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The Kinamed SuperCable Iso-Elastic Cerclage System is intended to be used in the following: repair of long bone fractures due to trauma or reconstruction; reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy; sternotomy closure; and sublaminar and intrafacet wiring of the spinal column.

The Kinamed SuperCable® Iso-Elastic™ Cerclage System consists of an implantable cable and locking clasp (the locking clasp consists of a clip and a wedge). The cable is comprised of a monofilament core of nylon with a jacket of ultra-high molecular-weight-polyethylene (UHMWPE) fibers braided around the nylon core. Manual instrumentation is used for applying the cable. The subject of the present Special 510(k) submission is a line addition of a cable implant whose locking clasp is manufactured using a metal injection molding (MIM) process.

The provided document is a 510(k) summary for the Kinamed SuperCable® Iso-Elastic™ Cerclage System. It describes a line extension to an existing device, specifically a change in the manufacturing process for the locking clasp. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical efficacy studies typically found for novel devices.

Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies that would be present for an AI/ML-based medical device or a device requiring new clinical efficacy data.

Based on the information provided in the document:

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

The document mentions "Performance testing of the SuperCable Iso-Elastic Cerclage System includes ISO 10993 testing, Bacterial endotoxin levels (LAL), Static construct tensile testing, and Fatigue construct tensile testing." However, the specific acceptance criteria and the reported results for each of these tests are not provided in this 510(k) summary. The document only states that the device "meets the specifications of ASTM F2885 (Type 1, Densified)" for the locking clasp material. This implies the acceptance criteria for the material are the ASTM F2885 specifications.

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

Not applicable. This submission is for a modification to an existing device (change in manufacturing process for a component), not an AI/ML device that uses test sets or clinical data in the typical sense for performance evaluation. The performance testing mentioned (tensile, fatigue, etc.) would be conducted on a sample of manufactured devices, but the sample sizes are not reported.

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

Not applicable. Ground truth establishment by experts is not relevant for this type of device modification.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This 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-based algorithm.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth." The "ground truth" for this device would be defined by engineering specifications and material standards (e.g., ASTM F2885 for the material, and internal specifications for tensile strength and fatigue life).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

Summary of what is presented in the document regarding acceptance criteria and study:

The submission focuses on demonstrating that a manufacturing change (Metal Injection Molding for the locking clasp) does not alter the safety or effectiveness of the device compared to the predicate. The basis of substantial equivalence is outlined by comparing properties such as:

• Same polymer cable
• Same intended use
• Same indications for use
• Same raw material alloy (Ti-6Al-4V) for locking clasp (though the manufacturing process changed)
• Same design
• Similar size and dimensions
• Same type of mating components
• Same shelf life
• Same biocompatibility
• Same sterilization and packaging methods

The performance testing mentioned (ISO 10993, LAL, Static construct tensile testing, Fatigue construct tensile testing) would serve as the "studies" to prove the device meets acceptance criteria, which would be the established specifications derived from the predicate device's performance and relevant standards. However, the specific data from these tests and the exact acceptance criteria are not included in this summary. The key statement regarding acceptance criteria is that the material "meets the specifications of ASTM F2885 (Type 1, Densified)."

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The NeuroPro® Low Profile Cranial Plating System Family is intended for:

1. Internal fixation of fractures and osteotomies of the cranial skeleton.
2. Internal fixation of cranial bone flap osteotomies.
3. Reconstruction of bony defects and deficits in the cranial skeleton.

The NeuroPro® Low Profile Cranial Plating System is not indicated for use in the spine or high load bearing applications.

The NeuroPro® Low Profile Cranial Plating System provides rigid fixation of cranial bone flaps with a thin profile for reduced palpability. The system consists of bone screws and mating bone plates and panels with a beveled plate edge and thinner profile to reduce palpability. Malleable bone plates and panels are easily shaped by hand and/or with stainless steel instruments. The bone screws are used to secure various shapes of bone plates and panels to the cranium. The NeuroPro® Low Profile plates and panels are manufactured from Commercially Pure Titanium and meet all of the specifications of ISO 5832-2 or ASTM F-67. The NeuroPro® Low Profile screws are manufactured from 6AV4V ELI (Extra Low Interstitial) Titanium Allov and meet all of the specifications of ISO 5832-3 or ASTM F-136.

The NeuroPro® Low Profile Cranial Plating System is a modification of the standard NeuroPro® Cranial Plating System to be made thinner than those in the original submission (K964362), with exception of the hex panels which are the same thickness.

