(159 days)
- It is the intention of Miltex Inc. to introduce into the marketplace a line of Fixation/Steinmann Pins both Smooth and Threaded.
- The material is 316LVM, Stainless Steel and the Pins are to be utilized for internal fixation of bone fractures.
- The Pins are used specifically for fractures of the proximal or distal end of long bones such as intracapsular intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur.
- The device(s) may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Steinmann and Fixation Pins, Smooth and Threaded. The material is 316LVM, Stainless Steel.
The provided text describes a 510(k) summary for Steinmann and Fixation Pins and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or benchmark study.
Instead, the submission relies on the concept of Substantial Equivalence to legally marketed predicate devices.
Therefore, most of the requested information cannot be extracted from this document, specifically:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
Here's what can be extracted, based on the provided text:
1. Acceptance Criteria and Reported Device Performance:
The document states:
- "Miltex Inc. will assure that product will be manufactured as indicated above and with the further confirmation that the Pins will meet all parameters of our print specifications and current ISO standards referenced under Performance Standards, Miltex Inc. then hereby claims that these Steinmann/Fixation Pins are Substantially Equivalent."
- "The above attestation therefore deems this product as being Safe and Effective. Our (5) plus years in which Miltex Inc. has already sold Steinmann/Fixation Pins in the Veterinary marketplace, serves as additional confirmation of the Safety and Effectiveness of this new product line. Miltex Quality records for these products support our claim."
There are no explicit quantitative acceptance criteria or reported device performance metrics in the provided text. The acceptance criteria are implicitly linked to manufacturing consistency, adherence to print specifications, and current ISO standards. Device performance is not quantitatively reported but is inferred from the substantial equivalence claim and prior use in veterinary medicine.
2. Study that proves the device meets the acceptance criteria:
The primary "proof" for regulatory clearance is based on the claim of Substantial Equivalence to legally marketed predicate devices, rather than a clinical study evaluating specific performance criteria against predefined acceptance thresholds.
The relevant statements are:
- "Miltex Inc. is claiming Substantial Equivalence for our Fixation Pins, Smooth and Threaded based upon the cross referenced information as presented in the Spread Sheet, pages 5-2 and 5-3, which clearly indicates a large representation of other manufacturers. Their similar products have been utilized in the medical device market for many years."
- "The subject Pins have already been assigned Product Codes of 87HTY and 87JDW by the FDA. The FDA in these classifications has already issued 510(k) numbers to manufacturers who sell and or distribute these product lines."
- "Our (5) plus years in which Miltex Inc. has already sold Steinmann/Fixation Pins in the Veterinary marketplace, serves as additional confirmation of the Safety and Effectiveness of this new product line. Miltex Quality records for these products support our claim."
Summary of available information:
| Category | Detail |
|---|---|
| Acceptance Criteria | Implicit: Adherence to print specifications, current ISO standards, and manufacturing consistency. No explicit quantitative performance metrics or thresholds are provided. |
| Device Performance | Not quantitatively reported. Performance is considered "Safe and Effective" based on substantial equivalence to predicate devices and 5+ years of use in the veterinary marketplace. |
| Sample size (test set) | Not applicable, as no specific performance study against acceptance criteria is described. The assessment is based on substantial equivalence and historical performance in veterinary use. |
| Data Provenance (test set) | Not applicable for a separate "test set" in the context of this submission. The claim relies on the long-standing use of similar products in the medical device market and Miltex's own veterinary sales history. |
| Number of Experts (ground truth) | Not applicable, as no ground truth establishment for a test set is described. |
| Qualifications of Experts | Not applicable. |
| Adjudication Method | Not applicable. |
| MRMC Comparative Effectiveness | No. This is a claim of substantial equivalence for a physical medical device, not an AI-based system or a comparative effectiveness study with human readers. |
| Standalone Performance Study | No. The submission focuses on comparison to predicate devices and past veterinary use, not a standalone performance study with specific metrics. |
| Type of Ground Truth | Not explicitly defined as no specific study establishing ground truth for performance is presented. The "ground truth" for clearance is essentially the established safety and effectiveness of predicate devices and the device's own history in veterinary applications. |
| Sample size (training set) | Not applicable, as this is not an AI/machine learning device. |
| Ground truth for training set | Not applicable. |
§ 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.