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The IntraLock System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints of the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.

The IntraLock System is a three-part construct, consisting of a Locking Lag Screw of 2 diameters and lengths ranging from 22mm to 55mm, a Setting Screw of 1 diameter with lengths ranging from 14mm to 24 mm, as well as a mating washer component consisting of 1 diameter and lengths ranging from 20mm to 28mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are primarily made of surgical grade stainless steel (per ASTM F899) with certain components made from aluminum alloy (Al6061).

This FDA 510(k) summary describes a medical device, the IntraLock System, but does not include information about a study based on AI or software performance. Instead, it focuses on the device's substantial equivalence to predicate devices through non-clinical mechanical testing.

Therefore, I cannot provide an answer that includes acceptance criteria and study details related to AI or software performance, as this information is not present in the provided document.

Here's an analysis of what is available in the document, framed by your questions where applicable, and noting where the requested information is absent:

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

• Acceptance Criteria: The document implies that the acceptance criteria are met if the IntraLock System's mechanical performance is "equivalent to that of the predicate." However, specific numerical acceptance criteria (e.g., in terms of load capacity, fatigue cycles, or specific failure modes) are not provided.
• Reported Device Performance: Similarly, specific numerical reported performance data from the non-clinical tests are not provided. The document only states that "Both Static and Dynamic mechanical testing is presented to provided evidence that the IntraLock System is equivalent to that of the predicate."

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

• This question is not applicable as the study described is non-clinical mechanical testing of a physical device, not an AI or software performance study using a test set of data. The document does not specify the number of samples used for the static and dynamic mechanical tests.

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 question is not applicable. Ground truth, in the context of AI/software performance, refers to expert-validated labels or outcomes. The described study is mechanical testing of a device where "ground truth" would be the measured physical properties or failure points, not expert interpretation of data.

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

• This question is not applicable. Adjudication methods are typically used in clinical studies or AI/software validation studies to resolve discrepancies in expert labeling or diagnoses.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This type of study is relevant for AI-assisted diagnostic tools, not for a bone fixation system's mechanical performance.

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 device is a physical bone fixation system, not an algorithm.

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

• This question is not directly applicable in the context of mechanical testing. The "ground truth" for the non-clinical mechanical tests would be the established engineering standards, material properties, and physical measurements (e.g., force applied, displacement, cycles to failure) observed during the testing, compared against the predicate device.

8. The sample size for the training set

• This question is not applicable. The device is a physical product, not an AI model, and therefore does not have a "training set."

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

• This question is not applicable for the same reasons as #8.

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The TopLock Anchor System is intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation, Rotator Cuff Repair, Capsule Repair, Biceps Tenodesis. Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction, Bicep Tendon Reconstruction, Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction, Ulnar / Radial Collateral Ligament Reconstruction, Extensor Tendon Repair, Flexor Tendon Repair
The Knee:
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Tendon Repair
The Ankle and Foot:
Lateral Ligament Stabilization Repair, Medial Ligament Stabilization Repair.
Achilles Tendon Repair / Reconstruction, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Mid and Rear Foot Reconstruction

The TopLock Anchor System consists of a collection of barbed suture anchors, manufactured from medical grade Polyetheretherketone or PEEK (ASTM F2026). The anchors are offered from diameters of 3.5mm to 5.0mm with each size offering two eyelet size options to accommodate suture and suture tape. The size range and configurations are offered for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

This document is a 510(k) premarket notification for a medical device (TopLock Anchor System). It describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence.

Crucially, this document explicitly states that no clinical studies were performed to prove the device meets acceptance criteria. Instead, non-clinical tests (mechanical testing, cleaning, packaging, sterilization, pyrogenicity) were conducted to demonstrate design equivalence to predicate devices.

Therefore, I cannot provide the detailed information requested in the prompt regarding acceptance criteria, study design, ground truth, or expert involvement for clinical performance. The information provided in the document pertains to non-clinical acceptance criteria and testing for mechanical and material equivalence.

Based on the provided text, here's what can be extracted regarding the device's validation:

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Regarding the specific questions about clinical performance and AI-related studies:

1. A table of acceptance criteria and the reported device performance: Covered above for non-clinical aspects. No clinical performance criteria or data are provided.
2. Sample size used for the test set and the data provenance: Not applicable to clinical performance as no clinical studies were performed. For non-clinical tests, specific sample sizes are not detailed, but standard validation protocols would have been followed for mechanical and material testing.
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 clinical outcomes was not established as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical performance. For non-clinical testing, the "ground truth" would be established engineering and material specifications, and regulatory standards.
8. The sample size for the training set: Not applicable. No training set for an AI/algorithm was used.
9. How the ground truth for the training set was established: Not applicable.

