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The NexFix™ Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.

The Nexa Orthopedics, Inc Implant is a one-piece device made of Stainless Steel or Titanium Alloy, intended for fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis. The implant is designed in 10 sizes. The device is tapered and threaded on the leading end and smooth on the trailing end. The implant is used in the treatment of bone fractures or bone reconstruction, including osteotomy, and joint fusion. The design of the NexFix™ Compression Pin is similar to the predicate devices. No new materials or processes are used in the development of this implant.

This 510(k) summary describes a traditional medical device (a threaded pin for bone fixation), not an AI/ML-powered device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices based on design characteristics, intended use, and materials. There is no mention of an algorithm, data analysis, or performance evaluation in the context of AI/ML.

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The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:

• . Rheumatoid arthritis with pain
• . Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• . Correction of functional deformity
• . Fractures of the humeral head
• . Traumatic arthritis
• Revision of other devices if sufficient bone stock remains .

All components are single use. The humeral stem is intended for cementless use while the all polyethylene glenoid is intended for cemented use only.

The Nexa Orthopedics Total shoulder system is comprised of a line of humeral stems, humeral heads, and all polyethylene glenoid components. The humeral stems are sized and shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally filling shape, are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading, and proper head placement with 0 to 3 mm of head adjustment possible. The humeral heads are offered with both spherical and non-spherical articulating surfaces and allow both neutral and offset head positioning via offset taper. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the Nexa all polyethylene, cemented glenoid. The glenoid has two or three pegs, depending on size, and is designed to function with both the spherical and non-spherical heads of the Nexa system.

The provided text describes a 510(k) summary for the Nexa Orthopedics Total Shoulder System. However, it does not include detailed acceptance criteria or a study proving device performance against such criteria in the format requested.

The document lists various ASTM standards to which the device components have been evaluated. These standards define test methods and specifications, which imply certain performance requirements, but the specific acceptance criteria values and the results showing the device meets them are not provided in this summary.

Therefore, I cannot fully complete the table or answer all sub-questions based solely on the provided text. I will fill in what can be inferred and explicitly state where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document. The listed ASTM standards typically define test methodologies, including sample size recommendations, but the specific number of units tested for this device is not reported here.
• Data Provenance: Not specified. This would typically be from laboratory testing as per the ASTM standards.

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

• Not applicable. This device is an orthopedic implant and its performance is evaluated through mechanical testing against established engineering standards (ASTM), not through expert clinical review of data for "ground truth" in the way a diagnostic AI might be.

4. Adjudication method for the test set

• Not applicable for mechanical testing of an orthopedic implant. Adjudication methods like "2+1" are relevant for clinical or imaging studies involving human interpretation or consensus.

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 is not an AI/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used

• Not applicable in the typical sense of "ground truth" for clinical or diagnostic devices. The "ground truth" for this device's performance is defined by its adherence to established engineering specifications and material properties as outlined in the ASTM standards.

8. The sample size for the training set

• Not applicable. This is an orthopedic implant, not a machine learning model. There is no "training set."

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

• Not applicable. As noted above, there is no "training set" or "ground truth" in the context of training a model for this device.

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The NexFix™ Compression Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.

The Nexa Orthopedics NexFix™ Compression Staple is made of Stainless Steel intended to be implanted into the bones of the fore foot, mid foot and hind foot. The stables are provided in 21 sizes. The staples are used for fracture fixation, fusion, and osteotomy of the bones of the hand and foot.

The provided document is a 510(k) summary for the Nexa Orthopedics NexFix™ Compression Staple. It states that no clinical testing was performed as a basis for substantial equivalence. Therefore, there are no acceptance criteria, device performance data, or studies that prove the device meets acceptance criteria as typically found in clinical trials.

The substantial equivalence was based on non-clinical laboratory testing and the device having similar design characteristics and intended use to legally marketed predicate devices.

Here's a breakdown based on the information provided, highlighting the absence of clinical study details:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission states "Clinical Testing: None provided as a basis for substantial equivalence." The non-clinical testing results "indicate that the device was functional within its intended use," but specific acceptance criteria and detailed performance metrics from these tests are not provided in this summary.

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

Not applicable. No clinical test set was used for substantial equivalence. For non-clinical testing, the sample size and data provenance are not specified in this summary.

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

Not applicable. No clinical test set requiring expert-established ground truth was used for substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was performed for substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant (compression staple), not a software algorithm, so the concept of standalone algorithmic performance is irrelevant.

