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The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.

The provided text, a 510(k) summary for the IFS Subtalar Implant, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics for the device itself. Therefore, detailed information required by your request about acceptance criteria, study design, expert involvement, and ground truth establishment is not available in the provided document.

Here's a breakdown of what can and cannot be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available. This document describes the device's design, material, and intended use, and compares it to predicate devices. It does not contain a table of performance metrics (e.g., accuracy, sensitivity, specificity) against predefined acceptance criteria for the device itself. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence, not to statistical performance of an AI or diagnostic device.

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

• Not Applicable/Not Available. The provided document is a 510(k) submission for a medical implant (bone fixation fastener), not a study evaluating an AI or diagnostic device. There is no "test set" in the context of evaluating an AI's performance. The review focuses on the device's design, materials, and intended use as compared to existing devices.

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

• Not Applicable/Not Available. Same as above, there is no "test set" or "ground truth" establishment in the context of typical AI/diagnostic device evaluation. The "experts" involved are likely the FDA reviewers assessing the 510(k) submission and the engineers/clinical staff from Internal Fixation Systems, Inc. who designed, developed, and documented the device.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Available. No test set as described for an AI/diagnostic 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:

• Not Applicable/Not Available. This is a hardware implant, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

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

• Not Applicable/Not Available. This is not an algorithm.

7. The Type of Ground Truth Used:

• Not Applicable/Not Available. No ground truth in the context of an AI/diagnostic device evaluation. The "ground truth" for this device would be its physical properties, biocompatibility, and mechanical performance, which are assessed through engineering tests and material analysis (though details are not in this summary).

8. The Sample Size for the Training Set:

• Not Applicable/Not Available. This is a physical implant, not an AI model. There is no concept of a "training set."

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

• Not Applicable/Not Available. No training set.

Summary based on the provided document:

The IFS Subtalar Implant's acceptance criteria for market clearance (510(k)) were based on demonstrating substantial equivalence to existing legally marketed predicate devices, specifically:

• Nexa Subtalar Arthrorisis Implant (K032902)
• Osteomed Subtalar Implant System (K031155)

The study proving this involved a comparison of technological characteristics, focusing on:

• Design: Similar overall diameters and lengths.
• Function: Intended to treat hyperpronated foot, stabilize the subtalar joint, and block excessive pronation, acting as a spacer.
• Material: Made of Ti 6Al-4V ELI, which is a common material for such implants and likely comparable to the predicates.
• Intended Use: Identical or very similar to the predicate devices (treating hyperpronated foot and stabilizing the subtalar joint).

The document explicitly states: "The IFS Subtalar Implant is substantially equivalent to the predicate devices with respect to the design, function, and material. The implants have the same overall diameters, lengths, and material composition. ... There are no significant differences between the subtalar implant and the other implants as listed in the Substantially Equivalent Devices. The IFS Subtalar Implant and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent."

This is a regulatory pathway for medical devices that are similar in technology and intended use to devices already on the market, meaning a full clinical trial demonstrating novel safety or effectiveness might not be required. The "study" in this context is the detailed comparison and justification provided in the 510(k) submission to the FDA.

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IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula.

The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.

IFS bone plates consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of Titanium 6Al-4V ELI or stainless steel.

This document is a 510(k) summary for Internal Fixation Systems, Inc.'s IFS Bone Plates, Screws, and Washers. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.

This document is a 510(k) premarket notification summary and does NOT contain information about acceptance criteria or a study proving device performance against such criteria. It's a regulatory submission to demonstrate equivalence to already-marketed devices, not a performance study report.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory equivalence rather than performance metrics.

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The IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Warning: IFS Bone Fixation Devices are not indicated for spinal fixation.

The IFS Bone Fixation Devices consist of cancellous, malleolar, or cortical screws ranging from 6 to 160mm in length and 1.5mm to 7.3mm in diameter. Threaded, spaded or blunt guide wires range from 0.028 to 0.188 of an inch in diameter and 4 to 12 inches in length. All IFS Bone Fixation Devices are manufactured using 316L stainless steel.

The provided text is a 510(k) summary for a medical device (IFS Bone Fixation Devices) seeking clearance from the FDA. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials to prove safety and effectiveness through specific acceptance criteria and performance studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way a de novo or PMA submission would.

Here's why and what information is available:

• No specific acceptance criteria or performance study results: The core of a 510(k) is to show that the new device is "substantially equivalent" to an already legally marketed predicate device. This means the new device has "similar design attributes, material, and intended use" and the same technological characteristics as the predicate. It does not typically involve setting specific performance metrics (like sensitivity, specificity, accuracy) and then conducting a new study to meet those targets.
• Focus on substantial equivalence: The provided text explicitly states: "There are no significant differences between bone fixation devices and the other devices as listed in the Substantially Equivalent Devices. The IFS Bone Fixation Devices and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, experts, or ground truth, as this information is not part of a 510(k) summary focused on substantial equivalence.

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The Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.

The IFS Cannulated Screw is a self-tapping, self-drilling screw with a cancellous thread that can be guided into position by guidewire placement. Partial or fully threaded screws are available in 3.0mm, 3.5mm, and 4.0mm thread diameters and 10mm to 75mm in length.

The provided document is a 510(k) summary for a medical device called the "IFS Cannulated Bone Screw". This type of document is for demonstrating substantial equivalence to a predicate device, not for presenting a study proving a device meets specific acceptance criteria related to its performance in a clinical or diagnostic context.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, how training set ground truth was established) are not applicable to the information contained within this document. The document focuses on regulatory compliance and comparison to existing, legally marketed devices.

However, I can extract the acceptance criteria as implied by the substantial equivalence declaration.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for IFS Cannulated Bone Screw

There are no explicit "acceptance criteria" and "device performance" metrics in the conventional sense (e.g., sensitivity, specificity, accuracy) detailed in this 510(k) summary. Instead, the "acceptance criteria" for this submission are implicit in demonstrating substantial equivalence to a predicate device. The "study" described is a comparison of design attributes, materials, and intended use.

1. Table of acceptance criteria and the reported device performance:

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

• Not Applicable. This document does not describe a clinical study with a test set of human subjects or data. The "study" primarily consists of a comparison of device characteristics against predicate devices for regulatory clearance.

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

• Not Applicable. No ground truth establishment by experts is described in this regulatory submission for a clinical test set.

4. Adjudication method for the test set:

• Not Applicable. No clinical test set or adjudication process is described.

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 a bone screw, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not a standalone algorithm.

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

• Not Applicable. The ground truth in this context is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and market history. The submission argues that the new device is "substantially equivalent" to these known and accepted devices.

8. The sample size for the training set:

• Not Applicable. This document does not describe the development or training of an algorithm.

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

• Not Applicable. No training set or ground truth establishment for a training set is described.

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