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The Michler-Kapp Cardiovascular Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.

This balloon-tipped left ventricular vent is intended to drain the left ventricle and left atrium of air, blood, and solid particles generated during surgery. The balloon-tipped IV vent is intended to be inserted through the open left atrium or through the right superior pulmonary vein and across the mitral valve into the left ventricle. In addition, it can be introduced directly into the left ventricle during mitral valve surgery. The design of the balloon-tipped LV vent focuses on ease of passage, position and safety. The soft balloon will inflate in the left ventricle, keeping the catheter tip below the mitral valve to ensure drair, debris and blood from the left ventricle. In addition, the proximal holes will drain air, particulate debris, and blood from the left atrium.

I am sorry, but the provided text does not contain information regarding the acceptance criteria of a device or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for a medical device (Michler-Kapp Cardiovascular Vent Catheter), outlining its intended use, design, and comparison to a predicate device to establish substantial equivalence.

It includes:

• Indications for Use: The Michler-Kapp Cardiovascular Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.
• Device Description and Attributes: Detailed description of the catheter's features, dimensions, and materials.
• Comparison to a Predicate Device: A table comparing the technological characteristics of the proposed device to the Medtronic/DLP 16 Fr Vent Catheter, Model 12116 (K834352), highlighting similarities and differences.
• Non-Clinical Testing: A list of non-clinical tests performed, including liquid and air leakage, tubing tensile force, balloon inflation, suction, kink testing, flexibility testing, and hemolysis.
• Biocompatibility Testing: A list of biocompatibility tests performed, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity (including pyrogenicity assessment), and hemocompatibility.
• No Clinical Testing: Explicitly states that no clinical testing was performed for this submission.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than defining specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) and a study to meet those criteria.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth was established for the training set.

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The KAPP Bari-Ring Endoscopic Marker is intended to be used to radiographically (limited to x-ray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).

The KAPP Bari-Ring Endoscopic Marker consists of a nickel titanium stainless steel ring deployed during surgery. It is supplied non-sterile for single long term (30 day) use to mark the spot expected to require further surgery within 30 days. The ring is homogenously constructed of a ring of nickel titanium conforming to ASTM F 2063-05.

The provided text describes a 510(k) summary for the KAPP Bari-Ring Endoscopic Marker, focusing on its substantial equivalence to previously marketed devices. This type of submission relies on demonstrating that a new device is as safe and effective as a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding acceptance criteria and performance studies for an AI/ML device is not applicable in this context.

Here's an breakdown of the available information and why other items are not present:

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

• Acceptance Criteria: The submission does not specify numerical acceptance criteria for clinical performance for the new KAPP Bari-Ring Endoscopic Marker. Instead, the approach is to demonstrate substantial equivalence to predicate devices in specified areas.
• Reported Device Performance:

  Performance Area	Result / Conclusion
  Corrosion resistance	Tests demonstrated substantial equivalence.
  Hardness	Tests demonstrated substantial equivalence.
  Tensile	Tests demonstrated substantial equivalence.
  Overall Conclusion	The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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

• Not Applicable. This submission details the premarket notification for a physical medical device (an endoscopic marker), not an AI/ML diagnostic or predictive tool. Therefore, there is no "test set" in the context of AI/ML performance evaluation (e.g., images for classification). The "tests" mentioned are laboratory tests on the material properties of the device itself.

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

• Not Applicable. As above, there is no "test set" requiring ground truth established by experts for an AI/ML algorithm.

4. Adjudication method for the test set

• Not Applicable. No test set in the AI/ML context.

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-assisted device.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used

• Not Applicable. Ground truth in the context of AI/ML performance is not relevant here. The evaluation of this device is based on laboratory test results (corrosion resistance, hardness, tensile strength) to demonstrate that its physical properties are comparable to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. No training set.

In summary: The provided 510(k) summary is for a physical medical device (KAPP Bari-Ring Endoscopic Marker) and focuses on demonstrating substantial equivalence to predicate devices through physical and material property testing, rather than performance of an AI/ML algorithm against specific acceptance criteria. Therefore, the questions related to AI/ML study design and metrics are not applicable to this document.

