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The WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.

The FITBONE®TA A intramedullary lengthening system is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

The FITBONE® TAA System is a fully implantable intramedullary lengthening device. Changes to the existing FITBONE® TAA (K163368) have been introduced to extend the current portfolio by new Subject FITBONE® TAA09 intramedullary lengthening nail model fixed to the bone by new Subject Locking Screws and a new Subject Receiver connected to the Subject nail by a bipolar feed line with new Subject external Retraction Control Set consisting of a control electronics with a Retraction Transmitter. New Subject surgical tools are provided to facilitate the surgical process.

The Subject FITBONE® TAA09 intramedullary lengthening nail model, line extension of the primary predicate FITBONE® TAA (Κ163368) models is implanted into the medullary canal of the femur or tibia. The nail is fixed to the bone by Locking Screws through longitudinal openings in the nail.

The Subject FITBONE® TAA09 intramedullary lengthening nail consists of a telescoping system that allows it to expand. It is powered by hermetically enclosed electromagnetic motor which draws the telescope apart, during which the extension is externally steered via electronic impulses. The Subject FITBONE® TAA09 intramedullary lengthening nail elongation is propelled by a highly sensitive gear and spindle mechanism which converts the rotation of the motor into an axial movement with high force.

The energy needed for the distraction process of the nail is transmitted from the outside by placing the external Transmitter over the implanted Receiver which is placed in the subcutaneous tissue during FITBONE® surgery. The energy transmission will be triggered by pressing the "Patient" button on the control electronics by the patient. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body.

The nail and Receiver are offered in sterile conditions and the Locking screws and non-implantable external electronic controlling components in non-sterile packaging configurations.

The Subject FITBONE® TAA09 nail model is fixed to the bone by Locking Screws, made from Stainless steel AISI 316LVM, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

Surgical procedures with the use of the Subject FITBONE® TAA09 model shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The surgical instruments offered by WITTENSTEIN intens GmbH as part of this submission under product code: LXH (21 CFR 888.4540).

The orthopedic instruments are made by medical grade stainless steel, Aluminum and Silicone.

The Subject FITBONE® TAA09 and the Subject external electronic controlling components are designed to be used in the operating theatre and home environment.

The FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia. It is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (FITBONE® TAA, K163368) and other similar devices, rather than establishing specific, quantified acceptance criteria for a new clinical performance study. The "Performance Analysis" section summarizes that the device performs "as well as or better than the predicate devices" based on various testing.

Therefore, the table below reflects what can be inferred as "acceptance criteria" based on the substantial equivalence argument, which inherently means meeting or exceeding the predicate's performance. Specific quantitative targets for clinical outcomes are not explicitly stated in this document.

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

The document describes non-clinical performance data, specifically engineering, electrical, bench, and human factors testing. It does not mention a test set from a clinical study with human subjects.

• Sample Size: Not applicable as no clinical test set is described. The performance assessment relies on engineering and bench testing, for which sample sizes (e.g., number of nails tested for fatigue) are not specified in this summary.
• Data Provenance: Not applicable as no clinical data (e.g., country of origin, retrospective/prospective) is associated with a "test set" in the context of this 510(k) summary. The testing appears to have been conducted by the manufacturer, WITTENSTEIN intens GmbH.

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

This information is not provided in the document. As no clinical "test set" is described for algorithm evaluation, the concept of establishing ground truth by experts is not applicable to the data presented. The "ground truth" for the engineering and bench testing would be defined by established standards and internal validation protocols.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable as no clinical "test set" requiring expert adjudication is described in the document.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission is based on engineering, electrical, bench, and human factors testing to demonstrate substantial equivalence to a predicate device, not on a clinical effectiveness study involving human readers or AI assistance.

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

This is not applicable. The device, FITBONE® TAA, is an intramedullary lengthening system, a physical medical device, not an AI algorithm or software device. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this submission is established through:

• Engineering Standards and Bench Testing Results: Compliance with established mechanical, material, and electrical performance standards (e.g., ASTM F138-13 for stainless steel). The performance of the predicate device also serves as a benchmark for equivalence.
• Risk Management Activities: Identification and control of potential hazards.
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (FITBONE® TAA, K163368) forms the basis for demonstrating substantial equivalence.

