(88 days)
The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.
The Acu-Cut Vertebral Augmentation System consists of:
- the Acu-Cut Cutting Instrument .
- . 2 Cannulas
- 1 Tri-Point Tip Trocar .
- 1 Bevel Tip Trocar ●
- 1 Hand Drill ●
- · 5 Cement Delivery Tubes with Plungers
- · A previously FDA cleared bone cement.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the Acu-Cut Vertebral Augmentation System:
Summary of Acceptance Criteria and Device Performance:
The provided 510(k) summary for the Acu-Cut Vertebral Augmentation System (K113452) primarily focuses on demonstrating substantial equivalence to a predicate device. While it lists various tests performed, it does not explicitly state specific numerical acceptance criteria (e.g., "torque shall be greater than X Nm") or corresponding reported quantitative performance values for each test. Instead, it broadly states that "The testing demonstrated that the System conforms to its design specifications" and "In all instances, the Acu-Cut System functioned as intended." This approach is common in 510(k) submissions where substantial equivalence is the primary pathway.
However, based on the general descriptions of the tests, we can infer the types of acceptance criteria being met. The performance data section describes comprehensive bench and clinical testing.
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Bench Testing (Acu-Cut Cutting Instrument): | |
| - Cutting torque in osteoporotic vertebrae and sawbones meets design specifications (e.g., sufficient torque to cut bone). | System conforms to design specifications; functioned as intended. |
| - Tensile strength of Cutting Instrument band meets design specifications (e.g., band does not break under expected tension). | System conforms to design specifications; functioned as intended. |
| - Cutting Instrument flex cable weld strength meets design specifications (e.g., welds are secure). | System conforms to design specifications; functioned as intended. |
| Bench Testing (Trocars, Cannulas, Hand Drills, Cement Delivery Devices): | |
| - Insertion testing demonstrates safe and effective insertion. | System conforms to design specifications; functioned as intended. |
| - Trocar Handle Strength Testing shows adequate handle integrity. | System conforms to design specifications; functioned as intended. |
| - Torque and Tensile Strength Testing (of components) meets design specifications for robust use. | System conforms to design specifications; functioned as intended. |
| - Cement Delivery Instrument Testing demonstrates effective and controlled cement delivery. | System conforms to design specifications; functioned as intended. |
| - Removal Force Testing shows instruments can be removed appropriately. | System conforms to design specifications; functioned as intended. |
| Other Testing: | |
| - Sterilization Validation confirms sterility. | Validated. |
| - Packaging and Shipping Validations ensure product integrity. | Validated. |
| - Biocompatibility Testing confirms material safety. | Pass. |
| - Clinical Testing (Ascendx VCF Repair System IDE study) demonstrates safety and effectiveness in human subjects. | Implicitly demonstrated safety and effectiveness for its intended use (no specific outcomes or metrics provided in 510(k) summary). |
| - Accelerated and Real Time Aging Testing confirms shelf-life and stability. | Pass. |
| Overall Mechanical Withstand: | Demonstrated ability to mechanically withstand insertion and deployment within a vertebral body. |
| Functionality: | Functioned as intended in all instances. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Bench Testing: Not explicitly stated for each test (e.g., how many osteoporotic vertebrae or sawbones were used for torque testing).
- Sample Size for Clinical Testing: The summary mentions "Clinical Testing Ascendx VCF Repair System IDE study," but does not provide the sample size used in this study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The mention of an "IDE study" implies a prospective clinical trial conducted under an Investigational Device Exemption.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable / Not Provided: The nature of the bench and clinical tests described does not typically involve "experts" establishing a ground truth in the way it would for an AI- radiology study. Bench tests rely on engineering measurements and standards. Clinical studies involve patient outcomes and clinician assessments (e.g., surgeons performing the procedure), but no specific number or qualification of "experts" for ground truth establishment is given in this context.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided: Adjudication is generally relevant for studies where observer variability or interpretation of findings is key (e.g., interpreting medical images). For a device like the Acu-Cut system, performance is assessed through mechanical tests and clinical outcomes, not typically requiring adjudication in the common sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No: The provided documentation is for a physical medical device (vertebral augmentation system), not a diagnostic artificial intelligence product. Therefore, an MRMC study is not relevant to this submission.
6. Standalone Performance:
- Yes (for bench testing): The bench tests described (cutting torque, tensile strength, insertion testing, etc.) represent the standalone performance of the device components.
- Yes (for clinical performance): The clinical testing of the "Acu-Cut System" inherently evaluates its standalone performance in human subjects, although specific metrics are not detailed in this summary.
7. Type of Ground Truth Used:
- Bench Testing: Engineering measurements, adherence to design specifications, material properties, and functional performance (e.g., successful cutting, no breakage, correct cement delivery).
- Clinical Testing: Patient outcomes, functional assessments, and clinician observations regarding the safety and effectiveness of the device in treating vertebral compression fractures. The summary does not specify particular outcome measures.
8. Sample Size for the Training Set:
- Not Applicable: This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As stated above, this is not an AI/ML device, so there is no training set or ground truth establishment method for one.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”