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The KAPP Bari-Ring Endoscopic Marker is intended to radiographically (limited to xray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).

The KAPP Bari-Ring Endoscopic Marker consists of a stainless steel ring deployed during surgery supplied non-sterile for single long term use to radiographically (limited to x-ray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).

The provided text pertains to a 510(k) premarket notification for the KAPP Bari-Ring Endoscopic Marker. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving device efficacy through extensive clinical studies with specified acceptance criteria and measured performance in the way a Class III device or new technology would. Therefore, the information requested in the prompt, particularly points 2-7, which relate to detailed study design and statistical performance, is largely not applicable or present in this document.

The document primarily focuses on comparing the new device's intended use, design, and performance standards/specifications to those of legally marketed predicate devices to establish substantial equivalence.

Here's an attempt to address the prompt based on the available information:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) for a substantially equivalent device, the "acceptance criteria" are not reported as specific performance metrics against a threshold. Instead, the acceptance criteria are met by demonstrating that the device is as safe and effective as the predicate device(s). The "performance" is described in terms of shared attributes and testing.

Note: The document states "Biocompatibility testing, and bench testing support fact that no new issues of safety, effectiveness, or performance raised" which is the reported "performance" in the context of a 510(k) submission, confirming it meets the regulatory expectation for equivalence.

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

• Not applicable / Not provided. This document does not describe a clinical study with a "test set" in the context of device performance metrics. The demonstration of equivalence primarily relies on material properties, design, and intended use comparison, along with general biocompatibility and bench testing.

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

• Not applicable / Not provided. No specific "ground truth" establishment by external experts for a test set is described. The relevant "experts" would be the engineers and scientists at Kapp Surgical Instrument Co. responsible for design, testing, and regulatory submission, and the FDA reviewers themselves.

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

• Not applicable / Not provided. No adjudication method for a test set is described as there isn't a performance study with a test set in the clinical sense.

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

• Not applicable. This device is an implantable radiographic marker, not an AI-powered diagnostic tool. Therefore, 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 an implantable radiographic marker, not a standalone algorithm.

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

• Not applicable / Not provided. For the purpose of a 510(k), the "ground truth" is that the predicate devices are legally marketed and have demonstrated safety and effectiveness for their intended use. The new device's "ground truth" is its physical and material properties (e.g., biocompatibility) meet recognized standards, which are evaluated through bench testing. No clinical "ground truth" derived from patient outcomes or pathology is detailed in this document.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/machine learning device. The "training" for such a device would be based on established engineering principles, material science, and regulatory standards.

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

• Not applicable / Not provided. As there is no training set, this question is not applicable.

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The Mondeal® CONTOUR HO System is intended to be used for the internal fixation of small bones including the hand and foot.

Dorted Desert from Hand Osteosynthesis System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation

This submission does not contain the information required to complete the request. The provided text is a 510(k) summary for a medical device (Mondeal® CONTOUR HO System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study design with performance metrics.

Here's a breakdown of why the information is missing and what would typically be expected for each point:

• Acceptance Criteria and Reported Device Performance: This type of submission usually focuses on material equivalence and mechanical testing that mimics physiological loads, rather than clinical performance metrics (like sensitivity, specificity, accuracy) that would apply to diagnostic devices or devices with measurable clinical outcomes. The document states "overall performance characteristics," but does not list specific numerical acceptance criteria or performance results (e.g., in terms of strength, fatigue life, or clinical success rates).

• Sample Size for Test Set and Data Provenance: Not applicable. As this is a mechanical fixation device, the "test set" would refer to the materials and constructs tested. The provided document doesn't specify the number of samples used in any mechanical tests, nor does it mention any clinical data or its provenance.

• Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the context of clinical studies, refers to the definitive determination of a condition or outcome. For a device like a bone fixation system, clinical trials might establish ground truth through imaging follow-ups, surgical assessment, or patient outcomes, but this is not covered in a 510(k) summary focused on substantial equivalence.

