(211 days)
Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.
The Anspach Helix™ Dissection Tools (otherwise known as burs) are part of a drill system that consists of a control console, a handpiece (motor), a control switch and various attachments and accessories. The Anspach Helix™ Dissection Tools are onepiece metal bone cutting and shaping devices that attach to the handpiece/attachment of a pneumatic or electric powered drilling system. The Anspach Helix™ Dissection Tools are manufactured from M2 tool steel and feature a 2-fluted ball sharp cutting edge at the distal end. The proximal end, which secures the dissection tool to the handpiece of the power system, incorporates a patented Diamond Flat configuration locking mechanism. The Anspach Helix™ Dissection Tools are provided sterile.
This document is a 510(k) summary for the Anspach Helix™ Dissection Tools, which are intended for cutting and shaping bone, including the spine and cranium. The submission demonstrates substantial equivalence to a predicate device (K113476).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Verification Analysis - Mating Clearance & Anti-Rotation Interference | Mating clearance and anti-rotation interference when engaged with drive spindle of EG1, XMAX, & EMAX2PLUS handpieces. (Design output meets design input.) | The analysis shows that the design output meets the design input; the proposed Helix dissection tools drive feature meets the acceptance criteria of mating clearance and anti-rotation interference when engaged with drive spindles of EG1, XMAX, & EMAX2PLUS handpieces. |
| Helix Dissection Tool and Attachment Compatibility - Shaft Diameter/Shaft Length | Minimum and maximum clearance between the shaft diameter of the dissection tool and inner race bearing diameter of the attachment must be within the required range. | |
| Minimum length in the lock position exists to prevent interference. | ||
| Tapered section of the dissection tool does not interfere with the distal bearing inner diameter of the attachment. | Analysis confirmed compatibility. | |
| Tolerance analysis reflects 0.0001 to 0.0007 inches of clearance between dissection tools and the attachment, which is in the required range for a 3/32-inch shaft diameter and compatible attachments. | ||
| Tolerance analysis reflects that the minimum length in the lock position exists and the tapered section will not interfere with the distal bearing inner diameter of the attachment. | ||
| Helix Ball Bur Chatter/Cut and Shape Verification Report | Chatter: The % chatter for each group of same-size Helix ball burs must be less than the chatter of the corresponding group of same-size predicate G1 burs, as determined by a hypothesis test with a significance level (alpha) = 0.10. | All samples met the acceptance criteria and exhibited statistically lower % chatter than the corresponding same size predicate devices, with the exception of the S-25SB-HX-G1-1. For this specific size, while lower, the results were not statistically significant as compared to the corresponding same size predicate. |
| Cutting and Shaping: Each Helix ball bur used to cut into Bi-resin (simulated bone) samples shall be evaluated to confirm that they cut and shape bone the same as the predicate. | All samples met the acceptance criteria to cut and shape bone, the same as the predicate. | |
| Cutter Head Fracture: Each Helix ball bur used to cut into Bi-resin (simulated bone) samples shall be visually inspected for cutter head fracture, with the acceptance criteria of the bur head intact on the cutter and not broken, the same as the predicate. | All samples met the acceptance criteria for the head of the cutter to remain intact, the same as the predicate. | |
| Biocompatibility Testing | Meet requirements per FDA guidance document Use of International Standard ISO 10993-1. | The Anspach Helix™ Dissection Tools are manufactured and packaged in the same manner with identical material as the predicate device (K113476). No new or additional processing steps were introduced, therefore, biocompatibility requirements have been met by reference to the predicate. |
Study Details for Meeting Acceptance Criteria:
The document describes design verification activities rather than a standalone clinical study involving human patients or a multi-reader, multi-case study. The testing focused on technical and performance characteristics compared to a predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a single number for all tests. For the Helix Ball Bur Chatter/Cut and Shape Verification, it mentions "each group of same-size Helix ball burs" and "Each Helix ball bur used to cut into the Bi-resin samples." This implies multiple burs were tested across different sizes. However, specific quantities (e.g., "n=X burs per size") are not provided.
- Data Provenance: The tests utilized simulated bone (Bi-resin) and a tolerance analysis. This is laboratory-based data, not human patient data. There is no country of origin for data as it's not a clinical study. It's prospective in the sense that these tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was not a study requiring expert readers or ground truth established by medical professionals. The "ground truth" was based on engineering specifications, physical measurements, and comparison to the performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication was described for these engineering and performance tests. The acceptance criteria were objectively defined (e.g., statistical significance for chatter, visual inspection for fracture, tolerance ranges).
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, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a manual surgical tool that requires human operation; it is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For technical specifications (mating, compatibility): Engineering tolerance analysis and physical measurements.
- For performance (chatter, cut and shape, fracture): Quantitative measurements for chatter (statistical comparison to predicate) and visual inspection against a predicate device for cutting/shaping and integrity.
- The predicate device's established performance served as a de facto "ground truth" for comparison.
8. The sample size for the training set:
- Not applicable. This device did not involve a training set as it is not an AI/machine learning system.
9. How the ground truth for the training set was established:
- Not applicable. There was no training set.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).