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Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.

The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.

The provided document is a 510(k) summary for the SIGN Hip Construct (SHC). It describes a medical device, specifically a metallic bone fixation appliance, and its submission for regulatory clearance.

This document describes mechanical testing for the device, not a study involving human subjects or AI. Therefore, most of the requested information (related to AI, human readers, experts, ground truth methodologies, etc.) is not applicable.

Here's an analysis of the available information:

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

The document states: "Mechanical testing was performed on the SHC implant and the results demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device."

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

The document does not specify the sample size used for the mechanical testing. It also does not provide details on "data provenance" as this typically refers to patient data, which is not relevant for this type of mechanical engineering study.

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

Not applicable. This was a mechanical engineering study, not a study requiring expert consensus for ground truth on clinical data.

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

Not applicable. This was a mechanical engineering study, not a study requiring adjudication of expert interpretations.

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 study was not done. The device is a physical orthopedic implant, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a physical orthopedic implant, not an algorithm.

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

The "ground truth" for this mechanical study would be established engineering standards and specifications for orthopedic implants (e.g., ASTM standards for material strength, fatigue testing protocols). The reported results indicate that the device met these intrinsic engineering performance metrics.

8. The sample size for the training set

Not applicable. This was a mechanical engineering study; there is no "training set" in the context of machine learning.

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

Not applicable.

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The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.

The SIGN Fin Nail system includes intramedullary nails, Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN Fin Nail is available with diameters of 7mm, 8mm, 9mm, 11mm, 11mm, and 12mm in the following lengths: 160mm, 190mm, 240mm and 280mm. Each nail is made from a solid type 316, ASTM F138, solid stainless steel bar with distal and proximal bends. Each nail has a hole and a slot at the proximal end to accept solid 4.5mm diameter cortical bone screws for fixation and uses rigid distal fins for rotational stability. The SIGN Fin Nail may be removed upon fracture healing.

This looks like a 510(k) summary for a medical device called the "SIGN Fin Nail." This type of document is for regulatory clearance and focuses on substantial equivalence to already approved devices, rather than a clinical study proving performance against acceptance criteria in the way a novel technology might.

Therefore, the requested information elements related to a human subject study or detailed performance criteria are largely not applicable in this document. The document primarily focuses on establishing that the SIGN Fin Nail is similar in design, materials, and intended use to existing, legally marketed devices.

Here's the breakdown based on the provided text:

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

• Not Applicable. This document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported performance from a clinical study. The clearance is based on substantial equivalence, implying that since predicate devices are safe and effective, and the new device is substantially equivalent, it too is safe and effective.

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

• Not Applicable. There is no mention of a "test set" in the context of a clinical performance study. The evaluation is based on design, material, and indications for use comparison to predicate devices.

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. Ground truth in the context of a clinical study is not established or discussed in this document.

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

• Not Applicable. No adjudication method is mentioned as there's no clinical test set being adjudicated.

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 device is an intramedullary nail, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not Applicable. This is a medical implant, not an algorithm, so standalone performance is not relevant.

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

• Not Applicable. Ground truth for clinical performance is not established or discussed. The "ground truth" for regulatory clearance is that predicate devices are legally marketed and considered safe and effective.

8. The sample size for the training set

• Not Applicable. No training set is mentioned as this device is not an AI/ML algorithm requiring one.

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

• Not Applicable. No training set, no ground truth establishment for it.

Summary based on the provided document:

The regulatory clearance for the SIGN Fin Nail is based on its substantial equivalence to already legally marketed predicate devices. The document explicitly states:

• Predicate Devices: SIGN IM Nail System, Howmedica Alta IM Rod System, Biomet Brooker Femoral nail, Encore True/Flex Upper Extremity Nail.
• Basis for Safety and Effectiveness: "The safety and effectiveness of the SIGN Fin Nail is also based on a long history of use of this type of device in the market place."
• Device Description: The document provides a detailed description of the device materials (stainless steel, type 316, ASTM F138), dimensions (diameters, lengths), design features (hole, slot, rigid distal fins), and mechanism of action (internal fixation, rotational stability). These details are implicitly compared to the known characteristics of the predicate devices to establish equivalence.
• Indications for Use: "The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus." This indication is also compared to the predicate devices.