7. Type of Ground Truth Used

Not applicable for clinical studies. For the non-clinical testing that was performed, the "ground truth" would be engineering specifications and mechanical testing standards, but the specific details are not provided in this summary.

8. Sample Size for the Training Set

Not applicable. No training set was used as no clinical study or algorithm development was detailed for this 510(k) submission.

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

Not applicable. No training set was used.

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The device is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb with limited range of motion.

The Nexa Orthopedics CMI implant and surgical instruments are provided in 3 sizes. The device is intended to be implanted into the metacarpal of the thumb. The device is made of pyrocarbon. No new materials are used in the development of this implant.

The provided text is a 510(k) summary for the Nexa carpometacarpal (CMI) implant. This document is a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and device performance results.

Therefore, the information requested in your prompt (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) is not available within the provided text.

The document states:

• "Documentation is provided which demonstrated the device to be substantial equivalent to other legally marketed devices."
• "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device."

This indicates that the FDA's decision was based on a comparison to an already approved device, likely through engineering bench tests and a review of the device's design and materials, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria.

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The Nexa Compression Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The Nexa Compression Screw is made of 316L Stainless Steel, per ASTM F138, and is intended to be implanted into the bones of the foot and hand, and bones appropriate for the size of the device. The screws are provided in three diameters of various lengths. No new materials are used in the development of this implant.

This document, K060076, is a 510(k) Summary for a medical device called the "Nexa Compression Screw." It does not describe an AI/ML medical device. Therefore, a study proving the device meets acceptance criteria related to AI/ML performance metrics (like sensitivity, specificity, or reader improvement) is not applicable and not present in the provided text.

The information provided describes a traditional medical device (a surgical implant) and its substantial equivalence to predicate devices, which is the regulatory pathway for such devices.

Here's a breakdown of why the requested information about acceptance criteria and study proving performance cannot be extracted for an AI/ML device:

1. AI/ML Device Implication: The request is designed for AI/ML devices that generate data, such as images, interpretations, or diagnostic aids.
2. Device Type: The Nexa Compression Screw is a physical implant made of 316L Stainless Steel. Its performance is evaluated through material properties, mechanical testing, and clinical use cases, not through algorithmic output.
3. Regulatory Pathway: The 510(k) pathway for this device focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, primarily through comparison of materials, design, indications for use, and mechanical characteristics. It does not typically involve clinical studies with performance metrics like those for AI/ML algorithms.

Therefore, I cannot provide the requested table or details about AI/ML performance for K060076 as it is not an AI/ML medical device.

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The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomies. The system consists of plates and screws for treatment of the phalanges, and metatarsals.

The Nexa Orthopedics bone plate and screw system of plates and screws made of Stainless Steel (316L) and Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, ankle, hand, wrist, ulna and radius. The plates are provided in 4 sizes, right and left configuration. The screws are provided in 2 diameters 2.7 and 3.2 and lengths from 12-28 mm. The plates and screws are used for fracture fixation, fusion, and osteotomy of the bones of the foot.

This document is a 510(k) premarket notification for the Nexa bone plate and screw system, dated December 22, 2005. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance criteria or a comprehensive clinical study report. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria cannot be directly extracted from this document in the typical sense of a modern medical device clinical study report.

However, I can extract and infer information relevant to the context of a 510(k) submission at that time, focusing on how the device demonstrates substantial equivalence rather than meeting specific quantifiable performance targets like sensitivity/specificity for an AI algorithm.

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

In the context of the 2005 510(k) for this device, "acceptance criteria" and "reported device performance" are primarily about demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing design characteristics, material, and intended use. The "acceptance criteria" are implied to be that the new device is as safe and effective as the predicate based on these comparisons.

Study that proves the device meets the acceptance criteria:

The document describes a comparison to a predicate device as the "study" demonstrating that the device meets the implied acceptance criteria for substantial equivalence.

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 for Test Set: Not applicable in the context of this 510(k) submission. This is not a study assessing clinical performance with a "test set" of patient data or images in the way an AI/software device would. The "test" here is the comparison of device specifications and intended use against a legally marketed predicate device.
• Data Provenance: Not applicable. The "data" consists of device specifications, materials, and intended use as described by the manufacturer in comparison to public information about the predicate device.

