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The Phalangeal Fixation System is indicated for the fixation of transverse or short oblique fractures of proximal phalanx of the fingers.

The PFS is a single use, non-toxic, disposable, sterile device. The PFS consists of the Cannulated Awl Assembly, the Implantable Pin Handle Assembly, and Exchange Guide and Bend Tube.

Prior to use, the implantable pin assembly is nested in the cannulated awl assembly. The cannulated awl assembly has a trocar point. The implantable pin has a blunt point that is positioned just behind the trocar point of the cannulated awl. The sharp point of the cannulated awl assembly is passed through a small incision. A hole is drilled into the Phalangeal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the cannulated awl handle is held stationary while the implantable pin is then advanced distally from the base of the phalangeal bone.

The awl handle is then withdrawn and removed for advancement of the implantable pin. Multiple pins, usually two, are implanted in the manner previously described. The pins are placed in a arrangement to minimize radial movement.

The implantable pin(s) is then cut at the taper near the proximal end of the pin. Using the bending tube end of the exchange guide the implantable pin is bent to 90° with the apex of the bend at the implantable pin insertion site. The pin is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable pin subsequent to healing. The implantable pin will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable pin is percutaneously removed.

The provided text is a 510(k) summary for the Medcanica, Inc. Phalangeal Fixation System (PFS). It focuses on demonstrating substantial equivalence to a predicate device (MicroAire Surgical Equipment, Inc. K-wire) primarily through bench testing and comparison of technological characteristics, rather than clinical performance studies. Therefore, much of the requested information regarding acceptance criteria for device performance in clinical settings, human reader studies, and detailed ground truth establishment in a clinical context is not available in this document.

Here's an attempt to extract and infer the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify the exact eleven technological characteristics or five performance characteristics. It only states that comparisons were made and substantial equivalence was found.

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

• Sample Size: Not explicitly stated. The document mentions "extensive bench testing of both devices." This implies a sample size adequate for the bench tests conducted, but no specific number is provided.
• Data Provenance: The study was "bench testing." This means it was conducted in a laboratory setting, not on human subjects. Therefore, there's no country of origin or retrospective/prospective classification in a clinical sense.

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

• Not Applicable. This was a bench testing study comparing the physical and mechanical properties of two medical devices. Ground truth, in this context, would be established by validated testing methods and measurements, not by expert clinical review of test data in the way it would be for diagnostic AI.

4. Adjudication Method for the Test Set

• Not Applicable. As this was bench testing, there's no clinical adjudication process involving multiple human experts. The "adjudication" would be based on established engineering and materials science principles and validation of test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI device. It is a traditional medical device (K-wire for phalangeal fixation). Therefore, no MRMC study or AI-related comparative effectiveness was performed or would be applicable.

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

• No. This is not an AI algorithm. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

• Bench Test Results / Engineering Specifications / Material Standards. The "ground truth" for this study would be the scientifically validated results from the bench tests (e.g., measurements of strength, biocompatibility, dimensions, material composition) and the established performance characteristics and specifications of the predicate K-wire as a benchmark.

8. The Sample Size for the Training Set

• Not Applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided device (Phalangeal Fixation System).

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The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies.

The EMB is sterile, single use, radiopaque, disposable device that is delivered non-toxic and non-pyrogenic. The device is transvascularly deployed to the right ventricle of the heart for the acquisition of endomyocardial tissue samples Typically, the approach is made from the jugular vein or femoral arteries. The EMB consists of 4 major components: the moveable handle, end-effectors (jaws), core wire, and sheath. The core wire is attached to the handle. Moving the handle opens and closes the jaws.

This document is a 510(k) premarket notification for a medical device called the Endomyocardial Biopsy Forceps (EMB) manufactured by Medcanica, Inc. It seeks to establish substantial equivalence to a predicate device, the BiPal Biopsy Forceps from Cordis Corporation (510(k) K914567).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" in the way one might expect for a diagnostic or AI device study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with recognized consensus standards.

The closest representation of "acceptance criteria" and "performance" can be inferred from the comparison table of technological characteristics and the declaration of compliance with standards.

The general acceptance criterion is "substantial equivalence" to the predicate device. The performance is demonstrated by the device sharing similar technological characteristics and meeting the cited consensus standards, indicating that it performs "as well as or better than the predicate device."

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

The document primarily describes bench testing for the EMB device to demonstrate substantial equivalence. It does not refer to a "test set" in the context of a dataset of cases or clinical images.

• Sample Size for Test Set: Not applicable in the context of image analysis or AI. The testing described is for the physical device itself. The specific number of devices tested for tensile, flexibility, dimensional, and performance tests is not quantified in the provided text.
• Data Provenance: Not applicable. The "data" refers to the results of bench tests on the physical device, not patient data or clinical images.