The NeuroPro® Low Profile Cranial Plating Screws are a modification of the standard NeuroPro® Quick Tap® Bone Screws to have a shorter screw head height than those in the original submission (K982927). The plates, panels and screws are similar in sizes, dimensions and identical in functionality as the standard NeuroPro® Cranial Plating System which was cleared as part of the original 510(k) submission (K964362).

The NeuroPro® Low Profile Cranial Plating System is identical to the standard NeuroPro® Cranial Plating System in terms of intended use, indications for use, material of construction, manufacturing process, functionality, compatibility of the plates and panels with all screw types, shelf life, biocompatibility, packaging and sterilization method.

The provided text describes the NeuroPro® Low Profile Cranial Plating System, a medical device for internal fixation of cranial bone, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device evaluation (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this documentation.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance for NeuroPro® Low Profile Cranial Plating System

The document states that "The testing met all acceptance criteria and verifies that the performance of the NeuroPro® Low Profile Cranial Plating System is substantially equivalent to the predicate devices." However, specific numerical acceptance criteria and reported performance values are not detailed in a table. Instead, the performance is described qualitatively in relation to established standards and predicate devices.

• Plates and panels: Manufactured from Commercially Pure Titanium, meeting specifications of ISO 5832-2 or ASTM F-67.
• Screws: Manufactured from 6AV4V ELI (Extra Low Interstitial) Titanium Alloy, meeting specifications of ISO 5832-3 or ASTM F-136.
• Acceptance: Materials conform to international and/or FDA recognized consensus standards for the type of material, with a long successful history in similar neurosurgical implant applications. |
  | Mechanical Performance |
• Bone plates and panels: Subjected to bend testing according to ASTM F67-06.
• Bone screw testing: Consisted of Kinamed test methods for:
  • Rate of Insertion (Amount of screw advancement per revolution)
  • Ease of Insertion (Driving torque required per revolution)
  • Torsional Strength
  • Screwdriver Interface Integrity
  • Simulated Use in Animal Bone
• Acceptance: All testing met pre-defined acceptance criteria, verifying substantial equivalence to predicate devices. |
  | Design & Functionality |
• Profile: Thinner profile for reduced palpability compared to the standard NeuroPro® Cranial Plating System (exception: hex panels are same thickness).
• Screw head height: Shorter screw head height compared to standard NeuroPro® Quick Tap® Bone Screws.
• Malleability: Malleable bone plates and panels are easily shaped by hand and/or with stainless steel instruments.
• Acceptance: "Similar in sizes, dimensions and identical in functionality as the standard NeuroPro® Cranial Plating System." The new Low Profile System has "some thinner plates/panels, shorter screw head height and is a differentiating color." |
  | Substantial Equivalence |
• Acceptance: Substantially equivalent to predicate devices (K964362 NeuroPro® Cranial Plating System and K982927 NeuroPro® Quick Tap® Bone Screws) with respect to:
  • Same intended use
  • Same indications for use
  • Same raw material
  • Same method of manufacture
  • Same design
  • Similar sizes and dimensions
  • Same type of mating components
  • Same shelf life
  • Same biocompatibility
  • Same sterilization and packaging methods |

Details Not Applicable or Not Provided for AI/ML Devices:

1. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a data test set. Testing was conducted on "worst case component size and option/design."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is the performance against engineering standards and comparison to predicate devices, verified through physical and mechanical testing.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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• a. Repair of long bone fractures due to trauma or reconstruction;
• b. Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
• c. Sternotomy closure; and
• d. Sublaminar and Intrafacet wiring of the spinal column.

Not Found

The provided text is a U.S. FDA 510(k) clearance letter for the "Iso-Elastic Cerclage System (1mm and 2mm cable diameter)". It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested table and information based on the given text. The text only specifies:

• Trade/Device Name: Iso-Elastic Cerclage System (1mm and 2mm cable diameter)
• Regulation Number: 21 CFR 888.3010
• Regulation Name: Smooth or threaded metallic bone fixation fasteners
• Regulatory Class: Class II
• Product Code: JDQ
• Indications For Use:
  • Repair of long bone fractures due to trauma or reconstruction;
  • Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
  • Sternotomy closure; and
  • Sublaminar and Intrafacet wiring of the spinal column.

To address your query, you would need a clinical study report or a performance data summary for the device, which is not present in this regulatory clearance letter.

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The SuperCable" Grip and Plate System is indicated for use where wire, cable, or band cerclage is used in combination with a trochanteric grip or bone plate. The SuperCable™ Grip and Plate System is intended to be used in conjunction with the SuperCable™ Iso-Elastic Cerclage System for reattachment of the greater trochanter following osteotomy or fracture, and for fixation of long bone fractures.

