Spine, Inc. and ultimately the FDA.

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 submission does not involve Artificial Intelligence (AI) or reader interpretation of images. It is for a physical medical device (pedicle screw system accessory). Therefore, an MRMC comparative effectiveness study is not applicable.

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

This is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For this device modification, the "ground truth" was established by:

• Engineering Specifications: The design verification tests measured physical properties and performance against defined engineering requirements and tolerances.
• Predicate Device Performance: The primary ground truth for substantial equivalence was the established performance and safety profile of the legally marketed predicate device (PathFinder NXT® Minimally Invasive Pedicle Screw System, #K100845). The modified accessory was deemed equivalent if it performed at least as well as the predicate under specified conditions and did not introduce new safety or effectiveness concerns.
• Industry Standards: Compliance with ASTM A-564 for material specification.

8. The Sample Size for the Training Set

There was no "training set" in the context of machine learning or AI. The design and manufacturing process for a physical device doesn't involve a training set. If interpreted in a broader sense as development and testing, the "samples" would be the prototype devices and test articles subjected to the design verification tests. The exact number of units tested is not specified in the summary but would be detailed in the full design verification report.

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

As there was no "training set" in the AI sense, this question is not applicable. If referring to the development process of the device itself, the design "ground truth" was established through engineering design processes, material selection based on established standards, and performance goals derived from clinical needs and the performance of the predicate device.

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The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedFix Suture System is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

The provided text describes a 510(k) summary for the ArthroCare Corporation SpeedFix Suture System, not a study involving acceptance criteria and device performance in the context of AI or a reader study.

The document states that a "side-by-side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors." However, it does not provide details of the acceptance criteria, the specific test results, sample sizes, or the other information requested in the prompt (e.g., data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets).

Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (SpeedFix Suture Implant cleared under K101437) rather than presenting a detailed performance study against defined acceptance criteria in the manner described by the prompt.

The document explicitly states: "The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices." This indicates a reliance on the predicate device's established safety and effectiveness, supported by bench testing, rather than a de novo performance study against explicit internal acceptance criteria.

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