In summary, the TopLock Anchor System received 510(k) clearance based on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing (mechanical, material, and sterility validations), rather than through clinical performance studies. The document explicitly states: "No clinical studies were performed."

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The PolyLock System is indicated for use in the treatment of bone fractures, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.

The PolyLock Plating System consists of various shapes and sizes of plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm, 2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device meets acceptance criteria:

Based on the provided FDA 510(k) summary for the PolyLock Plating System, it's crucial to understand that this submission does not involve an AI/ML powered device. The device is a traditional orthopedic implant (plating system). Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI, standalone performance, ground truth establishment for training set, etc.) are not applicable here.

The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than performance metrics for an AI algorithm.

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

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

• Not applicable in the context of an AI/ML device. For this traditional medical device (orthopedic plating system), the "test set" refers to the specific implant designs and materials subjected to non-clinical testing (e.g., sterilization tests, mechanical property tests).
• The document does not specify exact "sample sizes" for each non-clinical test (e.g., how many plates were sterilized, how many screws were tested for torque). However, engineering rationales and validation protocols typically involve statistically relevant sample sizes for specific tests.
• Data provenance: Not explicitly stated beyond "non-clinical tests were performed." These would generally be performed in a laboratory setting by the manufacturer or a third-party testing facility.

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

• Not applicable. "Ground truth" in the context of expert consensus is specific to AI/ML performance evaluation. For a traditional medical device, the "ground truth" for material properties or mechanical performance is established through standardized engineering tests and specifications (e.g., ASTM standards for materials).
• The "experts" would be the engineers and quality assurance professionals conducting and verifying the non-clinical tests, following recognized standards and protocols.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts when establishing ground truth for AI/ML performance studies.
• For non-clinical device testing, results are typically objective (e.g., passing a specific mechanical load, achieving a certain sterility assurance level) and validated against established standards. Data analysis and interpretation would be reviewed by internal quality and regulatory personnel.

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

• No. A Multi-Reader Multi-Case (MRMC) study is specifically for evaluating the performance of AI-assisted diagnostic devices with human readers. This device is an orthopedic implant, not an AI diagnostic tool.

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

• No. This device does not have an algorithm or AI component.

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

• Not applicable in the AI/ML sense. For this device, the "ground truth" is defined by:
  • Material Standards: Adherence to ASTM F899 (Stainless steel) and ASTM F136 (Ti-6Al-4V) specifications.
  • Engineering Standards: Meeting predefined mechanical performance criteria (e.g., strength, stiffness, fatigue resistance) typically derived from industry standards or comparison with predicate devices.
  • Validation Standards: Compliance with validated cleaning, packaging, and sterilization protocols (e.g., ISO or AAMI standards).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model, so there is no "training set."

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

• Not applicable. This device is not an AI/ML model, so there is no "training set" or ground truth established for one.

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The PolyLock System is indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.

The PolyLock System consists of various shapes and sizes of plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm and 2.7mm and lengths from 8mm to 26mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.

This document is a 510(k) Summary for the PolyLock Small Bone Plating System, which is a medical device. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing clinical performance data against specific acceptance criteria like an AI device would.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML device.

Specifically, the document states:

• "No clinical studies were performed" (page 4, "Clinical Test Summary").
• The review is based on substantial equivalence for "terms of intended use, design, materials used, mechanical safety, and performances." (page 4, "Substantial Equivalence Claimed to Predicate Devices").
• "Engineering rational was performed to show performance equivalence." (page 4, "Non-clinical Test Summary"). This refers to non-clinical bench testing, not clinical studies with acceptance criteria for device performance.

Without a clinical study, there are no acceptance criteria, no reported device performance against those criteria, no sample sizes for test sets, no ground truth, no experts, and no MRMC or standalone performance data.

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The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The GAIT 2.0 Implants are intents presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The SHIP Long Implants, are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.
The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impared function and stability; Pain; Impaired toe length ratio.
The SHIP Short Implants are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.