• Adjudication Method: Not applicable for this type of submission. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human readers are interpreting images or clinical data, which is not the focus here.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. MRMC studies are used to evaluate the performance of diagnostic imaging devices or algorithms with and without AI assistance, comparing human reader performance. This device is a surgical implant, not a diagnostic tool.

• Standalone Performance Study: Not applicable. "Standalone performance" usually refers to the algorithm-only performance of an AI-powered diagnostic device. For a surgical implant, performance is assessed through mechanical testing and, in some cases, clinical follow-up. This document doesn't detail such studies.

• Type of Ground Truth Used: Not applicable in the context of clinical "ground truth" for a diagnostic device. For an implant, "ground truth" might pertain to the success of the fixation in a mechanical test (e.g., did it fail at a certain load?) or clinical outcome measures in a trial. This document does not elaborate on these.

• Sample Size for Training Set: Not applicable. This device is a mechanical implant, not an AI or machine learning system that requires training data.

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

In summary, the provided 510(k) summary is designed to demonstrate substantial equivalence based on material properties, design, and intended use compared to a predicate device, rather than providing detailed clinical study results with acceptance criteria and performance metrics typically associated with diagnostic or AI-powered devices.

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The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

The Mondeal® Radius Hand Osteosynthesis System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and left hand configurations.. Manual reusable surgical instruments are supplied to facilitate implantation

This document describes a 510(k) submission for the Mondeal® RADIUS HO System, a bone fixation system. The information provided is primarily focused on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of device performance metrics often seen in AI/software device submissions.

Therefore, many of the requested fields cannot be directly answered from the provided text. The submission focuses on comparing physical attributes and intended use.

Here's an analysis of the provided text in relation to your request:

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

The provided text does not present explicit acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a study. Instead, it demonstrates substantial equivalence to predicate devices based on a comparison of design, materials, intended use, and other physical characteristics.

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

This information is not provided in the document. This type of detail is typical for software or AI device studies involving patient data, not for traditional mechanical devices like bone plates, where performance is often evaluated through bench testing and material characterization against established standards.

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)

This information is not applicable and not provided. Ground truth in the context of this device would involve engineering specifications, material properties, and mechanical testing, not expert interpretation of diagnostic data like images.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers are making subjective interpretations of data, such as images, and their agreement needs to be reconciled.

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

This information is not applicable and not provided. MRMC studies are specific to evaluating the impact of AI or other tools on human reader performance, which doesn't apply to a bone fixation system.

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

This information is not applicable and not provided. This device is a physical implant, not an algorithm.

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

The ground truth for this type of device would be derived from:

• Material specifications and standards: Verification that the Ti-6Al-4V ELI material meets industry standards.
• Design specifications: Verification that the dimensions and geometry match the intended design.
• Mechanical testing data: (Implied, but not detailed in this summary) This would involve tests for strength, fatigue, bending, and torsion to ensure the plate and screws can withstand physiological loads, often compared against established ASTM or ISO standards for bone fixation devices.

The document does not elaborate on specific test results or ground truth methodology, focusing instead on descriptive comparison to predicates.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a physical medical device.

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

This information is not applicable and not provided.

In summary:

The provided document is a 510(k) summary for a traditional medical device (bone fixation system). The "study" proving the device meets acceptance criteria is fundamentally a comparison to predicate devices to demonstrate substantial equivalence in terms of design, materials, intended use, and general performance characteristics. It is not an AI/software performance study, and therefore, many of the requested details about statistical significance, reader studies, and AI-specific metrics are not present or applicable. The "acceptance criteria" are implicitly defined by the attributes and performance of the chosen predicate devices, which the Mondeal® RADIUS HO System is shown to match or be comparable to.

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The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for:

• Replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
• Replacement of the radial head for degenerative, rheumatoid, or post-traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment;
• Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and
• Failed ulnar head resection.
  It is intended for patient matched use with bone cement and or press-fit fixation.

