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The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet.

The Instratek STAPIX™ Superelastic Implant Bone Staples kits are comprised of superelastic bone staples in 16 configurations. The Nitinol staples have a finished A(f) temperature of 10°C +/7° to ensure that the material is superelastic at room and body temperatures. The Instratek STAPIX™ Superelastic Implant is indicated for use in the treatment of bone fractures, osteotomies, and arthrodesis for the reconstructive surgeon. The device is intended for hand and foot surgery. STAPIX™ bone staples are made from superelastic nickel titanium that does not require cold storage or heating. Implant sizes range from 9mm to 24mm.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the STAPIX™ Superelastic Implant Bone Staples:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it relies on comparison to predicate devices and performance testing to demonstrate substantial equivalence.

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

• Sample Size for Test Set: Not specified. The summary only mentions "performance testing consisted of bending fatigue, static bending, and corrosion." This implies in vitro mechanical testing, not a clinical test set with human subjects.
• Data Provenance: Not applicable for in vitro mechanical testing. There is no mention of country of origin or whether the data is retrospective or prospective, as it's not a clinical study.

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

• This information is not applicable as the provided documentation describes in vitro mechanical testing and a comparison to predicate devices for substantial equivalence, not a clinical study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

• This information is not applicable as the provided documentation describes in vitro mechanical testing, not a clinical study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technological characteristics and in vitro performance testing compared to predicate devices.

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

• Not applicable. This device is a bone staple. It is not an algorithmic or AI-based device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established through physical and mechanical testing standards (for bending fatigue, static bending, and corrosion) and material science properties (like the A(f) temperature of Nitinol). The comparison point ("truth") for regulatory approval is the performance and characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware medical device (bone staple), not an AI/ML algorithm that requires a training set.

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

• Not applicable. As the device is a bone staple, there is no training set or associated ground truth establishment in the context of AI/ML.

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The Instratek 4.5mm, 5.5mm, and 6.5mm screws are indicated for fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction. These devices are not intended for use in the spine.

The Instratek 4.5mm, 5.5mm, and 6.5mm screws are intended for the following surgical indications:

• Metatarsal fractures
• Fixation of malunions and nonunions
• Acute fractures
• Avulsion fractures
• Repetitive stress fractures
• Malleolar fractures
• Talus fractures
• Greater tuberosity fractures
• Small joint fusion
• Jones fractures
• Osteotomies and non-unions in the foot and ankle

The Instratek Jones-FX System is comprised of screws in diameters 4.5mm, 5.5mm and 6.5mm. The screws are available in cannulated and non-cannulated versions and are constructed of TI-6AL-4V anodized titanium alloy conforming to ASTM F136. The screws have Torx heads. Instruments provided in the set include: Tissue protector K-wire guides Drill guide inserts (3.1mm, 4.0mm and 4.9mm) Tap Guide inserts (4.5mm, 5.5mm and 6.5mm) K-wire (1.7mm x 230mm) Cannulated drill bits (3.1mm, 4.0mm and 4.9mm) Screw Taps, Cannulated (4.5mm, 5.5mm, 6.5mm) Depth gauge Driver blade Fixed and Rachet Quick Connect Drivers Countersink Tray with Caddy

The provided text is for a 510(k) summary for a bone screw system (Instratek Jones-FX System). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving new clinical efficacy or performance through extensive studies with acceptance criteria as one might see for novel diagnostic AI devices.

Based on the provided information, no study was conducted to prove the device meets acceptance criteria. The submission explicitly states:

"No testing was conducted for inclusion with this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the submission does not contain such a study. The basis for substantial equivalence is the similarity in design, materials, intended use, and technological characteristics to predicate devices, not through performance testing against specific acceptance criteria.

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The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These devices are not intended for use in the spine.
The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
• Scaphoid Fractures
• Capitate
• Metacarpal Fractures
• Phalangeal Fractures
• Ulnar Styloid Fractures
• Small Joint Fusion
• Humeral head Fractures
• Intercarpal Fractures
• Tarsal Fusions
• Patellar Fractures
• Interfragmentary Ulnar Fractures
• Small Hand and Wrist Bone Fractures
• Forefoot Interfragmentary Fractures
• Lunate Fractures
• Trapezial Fractures
• Metatarsal Fractures
• Radial Head Fractures
• Osteo-Chondral
• Ostero-Chondral Fractures
• Glenoid Fractures
• Interphalangeal Fractures
• Malleolar Fractures
• Metaphyseal Fractures
• Interfragmentary Radius Fractures
• Distal Metatarsal Osteotomies
• Midfoot Interfragmentary Fractures

The Instratek Mini Cannulated Titanium Headed and Headless Screw Set is comprised of screws in diameters 2.5mm through 4.0mm. The screws are all cannulated and constructed of anodized titanium alloy. The screws have Torx heads. Instruments provided in the set include drivers (fixed and rotating) and blades, countersink/depth gauge, screw pickup, drill bits, threaded and unthreaded kwires and a caddy/tray.