The SuperCable" Grip and Plate System consists of trochanteric reattachment grips, cable-plates, and cortical bone screws that are intended to be used in conjunction with 1.5mm diameter SuperCable Iso-Elastic Cerclage polymer cables. The cables pass through the grips and plates and provide fixation by attaching these devices to fractured or osteotomized bone fragments. Cortical bone screws may be used in combination with the cable-plates for additional fixation as deemed necessary by the surgeon user. The system includes a range of cable grip, cable-plate, and bone screw sizes and material options, with associated manual surgical instrumentation.

Trochanteric reattachment grips are available in a minimum of four lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the grip on the anterior or posterior surface of the proximal femur. The cable hole exit geometry is designed for optimal cable trajectory and cable contact stress when the grip is affixed to the greater trochanter. Each grip contains two proximal claws that hook into or over the proximal portion of the trochanter fragment and prevent the grip from migrating distally. Each grip also contains two smaller distal claws that penetrate the trochanter fragment distally for additional fixation and stability. The longer grips incorporate an extension to allow for transversely oriented cables around the diaphysis below the lesser trochanter to better resist trochanteric migration or rotation. These longer extensions contain slots for the insertion of compression or locked cortical bone screws into the bone. The grips are available in titanium alloy, cobalt-chromium allov, or stainless steel allov.

Cable-plates are available in a minimum of three lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse plate holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the plate. The plates also contain alternating slots for the insertion of compression or locked cortical bone screws into the bone. By combining locking screw holes with compression slots. the plates can be used as both locking devices and fracture compression devices. The plates resemble standard plates, but have figure-of-eight shaped slots that accommodate standard or locking screws. Thus the plate can be used, depending upon the fracture situation, as a compression plate, a locked internal fixator or as a system combining both techniques. The cable hole exit geometry is designed for optimal contact stress within the cable when the plate is affixed to a long bone. The cable-plates are available in titanium alloy, cobalt-chromium alloy, or stainless steel alloy.

Bone screws are standard self-tapping cortical bone screws and are available in multiple lengths. The screws heads are available in standard compression or locked designs. The bone screws are available in titanium alloy or stainless steel. The product labeling specifies the screw and plate/grip material combinations which may be used together.

Manual instrumentation includes a grip inserter/impactor, drill, depth gage, screwdriver, and sterilization case. All implants are supplied in a non-sterile condition.

Here's an analysis of the provided information, focusing on acceptance criteria and the study proving adherence, as requested:

Acceptance Criteria and Device Performance for K072250

Based on the provided document, the device in question is the SuperCable™ Grip and Plate System. This is a premarket notification (510(k)) submission for a medical device, and as such, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices rather than specific quantitative performance metrics like sensitivity or specificity that would be typical for an AI/diagnostic device.

The study employed to demonstrate this "acceptance" (i.e., substantial equivalence) is a performance analysis that relied on mechanical and finite element analyses.

Here's the breakdown of your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the traditional sense of a clinical or imaging study. The "test set" here refers to the models and physical specimens used for mechanical and finite element analyses. The document does not specify the number of simulations or physical parts tested.
• Data Provenance: Not applicable in the context of clinical data. The "data" comes from engineering analyses (mechanical testing and finite element modeling). This is not retrospective or prospective patient data from a specific country. This type of data provenance is typical for non-clinical performance studies of orthopedic implants.

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

• Number of Experts: Not applicable. Ground truth for mechanical and finite element analyses is typically established by engineering principles, material science, and established biomechanical testing standards, not by clinical expert consensus in the way an AI diagnostic algorithm's ground truth would be.
• Qualifications of Experts: While not explicitly stated as "experts for ground truth," the performance analysis would have been conducted or overseen by engineers and potentially biomechanical specialists familiar with mechanical testing and finite element analysis. Their qualifications would stem from their expertise in these engineering disciplines.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretative "test set" requiring adjudication. The outcomes of mechanical tests and finite element analyses are based on physical measurements and computational models, not subjective human judgment.

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

• MRMC Study: No, an MRMC study was not performed, nor would it be appropriate for this type of device (an orthopedic implant). MRMC studies are typically used for evaluating diagnostic imaging or AI systems where human readers interpret medical images.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: Not applicable. This device is an orthopedic implant, not an algorithm. Therefore, there is no "standalone" algorithm performance to measure. Its performance is inherent in its physical and mechanical properties.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the performance analysis was derived from:
  • Engineering principles and material properties: For Finite Element Analysis (FEA).
  • Physical measurements and established biomechanical test methods: For mechanical testing.
  • Comparison to predicate device performance benchmarks: To demonstrate "greater strength" or at least comparable performance.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set." The design is based on engineering principles, materials science, and established medical needs, not data-driven algorithmic training.

