(86 days)
The RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.
The RMB Staple is a sterile, single use polymer strap with cleat tips. RMB Staple is composed of PEEK material. The RMB Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical.
This document describes the Rotation Medical Bone Staple (RMB Staple) and its approval through the 510(k) pathway. The goal of the 510(k) process is to demonstrate substantial equivalence to legally marketed predicate devices, rather than to establish new safety and effectiveness through clinical trials with specific acceptance criteria in the same way a PMA (Pre-Market Approval) study would.
Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" needs to be interpreted within the context of a 510(k) submission, where the "acceptance criteria" are the demonstration of similarity in intended use, technological characteristics, and safety and performance testing to predicate devices. The "study" is the battery of tests performed to support substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, there isn't a table of specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding study results in the traditional sense, as there would be for a device seeking novel claims or a PMA. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating the device is as safe and effective as a legally marketed predicate through a comparison of technological characteristics and performance in pre-clinical studies (in vitro and in vivo bench and animal testing).
The document states:
- "The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices."
- "The results of the in vitro product characterization studies, bench testing and in vitro and in vivo biocompatibility studies, as well as the animal efficacy study demonstrate that the RMB Staple is safe and substantially equivalent to the predicate devices."
Therefore, the "acceptance criteria" are the successful completion and positive results from these specific tests, showing comparability to the predicate devices.
| Acceptance Criteria (Demonstrated through testing) | Reported Device Performance (Implied by conclusion) |
|---|---|
| Biocompatibility: Meet FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards for biological evaluation. | Passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. Confirmed to be biocompatible through cytotoxicity, sensitization, intracutaneous reactivity, toxicity, and animal testing with histology. |
| Product Characterization (In vitro): Demonstrate similar characteristics to predicate. | Results from in vitro product characterization studies support substantial equivalence. |
| Bench Testing (In vitro): Evaluate performance characteristics (e.g., strength, retention). | Results from bench testing (including strength and retention) support substantial equivalence. The RMB Staple is optimized for fixation to bone, differentiating it from one predicate (Ethicon Securestrap™) but aligning with the material (PEEK) and bone fixation goal of the other (SwiveLock Anchor), albeit with direct vs. indirect fixation. |
| Animal Efficacy (In vivo): Assess performance in a biological model. | Results from the animal efficacy study demonstrate safety and substantial equivalence. |
| Substantial Equivalence: Demonstrate that the RMB Staple is as safe and effective as the predicate devices. | The conclusion explicitly states the device is "safe and substantially equivalent to the predicate devices" based on the performed studies. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the individual in vitro or in vivo tests performed. It generically mentions "number of in vitro and in vivo tests."
- Data Provenance: The tests are pre-clinical studies (in vitro and in vivo animal testing), not human clinical data. The country of origin for the data is not specified, but typically these tests would be conducted by or for the applicant (Rotation Medical, Inc. based in Plymouth, MN, USA). The studies are inherently "prospective" in the sense that they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of submission. "Ground truth" established by human experts for a test set (e.g., radiologists interpreting images) is relevant for AI/CADe device submissions or clinical trials requiring human assessment of outcomes. For a medical device like a bone staple, the "ground truth" or acceptability is determined by physical and biological performance against established scientific standards and comparison to predicate devices, not by expert consensus on individual cases.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in human expert interpretations in clinical studies or AI validation, which is not the nature of the studies described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. MRMC studies are specific to evaluating the impact of AI on human readers for diagnostic or screening tasks (e.g., radiology interpretation). This device is a mechanical implant, and its assessment involves pre-clinical performance testing, not human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone staple, not an algorithm or AI system. Its performance is evaluated through material science, mechanical testing, and biocompatibility, not as a standalone algorithm.
7. The Type of Ground Truth Used
For the pre-clinical tests, the "ground truth" is based on:
- Scientific Standards: Meeting established FDA and ISO standards for biocompatibility (e.g., ISO 10993-1, FDA Blue Book Memorandum G95-1).
- Engineering Specifications/Benchmarking: Performance metrics (strength, retention) are evaluated against pre-defined engineering requirements and/or compared to the performance of the predicate devices.
- Histopathology: In animal studies, histological analysis would be used to assess tissue response and integration, with findings interpreted by veterinary pathologists or similar experts.
- Gross observation of efficacy: In animal efficacy studies, the "efficacy" (e.g., successful fixation of tissue to bone) would be observed and measured.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.