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The EndoLIF® Delta-Cage and DoubleWedge-Cage are intended for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with autogeneous bone and implanted via a posterior or posteriolateral approach. The EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment with an EndoLIF® cage.

The EndoLIF® devices are interbody fusion devices that have a hollow center chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The product family includes cages of a variety of lengths, widths, heights, and lordotic to suit the individual pathology and anatomical conditions of the patient. The device footprint allows for posterior or posterolateral surgical approaches for insertion. All implant components are made from titanium alloy Ti6A14V ELI using electron beam melting additive manufacturing technology. The EndoLIF® product family is being expanded to include the Delta-Cage and DoubleWedge-Cage implant configurations.

The product family also includes instruments to allow for implant size trialing and insertion.

The EndoLIF® devices are provided in sterile form. All implants are intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device (EndoLIF® Delta-Cage and DoubleWedge-Cage) and an assessment of its substantial equivalence to a predicate device. This type of FDA submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to performance testing demonstrating the new device's engineering characteristics are comparable to the predicate. It does not refer to clinical studies demonstrating patient outcomes or the performance of an AI algorithm.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test (e.g., how many devices were subjected to static compression). These are in vitro mechanical performance tests, not clinical trials with patient data. The "data provenance" refers to the results of these standardized mechanical tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable. The "ground truth" for these types of engineering performance tests is defined by the technical specifications and requirements of the ASTM standards, not by expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiologic readings). Here, the performance is determined by meeting objective engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the subject of this 510(k) submission.

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

No, a standalone algorithm performance study was not done. This device is an intervertebral body fusion cage, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these tests is the set of established physical and mechanical properties and performance thresholds defined within the respective ASTM standards (F2077 and F2267). The device's performance is compared against these engineering criteria.

8. The Sample Size for the Training Set

This information is not applicable. A "training set" is used in the development of machine learning models. This document describes mechanical testing of a medical implant, not an AI algorithm.

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

This information is not applicable for the reasons stated above.

Summary of the Study:

The study referenced in the document is a series of benchtop, in vitro mechanical performance tests conducted according to established ASTM standards (F2077 and F2267). These tests evaluated the EndoLIF® Delta-Cage and DoubleWedge-Cage's static compression, static compression shear, dynamic compression, static torsion, dynamic torsion, and subsidence characteristics. The purpose of these tests was to demonstrate that the new device has a "safety and effectiveness profile that is similar to the predicate device" by meeting all specified criteria within these engineering standards. The conclusion was that the design testing demonstrated the performance of the device is "equal to the legally marketed predicate devices."

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The joimax® Intracs® m Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures.

The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:

· Transforaminal procedure

• Interlaminar procedure

The joimax® Intracs® em System is a surgical navigation system based on electromagnetic (EM) tracking technology, designed specifically for applications in minimally invasive spine surgery. The system displays instrument position relative to the patient's anatomy.

The joimax® Intracs® em System is a surgical navigation system. The provided text, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device (StealthStation S8 Spine Software) rather than detailing a specific clinical study with granular acceptance criteria and performance data for a standalone AI algorithm.

However, based on the performance data section and the comparison table, we can infer the primary performance metric for this stereotaxic instrument: System Accuracy.

Here's an attempt to structure the information based on the provided text, recognizing that this document is a regulatory submission for substantial equivalence, not a detailed research paper on an AI's performance for a diagnostic task. The AI component here is implied within the "surgical navigation system" which uses electromagnetic tracking to continuously display instrument position relative to anatomy. The "device performance" in this context is its accuracy in tracking.

Acceptance Criteria and Device Performance Study for joimax® Intracs® em System

The joimax® Intracs® em System is a surgical navigation system primarily focused on continuously displaying the position and orientation of surgical instruments relative to anatomical structures using electromagnetic tracking. The "performance data" supplied in support of its substantial equivalence to a predicate device focuses on its accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the joimax® Intracs® em System are directly compared to the performance characteristics of its predicate device, the StealthStation S8 Spine Software. The primary performance metric detailed is System Accuracy.

Note: The K192663 document states the predicate has 'mean positional error of 2.0 mm and a mean trajectory error of 2°', implying these were the benchmarks for the subject device.

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

The provided document does not specify the exact sample size used for the performance testing related to accuracy (e.g., number of measurements, number of phantoms/cadavers).

• Test Set Description: Performance testing was conducted using phantoms and human cadavers.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission, these would typically be conducted prospectively as part of product development and validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth during the performance testing. In the context of a navigation system's accuracy, the ground truth would likely be established by precise measurements (e.g., CMM, optical tracking gold standard) rather than subjective expert consensus.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method as it's not a reader study or a diagnostic performance evaluation in the typical sense of AI for image interpretation. The "ground truth" for system accuracy would be based on physical measurements against known values and not on human interpretation needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted/mentioned as this device is a surgical navigation system, not a diagnostic imaging AI designed to assist human readers in interpreting medical images. Its performance is about the accuracy of instrument localization, not diagnostic accuracy requiring human reader comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The "performance testing (accuracy)" mentioned in the document is effectively the standalone performance of the algorithm and hardware system. The reported values for positional and trajectory error (≤2.0 mm and ≤2°) are the standalone performance metrics. The nature of a surgical navigation system means the "in-the-loop" performance is the surgeon using the system, and the accuracy metrics directly reflect the system's ability to provide correct information to the surgeon.

