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The Hintermann Series H2 Total Ankle (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint.

The Hintermann Series H2 is indicated as a total ankle replacement in primary of ankle joints damaged bv:

• Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)

• Primary arthritis (e.g., degenerative disease)

• Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)

The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present.

Note: In the United States, this device is intended for cemented use only.

The Hintermann Series H2 Total Ankle System is a total ankle prosthesis designed to replace the ankle joint. The Hintermann Series H2 Total Ankle System includes the following implantable components.

• H2 Tibial Component
• H2 Tibial Polyethylene (PE) Inlay
• Hintermann Series Talar Component

The tibial and talar components are coated with plasma spray titanium on the cement contacting surfaces. These components are used together to address the indications as outlined.

The provided text is a 510(k) summary for the Hintermann Series H2 Total Ankle System, a medical device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device, rather than providing an acceptance criteria table and detailed study results typical of an AI/ML medical device submission.

As such, the information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria (especially in the context of AI/ML performance) is not present in the provided text.

The document describes non-clinical testing/performance data for the ankle system, which refers to mechanical and material tests to ensure the physical properties and safety of the implant, not the performance of an AI/ML algorithm.

Here's why the document doesn't contain the requested information:

• Device Type: The Hintermann Series H2 Total Ankle System is a physical orthopedic implant (an ankle joint prosthesis), not an AI/ML-driven diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission for a physical device like this primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis, material characterization, and mechanical testing (e.g., wear, fatigue, range of motion). It does not involve AI/ML performance metrics, ground truth establishment, or human reader studies.

Therefore, for each of your points, the answer based solely on the provided text would be:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document lists mechanical tests (e.g., Range of Motion per ASTM F2665-09, Locking Mechanism Testing per ASTM F1814) that were performed, but it does not present a table of specific quantitative acceptance criteria or the numerical results of these tests. It simply states that testing was done to support substantial equivalence.
2. Sample sizes used for the test set and the data provenance: Not applicable in the context of AI/ML. For mechanical testing, sample sizes would refer to the number of prostheses tested, but this information is not detailed in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human experts are establishing ground truth for an AI/ML algorithm in this context.
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.
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 concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical device would be established by standardized testing protocols (e.g., ASTM standards) measuring physical parameters, not by expert consensus on clinical cases.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is for a physical medical device (an ankle prosthesis) and not an AI/ML-driven device. As such, it does not contain the information related to acceptance criteria, test sets, ground truth, or human reader studies typically associated with AI/ML medical device performance evaluation.

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The REDEMPTION™ Charcot Plating System bone plates and screws are indicated for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, and digits. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for patients with osteopenic bone in neuropathic osteoarthropathy (Charcot).

The REDEMPTION™ Charcot Plating System contains bone plates, screws, and accompanying instruments to aid in the surgical procedures. The system is a multi-indication reconstruction solution providing polyaxial locking technology and low-profile design. The system is optimized for use in osteopenic bone, such as those of neuropathic osteoarthropathy (Charcot) patients.

The system contains poly-axial locking and non-locking 4.0mm and 5.5mm diameter screws with threads optimized for osteopenic bone purchase.

All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel, with a few Aluminum and Silicone components.

I am sorry, but the provided text from the FDA 510(k) K233816 document for the "REDEMPTION™ Charcot Plating System" does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document describes a traditional 510(k) submission for a metallic bone fixation system (plates and screws), not an AI/ML-driven diagnostic or therapeutic device. The "Performance Data" section details mechanical and material testing for the bone fixation system, such as:

• Static four-point bend testing per ASTM F382-17
• Screw Torsional Properties per ASTM F543-17 A1
• Screw Insertion and Removal Torque per ASTM F543-17 A2
• Screw Pullout Testing per ASTM F543-17 A3
• Cleaning and sterilization validations

These tests are standard for orthopedic implants to demonstrate structural integrity, and biocompatibility, and ensure the device can be properly cleaned and sterilized.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are concepts applicable to AI/ML software validation, not the mechanical testing of orthopedic hardware described in this document.