The Kapp Patient Matched Ulnar Head Wrist Implant includes various sizes of implants and accessory surgical instruments. The implant allows for replacement of the ulnar head.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Kapp Patient Matched Ulnar Head Wrist Implant) and details its identification, description, and indications for use, but does not include performance data, study designs, or acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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The KAPP Custom Radial Elbow Implant is intended to be used for: replacement of the proximal end of the radius: Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on x-ray and or resistance to conservative treatment; primary replacement after fracture of the radial head; symptomatic sequelae after radial head resection; revision following failed radial head arthroplasty. It is intended for custom single use with bone cement.

The Kapp Custom Radial Head Elbow Implant includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

This submission describes the Kapp Custom Radial Head Elbow Implant, a medical device designed to replace the proximal radial head. The document is a 510(k) summary, which indicates that the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.

Therefore, the typical acceptance criteria and study designs associated with novel AI/software applications are not applicable here. This device is an orthopedic implant, where "performance" is assessed through material properties, mechanical testing, and comparison to existing implants, rather than through accuracy, sensitivity, or specificity metrics of a diagnostic algorithm.

Here's a breakdown of why many of your requested points cannot be directly addressed from this document and what information can be inferred or is typically involved in such device submissions:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: For orthopedic implants like this, acceptance criteria typically revolve around substantial equivalence to predicate devices in terms of:
  • Indications for Use: Must be the same or very similar.
  • Technological Characteristics: Materials, design, fixation, constraint must be similar or demonstrate equivalent performance.
  • Safety and Effectiveness: Demonstrated through comparison to predicate devices, material testing, mechanical testing (e.g., fatigue, static strength), and biocompatibility.
• Reported Device Performance: The document primarily focuses on demonstrating equivalence to predicate devices, rather than establishing new performance metrics. Performance here means the implant's ability to mechanically function as intended and integrate into the body safely.

Study that Proves the Device Meets the Acceptance Criteria:

The "study" in a 510(k) for a device like this is not a clinical trial in the sense of comparing outcomes in patients directly. Instead, it relies on:

• Comparison to Predicate Devices: This is the primary "study" presented in the document (see the "Comparison to the Predicate Devices" table). The manufacturer argues that their device is substantially equivalent to the Avanta Radial Head Implant and Wright Medical Metallic Radial Head Implants based on shared attributes like indications for use, fixation, constraint, and general purpose.
• Bench Testing / Mechanical Testing (Implicit): While not detailed in this summary, a 510(k) for an orthopedic implant always includes data from in-vitro mechanical testing to demonstrate that the device meets appropriate strength, fatigue, and wear resistance standards. This would be crucial, especially since the material (316L Stainless Steel) of the candidate device differs from the predicates, requiring evidence that it performs equivalently in a simulated physiological environment. These tests would have their own acceptance criteria (e.g., withstand X load for Y cycles without failure).
• Material Biocompatibility (Implicit): Data showing the 316L Stainless Steel is biocompatible and suitable for implantation would also be part of the submission, typically adhering to ISO 10993 standards.

The following points are not applicable or cannot be answered from the provided 510(k) summary, as they relate to AI/Software studies, which this device is not:

2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the AI sense for an orthopedic implant. Mechanical testing would involve a sample size of physical implants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no "ground truth" established by experts for a diagnostic output.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 is not an AI-assisted diagnostic device.
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 (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical implant is its performance in specific mechanical tests and comparison to established, safe materials and designs.
8. The sample size for the training set: Not applicable. There is no AI training set. The "training" in a sense comes from the established history of materials science and orthopedic implant design.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for an orthopedic implant. Its "acceptance criteria" and "proof" primarily hinge on demonstrating substantial equivalence to already cleared predicate devices through direct comparison of indications and technological characteristics, supported by (undisclosed in this brief sumamry) mechanical testing and biocompatibility data. It does not involve the types of studies or performance metrics associated with AI/software medical devices.

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