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. There is no "ground truth" establishment by external experts for a test set in this type of submission. The "ground truth" for substantial equivalence is the information presented by the applicant and evaluated by the FDA reviewer.
• Qualifications of Experts: FDA reviewers (e.g., in the Orthopedic Reviewing Panel, Office of Device Evaluation) would analyze the information, but they are not establishing a clinical "ground truth" for a dataset.

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

• Adjudication Method: Not applicable. There is no test set requiring expert 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

• MRMC Study: No, absolutely not. This is a 510(k) for a physical orthopedic implant (bone plate and screw system), filed in 2005. MRMC studies, especially those involving AI assistance, are relevant to diagnostic imaging algorithms or CAD systems, which are completely different device types.

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

• Standalone Performance Study: No. This is a physical implant. There is no "algorithm" to evaluate.

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

• Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate device (Wright Medical Charlotte Small MTP Fusion Plate), and the demonstration that the new device is substantially equivalent to it based on shared technological characteristics, materials, and intended use. There is no clinical "ground truth" dataset in the sense of patient outcomes or pathology.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.

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

• Ground Truth for Training Set Establishment: Not applicable.

Summary for the context of this 2005 510(k) for an orthopedic implant:

The "acceptance criteria" here implicitly revolve around demonstrating that the Nexa bone plate and screw system is substantially equivalent to its predicate device (Wright Medical Charlotte Small MTP Fusion Plate) in terms of:

• Intended use
• Device materials
• Design characteristics
• Principles of operation

The "study" that proves the device meets these acceptance criteria is the comparative analysis presented in the 510(k) submission, specifically the "Comparison to Predicate Device" section. This comparison highlights similarities in all critical aspects (use, fixation, material, general indications for use, and manufacturing standards) between the proposed device and the predicate. The FDA's issuance of the 510(k) clearance (DEC 22 2005) serves as the "proof" that the device met these implicit acceptance criteria for substantial equivalence.

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The Nexa bone screw system provides fixation of fractures, fusions, or osteotomies of bones of the hand and foot.

The Nexa Orthopedics bone screw system consists of screws made of Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, and hand. The screws are provided in 6 sizes. The screws are used for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The design of the Nexa bone screw system is similar in shape and size to the Wright Medical Charlotte Snap-Off Screw. No new materials arc used in the development of this implant.

This document describes a medical device submission (K053394) for the Nexa bone screw system. This is a premarket notification (510(k)), which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not involve clinical studies with acceptance criteria for device performance as would be seen for new, high-risk devices.

Instead, substantial equivalence is established by comparing the new device's design, materials, indications for use, and technological characteristics to those of a predicate device. The "acceptance criteria" here are therefore about demonstrating this substantial equivalence, rather than meeting specific performance metrics from a clinical trial.

Based on the provided text, there is no study described that proves the device meets specific performance acceptance criteria in the way you might expect for a diagnostic or AI-powered device. This 510(k) is for a bone screw system, which is a physical implant, and the primary demonstration of safety and effectiveness relies on its similarity to an already approved device.

Here's an analysis based on your requested information, highlighting what is (and isn't) present in the provided text:

Description of Acceptance Criteria and Proving Device Meets Criteria (Based on Substantial Equivalence)

The "acceptance criteria" for K053394 are implicitly tied to the demonstration of substantial equivalence to the predicate device, the Wright Medical Charlotte Snap-Off Screw (K043583). The study performed is a comparison study of device characteristics. The "device performance" in this context refers to the characteristics and intended use being sufficiently similar to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a physical implant, the "acceptance criteria" are not reported as numerical performance metrics (like sensitivity, specificity, etc.) but rather as successful demonstration of similarity in key attributes to the predicate device.

• Same principle of operation.
• Similar design (shape, size).
• Same materials.
• Single-use.
• Surgical implantation duration (>30 days). | Meets:
• Both are screw fixation devices.
• Similar in shape and size.
• Both use Titanium (6AL-4V ELI / 6AL-4V alloy).
• Both are single-use.
• Both are intended for surgical implantation longer than 30 days. |
  | Safety and Effectiveness: No new questions of safety or effectiveness are raised. | Meets: The submission asserts "no new materials are introduced" and "the new device is substantially equivalent to the predicate device," implying no new safety/effectiveness concerns. |

Summary: The comparison table in the submission (Table 1) acts as the "study" demonstrating that the Nexa bone screw system meets the implicit acceptance criteria of substantial equivalence by showing its characteristics align with the predicate device.

