(85 days)
The ORTHOSORB Resorbable pin are indicated for use to fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
The ORTHOSORB 1.3mm and 2.0mm Resorbable Pins are made from poly-p-dioxanone and are available in 1.3mm and 2.0mm diameters and 40mm and 50mm lengths with their accompanying instrumentation.
This is not a medical imaging AI device. The provided text describes a 510(k) summary for a resorbable pin (ORTHOSORB Resorbable Pin) made from poly-p-dioxanone, intended for fixing small bony or chondral fragments.
Therefore, many of the requested categories (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, MRMC studies, etc.) are not applicable to this type of medical device submission.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance for ORTHOSORB Resorbable Pin (K111077)
| Acceptance Criteria Category | Reported Device Performance / Description |
|---|---|
| Substantial Equivalence | The ORTHOSORB Resorbable pins that are the subject of this submission are equivalent to the predicate device (ORTHOSORB Resorbable Pin, K901456). The technological characteristics are identical in terms of design, material, and performance. |
| Material Composition | Made from poly-p-dioxanone. Based on material, the pins are considered MR Safe as defined in ASTM F2503. |
| Device Dimensions | Available in 1.3mm and 2.0mm diameters and 40mm and 50mm lengths. |
| Intended Use/Indications | To fix in place small bony or chondral fragments in the knee and hand (e.g., osteochondritis dissecans, fractures of phalanges and metacarpals); for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for lesser toe deformities. Can provide additional support in finger joint fusion and digit replantation where standard fixation/support techniques are also employed. This aligns with the predicate device's indications. |
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act for these devices. (This is a statement of non-applicability of specific FDA performance standards, not a device-specific performance metric.) |
| Regulatory Classification | Class II, Regulation Number 21 CFR 888.3040, Product Code OVZ (Smooth or threaded metallic bone fixation fastener). The device is regulated as substantially equivalent to a predicate product in this class. |
Non-Applicable Information for this Device (as it's not an AI/imaging device)
- Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI model. "Test set" refers to data for evaluating AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context refers to clinical labels for AI data. The "truth" for this device is its physical and material properties and its function.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This applies to expert labeling for AI device evaluation.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are used to evaluate diagnostic performance of imaging AI with human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI evaluation. For this device, the "ground truth" would relate to its manufacturing specifications, material properties, and mechanical performance tests, which are not detailed in this 510(k) summary (as it relies on equivalence to a predicate).
- The sample size for the training set: Not applicable. There is no training set for a physical resorbable pin.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):
The provided 510(k) summary indicates that the device (ORTHOSORB Resorbable Pin) meets its "acceptance criteria" primarily through a demonstration of substantial equivalence to a previously legally marketed predicate device (ORTHOSORB Resorbable Pin, K901456).
The "study" or justification for this is a direct comparison of the new device to the predicate device, asserting that:
- Technological Characteristics: They are identical in terms of design, material, and performance.
- Indications for Use: The indications for use are the same.
- Material Properties: Both are made from poly-p-dioxanone, and the MR safety (based on ASTM F2503) of the material is noted.
This type of submission typically relies on a comparison of specifications, engineering drawings, material data, and, if necessary, non-clinical bench testing (e.g., mechanical strength, degradation profiles) to demonstrate that the new device performs as safely and effectively as the predicate, and thus meets the "acceptance criteria" for market clearance via the 510(k) pathway. The specific details of these comparative tests are not provided in the summary document but form the basis of the substantial equivalence claim.
§ 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.