The Fusion Silastic System consists of a collection of flexible toe joint prostheses, manufactured from medical grade silicone (ASTM F2042). The product family is offered in five configurations to address varying indications and patient anatomy; the Gait Implant, the Gait 2.0 Implant, the SHIP Long Implant, the SHIP Short Implant and the Shaw Rod. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

This document is a 510(k) premarket notification for the Fusion Silastic System, a toe joint prosthesis. It outlines the company's claim of substantial equivalence to predicate devices.

Based on the provided document, there is NO information about acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.

The document is for a physical medical device (toe joint prosthesis) and does not describe any AI component or a study to evaluate AI performance. The "Non-clinical Test Summary" and "Clinical Test Summary" explicitly state:

• Non-clinical Test Summary: "Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational was performed to show performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above."
• Clinical Test Summary: "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria because the provided text describes a physical implant and its regulatory clearance process, not an AI-powered device.

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The IntraLock Lapidus System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints in the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.

The IntraLock Lapidus System is a two-part construct, consisting of a lag screw of two diameters and lengths ranging from 22mm to 50mm, as well as a mating washer component consisting of one diameter and lengths ranging from 16mm to 35mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are made of surgical grade stainless steel (ASTM F899).

The provided document is a 510(k) premarket notification for a medical device called the "IntraLock Lapidus System." It is a submission to the FDA seeking to demonstrate substantial equivalence to previously cleared devices.

Based on the content of the document, the device described is a bone fixation fastener (IntraLock Lapidus System), not an AI/ML-based diagnostic device. Therefore, the questions about acceptance criteria (in terms of AI performance metrics like sensitivity, specificity, AUC), sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance do not apply to this type of medical device submission.

This document describes a traditional medical device, and its acceptance criteria and the study to prove it meets them are related to mechanical properties, biocompatibility, and intended use equivalence to predicate devices, rather than AI performance.

Here's an analysis of the provided information relevant to this type of device:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

The "acceptance criteria" for a traditional Class II device like this are primarily demonstrated through non-clinical testing to show that the device performs as intended and is substantially equivalent to predicate devices in terms of safety and effectiveness.

Study Proving Device Meets Acceptance Criteria:

1. Sample sizes used for the test set and the data provenance:

   • For mechanical testing, the "sample size" refers to the number of test specimens (e.g., screws, washers) subjected to the specified tests. The document does not specify the exact number of samples for each mechanical test (e.g., how many screws were pulled out, how many were bent). The provenance is laboratory testing conducted by the manufacturer, Fusion Orthopedics, LLC.

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

   • Not applicable. This device classification does not involve medical image interpretation or clinical ground truth establishment in the way AI/ML devices do. The "ground truth" for this device's performance is established by standardized engineering and biocompatibility testing methods against predefined specifications.

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

   • Not applicable. No human adjudication is involved in the mechanical or biocompatibility testing of a bone fixation device for a 510(k) submission.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. MRMC studies are specific to diagnostic devices (especially imaging-based ones) where human reader performance is a critical outcome. This is a surgical implant.

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

   • Not applicable. This is not an algorithm.

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

   • The "ground truth" for this device's performance is based on engineering standards and specifications (e.g., acceptable loads, torques, displacement) and biocompatibility standards (e.g., endotoxin limits). It's not based on clinical "ground truth" like pathology or expert consensus on a diagnosis.

7. The sample size for the training set:

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

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

   • Not applicable. There is no training set.

In summary, the provided document describes a traditional orthopedic implant device undergoing a 510(k) premarket notification. The "acceptance criteria" and "proof" are based on non-clinical laboratory testing to demonstrate mechanical integrity, material compatibility, and substantial equivalence to existing predicate devices, rather than the performance metrics and study designs typically associated with AI/ML-based medical devices.

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The HammerTech device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The HammerTech Fixation System consists of PEEK (Polyetheretherketone (ASTM F2026)) and titanium alloy (Ti6Al4V ELI (ASTM F136)) threaded bone implants intended for fixation of the interphalangeal joint of the lesser toes. The device is offered in three configurations; straight cannulated PEEK, straight cannulated titanium, and angled solid titanium. Each configuration is offered in five different sizes to address to a variety of patient anatomy. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899). The implant and associated instrumentation is supplied sterile and non-sterile.