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

Not applicable. This is not a study involving a "test set" of patient data in the context of diagnostic or AI performance. The "test set" here would be the physical device itself being compared to the predicate's specifications and historical performance. Data provenance similarly is not applicable as there is no patient data or clinical outcomes data presented.

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

Not applicable. Ground truth for a physical implant's design and material equivalence is established by engineering and material specifications, not expert consensus on patient cases.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in this type of submission.

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 physical bone screw, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" is primarily based on:

• Engineering specifications and material science: Verification that the materials (Titanium 6AL-4V ELI) and design (shape, sizes) of the Nexa screw meet established standards and are comparable to the predicate.
• Predicate device's established safety and effectiveness: The Charlotte Snap-Off Screw, being a legally marketed device, serves as the benchmark for what is considered safe and effective for its indicated uses.
• Regulatory definitions: Adherence to FDA regulations for Class II devices and product codes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/algorithm. For an implant like this, manufacturing quality control would involve testing samples from production batches, but this is distinct from a "training set" in AI.

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

Not applicable, as there is no training set.

In summary: The provided document is a 510(k) premarket notification for a physical bone screw system. The "study" for acceptance involves a comparison of the new device's characteristics (materials, design, intended use) to those of a legally marketed predicate device to demonstrate substantial equivalence. It does not involve clinical performance studies with patient data, AI algorithms, or expert ground truth adjudication as described in your prompt criteria, which are more relevant to diagnostic or AI-powered devices. The FDA's acceptance of this 510(k) indicates that they agreed the device is substantially equivalent to the predicate, and therefore, does not raise new questions of safety or effectiveness.

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The Futura Biomedical Tapered Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.

The Futura Biomedical Implant is a one-piece device made of Stainless Steel or Titanium Alloy, intended for fixation of bone fractures, bone reconstruction, osteotomy or Andy, intended 101 - 121 is designed in 3 sizes. The device is tapered and threaded on the leading end and smooth on the trailing end. The implant is used in the treatment or the feactures of bone reconstruction, including osteotomy, and joint fusion. The design of the Futura Biomedical Tapered Pin is similar in shape and size to the Newdeal TAC of the Patare Dietices consist of a tapered, threaded pin that fits into a pin driver. Surgical instruments include a k-wire, drill, pin cutter, pliers, and trephine. No new materials are used in the development of this implant.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) summary for a medical device called the "Tapered Compression Pin" and its associated FDA clearance letter. It details the device's description, indications for use, comparison to a predicate device (Newdeal TAC pin), and the FDA's decision of substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study as requested, as this information is not present in the given text.

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The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.

OsteoCure paste cured in-situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.

OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.

OsteoCure Resorbable Bead Kit and OsteoCure Injectable Graft Kit consist of premeasured surgical grade calcium sulfate, pre-measured mixing solution, and the tools necessary to mix the components into a paste. These products are provided sterile for single patient use. When mixed according to directions, the OsteoCure Kits produce biodegradable, radiopaque paste/molded beads that resorb in approximately 30-60 days, when used according to labeling.

After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

The provided document, K051406, is a 510(k) premarket notification for the OsteoCure Resorbable Bead Kit and OsteoCure Injectable Graft Kit. A 510(k) notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific, quantitative acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the specific information requested about acceptance criteria and a dedicated study to prove the device meets these criteria in the way one might find for a novel diagnostic or AI device.

However, based on the information provided, here's a breakdown of what can be inferred and what is not available:

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

This information is not explicitly stated in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices (Biogeneration, ProFusion Bone Graft Substitute Kits and Wright Medical OsteoSet) in terms of:

• Intended Use: The OsteoCure Kits are intended for filling non-load bearing bone voids/gaps, which may be surgically created or due to traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The paste also augments provisional hardware for temporary support.
• Material Composition: "The OsteoCure Kits have the equivalent chemical composition...as the predicate device."
• Technological Characteristics: "The OsteoCure Kits have...the technological characteristics as the predicate device."
• Performance Data: "Testing demonstrated that the performance of the OsteoCure Kits are substantially equivalent to the performance of the predicate device."

Without specific acceptance criteria for a new clinical outcome or performance benchmark, it's impossible to create a table of acceptance criteria and reported device performance. The "performance data" mentioned is not detailed, but broadly states "substantially equivalent."

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 available in the provided document. The 510(k) summary does not describe a clinical study in the traditional sense with a "test set" of patients. The performance data mentioned likely refers to non-clinical (e.g., in-vitro, mechanical, animal) testing to support material and characteristic equivalence.

