(59 days)
The 2.7mm Extremity Bone Screw is intended for fracture and osteotomy fixation of the upper and lower extremities. This screw is not intended for usage in the spine and is not for use with any available bone plates, washers, etc.
The 2.7mm Extremity Bone Screw is available in lengths of 12mm. 14mm. 16mm, 18mm, 20mm, 22mm, and 24mm. The screw is driven by a conventional 2.5mm hex head. Hex dimensions are in accordance with ASTM F 543. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided non-sterile.
Acceptance Criteria and Study Details for the 2.7mm Extremity Bone Screw
Based on the provided Enclosure D - 510(k) Summary for the ACUMED 2.7mm Extremity Bone Screw (K963118), here's a breakdown of the acceptance criteria and the study information:
The document explicitly states that the device is "similar to Synthes' 3mm Cannulated Screw System in design, function, indications, and surgical technique and is expected to perform as well as similar devices." This implies that the acceptance criteria are largely based on demonstrating equivalence to the predicate device (Synthes' 3mm Cannulated Screw System) and compliance with relevant industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Indications for Use | Intended for fracture and osteotomy fixation of the upper and lower extremities. Not for use in the spine or with certain plates/washers. | "Intended for fracture and osteotomy fixation of the upper and lower extremities. This screw is not intended for usage in the spine and is not for use with any available bone plates, washers, etc." (Matches) |
| Material Composition | Manufactured from a biocompatible material suitable for bone implantation. | "Manufactured from a titanium alloy per ASTM F 136." (Meets international standard for titanium alloy implants) |
| Sterilization | Capable of achieving a Sterility Assurance Level (SAL) of 10^-6 via steam sterilization (even though provided non-sterile). | "On file at Acumed is test data which shows that the screw can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 10^-6." (Demonstrated capability) |
| Dimensions/Fit | Consistent with conventional surgical tools (e.g., hex head size) and available in a range of lengths. | "Available in lengths of 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, and 24mm. The screw is driven by a conventional 2.5mm hex head. Hex dimensions are in accordance with ASTM F 543." (Meets specific dimensions and ASTM standard) |
| Design/Function | Similar to the predicate device (Synthes' 3mm Cannulated Screw System) in design and function. | "The 2.7mm Extremity Bone Screw is similar to Synthes' 3mm Cannulated Screw System in design, function, indications, and surgical technique." (Claimed similarity) |
| Performance (General) | Expected to perform as well as similar predicate devices. | "and is expected to perform as well as similar devices." (Claimed equivalent performance) |
2. Sample Size Used for the Test Set and the Data Provenance
The document provides very limited detail on specific "test sets" for the performance claims beyond the sterilization data.
- Sample Size: Not explicitly stated for most performance claims. For sterilization, it refers to "test data," but the sample size of screws tested for SAL is not provided.
- Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the data would typically be generated by the manufacturer (Acumed) through bench testing rather than clinical studies on human subjects, especially for a predicate-based submission like this one. It's safe to assume this is retrospective testing performed by the manufacturer to support the claim. The country of origin of the data is implicitly the country where Acumed is located and performs its testing, which is not specified in this snippet.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. The "ground truth" for the performance of a bone screw is typically established through:
- Compliance with engineering standards (e.g., ASTM F 136 for material, ASTM F 543 for hex dimensions).
- Bench testing for mechanical properties (though not explicitly detailed beyond sterilization).
- Demonstration of equivalence to a legally marketed predicate device.
There is no mention of expert consensus or clinical expert adjudication used to establish ground truth for this device's performance claims as if it were a diagnostic AI device.
4. Adjudication Method for the Test Set
Not Applicable. Since there's no mention of expert-reviewed data or clinical studies requiring adjudication of outcomes, this concept does not apply here.
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
Not Applicable. This is a hardware medical device (bone screw), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware medical device. There is no algorithm or AI component to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's claims relies on:
- Engineering Standards Compliance: For material (ASTM F 136) and dimensions (ASTM F 543).
- Bench Test Results: Specifically mentioned for sterilization (achieving SAL of 10^-6).
- Predicate Device Equivalence: The primary "ground truth" for its overall performance and safety is its demonstrated similarity to the Synthes' 3mm Cannulated Screw System, which has established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not a machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, this question is not relevant.
§ 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.