7. Type of Ground Truth Used

The ground truth for the performance testing (accuracy) was established through physical measurements against known values in phantoms and human cadavers. This is implicitly derived from the types of "Performance testing with phantoms and human cadavers" and the quantified "System Accuracy" metrics (positional and trajectory error). It is not expert consensus, pathology, or outcomes data in the usual sense.

8. Sample Size for the Training Set

The document does not specify a separate "training set" as this is not a deep learning or machine learning model that undergoes a distinct training phase on a large dataset for image analysis. The system's "training" refers to its engineering design, calibration, and validation, not a data-driven machine learning training set in the typical AI sense.

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

As there's no mention of a traditional machine learning "training set," this question is not applicable in the context of the information provided for this specific device. The system's underlying principles (electromagnetic tracking) are based on established physics and engineering, validated through rigorous testing and calibration.

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The Percusys® Plus Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Percusys® Plus Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws and rods. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136).

The Percusys® Plus Pedicle Screw System is provided in sterile form. All implants are intended for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding the joimax GmbH's Percusys® Plus Pedicle Screw System. It is primarily concerned with establishing substantial equivalence to legally marketed predicate devices, not with clinical performance based on AI or advanced algorithms requiring extensive performance studies as outlined in the prompt's request.

Therefore, the requested information regarding acceptance criteria, training/test set sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not present in this document. This typically applies to devices that rely on novel algorithms or AI for diagnosis or treatment.

The performance data provided for the Percusys® Plus Pedicle Screw System is mechanical in nature, focusing on the physical properties and stability of the pedicle screw system itself. The document states:

"The following performance data were provided in support of the substantial equivalence.

• Dynamic Axial Compression Bending (ASTM F1717)
• Dynamic Flexion Bending (ASTM F1798)
• Buckling Test
• Torsion Testing
  The Percusys® Plus Pedicle Screw System met all specified criteria and did not raise new safety or performance questions."

This indicates that the acceptance criteria for this device are based on meeting specific mechanical testing standards (ASTM F1717, ASTM F1798) and other physical tests (Buckling, Torsion). The "performance" here refers to the device's structural integrity and mechanical behavior, not its diagnostic or clinical efficacy in the context of AI assistance.

Therefore, I cannot provide the requested table and detailed study information because the provided text describes a mechanical device clearance based on substantial equivalence, not an AI-driven medical device requiring the type of performance study details you've asked for.

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The joimax® Endovapor®2 RF device is intended for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.

Not Found

This document is a FDA 510(k) clearance letter for the joimax Endovapor 2, an electrosurgical device. It primarily focuses on regulatory approval and does not contain specific details about acceptance criteria, study data, or performance metrics in the way a clinical study report or a more detailed technical submission would.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Device Name: joimax® Endovapor®2
• Regulation Number: 21 CFR 878.4400
• Regulation Name: Electrosurgical cutting and coagulation device and accessories
• Regulatory Class: Class II
• Product Code: GEI
• 510(k) Number: K170358
• Indications for Use: The joimax® Endovapor®2 RF device is intended for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.

The letter states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. This implies that the device met the necessary criteria for substantial equivalence, which typically involves demonstrating that the new device is as safe and effective as the predicate device. However, the specific technical or clinical performance data used to support this determination are not detailed in this clearance letter.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided document:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance (This device is an electrosurgical tool, not an AI diagnostic device, so this is unlikely to apply in the traditional sense).
6. If a standalone performance study (algorithm only without human-in-the-loop performance) was done (Again, this is not an AI diagnostic device).
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

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joimax® Bipolar Electrosurgical Instruments
The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.

joimax® Monopolar Electrosurgical Instruments
The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator.
The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The joimax® Electrosurgical Instruments are comprised of a series of instruments to facilitate the delivery of electrical energy from an RF generator to the patient tissue for use in cutting and/or coagulation of tissue.
The joimax® Electrosurgical Instruments use Radio Frequency (RF) energy to induce thermal effects on tissue. The radio frequency is generated by high oscillating electrical current received from a commercially available RF generator.
The joimax® Probes are available in both monopolar and bipolar probe configurations. All joimax® Probes are designed for specific use with joimax® Handpieces. The joimax Handpieces can be used with compatible commercially available surgical generators.

