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510(k) Data Aggregation
(399 days)
Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium. The taps may be used to prepare cranial bone to insert bone fixation screws.
Taps are used to drill a hole and simultaneously create threads in order to accommodate a Rapid Resorbable Fixation System bone screw. The self-drilling fixed-stop taps are manufactured from Stainless Steel 440A which conforms to ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments and ASTM A276 Specification for Stainless Steel Bars and Shapes. The adjustable-length taps (final assembly) are assembled from three components; the adjustable tap (Stainless Steel 440A), the locking collar (Makrolon Rx2530 W/1118 Tint), and the stop collar (Stainless Steel 316L with an aluminum titanium nitride coating).
The provided document describes the Synthes Taps for Resorbable Screws (K153587) and the performance testing conducted to support its substantial equivalence to predicate devices. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use/Bioskills Lab - RapidSorb Instruments | Full validation of various aspects of the device design (torque resistance, length, screw size diameter). | The results indicated full validation of the subject device. All acceptance criteria were met. |
| Saw Bones Lab - RapidSorb Instruments | All four users must be able to use each of the three subject taps to create three separate tapped holes that accommodate the corresponding screw (36 total insertions). | The acceptance criteria was met in that all four users were able to use each of the three subject taps to create three separate tapped holes that will accommodate the corresponding screw (36 total insertions). |
| Mechanical Test - Torsional Testing of RapidSorb Taps | The failure torque of RapidSorb self-drilling taps must be above the torque at which the same diameter taps will bottom-out in the testing substrate. | P-values of 0.000 for all three sizes (1.5, 2.0, and 2.5 mm) when comparing failure torque to bottoming or stripping torque. This is sufficient evidence to reject the null hypothesis, indicating the RapidSorb failure torque is superior, satisfying the acceptance criteria. |
| Mechanical Test - RapidSorb Self-Drilling Tap Axial Load at Strip Out | The axial force required to cause the adjustable stop to unintentionally move must be greater than the axial force generated by the strip-out torque of each tap. | P-value of 0.000 for all comparisons (1.5, 2.0, and 2.5mm) for axial load, indicating the axial load required to move the adjustable stop was superior to the axial load at strip-out in all cases, satisfying the acceptance criteria. |
| Validation of Hex Coupling for RapidSorb Adjustable Taps | All tested parts must couple with the designated hex handles and then be fully inserted into 40 lbs/cf polyurethane foam with no slippage or visible damage (no magnification) of taps proximal coupling. | All participants were able to drive all 12 taps with a combination of the 3 specified handles, with no visible damage to the proximal coupling end of the tap. |
| Biocompatibility (Cytotoxicity) | No reactivity of causing cell lysis or toxicity. All test method acceptance criteria met. | The test articles extract showed no reactivity of causing cell lysis or toxicity. All test method acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Simulated Use/Bioskills Lab:
- Sample Size: 5 individual participants (users) and 4 cadaveric cephaluses (heads).
- Data Provenance: Prospective, from cadaveric cephaluses. Likely from the US, given the submission to the FDA.
- Saw Bones Lab:
- Sample Size: 4 users and an unspecified number of "saw bones" (synthetic bone models). The test involved 36 total insertions (implying 3 subject taps x 3 tapped holes x 4 users).
- Data Provenance: Prospective, using synthetic bone models (Sawbones).
- Mechanical Tests (Torsional, Axial Load, Hex Coupling Validation):
- Sample Size: For Torsional Testing, all three sizes of RapidSorb Self-Drilling Taps (1.5, 2.0, and 2.5 mm) were tested. For Axial Load, adjustable length taps (311.100, 311.101, 311.102, 311.110, 311.111, 311.112) of 1.5, 2.0, and 2.5mm were compared. For Hex Coupling Validation, 12 taps were driven by "all participants" (number not specified but implied to be multiple, likely the same 5 as the simulated use or similar).
- Data Provenance: In-vitro / bench testing. No specific country of origin or retrospective/prospective distinction is given for the collected data, but it is implied to be newly generated for this submission.
- Biocompatibility Testing:
- Sample Size: Not specified for the extract, but presumably standard in-vitro cell culture methods.
- Data Provenance: In-vitro lab testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The concept of "experts" establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here as this is a medical device for surgical procedures (taps).
- Simulated Use/Bioskills Lab: "The users are independent from the design of the subject device." No specific qualification (e.g., surgeon, resident) or experience level is mentioned for the 5 participants.
- Saw Bones Lab: 4 users. No specific qualifications mentioned.
For mechanical and biocompatibility testing, the "ground truth" is established by the physical and biological properties being measured against established engineering and biological standards.
4. Adjudication Method for the Test Set
No formal adjudication method (like 2+1 or 3+1 consensus) is described for any of the performance tests. The tests appear to involve direct measurement (mechanical tests) or observed outcomes (simulated use, Sawbones lab), with success defined by meeting the specified acceptance criteria. For the "Simulated Use/Bioskills Lab," "The results indicated full validation... All acceptance criteria were met," suggesting a pass/fail outcome rather than a consensus on a specific finding.
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. This device is a manual surgical instrument, not an AI or imaging diagnostic tool where MRMC studies are typically performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical, manual surgical instrument. There is no "algorithm" or AI component to this device.
7. The Type of Ground Truth Used
The "ground truth" primarily relies on:
- Performance against engineering specifications: For mechanical tests (torsional, axial load, hex coupling), the ground truth is defined by the device's ability to withstand forces, prevent stripping, and couple correctly according to established engineering benchmarks and statistical comparisons with null hypotheses.
- Direct observation of functional performance: For the Simulated Use and Saw Bones labs, the ground truth is observed successful drilling/tapping and accommodation of screws by human users, as per the defined acceptance criteria.
- Biological standards: For biocompatibility, the ground truth is the absence of cytotoxicity, evaluated against ISO 10993-5 guidelines.
8. The Sample Size for the Training Set
No training set is mentioned as this device is not an AI/ML algorithm. The performance data presented are for validation/verification testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device submission.
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