The provided document is a 510(k) summary for the Instratek Mini Cannulated Titanium Headed and Headless Screw Set. It is a submission to the FDA for a medical device, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information (related to AI acceptance criteria, study design, ground truth, expert adjudication, MRMC studies, and standalone performance) is not applicable or cannot be extracted from this document.

However, I can extract information related to the device itself and the regulatory submission.

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

This document does not specify quantitative acceptance criteria or performance metrics for the device itself (e.g., screw strength, biocompatibility). Instead, it's a regulatory submission demonstrating substantial equivalence to predicate devices. The "performance" in this context refers to the device being considered "as safe and effective" as legally marketed predicate devices.

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. This document is a 510(k) summary for a physical medical device (bone screws), not a study evaluating an AI algorithm. Therefore, there is no "test set" in the context of an AI study, nor is there data provenance as described for algorithms.

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. As explained above, this is not an AI study. The "ground truth" for this device's safety and effectiveness is established through comparison to legally marketed predicate devices, which implicitly have a history of safe and effective use based on clinical practice and regulatory oversight. There are no specific experts mentioned for establishing "ground truth" in the context of this submission.

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

Not Applicable. This is not an AI study, so there is no adjudication method for a test set.

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 algorithm, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed (and would not be relevant).

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 an algorithm.

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

The "ground truth" in this 510(k) submission is based on substantial equivalence to legally marketed predicate devices. This means the new device is compared to existing devices with a known history of safety and effectiveness, based on their design, materials, technological characteristics, and intended use. There's no specific "ground truth" in the sense of a definitive diagnosis or outcome used to evaluate an AI algorithm.

8. The sample size for the training set:

Not Applicable. This document does not describe the development or evaluation of an AI algorithm, so there is no training set mentioned.

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

Not Applicable. As there is no AI algorithm or training set, this question is not relevant to the provided text.

In summary, the provided text is a regulatory submission (510(k) summary) for a physical medical device (bone screws) to demonstrate substantial equivalence to predicate devices, not a study evaluating the performance of an AI algorithm. Therefore, most of the detailed questions about AI acceptance criteria, study design, and ground truth are not addressed by this document.

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The Instratek CMC Cable FIX is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable FIX is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability.

The Instratek CMC Cable FIX is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable FIX is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability. The implanted device consists of three (3) components: Plate - 2-hole round - Ti-6Al-4v Plate - 2-hole oblong w/break away guide wire - Ti-6AL-4v #2 Suture - Ultra High Molecular Weight Polyethylene There are 3 accessories required to implant the device: Cannulated Drill Bit - 17-4 Stainless Steel K-wire - 316L Stainless Steel Suture Passer - PTFE tubing

This is a 510(k) premarket notification for a medical device called the "Instratek CMC Cable FIX," a suture button implant. The submission aims to establish substantial equivalence to predicate devices and does not describe a study involving AI or complex statistical analyses of diagnostic performance.

Here's a breakdown of the requested information based on the provided text, outlining why certain sections cannot be completely filled:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the given text. The submission describes "Comparative Suture Tensile Force (N) vs. Displacement (mm)" testing, which is likely mechanical testing of the device components, not a study on a "test set" of patients or data in the typical sense applied to diagnostic algorithms. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable here.

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

This information is not applicable/not provided. The "test set" described is mechanical testing, not a dataset requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human judgment for ground truth establishment. This submission describes mechanical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (suture button implant) and focuses on demonstrating substantial equivalence through technological characteristics and mechanical testing, not on comparative effectiveness with human readers or AI assistance.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical implant, not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" for the testing performed appears to be measured physical properties (suture tensile force and displacement) of the device components under various conditions, likely compared against established benchmarks or the predicate device's performance. It is not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This submission is for a physical medical implant, not an AI or machine learning model that requires a training set.

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

This information is not applicable/not provided. As no training set for an algorithm is involved, no ground truth establishment for it is relevant.

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The Michelangelo Bunion System is intended for the following surgical indication: To assist in the correction of hallux valgus deformities by providing reduction of the 1st intermetatarsal angle.