The provided text discusses the joimax® Electrosurgical Instruments and their substantial equivalence to predicate devices, focusing on safety and performance. However, it does not explicitly detail a study with specific acceptance criteria and detailed performance metrics as one might expect for an AI/ML device. The document primarily focuses on demonstrating that the electrosurgical instruments meet general safety and performance standards equivalent to existing legally marketed devices.

Based on the provided text, here's a breakdown of the requested information, noting where specific details are not available for this type of device (e.g., sample sizes for AI/ML models, expert ground truth for image interpretation).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in a quantitative manner for a comparative study against a specific numerical target. Instead, it confirms compliance with various standards and qualitative comparisons to predicate devices. The "acceptance criteria" are implied by adherence to these standards and the demonstration of similar performance to predicates.

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The EndoLIF® On-Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® On-Cage are to be used with autogenous bone and implanted via a posterior or posterolateral approach. The EndoLIF® On-Cage is to be used with a supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an EndoLIF® On-Cage.

Not Found

The provided document is an FDA 510(k) clearance letter for the EndoLIF On-Cage, an intervertebral body fusion device. This type of document declares substantial equivalence to a legally marketed predicate device, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria for analytical or clinical performance.

FDA 510(k) clearances typically focus on establishing that a new device is as safe and effective as an existing, legally marketed device (predicate device). This is primarily achieved through comparisons of technological characteristics, materials, and indications for use. Performance data, while sometimes included, is not typically presented in a format that would allow for the detailed breakdown requested in your prompt (e.g., specific acceptance criteria, sample sizes, ground truth methodology for AI/software devices).

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because this information is not present in this regulatory document.

The document indicates:

• Device Name: EndoLIF On-Cage
• Regulation Name: Intervertebral body fusion device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. To be used with autogenous bone and implanted via a posterior or posterolateral approach, and with a supplemental FDA cleared fixation.

For medical devices, especially implants like this, the "acceptance criteria" and "proof" typically involve:

• Biocompatibility testing
• Mechanical testing (e.g., fatigue strength, compressive strength, torsional strength) to ensure the device can withstand the forces it will experience in the body.
• Sterilization validation
• Bench testing comparing the new device's engineering properties to the predicate device.
• Animal studies or cadaveric studies (less common for 510(k) if predicate comparison is strong).
• Clinical data (often from the predicate device or a literature review, or specific clinical studies if novel features necessitate it, though not always required for 510(k) if substantial equivalence can be shown otherwise).

However, the specific quantitative details you requested for a study proving the device meets acceptance criteria (especially involving terms like "test set," "ground truth," "MRMC," and "AI/standalone performance") are typically relevant for AI/ML-driven software as a medical device (SaMD) or diagnostic devices, which this intervertebral cage is not. The provided document is for a physical implant.

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The THESSYS Multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.

A multi-channel endoscope having working channel and/or irrigation channel(s), used to visualize the operative site.
The THESSYS MULTISCOPE consists of light transmitting optical fibers and an image transmitting fiber bundle and lens, or a rigid rod-lens transmitting images. It has one or two irrigation channels and a working channel contained within a rigid stainless steel envelope.

The provided text is a 510(k) summary for the THESSYS MULTISCOPE. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, studies, or performance data for the THESSYS MULTISCOPE itself.

The 510(k) process in the US is primarily a "substantial equivalence" pathway. This means a new device is compared to a legally marketed predicate device, demonstrating that it is as safe and effective as the predicate. It often relies on a comparison of technological characteristics and intended use, rather than extensive clinical performance studies or specific acceptance criteria for the new device's performance.

Therefore,Based on the provided text alone, it is not possible to complete the requested table and answer the study-related questions. The document focuses on establishing substantial equivalence to existing devices rather than presenting new performance data against specific acceptance criteria.

Reasoning for Absence of Information:

• 510(k) Process: The 510(k) premarket notification is generally not focused on demonstrating new clinical performance. Instead, it aims to show that a new device is "substantially equivalent" to a predicate device already on the market. This typically involves comparing technological characteristics, materials, and intended use.
• Device Type: The THESSYS MULTISCOPE is an arthroscope, a surgical visualization tool. Its primary function is to provide visualization. Performance metrics for such devices often relate to image quality, field of view, illumination, and mechanical integrity, which might be assessed through bench testing and verification/validation activities that are not typically summarized in detail within a 510(k) document unless a novel characteristic requires it.
• Document Content: The provided 510(k) summary explicitly details:
  • Submitter and device identification.
  • Predicate devices.
  • Device description and intended use.
  • Technological characteristics.
  • A "Substantial Equivalence Comparison Chart" (Table 1) comparing the THESSYS MULTISCOPE to its predicates based on features like rod-lens type, channels, reusability, material, and general intended use.

This comparison chart is the primary "proof" of meeting acceptance criteria for a 510(k) in this context: proving substantial equivalence to already approved devices. There are no explicit performance numbers, clinical study details, or ground truth establishment methods discussed because they were likely not required for this type of submission.

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