This document is a 510(k) premarket notification for the HammerTech™ Fixation System, a bone fixation device. As such, it does not contain any information about a study proving that an AI/software device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: Fixing osteotomies and reconstructing lesser toes for hammertoe, claw toe, and mallet toe correction.
• Design & Materials: PEEK and titanium alloy threaded bone implants, offered in various configurations and sizes.
• Mechanical Safety and Performance: Non-clinical tests like static/dynamic 4-point bending, pull-out, torsion, and insertion torque were conducted to show equivalence to predicate devices, and pyrogenicity was evaluated.
• No Clinical Studies: The document explicitly states, "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance for an AI/software.
2. Sample sizes or data provenance for an AI/software test set.
3. Number of experts or their qualifications for ground truth establishment for an AI/software.
4. Adjudication method for an AI/software test set.
5. MRMC comparative effectiveness study for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI.
8. Sample size for the training set for AI.
9. How ground truth for the training set was established for AI.

The document pertains to a physical medical device (bone fixation system) and its mechanical and material properties, not an AI or software-as-a-medical-device (SaMD).

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DynaBridge is indicated for:

• · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• · Fixation of proximal tibial metaphysis osteotomy.
• · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
  · Fixation of small bone fragments (i.e. Small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremittes; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy (Nitinol) bone implant intended primarily for fixation of fractured, osteotomy, and arthrodesis of the hand, foot, and bone appropriate for the size of the device. The implant is offered in a range of sizes to address a variety of indications and patient anatomy with bridge sizes from 9mm to 25mm. The system is offered sterile and non-sterile.

This is a 510(k) summary for a medical device called DynaBridge, which is a bone staple. 510(k) summaries are for demonstrating substantial equivalence to a predicate device, not for providing detailed clinical efficacy data. Therefore, the information you are looking for regarding acceptance criteria and detailed study results to prove device performance for an AI/ML device is not present in this document.

Here's why and what information can be extracted:

• This is not an AI/ML device: The description identifies it as a "Nickel-Titanium alloy (Nitinol) bone implant intended primarily for fixation of fractured, osteotomy, and arthrodesis." This is a physical orthopedic implant, not a software or AI/ML diagnostic/therapeutic device. Therefore, the concepts of "acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, AUC), "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication methods," "MRMC studies," or "standalone performance" for an algorithm simply do not apply here.
• "Acceptance Criteria" for this device type: For a bone staple, acceptance criteria would typically involve engineering performance specifications and biocompatibility, not AI performance. The document lists "Non-clinical Test Summary" which implies performance testing such as "Static Four-Point Bend Test," "Dynamic Four-Point Bend Test," "Pull-out Test," "Corrosion Test," "AI Temperature Test" (likely a typo and meant to be "Atmospheric Temperature Test" or similar), and "Pyrogenicity" testing. The acceptance criteria for these tests would be defined in standards (e.g., ASTM standards referenced for materials) or internal specifications, and the reported performance would be that the device "meets the recommended maximum endotoxin level" and that "The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices."
• No Clinical Studies: The document explicitly states: "No clinical studies were performed." This further confirms that this submission relies on engineering and biocompatibility testing to demonstrate substantial equivalence, rather than clinical efficacy studies.

Given the nature of the device and the content of the 510(k) summary, I cannot populate the table or answer most of your detailed questions regarding AI/ML device performance or study design.

Here is the information directly extracted or inferred from the provided text, aligning with the type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML specific questions:

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device. The "test set" would refer to physical devices or materials tested in non-clinical studies.
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 would relate to accurate measurements against engineering standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. No clinical studies were performed, and it's not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, ground truth would be established by physical measurements and adherence to recognized engineering standards (e.g., ASTM) and biocompatibility limits.
8. The sample size for the training set: Not applicable. No AI/ML model.
9. How the ground truth for the training set was established: Not applicable. No AI/ML model.

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The TalarLift STS arthroereisis implant is designed for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequelae. The TalarLift STS 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 TalarLift STS 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 system consists of three configurations, conical, cylindrical, and anatomic. All three devices are manufactured from titanium alloy (Ti-6Al-4V) complying with ASTM F136.

The provided document is a 510(k) Premarket Notification for the TalarLift STS device, which is a subtalar spacer. It describes the device, its intended use, and claims substantial equivalence to predicate devices. This document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves an AI/ML device meets those criteria based on the provided text. The document primarily focuses on non-clinical testing for mechanical properties and pyrogenicity of a physical implant. It explicitly states, "No clinical studies were performed."

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The FuzeFix Mini System is intended for use in the stabilization of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for: scaphoid fractures, metacarpal fractures, phalangeal fractures, ulnar styloid fractures, small ioint fusions, humeral head fractures, intercarpal fractures, tarsal fusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bone fractures, forefoot interfragmentary fractures, trapezial fractures, metatarsal fractures, radial head fractures, osteo-chondral fractures, interphalangeal fractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distal metatarsal osteotomies, midfoot interfragmentary fractures. Not intended for use in the spine.

