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The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.

The OrthoPro Ankle Trauma system is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of lones and bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplies with the system to facilitate implantation.

The provided text is for a medical device (The OrthoPro Ankle Trauma System) that is a metallic bone fixation appliance. The acceptance criteria and the study performed for this type of device are primarily focused on non-clinical performance benchmarks, demonstrating substantial equivalence to predicate devices, rather than clinical performance measures or AI-driven diagnostic accuracy.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" will largely pertain to biomechanical testing and comparison with legally marketed predicate devices, and not to a clinical study involving human readers, AI assistance, or diagnostic accuracy metrics typically seen in AI/ML medical devices.

Here's the breakdown based on the provided text, addressing the points where information is available or applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by demonstrating substantial equivalence in performance to predicate devices through standardized biomechanical testing. The performance is reported as meeting or exceeding the predicate.

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

The text explicitly mentions tests conducted on "the worse case plate" and "the screws" from the Ankle Trauma System. This implies a limited number of physical samples for mechanical testing, not a large test set of clinical data from patients. The provenance of these physical samples would be the manufacturing facility, representing the device itself.

• Sample Size: Not explicitly stated as a numerical count, but refers to "the worse case plate" and "the screws," indicating physical samples for destructive testing. Typically, biomechanical testing involves a statistically significant number of samples of the device and predicate to demonstrate equivalence; however, specific numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data. The "data" comes from in vitro biomechanical testing of the manufactured devices.

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

This question is not applicable to the non-clinical testing described. "Ground truth" in this context would refer to the established standards and methodologies of the ASTM documents (ASTM F382-99 and ASTM F543-07), which are developed by expert consensus within the field of biomaterials and medical devices. There are no "experts used to establish ground truth for the test set" in the sense of clinical reviewers or annotators, as this is a non-clinical, mechanical performance study.

4. Adjudication Method for the Test Set

Not applicable. This refers to methods for resolving discrepancies among multiple expert reviewers in clinical studies. No such adjudication was performed as this was non-clinical biomechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No. This type of study is performed for diagnostic imaging devices, often involving AI. This device is a metallic bone fixation appliance, and no such clinical or AI-related study was performed. The document explicitly states: "No clinical studies were performed."

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

No. This question is relevant for AI/ML medical devices. This device is a physical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is established by:

• Standardized Biomechanical Testing Methods: ASTM F382-99 (Standard Specification and Test Methods for Metallic Bone Plates) and ASTM F543-07 (Standard Specification and Test Metallic Bone Screws).
• Performance of Predicate Devices: The measured mechanical performance of the legally marketed predicate devices serves as the benchmark against which the new device's performance is compared for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable, as there is no training set for this device.

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The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

The iFUSE Hammertoe System by OrthoPro is a single piece metal implant that is surgically inserted into the intramedullary canal of the bones in the toe, finger or small bones, designed to create a fusion.

The provided text does not contain information about a study proving the device meets acceptance criteria in the way typically required for AI/ML device submissions (i.e., with performance metrics, ground truth establishment, or human-in-the-loop studies).

Instead, this document is a 510(k) summary for a medical device (iFUSE Hammertoe System), which is a premarket submission to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. For this type of device (a bone fixation screw), substantial equivalence is primarily demonstrated through non-clinical testing (mechanical properties) and comparison to predicate devices, rather than clinical studies or performance against acceptance criteria derived from a complex AI/ML algorithm.

Here's why the provided text doesn't fit the requested criteria and what it does say:

1. Acceptance Criteria & Device Performance Table: Not applicable. The submission focuses on demonstrating substantial equivalence through mechanical testing rather than meeting specific performance thresholds against a diagnostic benchmark. The non-clinical tests performed are:

   • Pullout strength
   • Four-point bending and fatigue strength
     The document states: "The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices." This is the "performance" relative to the "acceptance criteria" of being equivalent to predicates for mechanical properties.