In essence, the "study" demonstrating the device meets "acceptance criteria" for a 510(k) is a comparison to predicate devices to show substantial equivalence. The acceptance criteria are implicitly that the new device does not raise new questions of safety or effectiveness compared to the similar, already-approved devices, given its design, materials, and intended use.

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The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions and fractures in the proximal femur.

The SIGN IM Nail may be removed upon fracture healing.

The SIGN IM Nail system includes Intramedullary nails, Interlocking Screws and Instruments. The SIGN IM Nail is manufactured from Solid Bar Stainless Steel, Type 316 as per ASTM F138. This device is available with diameters of 9mm, 11mm, 11mm, 12mm, 13mm and 14mm in the following lengths: 280mm, 300mm, 320mm, 340mm, 360mm, 380mm, 400mm. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws. Screws in a range from 25mm to 75mm in 5mm increments are supplied with the nails. Each nail uses distal and proximal bends to accommodate the shape of the femur.

The provided text is a 510(k) Summary and FDA clearance letter for the "SIGN IM Nail." This type of document is for a medical device (an intramedullary nail for fracture fixation), not an AI/ML powered device or a diagnostic device that would typically have acceptance criteria focused on performance metrics like sensitivity, specificity, or AUC.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, ground truth, experts, MRMC studies, standalone performance), and training set information is not applicable to this document.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence for devices like the SIGN IM Nail is typically proven through:

• Comparison of design and materials: The document states the device is "manufactured from Solid Bar Stainless Steel, Type 316 as per ASTM F138" and details its dimensions.
• Comparison of intended use and indications for use: The document provides a detailed list of indications for use, and states that this 510(k) "serves to extend the SIGN IM Nail line... by adding to the indications for use and providing a greater size range."
• Comparison of performance data (if applicable to non-AI devices): For mechanical devices like this, performance data usually involves mechanical testing (e.g., fatigue, static bending strength, torsional strength) to demonstrate that the new device performs at least as well as, or better than, the predicate devices in terms of mechanical properties. This document does not explicitly detail such mechanical test results, but it would have been part of the full 510(k) submission. The FDA's clearance letter implicitly confirms that such data was found acceptable.
• Safety information: The safety of the device is implicitly demonstrated by its similarity to long-marketed predicate devices and adherence to material standards.

Since the prompt specifically asks for details relevant to AI/ML or diagnostic device performance studies, and this document does not contain that type of study, I cannot fill in the requested table or answer the specific questions about sample sizes, ground truth, expert adjudication, or MRMC studies.

The closest analogue to "acceptance criteria" for this device would be that its design, materials, and mechanical performance (demonstrated via engineering tests, not clinical studies as described in the prompt) are substantially equivalent to and as safe and effective as the predicate devices.

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The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including Transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions.
The SIGN IM Nail may be removed upon fracture healing.

The SIGN IM Nail system includes Intramedullary nails. Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN IM Nail is available with diameters of 8mm. 9mm. 10mm, 11mm, and 12mm in the following lengths: 150mm, 190mm, 270mm, 270mm, 280mm, 320mm, 320mm, 340mm, 360mm, 380mm, 400. Each nail is made from a solid type 316. ASTM F138, stainless steel bar with distal and proximal bends. Each nail has holes and/or slots at both the distal and proximal ends to accept solid 4.5mm diameter cortical bone screws.

This document describes a medical device, the SIGN IM Nail, which is an intramedullary nail for internal fixation of certain fractures. It is a traditional medical device, not a software algorithm or AI-powered solution. Therefore, the requested information about acceptance criteria, study findings, sample sizes for test and training sets, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable in the context of AI/algorithm performance.

The document states that the safety and effectiveness of the SIGN IM Nail is based on a long history of use of this type of device in the market place and its substantial equivalence to predicate devices (Smith & Nephew "TriGen®" Knee Nail, ACE Medical "AIM" Titanium Tibial Nail, Synthes "Universal Nail").

The FDA's decision to clear the device (K013132) is based on a substantial equivalence determination, meaning it is similar in intended use, technology, and performance to legally marketed devices. This process typically relies on device comparisons, material testing, and sometimes bench or animal testing, rather than the kind of clinical performance studies with specific acceptance criteria that would apply to AI/software.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI study, nor can I provide information on sample sizes, ground truth, or expert involvement as these are not relevant to the substantial equivalence pathway for this type of conventional device.

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