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 information is not applicable/not available. As there is no described clinical study with a "test set" and a need for "ground truth" establishment by experts (e.g., for diagnostic accuracy), this detail is not present.

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

This information is not applicable/not available for the same reasons as point 3.

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 information is not applicable/not available. The OsteoCure devices are bone void fillers, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

This information is not applicable/not available. The OsteoCure devices are not algorithms or AI.

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

This information is not applicable/not available. Since there is no detailed clinical study described requiring ground truth for performance evaluation (e.g., diagnostic accuracy), this information is not present. For device performance in equivalence, the "ground truth" would be the known and accepted performance characteristics of the predicate device, which is established through its own regulatory history and performance data.

8. The sample size for the training set:

This information is not applicable/not available. The OsteoCure devices are not AI models requiring training sets.

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

This information is not applicable/not available for the same reason as point 8.

In summary:

The provided document is a 510(k) summary demonstrating substantial equivalence to predicate devices, primarily through comparison of materials, indications for use, and general performance. It does not detail a study designed to prove the device meets specific, quantitative acceptance criteria through a clinical trial with human subjects and associated performance metrics, as would be expected for a novel device or an AI/diagnostic product. The "acceptance criteria" here are implicitly meeting the standards of the predicate device to establish substantial equivalence.

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The Futura Biomedical Subtalar Peg 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. Examples include: Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ... ) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability This device is intended to be fixed with bone cement.

The Futura Biomedical Implant is a one-piece device made of UHMWPE or Cobalt Chromium with titanium plasma spray on the stem, intended to be implanted into the calcaneus of the foot. The implant is designed in 13 sizes and two configurations. 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.

This document is a 510(k) Summary for the Futura Biomedical Subtalar Peg Implant, comparing it to a predicate device, the Wright Medical STA-Peg implant. The purpose of this document is to demonstrate "substantial equivalence" to a legally marketed device, not to present a study proving the device meets specific acceptance criteria in the way an AI/ML device submission would.

Therefore, the requested information regarding acceptance criteria, study details, ground truth establishment, expert involvement, and sample sizes for training/test sets is not applicable in this context. This document pertains to a traditional medical device (an implant), not a software as a medical device (SaMD) or an AI/ML-driven device.

However, I can extract the comparison between the new device and the predicate device, which serves a similar purpose of demonstrating safety and effectiveness based on existing, accepted technology.

1. Table of Acceptance Criteria and Reported Device Performance:

For a traditional medical device like an implant, acceptance criteria are typically met through demonstrating equivalence in design, materials, and intended use as compared to a legally marketed predicate device. The "performance" in this context refers to its ability to function as intended based on these equivalences.

Summary of How the Device Meets "Acceptance Criteria" (Substantial Equivalence):

The study (the 510(k) submission itself) demonstrates that the Futura Biomedical Subtalar Peg Implant is substantially equivalent to the legally marketed predicate device (Wright Medical STA-Peg implant) based on the following:

• Similarities in Design Characteristics and Intended Use: Both devices are for single use, intended for surgical implantation, designed to prevent excessive pronation while allowing normal subtalar joint motion, and are made of comparably sized, industry-standard materials.
• Identical Indications for Use: The stated indications for both devices are precisely the same, covering various conditions associated with hyperpronated foot and subtalar joint instability.
• Similar Device Mechanics: Both implants function as spacers to maintain joint space and limit excessive pronation.
• Material Equivalence: While the new device offers an additional material option (CoCr/CpTi), UHMWPE is common to both, and the provided materials are understood to be suitable for this application.
• Fixation Method: Both devices are intended for stem-in-bone fixation, with the Futura device explicitly mentioning fixation with bone cement, which is a common and accepted method.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is a submission for a traditional implant, not a data-driven AI/ML device. There is no "test set" in the context of an algorithm's performance. The "test" is the comparison to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth, in the context of expert consensus for AI/ML devices, is not a concept applied to the substantial equivalence determination of a traditional implant. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
Not applicable. This concept does not apply to this type of device submission.

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 is not an AI-driven device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-driven device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context is the safety and effectiveness profile of the legally marketed predicate device (Wright Medical STA-Peg implant), which has already established its performance in clinical use and met regulatory requirements. The new device is deemed acceptable because it is substantially equivalent to this established device.

8. The Sample Size for the Training Set:
Not applicable. There is no "training set" for this type of device.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no "training set" for this type of device.

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