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The NITINEX Memory Compression Staple is intended for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

The NITINEX Memory Compression Staple is a single-use bone fixation appliance intended to be permanently implanted. The implantation of the NITINEX Memory Compression Staple facilitates hand and foot bone fragment osteotomy fixation and joint arthrodesis. NITINEX Staples are compression staples made of shape memory nickel titanium alloy, nitinol. Vilex LLC will offer NITINEX Staples ranging in width from 8-mm to 30-mm with leg lengths ranging from 8-mm to 30-mm.

The provided text is an FDA 510(k) summary for a medical device called the "NITINEX Memory Compression Staple." It focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.

Therefore, the document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in terms of clinical accuracy or diagnostic performance, such as those typically found for AI/ML-based medical devices. The assessments performed are primarily nonclinical (mechanical and corrosion testing) to confirm the device's physical properties are equivalent to the predicate.

Here's why the requested information cannot be extracted from this document:

• This is not an AI/ML device: The NITINEX Memory Compression Staple is a physical implant (a bone fixation device). The acceptance criteria and performance studies described in your prompt (e.g., diagnostic accuracy, human reader improvement with AI, ground truth establishment) are relevant for software as a medical device (SaMD) or AI-powered diagnostic tools, not for physical implants.
• 510(k) for physical devices focuses on substantial equivalence: For devices like the NITINEX staple, the 510(k) pathway primarily requires demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is typically done through comparisons of indications for use, technological characteristics, and non-clinical performance data (like mechanical strength and corrosion resistance). Clinical studies for physical implants are often more involved and specific to the device's function (e.g., healing rates, complication rates), but they are not detailed in a 510(k) summary in the way an AI performance study would be.
• The "performance data" mentioned is nonclinical: The document explicitly states: "The following nonclinical tests were performed to demonstrate the substantial equivalence of the subject device to the predicate device: Static Pullout Testing per ASTM F564-17, Bend Testing per ASTM F564-17, Cyclic Polarization Corrosion Testing per ASTM F2129-19a." These are mechanical and material property tests, not clinical performance studies involving human subjects or expert readers.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML device performance. The information provided in the document simply does not contain details about:

• Acceptance criteria for diagnostic accuracy (sensitivity, specificity, AUC)
• Sample size for test sets in an AI/ML context
• Data provenance for clinical images or patient data
• Number/qualifications of experts for ground truth establishment
• Adjudication methods for ground truth
• MRMC studies or effect sizes of human reader improvement with AI assistance
• Standalone algorithm performance
• Type of ground truth (pathology, outcomes data, expert consensus for diagnosis)
• Training set sample size or how training set ground truth was established

The document confirms the device passed the specified nonclinical tests and was found to be substantially equivalent to the predicate device in terms of mechanical strength, performance, and corrosion resistance.

If you intended to ask about the acceptance criteria and study for an AI/ML-based medical device, this document is not the correct source of information.

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The OPTIX H2 Patient Specific Instrument System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The OPTIX H2 Patient Specific Instrument System is intended for use with Vilex's Hintermann Series H2 Total Ankle System and its cleared indications for use. The OPTIX H2 Patient Specific Instrument System is indicated for single use only and is generated from CT imaging data.

OPTIX H2 Patient Specific Instrument System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Hintermann reusable instruments, facilitate the positioning of the Hintermann Series H2 Total Ankle implants. Vilex's OPTIX H2 PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information that would typically be required to fill out all aspects of your request for the OPTIX H2 Patient Specific Instrument System. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than providing granular performance data against predefined acceptance criteria.

However, I can extract the information that is present and indicate where details are missing.

Here's a breakdown based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

• Missing Details: The document does not specify what the "clinically justified acceptance criteria of the Hintermann Series H2 Total Ankle System" are (e.g., specific angular tolerances, cut depths, etc.), nor does it provide quantitative performance data (e.g., "equivalent implantation within X degrees of rotation" or specific debris generation measurements).