2. Sample Size for Test Set & Data Provenance: Not applicable for a clinical test set. The "testing" refers to mechanical properties of the device itself (hardware), not observational data.

3. Number of Experts & Qualifications / Adjudication Method: Not applicable. There was no clinical study involving human readers or expert radiologists for establishing ground truth from medical images.

4. MRMC Comparative Effectiveness Study: Not applicable. This device is a surgical implant, not an AI diagnostic tool.

5. Standalone (Algorithm Only) Performance: Not applicable. There is no algorithm.

6. Type of Ground Truth Used: Not applicable for a clinical study. For the mechanical tests, the ground truth would be the established engineering standards for strength and fatigue, and data from the predicate devices.

7. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There's no AI/ML algorithm requiring training data.

Key Information from the Document that Relates to "Proof" of Meeting "Acceptance Criteria" for this specific device:

• Acceptance Criteria (Implicit): The primary "acceptance criterion" for this 510(k) submission is that the iFUSE Hammertoe System is substantially equivalent to legally marketed predicate devices (Stayfuse, Pioneer Surgical Technology, K990804 and OthoPro Stemman Pins and Kirschner Wires, OrthoPro LLC, K070555) in terms of:
  • Intended use
  • Design
  • Materials used
  • Mechanical safety
  • Performance
• Study Proving Device Meets Acceptance Criteria: The "study" was non-clinical testing:
  • Tests Performed: Pullout strength; Four-point bending and fatigue strength.
  • Results/Conclusion: "The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices." And "The conclusions drawn from the comparison between the devices demonstrate that the iFUSE Hammertoe System is as safe, as effective, and performs as well as the predicate devices."
  • Clinical Studies: "No clinical studies were performed."

In summary, the provided text describes the submission for a Class II metallic bone fixation fastener, where "acceptance criteria" and "proof" primarily revolve around demonstrating mechanical equivalence to existing devices through non-clinical laboratory testing, not through clinical trials or performance metrics of an AI/ML system.

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The Ortho-Pro CSTS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:

• Severely pronated foot .
• Calcaneal stance position greater than 5° .
• Manually correctable deformities .
• . Mid-tarsal breech (arch pain)
• Forefoot varus greater than 10° .

The Ortho-Pro CSTS Screw consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is conical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. External flattened threads increase ease of insertion. It is available in five sizes, Ø8mm to Ø12mm in 1mm increments.

The provided document describes the 510(k) summary for the CSTS Screw, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical trials to establish new safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" and "reported device performance" are typically framed in terms of demonstrating substantial equivalence to a predicate device through non-clinical testing and comparing design features. There isn't a direct "acceptance criteria" in the sense of a numerical diagnostic performance target as would be seen in an AI/diagnostic device study. Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as the predicate.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical bench testing study combined with a comparison to predicate devices.

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the conventional sense of a clinical trial. The "test set" here refers to the samples of the CSTS Screw that underwent compressive testing. The exact number of screws tested is not provided in the summary.
• Data Provenance: The testing appears to be prospective bench testing conducted specifically for this submission. There is no mention of country of origin for data as it's a bench test, not clinical data from patients.

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

Not applicable. For a device like the CSTS Screw, "ground truth" and expert adjudication are typically associated with clinical outcomes, image interpretation, or pathological diagnosis. This submission relies on substantial equivalence and non-clinical engineering tests. There's no mention of experts establishing a "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in diagnostic studies. This document describes non-clinical mechanical testing, where results are objective measurements rather than subjective interpretations 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

Not applicable. This device is a subtalar screw, a physical implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this submission.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing: The "ground truth" would be the objective measurements obtained from the compressive testing (e.g., force at failure), and the engineering specifications/standards (e.g., ASTM F136 for materials). The "truth" of substantial equivalence is established by comparing these test results and design features to those of the predicate devices, which have already been deemed safe and effective.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning algorithms. This is a physical medical device.