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

This information is not applicable to this document. The device in question is a physical endomyocardial biopsy forceps, not a diagnostic algorithm or AI system that requires expert-established ground truth from images or patient data. The "ground truth" here would be the physical properties and performance characteristics of the device under specific testing conditions, measured by engineering methods.

4. Adjudication Method for the Test Set

This information is not applicable to this document, as there is no "test set" of cases/images requiring expert adjudication in the context of a 510(k) for a physical medical device.

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

No, an MRMC comparative effectiveness study was not done. This type of study relates to the performance of diagnostic algorithms or AI systems and their impact on human reading, which is not relevant to a physical biopsy forceps.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the EMB device is established through bench test results against engineering specifications and comparison to the characteristics of the predicate device. This includes:

• Dimensional measurements: Jaw volume, working lengths, sizes.
• Material properties: Compliance with ASTM F899 95 for stainless steel.
• Biocompatibility: Through selection of materials with a "long history of biocompatibility" and compliance with ISO 10993-7 for sterilization residuals.
• Sterilization efficacy: Compliance with ANSI/AAMI/ISO 11135-1994 and 21 CFR, § 821.100 regarding ethylene oxide sterilization.
• Functional performance: "Tensile, flexibility, and performance tests" demonstrating similar function to the predicate device.

Essentially, the ground truth is established by direct physical and chemical testing of the device and its components against established engineering and regulatory standards, and by comparison to the known characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing process are guided by engineering principles, regulatory standards, and the characteristics of the predicate device.

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

This information is not applicable as there is no training set for an AI/machine learning model. For the device itself, the design and manufacturing are founded on established engineering principles, materials science, and medical device regulations. Compliance with Good Manufacturing Practices (GMP) and the Quality System Regulation (QS) for Medical Devices (21 CFR Part 820) ensure the device is safe and effective.

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The Metacarpal Fixation System is indicated for the fixation of transverse or short oblique fractures of the diaphysis or diaphyseal-metaphyseal junction of metacarpal bones.

The MFS is a sterile, single use, disposable device that is delivered non-toxic. The MFS consists of the Cannulated Awl Assembly, the Implantable Pin Handle Assembly, and Exchange Guide and Bend Tube. Prior to use the implantable pin assembly is nested in the cannulated awl assembly. The cannulated awl assembly has a trocar point. The implantable pin has a blunt point that is positioned just behind the trocar point of the cannulated awl. The sharp point of the cannulated awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the cannulated awl handle is held stationary while the implantable pin is then advanced distally from the base of the metacarpal bone. The awl handle is then withdrawn and removed for advancement of the implantable pin. The implantable pin is then cut adjacent to the pin handle. Using the bending tube end of the exchange guide and bend tube, the implantable pin is bent to 90° with the apex of the implantable pin insertion site. The pin is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable pin subsequent to healing. The implantable pin will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable pin is percutaneously removed. In the event that it is desired to reform the implantable pin or implant a smaller pin, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable pin into the medullar space. Once the medullar space is accessed, the pin is removed. Another pin may be placed into the medulla by inserting it into the groove of the exchange guide. After the pin has been inserted into the medullar space, remove the exchange guide.

The provided text is a 510(k) premarket notification for a medical device (Metacarpal Fixation System) seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance as would be expected for a novel device or software. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not present in this document.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document mentions "extensive bench testing" and a "cutting geometry comparison" but does not provide details on the number of devices or trials included in these tests.
• Data Provenance: The data is derived from "bench testing" of the Medcanica MFS and the MicroAire Surgical Equipment, Inc. K-wire. This implies in-vitro testing rather than human or animal studies. No country of origin is mentioned for the data, but the submission is to the US FDA by a US-based company. The data is implicitly prospective testing performed for the 510(k) submission.

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

This information is not provided in the document. The testing described is primarily mechanical/material bench testing, which typically does not involve expert adjudication for ground truth.

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

This information is not applicable/provided as the "test set" described is for bench testing of mechanical properties and material compliance, not for clinical evaluation requiring adjudication.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical implant (Metacarpal Fixation System), not an AI-powered diagnostic or assistive tool. Therefore, questions regarding "human readers improve with AI" are not relevant to this submission.

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

A standalone performance study (algorithm only) was not done. This device is a physical medical implant and does not involve an algorithm.

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

The "ground truth" for this submission is based on:

• Compliance with recognized consensus standards: (ASTM F138-97, F899-95, F86-91, F366-82, ISO 5838-3).
• Physical and mechanical properties confirmed through bench testing: Stiffness/yield, cutting geometry, and drilling performance compared to the predicate device.
• Material specifications: 316LVM, ASTM F138-97.

8. The sample size for the training set:

There is no training set discussed in this document. The MFS is a physical implant, not a learning algorithm or AI device that would require a "training set."

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

As there is no training set, this question is not applicable.

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