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

• Sample Size: Not explicitly stated. The text refers to "surgical procedures performed during the validation lab," but does not give a number of cases or procedures.
• Data Provenance: The study was a "validation lab" setting, implying a prospective, controlled environment, likely in the US or wherever Vilex, LLC is based. No specific country of origin for patients or data is mentioned, as it appears to be a benchtop/ cadaveric study rather than a clinical trial with patient data.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The study involved "surgical procedures" and assessed "implantation" equivalence, so it implicitly involved surgeons or trained personnel. However, their specific qualifications (e.g., "orthopedic surgeon with 10 years of experience in total ankle arthroplasty") are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document states "An analysis of the surgical procedures performed during the validation lab showed...", but doesn't detail how multiple assessments were reconciled (e.g., 2+1, 3+1, or if a single assessor was used).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to the provided text. This device is a patient-specific instrument system for surgery, not an AI-assisted diagnostic or imaging interpretation tool that would typically involve "human readers" in an MRMC study context.
• Effect Size of Improvement with AI: Not applicable, as this is not an AI-reader assistance device. "Software-assisted design" is mentioned for the guides, but the performance validation described is on the physical instruments' ability to facilitate implantation, not on human interpretation skills.

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

• Standalone Performance: Not applicable in the sense of an "algorithm only" performance study. The device is a physical instrument system. Its "software-assisted design" is part of its creation process, but the validation focuses on the physical instrument's performance in surgery, which inherently involves human interaction.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" implicitly used was the outcome of the surgical procedures performed with both the subject device (OPTIX H2 PSI System) and the predicate device (Hintermann H2 Total Ankle System instrumentation). The comparison aimed to establish "equivalent implantation," suggesting a direct comparison of surgical results (e.g., placement accuracy, bone cuts) facilitated by each system. This is a form of empirical comparison against established surgical practice using the predicate device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not provided. The device relies on patient-specific CT imaging data to create the guides. The "design of the patient specific guides, models, and pre-operative plan is software-assisted," suggesting algorithms or software are used for individual patient customization, but there is no mention of a traditional "training set" in the context of machine learning model development for a generalized diagnostic/predictive task. Each guide is custom-designed based on an individual patient's CT data.

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

• Training Set Ground Truth: Not applicable for the reasons mentioned in point 8. The "ground truth" for the patient-specific design system relies on accurate interpretation of the individual patient's CT imaging data and established surgical principles for total ankle replacement.

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The REDEMPTION Beaming System is indicated for fracture fixation, osteotomies, reconstruction procedures, and fusions of bones in the foot and ankle including the Metatarsals, Cuboid, Navicular, Calcaneus and Talus. Specific examples include: Medial Column Fusion and Lateral Column Fusion resulting from neuropathic osteoarthropathy (Charcot).

The REDEMPTION Ø3.5mm Headless Screws are indicated for small bone fragments fracture and osteotomy in the lower extremities primarily the foot.

The REDEMPTION™ Beaming System, consisting of the REDEMPTION™ Beams and the REDEMPTION™ Nails, is a reconstruction solution providing various diameters of cannulated screws.

The REDEMPTION™ Beams are provided in diameters of Ø5.0 mm, Ø6.5 mm, and Ø8.0 mm, and are cannulated and either partially or fully threaded. The Ø5.0 mm beams are available in 35 mm to 130 mm lengths (5 mm increments) and the Ø6.5 mm and Ø8.0 mm beams are available in 40 mm to 160 mm lengths (5 mm increments).

The REDEMPTION™ Nails are provided in diameters of Ø7.5 mm and Ø8.2 mm and are partially threaded. The nails range in length from 50 mm (5 mm increments).

The REDEMPTION™ Headless 3.5 mm screw can be used as a cross screw with the nail and are offered in lengths from 12 mm to 60 mm.

