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The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The One-Piece PEEK Fusion Implant is manufactured from polyetheretherketone (PEEK). It is threaded on one end and ridged on the other to engage either side of an osteotomy or reconstruction site. The One-Piece PEEK Fusion Implant is threaded into the proximal phalanx and then it is press fit into the middle phalanx, allowing for reduction and fixation of the bone fragments.

This report describes the acceptance criteria and the study proving the device meets those criteria, based on the provided 510(k) summary for the One-Piece PEEK Fusion Implant.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical values for the acceptance criteria and corresponding device performance are not provided in the 510(k) summary. It only states that the device "met the pre-determined acceptance criteria." The summary also mentions that these are "the same tests performed on the predicate device to establish its substantial equivalence in submission K133515."

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

The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing described is nonclinical (mechanical/material properties), not clinical.

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

Not applicable. The described testing is nonclinical mechanical testing, not a study requiring expert-established ground truth on patient data.

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

Not applicable. This was nonclinical testing.

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 MRMC comparative effectiveness study was mentioned. This device is an 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 an implant, not an algorithm.

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

For the nonclinical testing, the "ground truth" would be the engineering or materials science standards and specifications defining acceptable performance for each test (Tensile Strength, Bending Strength, etc.).

8. The sample size for the training set

Not applicable. This device is an implant, not a machine learning model, so there is no "training set."

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

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

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The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.

Threaded K-Wire is manufactured from PEEK and is 1.6 mm in diameter over its entire length. Both ends of the K-Wire are threaded, providing for two implants per device. The diameter of the pin allows it to function well with standard K-Wire drivers and the device is meant to be trimmed to length once in place.

The provided text addresses the FDA 510(k) submission for the "Threaded PEEK K-Wire," which is a medical device, not a diagnostic AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this document.

The document discusses the testing and criteria used to demonstrate substantial equivalence to a predicate device, which is a common pathway for medical device clearance.

Here's a breakdown of the relevant information provided:

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

The document lists the types of nonclinical testing performed to establish substantial equivalence and demonstrate the device performs as intended. It states that "The Threaded PEEK K-Wire met all specified criteria performing as intended." However, specific quantitative acceptance criteria values and corresponding reported performance values are not detailed in the provided text.

The tests performed were:

• Simulated use Testing
• Ultimate Strength Testing
• Initial Stiffness Testing
• Suture Strength Testing
• Cyclic Testing

The conclusion explicitly states: "The results of this testing demonstrate that the Threaded PEEK K-Wire performs as intended and demonstrate that the Threaded PEEK K-Wire is substantially equivalent to its predicates."

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

• Sample Size: The document mentions "All testing was performed on test units representative of finished devices." However, it does not specify the sample size (number of units) used for each test.
• Data Provenance: The testing is described as "Nonclinical Testing," which means it was performed in a lab setting, not using human patient data. Therefore, questions of country of origin or retrospective/prospective clinical data are not applicable.

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 as the document describes nonclinical mechanical testing, not a diagnostic study requiring expert ground truth establishment.

4. Adjudication method for the test set:

This question is not applicable as there is no human interpretation or ground truth adjudication involved in the mechanical tests described.

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

This question is not applicable as this is a medical implant device, not an AI/ML diagnostic system. No MRMC study was conducted or is relevant here.

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

This question is not applicable as this is a medical implant device, not an AI/ML diagnostic system.

7. The type of ground truth used:

The "ground truth" for the mechanical tests would be the established engineering and material science standards and performance specifications for bone fixation devices and PEEK material. The testing aims to meet these predefined performance benchmarks. "Pathology" or "outcomes data" are not applicable to this type of testing.

8. The sample size for the training set:

This question is not applicable as this is a medical implant device undergoing nonclinical testing, not an AI/ML device requiring a training set.

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

This question is not applicable for the same reason as above.

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

The PEEK Fusion Implant is manufactured from polyetheretone (PEEK) and is composed of two threaded components, each designed to engage either side of an osteotomy or reconstruction site. Once in position, the components mate with one another allowing for reduction and fixation of the bone fragments.

