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The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.

The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and up to two distal locking bolts.

This 510(k) summary (K083648) describes a medical device, "The Gotfried PH (Physiological Hip) Nail," which is an intramedullary nail for hip fracture fixation. However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include information on software performance.

The document is a standard 510(k) summary for a Class II medical device (Intramedullary fixation rod). It primarily focuses on:

• Identification of the device and its submitter.
• Classification of the device and its predicate devices.
• Description of the device: An intramedullary nail with two proximal dynamic femoral neck screws and up to two distal locking bolts, made of stainless steel.
• Intended Use: Fractured bone stabilization, fixation, and management of specific types of proximal femur fractures (trochanteric, subtrochanteric, subcapital, and base of neck).
• Comparison to predicate devices: States that it is "substantially equivalent" in technology, construction, materials, and orthopedic design principles. It explicitly mentions its dimensions and tolerances are within the range of previously cleared devices.

Therefore, I cannot provide the requested table and information about acceptance criteria and study details because the provided text does not contain this information. This type of information (performance studies, acceptance criteria for software, sample sizes, ground truth) is typically found in the more detailed sections of a 510(k) submission, not usually in the publicly available 510(k) summary document itself, especially for a hardware device like an intramedullary nail. The substantial equivalence argument for this device relies on its similarity to existing, legally marketed predicate devices, rather than on new performance studies with specific acceptance criteria that would be relevant for software or AI.

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The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, and base of neck fractures of the proximal femur.

The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and two distal locking bolts.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Gotfried PH (Physiological Hip) Nail) and primarily discusses its intended use, comparison to predicate devices, and the FDA's clearance.

The text does not contain any details on:

• Acceptance criteria for performance metrics.
• Performance data from a study.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for any set was established.

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The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.

The GOTFRIED PC.C.P system is a plate and screw system, made of stainless steel, which utilizes dynamic femoral neck screws. The plate accepts two neck screws (length ranging from 90 mm to 140 mm) having barrel (sleeve) diameter of 9.3 mm and shaft diameter of 6.4 mm, and three 4.5 mm cortical screws (length ranging from 31 to 43 mm).

This 510(k) summary describes a medical device, the GOTFRIED PC.C.P, which is a surgical implant. The submission focuses on demonstrating substantial equivalence to predicate devices and provides information on the device's design, intended use, and biomechanical testing.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics commonly associated with AI/ML-driven diagnostics (e.g., sensitivity, specificity, accuracy against a referent standard).

Instead, the "study" referred to in this document is a biomechanical test that compares the GOTFRIED PC.C.P to other compression hip screw systems. The "acceptance criteria" here would be related to the performance of the device in these biomechanical tests in terms of bending and torsional stiffness and ultimate loads to failure, with the goal of demonstrating it is at least equivalent to predicate devices.

Given the nature of the provided document (a 510(k) summary for a surgical implant device), many of the requested elements are not applicable or cannot be extracted. The prompt implies a request for information typically found in submissions for diagnostic or AI/ML-driven devices.

Here's an attempt to answer the questions based on the available information, noting where information is absent or non-applicable:

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

Note: The document states the device's biomechanical characteristics are "at least equivalent" to other systems, but it does not specify the precise numerical acceptance thresholds or the exact performance values observed for the GOTFRIED PC.C.P or the comparator devices in these specific biomechanical tests.

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

This information is not provided in the document. Biomechanical tests typically involve a small number of devices or components tested under controlled laboratory conditions, not patient data sets.

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

This is not applicable to a biomechanical test on a surgical implant. Ground truth in this context would be the physical measurements of material properties and structural integrity, not expert interpretation.

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

This is not applicable to a biomechanical test.

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

This is not applicable as this is a surgical implant, not an AI-driven diagnostic device. No MRMC study was mentioned.

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

This is not applicable as this is a surgical implant, not an algorithm.

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

For the biomechanical study mentioned, the "ground truth" would be established by physical measurements and engineering principles to determine bending stiffness, torsional stiffness, and ultimate loads to failure. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This is not applicable. This is a surgical implant and does not involve AI/ML training data.

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

This is not applicable. This is a surgical implant and does not involve AI/ML training data or its associated ground truth establishment.

Summary of the Study Mentioned:

The document refers to "biomechanical test results" which conclude that "the biomechanical characteristic of the GOTFRIED PC.C.P is at least equivalent to other compression hip screw systems in terms of bending and torsional stiffness and ultimate loads to failure." This serves as evidence for substantial equivalence, a regulatory pathway for medical devices. The specific methodology, sample size (for the biomechanical tests), and detailed results are not provided in this 510(k) summary but would have been part of the full submission to the FDA.

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