All implant components are manufactured from titanium (Ti-6A1-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, drill guides, implant inserters, implant drivers, and a targeting guide are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel and radel (plastic).

The provided text is a 510(k) summary for the REDEMPTION™ Beaming System, a medical device for bone fixation. It details the device's description, indications for use, comparison to predicate devices, and performance data submitted in support of substantial equivalence.

However, the provided document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML device performance. The content is focused on the mechanical and material properties of a traditional medical device (bone fixation fastener), not an AI/ML powered device.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML)
• Sample size and data provenance for a test set (for AI/ML)
• Number and qualifications of experts for ground truth (for AI/ML)
• Adjudication method (for AI/ML)
• MRMC comparative effectiveness study or effect size (for AI/ML)
• Stand-alone (algorithm only) performance (for AI/ML)
• Type of ground truth used (for AI/ML)
• Sample size for training set (for AI/ML)
• How ground truth for training set was established (for AI/ML)

The "Performance Data" section in the document lists:

• Static Four Point Bend Testing per ASTM F1264-16
• Mechanical testing per ASTM F543-17 (Insertion Torque, Removal Torque, Pull-out Force, Ultimate Torque)
• Computational Analysis
• Cleaning and sterilization validations

These are all standard engineering and biocompatibility tests for traditional medical implants, not for the evaluation of AI/ML algorithms.

In summary, the provided document does not describe an AI/ML-driven device or study its performance against the criteria typically associated with AI/ML medical devices.

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The Vilex External Fixation System is intended for external fixation with the following indications:

• · Stabilization of Fractures & Osteotomy
• Rear and Mid-foot Arthrodesis
• · Adult and Pediatric Leg Lengthening
• · Correction of Bone Deformity in Upper & Lower Extremities

The Dynex Micro® falls within the Vilex External Fixation System product line. The system consists of the following components:

• Half pins and pins;
• Guidewires; ●
• External fixation rails; and ●
• Instruments.
  The half pins are constructed from stainless steel (ASTM F138 LVM) and are provided in multiple diameters (2.0, 2.5, 3.0, 4.0, 5.0, and 6.0 mm) and lengths (60 - 175 mm). The transfixation pins, also constructed from stainless steel, and are provided in three diameters (2.5, 3.0, and 5.0 mm) and two lengths (250 mm and 350 mm).
  Guidewires are available in 1.1 mm and 1.6 mm diameter configurations and range in length from 60 - 150 mm.
  The mini- and mono- rails are manufactured from stainless steel and aluminum and are provided in various sizes (100 - 300 mm) to accommodate variations in patient size.
  The Dynex Micro® components are used with general and dedicated surgical instruments such as drill guides, drills, drill sleeves, wrenches, pin inserters, guide wire holders, and removal tools.

This document is a 510(k) premarket notification for the Dynex Micro® device, asserting its substantial equivalence to a previously cleared predicate device (X-Fix, K052196). The key takeaway regarding acceptance criteria and performance is that no new performance data or studies were required or conducted because the Dynex Micro® is essentially the same device as the predicate, with only a change in trade name.

Therefore, the requested information regarding acceptance criteria and the study proving the device meets them, including sample sizes, ground truth establishment, expert involvement, and MRMC studies, is not applicable in this specific case. The FDA's determination of substantial equivalence here is based on the identity of the device's technical characteristics to the predicate rather than new performance testing against specific acceptance criteria.

Here's how to address each point based on the provided document:

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

   • Acceptance Criteria: Not explicitly stated as new testing was not performed. The implicit acceptance criterion for this 510(k) was that the device must be "identical" to the predicate in all critical aspects.
   • Reported Device Performance: Not applicable; no new performance data was generated or reported for the Dynex Micro®.

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

   • Not applicable; no new test set or data was used for performance validation.

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

   • Not applicable; no ground truth establishment was required as no new performance validation was conducted.

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

   • Not applicable; no adjudication was needed as no new test set was evaluated.