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

Not applicable. Training sets and their ground truth are not relevant for this type of device submission.

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The DC Ulnar Shortening System provides fixation for osteotomies of the ulna.

The DC Ulnar Shortening System is an implant intended for fixation of the ulna to assist healing. The implant is fabricated from titanium alloy. It is fixated with 3.5mm fixation screws and a 3.5mm self drilling self tapping headless interfragmentary screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.

The provided text describes a 510(k) summary for the "DC Ulnar Shortening System", a metallic bone fixation appliance. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on:

• Device identification: Trade name, common name, classification, and submitter details.
• Predicate device comparison: Stating that the device is substantially equivalent to previously cleared ulnar osteotomy bone plates and screws.
• Device description: Materials (titanium alloy Ti6Al4V), function (fixation for osteotomies of the ulna), and components (plate, 3.5mm fixation screws, 3.5mm self-drilling self-tapping headless interfragmentary screw, instruments).
• Intended Use: Fixation for osteotomies of the ulna.
• FDA clearance letter: Affirming substantial equivalence based on the provided information.

Based on the provided text, I cannot complete the requested tables and information. The submission appears to be a "traditional" 510(k) that relies on substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the answer in the requested format as the necessary information is absent from the input.

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The OrthoPro Steinman Pins and Kirschner Wires 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.

The OrthoPro Steinman Pins and Kirschner Wires are offered in a variety of lengths, diameters, tip styles, and threading. These devices are constructed of implant grade 316LVM stainless steel conformant to ASTM F138, are provided non-sterile, and are intended for single-use only. The OrthoPro Pins and Wires product family is available in a range of lengths, diameters, and tip styles, with and without threading. All pins and wires are manufactured from 316LVM surgical implant grade stainless steel certified to ASTM F138. The devices will range in diameter from 0.028 inches to 0.1875 inches. The devices range in length from 4 inches to 12 inches. The devices are available in a variety of tip styles, including but not limited to trocar point, diamond point, and cove point. The devices will have proximal tip styles including but not limited to trocar point, diamond point, check point, and round. The devices will be provided in fully threaded, partially threaded and nonthreaded versions.

Here's an analysis of the provided 510(k) summary for the OrthoPro Steinman Pins and Kirschner Wires, focusing on the acceptance criteria and supporting studies as requested:

Summary of Acceptance Criteria and Device Performance:

The 510(k) submission for the OrthoPro Steinman Pins and Kirschner Wires does not present specific quantitative acceptance criteria or a detailed "study" in the traditional sense (e.g., performance metrics with benchmarks). Instead, it relies on the concept of substantial equivalence to predicate devices. The primary "acceptance criteria" and "device performance" are centered around meeting the general characteristics of existing, legally marketed devices.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The provided 510(k) summary does not describe a clinical study or a non-clinical performance study with quantitative results to establish specific acceptance criteria and then demonstrate the device meets those criteria. Instead, it relies on the concept of substantial equivalence to predicate devices through a comparison of technological characteristics.

Here's why many of your detailed questions are not directly applicable or cannot be answered from this specific document:

1. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The device's characteristics are compared directly to the specifications of predicate devices.
2. 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 process is described as there isn't a performance test set.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 (Steinman Pins and Kirschner Wires) is a mechanical orthopedic fixation device, not an AI or imaging diagnostic tool. MRMC studies are irrelevant here.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm or AI component in this device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the traditional sense of a performance study. The "ground truth" for substantial equivalence is the established characteristics and performance of the legally marketed predicate devices.
7. The sample size for the training set: Not applicable. No AI/machine learning component to train.
8. How the ground truth for the training set was established: Not applicable.

Explanation of the "Study" and Approach:

The document explicitly states:

• "Summary of Non-Clinical Tests: The non-clinical testing to be conducted on the OrthoPro Steinman Pins and Kirschner Wires will include material and dimensional verification."
• "The OrthoPro Steinman Pins and Kirschner Wires are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices."