The FuzeFix Large System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Large System is indicated for: joint reconstructions, joint fusions, multiple fragment joint fractures, simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, metatarsal fractures and other fractures of the foot, ligament fixation of the proximal humerus, malleolar fractures, navicular fractures of the calcaneus, fractures of the talus, arthrodesis of the ankle joint, and fractures of the tarsal region. The devices and implants are not intended for use in the spine.

The FuzeFix Headless FT System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Headless FT System is indicated for: Osteochondral fragments (talar vault, femoral condyle), apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), cancellous fragments (talus), Carpal, meta-carpal, and small hand bone, tarsal and metatarsals, phalanges, Intra-articular fractures, ankle, proximal and distal humerus, proximal and distal radius, proximal and distal ulna, osteochondral fixation and fractures, Osteochondritis Dissecans, Fixation of fractures and osteotomies about the knee, Oblique fractures of the fibula, Reconstructive surgeries of the foot, and malleolar fixation. Not intended for use in the spine.

The FuzeFix Twist Off System is intended for use in the stabilization of bone fractures. osteotomies, and for bone reconstruction of the hand and foot. The FuzeFix Twist Off System is indicated for: fixation of small bone fragments, Weil osteotomy, mono-cortical fixation, osteotomies and fractures fixation in the foot and hand.

The FuzeFix Screw System consists of headed and headless, partial and full threaded cannulated, self-compressive screws and snap off screws and washers for the management of orthopedic osteotomies and trauma. The screws are self-drilling, self-tapping. The system consists of multiple screw lengths and diameters, and the necessary instruments to facilitate the placement of these implants.

The provided document describes the Fusion Orthopedics, LLC FuzeFix Screw System and its substantial equivalence to predicate devices, based on non-clinical testing. It explicitly states that "No clinical studies were performed." Therefore, the information requested about acceptance criteria and studies proving the device meets them, in the context of clinical performance or AI/software, is not largely applicable or available in this document.

However, I can extract information related to the device's non-clinical performance acceptance criteria and the study that proves it meets them, as documented for regulatory submission.

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

The document does not explicitly present a table of acceptance criteria and reported device performance in terms of specific numerical values for each test. Instead, it lists the types of non-clinical tests performed and states that the "testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device" and "The results of these evaluations indicate that the FuzeFix Screw System is equivalent to predicate devices." This implies that the device met the acceptance criteria for each test by showing equivalence or compliance with established standards.

The underlying acceptance criteria for "equivalence" would be that the device's mechanical properties (torque, pullout, driving/insertion/removal torque) perform within a comparable range or demonstrate similar failure modes and strengths to the established predicate devices, as typically determined through statistical comparison or by falling within a predefined performance envelope during mechanical testing.

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

The document does not specify the sample sizes used for each non-clinical test (e.g., number of screws tested for torque to failure). It also does not explicitly mention data provenance in terms of country of origin for these non-clinical tests, and non-clinical tests are inherently "prospective" in the context of generating new data for regulatory submission.

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

This question is not applicable. The "ground truth" for non-clinical mechanical and biocompatibility testing is established by conforming to recognized industry standards (e.g., ASTM F543-07 for mechanical tests, and general biocompatibility standards for pyrogenicity). It does not involve expert readers or clinical ground truth determination.

4. Adjudication method for the test set

This question is not applicable as the tests are non-clinical, objective measurements against established standards, not 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

No such study was performed, as stated in the document: "No clinical studies were performed." This is not an AI/software device, but a physical medical implant.

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

This question is not applicable. This is a physical medical implant, not an AI algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is based on:

• Established Industry Standards: ASTM F543-07 Annex A1, A2, and A3 for mechanical properties (torque to failure, axial pullout, driving/insertion/removal torque).
• Biocompatibility Standards: Implicit standards leading to the "recommended maximum endotoxin level of 20 EU per device" for pyrogenicity.
• Predicate Device Performance: The primary comparative "ground truth" for equivalence claims is the performance of the legally marketed predicate devices.

8. The sample size for the training set

This question is not applicable. There is no artificial intelligence or machine learning component mentioned that would require a training set.

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

This question is not applicable. There is no artificial intelligence or machine learning component mentioned.

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