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 a bone fixation system, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

   • Not applicable. This is a medical device (external fixation system), not an algorithm.

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

   • Not applicable; no new ground truth was established for performance validation. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

   • Not applicable. This is a hardware device submission, not an AI/ML product requiring training data.

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

   • Not applicable.

In summary, the core of this 510(k) submission and its acceptance by the FDA rests on the principle of substantial equivalence, specifically due to the device being identical to its predicate except for the trade name. Therefore, the detailed performance testing and associated criteria typically seen for novel devices or those with material changes are not present in this document.

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The Vilex External Fixation System is intended for external fixation with the following indications:

• Stabilization of Fractures & Osteotomy
• Rear and Mid-foot Arthrodesis
• Adult and Pediatric Leg Lengthening
• Correction of Bone Deformity in Upper & Lower Extremities

The Dynex® Ring Fixation System and Diametrix® Ring Fixation System fall within the Vilex External Fixation System product line. The systems consist of the following components:

• Dynex dynamic external fixation components (rings, footplates, and arches) or Diametrix static external fixation components (rings, footplates, and arches);
• Half pins and wires (regular and HA coated);
• Ball Markers for X-Ray;
• External fixation assembly hardware (e.g. wire fixation bolts, half pin bolts, struts, plates and posts, hinges, washers, support rods, and linear distractors); and
• Instruments (e.g. drills. drivers. tensioners. cutters, and benders).

The Dynex® Ring Fixation System components can be used as an external fixation and hexapod system, when configured with two or more rings and telescoping struts. The P&C CORA software (K151881) may be used in conjunction with the Dynex® Ring Fixation System to assist in pre-operative planning.

The Diametrix® Ring Fixation System components are traditional ring fixation components with frames that utilize tensioned wires and half pins.

Both systems utilize the same external fixation assembly hardware and instruments.

The Dynex rings, manufactured from aluminum, are offered in Full, 5/8, half and 3/8 sizes with footplates. The rings are circular with concentric inner and outer holes which provides versatility for hardware fixation points.

The Diametrix rings, manufactured from aluminum, are offered in in Full, 5/8, Half, and 3/8 sizes with footplates. The rings are tabbed which allows for multiple connection points and minimizes hardware interference.

The half pins and wires are constructed from stainless steel (ASTM F138 LVM). The coated half pins and wires are coated with Hydroxyapatite (HA). The half pins (Ø 3.0, 4.0, 4.5, 5.0, 6.0 mm) are provided in multiple lengths (60 – 200 mm) and are provided in sterile and non-sterile packaging. The wires are available in multiple designs (wire sharp bayonet, pear wire sharp bayonet, and wire bayonet olive) and are provided in 1.2. 1.5. and 1.8 mm diameters and range in length from 250 – 400 mm. The HA coated wires are provided sterile.

The external fixation rings, footplates, arches, struts, and assembly accessories are manufactured from stainless steel and anodized aluminum and are provided in various sizes to accommodate variations in patient size.

These components can be combined to create various frame assemblies.

The instruments and ball markers for X-Ray are manufactured from stainless steel.

This document (K202054) describes the Dynex Ring Fixation System and Diametrix Ring Fixation System. It is a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to existing legally marketed predicate devices.

Crucially, this document states: "As the only differences between the subject and predicate devices are the product trade names, no additional performance data was submitted to demonstrate the substantial equivalence of the subject device to the predicate device."

Therefore, the provided document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as no new performance data was generated or submitted for this specific 510(k) clearance due to the nature of the submission (trade name changes only).

The information you are asking for (acceptance criteria, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) is typically found in the documentation for the predicate devices that underwent more rigorous testing, or for novel devices that require de novo classification or PMA approval. This 510(k) is a "piggy-back" submission relying on the prior clearances of its predicates.

To answer your request, I must state that the provided text does not contain the necessary information. It explicitly says "no additional performance data was submitted."

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