No pathology, expert consensus, or outcomes data from a new clinical study are used as ground truth for a test set in this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable. The FITBONE® TAA is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and development of the device would involve engineering principles and prototypes, but not a data-based "training set."

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

This information is not applicable as there is no "training set" in the context of this medical device submission.

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The Precice® Screws are provided sterile and intended to be used with the systems below:

The Precice® Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Stryde System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Bone Transport Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones for pediatrics and small stature adult patients.

The Precice Screws accompanying previously cleared Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181) are available in a variety of lengths, materials and thread styles. The screws are offered in lengths between 10-100mm and styles including pegs, partially threaded and fully threaded shaft designs.

The purpose of this submission is to introduce a sterile option of previously cleared screws as part of the Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181).

Here's an analysis of the provided text, focusing on the acceptance criteria and study information related to the Precice® Screws.

It's important to note that the provided document is a 510(k) summary for a medical device (Precice Screws) intended to demonstrate substantial equivalence to previously cleared devices. It primarily focuses on the regulatory process and claims of equivalence rather than a detailed clinical study demonstrating new performance attributes against specific acceptance criteria for a novel device. The "performance data" section is very brief and refers to validation studies for sterilization and packaging, not clinical or functional performance of the screws themselves in a patient.

Acceptance Criteria and Study for Precice® Screws (K193617)

Given the nature of this 510(k) submission, the "acceptance criteria" discussed are primarily regulatory in nature (demonstrating substantial equivalence to a predicate device) rather than clinical performance metrics for a novel technology. The "study" mentioned refers to validation testing for the sterilization and packaging of the screws, not a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

• Equivalent design
• Equivalent labeling/intended use
• Equivalent material composition
• Equivalent function | The subject Precice® Screws were shown to be substantially equivalent to the predicate devices (Precice® System K172628, Precice® Stryde System K180503, Precice® Bone Transport K182170, and Precice® Plate System K192181) through comparison in these areas. |
  | Sterility:
• Product must be sterile | Gamma sterilization validation was performed. |
  | Sterile Packaging:
• Packaging maintains sterility
• Sterile barrier integrity over time | Sterile packaging validation and integrity of the sterile barrier over time validation were performed. |

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

• Test Set Sample Size: Not specified in the document. The "tests" here refer to validation studies (sterilization, packaging), not clinical trials with patient data.
• Data Provenance: Not applicable in the context of clinical/patient data. The studies are laboratory/engineering tests performed by the manufacturer.

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

• Number of Experts: Not applicable. These are validation studies, not studies relying on expert interpretation of clinical data to establish ground truth.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This refers to validation studies, not studies where human interpretation of medical data requires adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study investigates the performance of human readers, sometimes with and without AI assistance, which is outside the scope of this 510(k) submission for a fixation screw.
• Effect Size of Human Readers with/without AI: Not applicable.

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

• Standalone Study: No, a standalone algorithm performance study was not done. The device is a surgical screw, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the regulatory submission, the "ground truth" for substantial equivalence was established by comparing the characteristics of the subject device (Precice® Screws) against the characteristics of the legally marketed predicate devices. For the validation studies, the ground truth would be accepted engineering and scientific standards for sterility and packaging integrity.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission concerns a physical medical device (screws) and its manufacturing/sterilization processes, not an AI or algorithm that would require a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary of the Document's Research Focus:

The provided document, a 510(k) summary, is not a clinical study report evaluating the performance of a device or algorithm in a patient population. Instead, it is a regulatory document to demonstrate that the Precice® Screws, specifically a new sterile option for previously cleared screws, are substantially equivalent to existing cleared predicate devices. The "performance data" referenced relates to validation studies for manufacturing processes (sterilization and packaging), which are necessary to ensure the safety and efficacy of the product as a sterile medical device, rather than studies evaluating the clinical effectiveness of the screw design itself.

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