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

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

In summary, the provided document details a 510(k) submission for an orthopedic implant. The "acceptance criteria" revolve around demonstrating substantial equivalence to existing predicate devices in terms of materials, design, sizing, indications, and safety. The "study" proving this substantial equivalence was a performance analysis based on mechanical testing and finite element analysis, showing comparable or superior strength without introducing new risks. This is a standard non-clinical pathway for FDA clearance of Class II orthopedic devices.

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The NaviPro"" Shoulder Software Module is a system for computer-aided navigation of surgical instruments whose purpose is to intra-operatively report the orientation of the glenoid and humeral components during shoulder replacement surgery. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

The NaviPro" Shoulder Software Module is an extension of the previously cleared NaviPro Navigation System. It uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during shoulder replacement surgery. Measurements obtained from the system allow for intra-operative assessments of implant position and orientation.

The provided text is a 510(k) summary for the NaviPro™ Shoulder Software Module, focusing on its substantial equivalence to previously cleared devices. It describes the device's function, intended use, and technological characteristics. However, it does not contain any information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or study methodologies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided input.

The document essentially states that the device is substantially equivalent to a predicate device and provides its intended use, but it does not delve into the specific performance validation study details you've asked for.

To answer your questions, I would need additional information specifically outlining the performance study conducted for the NaviPro™ Shoulder Software Module.

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The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

The NaviPro™ Knee Software Module is an extension of the previously cleared The Navil Navigation System. It uses an optical localizing camera and infra-red Navil 10 - Navigation 173.60m. 'It ucces an valial position of bones and medical instruments during knee replacements obtained from the system allow for intra-operative assessments of implant position, orientation, and soft-tissue balance.

This 510(k) submission for the NaviPro™ Knee Software Module does not include a study describing acceptance criteria and device performance as typically expected for imaging or diagnostic AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a surgical navigation system.

Therefore, many of the requested sections regarding acceptance criteria, study design, and ground truth cannot be directly extracted from the provided text.

However, I can provide information based on what is available:

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

The provided document does not contain an explicit table of acceptance criteria or reported device performance metrics in the way one would typically see for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). The submission is for a surgical navigation software module, and its "performance" is more about its ability to accurately measure spatial orientation and alignment during knee replacement surgery, rather than a diagnostic output.

The summary of technological characteristics implies performance in terms of:

• Generating the position of tibial and femur resection guides.
• Measuring changes in the mechanical axis of the limb.
• Utilizing infra-red trackers for patient and instrument localization.
• Determining spatial information using trackers and palpated landmarks.

However, no quantitative acceptance criteria or specific performance data (e.g., accuracy in degrees or millimeters) are reported in this document.

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

The document does not describe a "test set" in the context of validating an algorithm's diagnostic or predictive performance. As a surgical navigation system, its validation would likely involve precision and accuracy testing on models or cadavers, and potentially clinical use observational studies, but details of such studies (including sample sizes or data provenance) are not present here.

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, as there's no mention of a "test set" requiring expert ground truth in the provided text.

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

Not applicable, as there's no mention of a "test set" requiring adjudication in the provided text.

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. The NaviPro™ Knee Software Module is a navigation tool for surgeons, not an AI-assisted diagnostic tool that would typically be evaluated with an MRMC study comparing human reader performance with and without AI. It assists the surgeon directly in guiding resections and assessing alignment.

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

The device is inherently "human-in-the-loop" as it is a navigation system used by a surgeon during an operation. Its purpose is to provide real-time spatial information to the surgeon, rather than operate autonomously.

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

Not applicable. The document focuses on the capabilities of the system to provide spatial measurements and guidance, rather than a diagnostic output that would have a "ground truth" established by pathology or expert consensus. The "ground truth" for a navigation system would relate to the physical accuracy of its measurements and guidance relative to a known reference standard (e.g., a highly accurate measuring device), but these details are not provided.

8. The sample size for the training set

The document does not describe a "training set" as it would for an AI/ML algorithm. The device is based on optical tracking and geometric calculations, not on a machine learning model trained on a dataset.

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

Not applicable, as there's no "training set" in the AI/ML sense described.

Summary of the Device and Submission Context:

The NaviPro™ Knee Software Module is an extension of an existing surgical navigation system. Its function is to provide real-time spatial orientation measurements of resection guides and limb alignment during total knee replacement surgery. It also assists in assessing soft tissue balance and changes in the mechanical axis. The submission focuses on demonstrating substantial equivalence to predicate navigation devices, rather than presenting a performance study with acceptance criteria and ground truth typical for AI/ML diagnostic tools. The technology described relies on optical tracking of infra-red markers and palpated landmarks to determine spatial relationships.