The Instratek Michelangelo Bunion System is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st. intermetatarsal angle. Like the predicate device, the Michelangelo Bunion System is intended to assist in the correction of hallux valgus deformities by providing reduction of 1st intermetatarsal angles up to and including 16 degrees. The Michelangelo Bunion System may eliminate the necessity of a traditional osteotomy in the correction of Hallux Valgus deformities within the indicated criteria. The implanted device consists of three components: Medial Plate, Lateral Plate, Suture. There are 6 accessories required to implant the device: suture lasso, kwire, cannulated drill bit, kwire guide, plate bender, suture scissor.

The provided document is a 510(k) summary for the Michelangelo Bunion System and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating direct device performance against such criteria. The document states that performance tests included "knot pull testing," but no specific acceptance criteria or results from this testing are provided.

Instead of a study proving the device meets acceptance criteria, the submission concludes that the device is "substantially equivalent" to predicate devices (HAV-Lok Bunion Correction System, K082384, and Arthrex Mini-Tightrope, K061925) based on similar technological characteristics and intended use. The core of the submission relies on this substantial equivalence argument rather than presenting a standalone study with defined acceptance metrics.

Therefore, most of the requested information cannot be extracted from this specific document.

However, based on the available information:

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

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

• Sample Size: Not specified. The document only mentions "knot pull testing" was performed, but no number of samples or tested units is provided.
• Data Provenance: Not specified. The document does not indicate the country of origin of any test data or whether it was retrospective or prospective.

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

• This information is not applicable and not provided. The study mentioned (knot pull testing) is a mechanical performance test, not one requiring expert human interpretation or ground truth establishment in a clinical sense.

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

• Not applicable/Not provided. Adjudication methods are typically associated with clinical studies involving human readers or expert consensus, which is not the nature of the "knot pull testing" mentioned.

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

• This is not applicable as the Michelangelo Bunion System is a surgical device, not an AI-based diagnostic or assistive technology for human readers. No MRMC study was done, and therefore, no effect size related to AI assistance is mentioned.

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

• This is not applicable for this device. The device is a surgical implant and associated accessories, not an algorithm.

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

• For the "knot pull testing," the ground truth would be the objectively measured force at which the knot failed. This is a physical measurement, not a clinical ground truth like pathology or expert consensus. No specific measurement data is provided.

8. The sample size for the training set

• Not applicable/Not provided. As this is a 510(k) submission for a physical device relying on substantial equivalence, there is no mention of a "training set" in the context of machine learning or AI.

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

• Not applicable/Not provided for the same reasons as above.

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The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the biomechanical reduction of abnormal intermetatarsal angle.
The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the correction of Hallux Valgus deformities by providing reduction of the 1st intermetatarsal angle.

Not Found

This device, the Instratek HAV-Lok Bunion Correction System, is a traditional 510(k) submission and does not include any studies related to AI/algorithm performance or acceptance criteria in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving the device meets those criteria, as no such information is present in the provided document.

The document states:

• "The technological characteristics between the predicate and proposed devices are the same."
• "There are no significant differences between the proposed and predicate device; therefore, the proposed device does not raise any questions regarding safety and effectiveness."
• "The HAV-Lok Bunion Correction System, as designed, is as safe and effective as the predicate devices. Comparisons have been made to a legally marketed predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."

This indicates that the device's acceptance was based on its similarity to an already approved device, not on new performance studies with specific acceptance criteria that would typically be associated with AI or novel diagnostic technologies.

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The Instratek Sub-Talar Lok arthroereisis implant restricts excessive subtalar pronation in all three planes, providing for a more normal subtalar joint motion in patients. The Sub-Talar Lok is intended for the following pathological conditions resulting from disease, injury, or other trauma.

• Hypermobile pes valgus
• Posterior tibial tendon dysfunction
• Severe pronation
• Subtalar instability
• Hypermobile flexible congenital flat foot

The Instratek Sub-Talar Lok Implant is designed to stabilize the subtalar joint of the hyperpronated foot. The implant is conical shaped with external threads of uniform depth and pitch. The device is cannulated for use with a guide wire. The product will be provided with a procedure kit containing: Five (5) dilators sized 7 through 11 mm Ten Sub-Talar Lok implants, two each of five sizes Regular driver, 4.3mm hex head Rescue driver, threaded

This submission is for a medical device (Sub-Talar Lok Implant), not an AI/ML device. Therefore, the requested information regarding AI/ML device performance, acceptance criteria, study design, expert involvement, and training/test set details is not applicable.

The document describes the device's technical characteristics and intended use within the context of a 510(k) summary for substantial equivalence to legally marketed predicate devices. The approval is based on a comparison of design, materials, intended use, and technological characteristics to existing devices, implying that the device meets acceptance criteria through this demonstration of substantial equivalence rather than a specific performance study with quantitative metrics and ground truth as would be required for an AI/ML product.

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