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Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional splints or night guards.

Partial Flex® dental resin is a polymer base material used for the fabrication of partial removable dentures and prosthesis. Partial Flex is made from a resin of polypropylene that is designed and manufactured for injection molding. Partial Flex® is available in two shades as a granular material (so-called pellets) contained in an aluminum tube with 27 g or in a plastic bag of 250 g. In addition to high biocompatibility, Partial Flex® material features hypoallergenic properties, no risk of discoloration and the dental prosthesis made are unbreakable, which differentiates the from acrylic materials. The resin material is pigmented in one color and without pigment presentation: Light pink and Natural color (without pigment).

The provided FDA 510(k) Clearance Letter for the device "Partial Flex" does not describe acceptance criteria, the study that proves the device meets acceptance criteria, or any details about AI/human reader studies.

The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device. It confirms that the device is a "Denture Relining, Repairing, Or Rebasing Resin" and lists some non-clinical performance tests conducted to show compliance with ISO standards (ISO 20795 and ISO 10993 for biocompatibility), but it does not provide specific acceptance values or the actual results of these tests beyond "passed the acceptance criteria" or "complies with the requirements."

Therefore, it's impossible to fill in the requested information based solely on the provided text. The prompt asks for details that are typically found in a clinical study report or a more detailed section of a 510(k) submission, neither of which is present in the provided clearance letter.

However, I can illustrate what a hypothetical response would look like if the information were available, using the structure of your request.

Hypothetical Response (Illustrative, as the provided document lacks the necessary data):

This document, an FDA 510(k) Clearance Letter, primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It details non-clinical performance testing but does not contain the specific acceptance criteria, detailed study results, or information pertaining to AI performance, human reader studies, or ground truth establishment that would be required to fully answer the prompt. The information below is hypothetical and structured as if the data were present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The provided document states "The material complies with the requirements" or "passed the acceptance criteria" without specifying the numerical values for the criteria themselves or the actual measured performance values. For example, under "Ultimate Flexural Strength," it only says "The material complies with the requirements." It does not give a specific threshold like "Ultimate Flexural Strength > 65 MPa" and then a result like "72 MPa".)

2. Sample Sizes and Data Provenance

The provided document describes non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests, nor does it refer to patient data (e.g., medical images, clinical outcomes) that would typically have provenance data.

• Test Set Sample Size: Not applicable/Not specified in the provided document for human data or AI model evaluation. For bench tests, typical sample sizes are per ISO standards but not detailed here.
• Data Provenance: Not applicable for the type of testing described (bench and biocompatibility). No mention of country of origin or retrospective/prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The provided document describes material testing and biocompatibility. It does not involve human readers, clinical data interpretation, or AI ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. No expert review or clinical test set adjudication is described in the provided document.

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

Not applicable. This is a material science device (dental resin), not a diagnostic imaging or AI-assisted interpretation device. No MRMC study was performed or is relevant to this device's 510(k) submission as described.

6. Standalone Algorithm Performance

Not applicable. This device is a physical dental resin, not an algorithm or software.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described in the document (material properties and biocompatibility) would be based on:

• Established ISO Standards (e.g., ISO 20795 for dental base polymers, ISO 10993 for biocompatibility): These standards define the test methodologies and acceptable performance limits.
• Laboratory Measurements and Biological Assays: Objective, quantitative measurements performed in a laboratory setting (e.g., measuring flexural strength, assessing cell viability, observing tissue reactions in animal models).

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this 510(k) submission.

8. Sample Size for the Training Set

Not applicable. This device is a manufactured resin, not an AI model requiring a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. This device is a manufactured resin, not an AI model.

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The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.

The Implant systems with which the system is compatible:

• Restoris Multicompartmental Knee System .
• Restoris Porous Partial Knee System ●

Partial Knee Application is an upgrade to RIO-PKA (K112507). The features of this application are to improve overall performance of the system in supporting partial knee arthroplasty. Partial Knee Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.

The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, cutting system, and a robotic arm. The system's architecture is designed to support partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.