This indicates that the "study" for this 510(k) submission primarily involved:

• Engineering Analysis and Documentation: Verification of the device's material composition (316LVM stainless steel per ASTM F138) and its physical dimensions (lengths, diameters, tip styles, threading options) against its own specifications and in comparison to the publicly available characteristics of predicate devices (DePuy Steinman Pins and Kirschner Wires K960385, Smith and Nephew Pins and Wires K994143, and a pre-amendment Smith and Nephew device).
• Predicate Comparison: The core of the submission is a detailed comparison demonstrating that the new device shares the same intended use, materials, and fundamental technological characteristics as already cleared devices, thus establishing substantial equivalence.

In essence, for this type of medical device (a well-understood mechanical component), "substantial equivalence" allows manufacturers to leverage the regulatory history and safety/effectiveness profile of existing predicate devices rather than conducting new, extensive clinical or performance studies, provided the new device does not raise new questions of safety or effectiveness. The "acceptance criteria" are implicitly met by being demonstrably equivalent to devices that have already met regulatory requirements.

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The Metal Hemi Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.

The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The Metal Hemi Implant requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).

This document is a 510(k) premarket notification for a medical device called the "Metal Hemi Implant." 510(k)s are primarily focused on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a comprehensive study proving the device meets specific acceptance criteria in the way a diagnostic AI or interventional device might.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth types) are not applicable or mentioned in this type of submission. This device is a physical implant, not a diagnostic algorithm or imaging device that would typically involve such studies.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

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

Explanation: For a 510(k) for an implantable device like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a previously legally marketed device (the predicate). The "device performance" is described through its design features, materials, and intended use, which are deemed equivalent to the predicate. There are no quantitative performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic algorithms.

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

• Sample size: Not applicable/Not provided. This is an implantable device, not a diagnostic algorithm tested on a dataset of patient images or readings.
• Data provenance: Not applicable/Not provided.

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)

• Number of experts: Not applicable/Not provided.
• Qualifications of experts: Not applicable/Not provided.

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

• Adjudication method: Not applicable/Not provided.

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

• MRMC study: No, this is not an AI-assisted diagnostic device.
• Effect size: Not applicable.

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

• This is not an algorithm; it is a physical medical implant. Therefore, a standalone performance study in this context is not applicable.

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

• Type of ground truth: For a 510(k) of an implant, the "ground truth" for demonstrating substantial equivalence typically involves engineering testing (e.g., material testing, mechanical load testing, biocompatibility evaluations, sometimes cadaveric studies for range of motion or surgical technique), and clinical experience/literature supporting the safety and effectiveness of the predicate device and the materials used. The document states "The Metal Hemi Implant does not incorporate any new technological characteristics as compared to the predicate device. The Metal Hemi Implant and the predicate devices are made from the same material. The Metal Hemi Implant has the addition of CP Ti plasma spray." This implies that the 'ground truth' for its performance aligns with the established performance of the predicate and the known properties of the materials.

8. The sample size for the training set

• Sample size: Not applicable/Not provided. This is a physical implant, not a machine learning model.

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

• Ground truth establishment: Not applicable/Not provided.

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The Ortho/Pro Hemi Toe is designed to supplement first metatarsal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.

The Ortho/Pro Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adiacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, majntain range of motion and reduce pain without altering the joint biomechanics. The Hemi Tor requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (OrthoPro Hemi Toe) and primarily focuses on establishing substantial equivalence to predicate devices, not on performance criteria or clinical study results.

The key statement regarding testing is: "The Ortho/Pro Hemi Toe does not incorporate any new technological characteristics as compared to the predicate devices. The Ortho/Pro Hemi Toe and the predicate devices are made ofinial the same material." This indicates that the regulatory approval was likely based on equivalence in design, materials, and intended use, rather than a specific performance study with acceptance criteria.

Therefore, I cannot provide the requested table or details about a study, as that information is not present in the provided text.

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