(113 days)
Not Found
The Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screw will be offered in two versions of an identical configuration. Both versions are identical with the exception of the overall thread length . One will be 16 mm and the second will be 32 mm in length. The length is measured from the distal tip up the shank. The screws will be fabricated from Titanium alloy Ti-6Al-4V, which complies with ASTM F-136. The device is of a single thread profile with a nominal major diameter of Ø6.5 mm (.256 in.) and a nominal shank, or minor diameter, of 4.82 mm (.190 in.). The lengths offered at this time are 30 mm through 150 mm, in 5 mm increments. The overall length is measured from the underside of the head to the distal tip. The cannula, or inner diameter, is a nominal Ø3.26 mm (1285 in.) bore which will allow the use of a Ø2.5 mm Guide Pin ensuring safe and accurate placement of the screw. The "head" portion off the screw will embody an internal hexagon pocket to facilitate the insertion / extraction instrumentation. The distal tip embodies a self reaming / self tapping design. The self reaming feature incorporates three cutting teeth, while the self tapping is accomplished with three cutting flutes. Two cutting flutes will be located at the thread runout to the shank. They will be located at 180° to each other. These flutes are provided to ease extraction of the device. The self reaming and self tapping cannulated screws simplify the surgical procedure by allowing the surgeon to place the screw directly over the guide pin which is holding the reduced fracture in place.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screw:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material | Complies with ASTM F-136 | Fabricated from Titanium alloy Ti-6Al-4V, which complies with ASTM F-136. |
| Design | Single thread profile, nominal major Ø6.5 mm, nominal shank Ø4.82 mm, lengths 30mm-150mm (5mm increments), cannula Ø3.26 mm bore (for Ø2.5 mm Guide Pin). Internal hexagon pocket head. Self-reaming/self-tapping with three cutting teeth and three cutting flutes (two at 180° for extraction). | Matches the description provided as "identical configuration" with two versions (16mm and 32mm thread length) and all dimensions listed. |
| Mechanical Strength & Stiffness | Equivalent bending strength and stiffness to predicate devices (Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws) as determined by a three-point bend test per ASTM E-8555. | "Comparison test values for the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws and the Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws were equivalent at all times." "Test reports demonstrated that the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws have been adequately designed to perform in a manner equivalent to that of the comparison device(s)." |
| Clinical Performance | Suitable for indications noted and anticipated conditions of use, with performance equivalent to predicate devices. Safe and effective for existing indications. | "The results of all testing revealed that the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws are suitable for the indications noted and the anticipated conditions of use imposed on the device." "Maintaining the same indications for use provides two specific benefits...expected physiological loads and performance are well known. Clinical performance of similar screws used in these well known conditions is extensively reported in medical literature." |
| Sterilization | Withstands high temperature steam sterilization (e.g., 270°F for 15 mins) to achieve a 10^-6 sterility assurance level (SAL). Also withstands ETO gas. | "Sterilization must be accomplished by the end user... High temperature steam sterilization with a cycle such as recommended by AORN or ACS is appropriate. This cycle should be performed with live steam at a temperature of at least 270° F. for a minimum of 15 minutes duration. Such a cycle has been validated by the manufacturer using the overkill method. Strict adherence to this sterility recommendation provides assurance of a 10^-6 level kill." "The materials of the device will withstand virtually any steam or ETO gas cycle." |
| Substantial Equivalence | Equivalent in performance to the Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws. | "Based on the testing, the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws are equal in performance to the Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws." "Therefore, based on the test results and indication demands, Northwest Precision Technologies believes that this device possesses sufficient strength and that parallel equivalency has been fully achieved." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for the "test set" (which refers to the mechanical testing). The document mentions "computer generated analysis" and "comparison test values" without specifying the number of screws tested or iterations.
- Data Provenance: Not specified. Given the nature of a 510(k) submission, this would typically involve internal lab testing by the manufacturer. No country of origin is mentioned, nor is it explicitly stated as retrospective or prospective (though mechanical testing is inherently prospective in its execution for a new device).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Ground Truth: For the mechanical testing, the "ground truth" is defined by the objective results of the ASTM E-8555 three-point bend test and comparison to predicate devices. This is a performance-based ground truth rather than an expert-opinion based one.
- Experts: No external experts were used to establish ground truth for this mechanical testing. The comparison relies on established engineering standards (ASTM) and performance metrics against existing devices.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable for the mechanical testing described. The "adjudication" is based on direct measurement and comparison of quantitative values from the three-point bend test against a defined standard/predicate performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a passive implantable device (a screw for bone fixation), not an imaging or diagnostic AI device that would typically involve human readers.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the mechanical testing, the ground truth was objective performance data derived from standardized engineering tests (ASTM E-8555 three-point bend) and comparison against the established performance of legally marketed predicate devices. For the broader clinical suitability, the ground truth refers to "well known" physiological loads and "extensively reported" clinical literature on similar screws, implying a historical and literature-based ground truth regarding the performance of this type of device in the human body.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This product is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the design and testing of a cancellous screw.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no "training set" in the context of this device. The design was likely based on engineering principles, existing medical knowledge, and the established designs of predicate devices.
§ 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.