The PEEK Fusion Implant underwent non-clinical performance testing to ensure its substantial equivalence to predicate devices and its intended performance.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size for Test Set and Data Provenance:

   • The document states that "All testing was performed on test units representative of finished devices." However, the specific sample size for each mechanical test (e.g., number of implants tested for tensile strength) is not provided.
   • The data provenance is from laboratory testing (non-clinical) conducted by the manufacturer, MTP Solutions LLC. There is no information regarding country of origin, but it is implied to be within the scope of the manufacturer's operations. The testing is described as pre-clinical and therefore inherently retrospective in the context of device design and validation.

2. Number of Experts and Qualifications for Ground Truth:

   • This is a non-clinical mechanical testing study, not a clinical study involving expert assessment of patient data. Therefore, the concept of "experts used to establish ground truth" related to clinical interpretation or diagnosis does not apply. The "ground truth" here is the objective measurement of mechanical properties of the device and its predicates.

3. Adjudication Method:

   • Not applicable as this is a non-clinical mechanical testing study, not a study requiring adjudication of clinical observations or diagnoses. The results are based on objective measurement of physical properties.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This document describes non-clinical mechanical testing of an implantable device, not an AI-assisted diagnostic or interpretive system that would typically use MRMC studies.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This document describes a physical medical device (an implant), not a software algorithm or AI. Therefore, standalone algorithm performance is not relevant.

6. Type of Ground Truth Used:

   • The ground truth for the performance claims derived directly from objective physical measurements and mechanical testing data (e.g., force, torque, displacement) as specified in the various tests (tensile, bending, torsion, fatigue, etc.). This data establishes the inherent properties of the PEEK Fusion Implant and its predicate devices.

7. Sample Size for Training Set:

   • Not applicable. This is a non-clinical mechanical performance study of a physical device. There is no "training set" in the context of machine learning or AI models. The "training" in this context would refer to the engineering design and manufacturing processes, which are not detailed as a "training set" here.

8. How Ground Truth for Training Set Was Established:

   • Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for this device. The physical properties being tested are intrinsic to the manufactured device.

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The Titanium Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis

Hip: Capsular repair, acetabular labral repair

The Titanium Suture Anchor is a titanium alloy threaded device designed to attach soft tissues to bone when used in conjunction with suture.

This is a 510(k) summary for a medical device called the Titanium Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of diagnostic or AI-driven devices.

Here's a breakdown of the information provided, tailored to your request, but acknowledging the nature of this particular submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (Titanium Suture Anchor), the "acceptance criteria" are related to mechanical performance and demonstrating equivalence to a predicate device. The document does not describe a clinical study comparing the device against specific clinical outcome metrics with statistical acceptance thresholds as one might see for a diagnostic tool or an AI algorithm. Instead, it relies on nonclinical mechanical testing.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a nonclinical testing program.

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

• Sample Size: Not explicitly stated as a numerical value (e.g., N=X units). The document states, "All testing was performed on test units representative of finished devices." This implies multiple units were tested for each type of nonclinical test.
• Data Provenance: Not applicable in the traditional sense of patient data. The "data" comes from laboratory mechanical testing of manufactured device units. It is not patient-derived or clinical.

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

Not applicable. For mechanical tests of a physical device, ground truth is established by engineering standards, test methods, and measurement equipment, rather than expert interpretation of data. The expertise resides in the engineers and technicians performing and validating the tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation discrepancies, typically in clinical readings or image analysis. Mechanical testing results are objective measurements.

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 a physical medical device (suture anchor), not an AI diagnostic or assistive technology. No MRMC study was conducted or is relevant for this type of submission.

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

Not applicable. This is a physical medical device. There is no algorithm to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests is based on engineering specifications, established test methods, and measurable physical properties deemed acceptable for a device of its type and in comparison to its predicate device. This is the closest equivalent to ground truth for this kind of submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense. The "design" of the device is developed through engineering principles, prototyping, and iterative testing, not through a data-driven training process.

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

Not applicable, as there is no training set for an AI algorithm. The device's design is validated against engineering requirements and established safety/performance standards for similar devices.

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