RIO's robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

The provided document describes the MAKO Surgical Corporation's Partial Knee Application (PKA) device, which received 510(k) clearance from the FDA. The document summarizes various performance tests conducted to demonstrate the device's substantial equivalence to predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table summarizing the validation and verification methods, their acceptance criteria, and the results, as shown below:

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

The document provides a list of tests and states "Pass" for each, but it does not specify the sample sizes used for any of the individual tests comprising the test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data). The studies are described as "nonclinical performance testing" and "simulated-use environment," indicating they were likely conducted in a lab or pre-clinical setting rather than with human patients.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The validation tests, particularly the "Full System Run-through test" and the "PKA System Validation," mention assessing "adequate functionality" and satisfying "customer requirements," which would implicitly involve expert assessment, but details are not given.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the tests (functional and system accuracy), it's more likely that predefined technical specifications were used as criteria rather than a consensus among multiple human adjudicators for subjective assessments.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The studies described are focused on the device's functional performance and accuracy, not on comparing the performance of human readers with and without AI assistance.

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

The "Partial Knee Application (PKA)" is described as being "intended to assist the surgeon" and "provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation." The "RIO's robotic arm... can serve as surgeon's 'intelligent' tool holder or tool guide." This clearly indicates a design for "human-in-the-loop" operation. Therefore, a standalone (algorithm-only) performance study is not explicitly described or implied as being relevant given the device's assistive nature. However, certain functional tests (e.g., System Accuracy Test, PKA Application Performance Test) would evaluate the algorithm's performance independent of surgical action, but within the context of ultimately assisting a surgeon.

7. The Type of Ground Truth Used:

The ground truth for most of these tests appears to be based on engineering specifications and predefined performance metrics. For example, the "System Accuracy Test" aims to determine "overall system accuracy as a result of bone registration and bone resection accuracy." This implies a comparison against a known, accurate standard or measurement. For the "Full System Run-through test" and "PKA System Validation," the ground truth would be the successful completion of the PKA procedure according to established clinical protocols and "customer requirements" (likely derived from surgical best practices and outcomes) in a simulated environment. There is no mention of pathology or long-term outcomes data used as ground truth in these nonclinical tests.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. As this device seems to be a complex robotic surgical assistance system, there would undoubtedly be internal development and training data used for its algorithms and software. However, such details are not disclosed in this 510(k) summary.

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

Similar to question 8, the document does not provide information on how the ground truth for any potential training set was established.

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A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.

Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:

(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

The Grace Medical Stapes Prostheses are manufactured from the same or similar materials as the predicate devices. Various designs of Stapes Prostheses are available to meet physician preference. Materials include Titanium, Fluoroplastic, Stainless Steel, Platinum, Tantalum, Silicone, and Nitinol. Shaft diameters range from 0.3 to 0.8 mm and functional lengths range from 3.0 to 6.5 mm. The devices are supplied sterile.

The provided documents do not contain information about specific acceptance criteria or a study designed to prove that the Grace Medical Partial Ossicular Replacement Prostheses meet such criteria.

The documents are a 510(k) summary for a medical device (Partial Ossicular Replacement Prostheses). In a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a dedicated study with defined acceptance criteria and statistical analysis.

Instead, the submission provides:

• Comparison Charts (Tables in sections {1} and {2}): These tables compare the Grace Medical device with several predicate devices based on attributes like:
  • Intended Use
  • Material(s)
  • Shaft Diameter (mm)
  • Functional Length (mm)
  • Loop Dia (mm)
  • How Supplied (Sterile)

The stated rationale for substantial equivalence is that "Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment as it is not present in the provided text.

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The MedNet Locator, INC., Partial Ossicular Replacement Prosthesis (PORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.

Partial Ossicular Replacement Prosthesis (PORP)

The provided text is an FDA 510(k) clearance letter for a medical device: "Partial Ossicular Replacement Prosthesis (PORP)". This type of document declares substantial equivalence to a predicate device, allowing it to be marketed. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The 510(k) process primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo performance studies with acceptance criteria as might be seen for novel technologies or PMA applications.

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