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The Gem™ Inset Patellar Component is intended to articulate with the Gem™ Total Knee femoral component or the KineMatch™ Patello-Femoral Resurfacing Implant. The Gem" Inset Patellar Component is a single use device that is intended for cemented applications on the surgically prepared posterior patella as part of primary or revision knee arthroplasty. The Gem " Inset Patellar Component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

Not Found

This FDA 510(k) letter for the Gem™ Inset Patellar Component does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It focuses on regulatory compliance rather than performance studies.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
• Whether MRMC or standalone studies were done, or their results.
• Type of ground truth used.
• Sample size for the training set or how its ground truth was established.

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• Repair of long bone fractures due to trauma or reconstruction; a.
• reattachment of the greater trochanter in total hip arthroplasty, surface replacement b. arthroplasty, or other procedures involving trochanteric osteotomy;
• c. sternotomy closure; and
• d. sublaminar and intrafacet wiring of the spinal column.

Not Found

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Kinamed Iso-Elastic Cerclage System, stating that the device is substantially equivalent to legally marketed predicate devices.

This type of document primarily confirms that the device can be marketed. It does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets, data provenance, or study types (retrospective/prospective).
• Information on the number or qualifications of experts for ground truth establishment, or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes for AI assistance.
• Confirmation of standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set or how its ground truth was established.

These details would typically be found in the 510(k) submission itself or in a separate clinical study report, which is not part of this FDA clearance letter.

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NaviPro™ is a system for computer-aided navigation of surgical instruments whose purpose is to optimally position the acetabular shell during hip replacement surgery, and to report changes in rotational center, limb length, and femoral offset as a result of prosthetic implantation. The system aids the surgeon in accurately positioning the acetabular shell during hip replacement and provides intra-operative measurements of femoral position and orientation in relation to the pelvis. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

NaviPro™ uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during hip replacement surgery. Measurements obtained from the system allow for intra-operative assessments of implant position and orientation.

NaviPro™ intra-operatively reports the position of the acetabular shell relative to the pelvis as well as the changed relationship between femur and pelvis as a result of joint replacement. The patient data needed to carry out this procedure is recorded intra-operatively. Pre-operative CT or fluoroscopic imaging is unnecessary. The link between patient and computer is established by infra-red reflective trackers that are securely attached to the patient. An infra-red localizing camera that is linked to the computer calculates the position and orientation of the trackers.

Surgical instruments, such as an acetabular shell impactor tool and a calibrated measurement probe, are also outfitted with infra-red trackers and can be brought into a spatial relationship with the patient. The NaviPro™ system requires only the information provided by the trackers to determine the orientation of the acetabular shell, as well as changes in limb length and femoral offset.

The provided text, K020764, describes the NaviPro™ system, a computer-aided surgical navigation system for hip replacement surgery. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary and the FDA's clearance letter, which focuses on:

• Device description: How NaviPro™ uses optical tracking to determine the spatial position of bones and instruments during hip replacement surgery.
• Intended use: Positioning the acetabular shell, reporting changes in rotational center, limb length, and femoral offset.
• Technological characteristics: Infra-red reflective trackers, an optical localizing camera, and intra-operative measurements without pre-operative imaging.
• Substantial equivalence: Claimed to OrthoPilot® (K003347).
• FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and is cleared for market.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided text.

The 510(k) process generally relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and detailed performance studies like those required for a PMA (Premarket Approval) application. While studies are often submitted as part of a 510(k), the provided summary does not detail them.

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The KineMatch™ Patello-Femoral Resurfacing Implant is intended to be used in patellofemoral joints with degenerative arthritis of the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery where patello-femoral joint pain, deformity, or dysfunction persists. The KineMatch™ Patello-Femoral Resurfacing Implant is intended for use with bone cement.

Not Found

This document is a 510(k) premarket notification letter from the FDA to Kinamed Incorporated for their KineMatch™ Patello-Femoral Resurfacing Implant. It states that the device has been found substantially equivalent to legally marketed predicate devices.

This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as requested in the prompt.

The prompt asks for details related to an AI/ML device and its performance, including:

• Acceptance criteria and reported device performance.
• Sample size and data provenance for the test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

Since the provided document is a 510(k) clearance for a physical medical implant (a knee joint prosthesis), it does not involve AI/ML performance studies, ground truth establishment, or human reader comparisons. Therefore, I cannot extract the requested information from this text.

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