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There are several items that make up this system. They will be listed separately with their intended use:

Cable Implants:

Femur and Tibial Fractures Prophylactic banding Trochanteric reattachment Olecranon fractures Patella fractures Ankle fractures Fixation of spiral fractures in conjunction with I/M nailing and screwing techniques. Sternum fixation after open chest surgery Stabilization of cortical onlay strut graft Trochanteric Grip: Reattachment of greater trochanter following osteomy for total hip or total hip Procedures or trochanteric advancement

Cable Plates

Fixation of femoral, tibial or humeral fractures near the site of an intramedullary implant

Fixation of fractures where a combination of screws and cerclage cables would improve stabilization

Supracondylar Cable Plate

Distal femoral fractures

Subtrochanteric fractures

Lateral Trochanteric Plate

Extended trochanteric osteomies

Trochanteric fractures

The BMP™ Cable System consists of cables, cable sleeves, trochanteric grip, cable plates and cable templates. The system also includes lateral trochanteric plates and supercondylar plates. The cables and cable sleeves are made of either cobalt chrome or stainless steel. All cables are 7x7 construction. Seven individual wires form a bundle and seven bundles are combined to form each cable optimizing strength and flexibility. The cobalt chrome is available in 2.0mm and 1.6mm diameter cables to be used with titanium and cobalt chrome implants. The stainless steel cables are 2.0mm diameter and used with stainless steel implant and the BMP cable plates. Three sleeves are available: 2.0mm CoCr. 1.6mm CoCr and 2.0mm stainless steel.

The trochanteric grips are cobalt chrome and are available in two sizes – medium and large. Each grip has two crimp locations and do not require additional sleeves. The holes on the tronchateric grip are full radius.

The cable plates are available in five lengths from 110mm to 310mm. Each plate is a one piece plate and sleeve construction manufactures from 316 LVM stainless steel. The one-piece construction allows for the sleeves to be machined directly on each plate, thus eliminating micromotion between the plate and sleeves. Stainless steel cable and screws are used to attach these plates to bone. The system includes templates for the corresponding plate size. A smaller plate for use on the humerous is being planned.

There are two specialty plates in the system. The supracondylar cable plate comes in two lengths, 165 mm and 241 mm. The plate is manufactured out of 316 LVM stainless steel. Stainless steel screws and cables are used to attach this plate to bone. The lateral trochanteric plate is a Co-Cr-Mo plate that is manufactured in one length -185 mm. It is attached to the bone with titanium screws and Co-Cr- Mo cable.

Instruments for use with these devices include cable passers, crimper, standard trochanteric grip impactor, T- handle tensioner, cable cutters, trochanteric grip manipulator/impactor and sterilization case.

The provided text is a 510(k) premarket notification for the BMP™ Cable System, an orthopedic metallic internal fixation device. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies as one might find for novel or high-risk devices.

Therefore, the document does not contain the typical acceptance criteria and study details requested for a device performance study. Instead, it relies on the established safety and effectiveness of its predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The document does not define specific performance acceptance criteria (e.g., tensile strength, fatigue life thresholds) or report device performance against such criteria. The basis for equivalence is the similarity in design, materials, and intended use to predicate devices already on the market.

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

• Not Applicable. No explicit "test set" or associated data provenance (country of origin, retrospective/prospective) and sample size are mentioned in the context of a performance study proving criteria. The submission relies on the established performance of predicate devices.

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

• Not Applicable. There is no mention of experts establishing ground truth for a test set, as this is not a clinical study designed to test the diagnostic or predictive accuracy of a device.

4. Adjudication Method for the Test Set:

• Not Applicable. No adjudication method is described as there is no performance study with a test set requiring ground truth establishment.

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

• No. An MRMC study is not mentioned. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance. The BMP™ Cable System is a surgical implant.

6. Standalone (Algorithm Only) Performance Study:

• No. No standalone performance study is mentioned. This concept is applicable to AI algorithms. The BMP™ Cable System is a physical medical device.

7. Type of Ground Truth Used:

• Not Applicable. The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to performance evaluation in diagnostic/predictive devices is not relevant to this submission. The "ground truth" for this device's approval is its substantial equivalence to already approved, safe, and effective devices based on design and intended use.

8. Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of this device, as it is a physical implant and not an AI algorithm requiring training.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

Summary based on the 510(k) document:

The provided document describes a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve extensive clinical performance studies with acceptance criteria like those for novel devices or AI/diagnostic tools.

The "study" in this context is the comparison to predicate devices already on the market. The criteria for acceptance are based on demonstrating:

• Similar intended use: The BMP™ Cable System is indicated for general orthopedic repairs, similar to its predicates.
• Similar technological characteristics: The system consists of cables, sleeves, grips, and plates made of materials like cobalt chrome and stainless steel, with similar constructions (e.g., 7x7 cable construction) to predicate devices.
• Similar potential risks: The document lists potential risks that are common to all cerclage systems, implying no new or increased risks compared to predicates.

The FDA's letter (K982545) confirms that they reviewed the submission and determined the device to be substantially equivalent to predicate devices. This determination is the "proof" that the device meets the regulatory acceptance criteria for market authorization based on the 510(k) pathway.

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