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1.) 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;

2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities.

3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.

Biomet OrthoSorb LS resorbable fixation devices include straight and tapered pins. Biomet OrthoSorb LS resorbable fixation devices are made of a resorbable copolymer, polyester derivative of L-lactic and glycolic acids. Poly L-lactic/polyglycolic acid copolymer degrades and resorbs in-vivo by hydrolysis into L-lactic and glycolic acids which are then metabolized by the body.

This is not an AI/ML device, therefore, the requested information is not applicable.

This is a medical device submission for the OrthoSorb LS, a resorbable fixation device (pin) made of a polyester derivative of L-lactic and glycolic acids. The document describes the device, its indications for use, and a summary of substantial equivalence to predicate devices based on mechanical testing.

Here's a breakdown of why an AI/ML device report is not appropriate:

• Device Description: The OrthoSorb LS is a physical pin. AI/ML devices typically refer to software algorithms that perform tasks like image analysis, diagnosis, or prediction.
• Technological Characteristics: The characteristics mentioned are "design, dimensions, and material," which are typical for physical implants.
• Summary of Substantial Equivalence: The equivalence is demonstrated through "mechanical testing that was performed to ASTM D6272" and "Single Shear testing." These are physical tests, not evaluations of algorithmic performance.
• No mention of AI/ML or Software: The document makes no reference to any artificial intelligence, machine learning, software, data processing, or algorithmic components.

Therefore, the requested fields related to acceptance criteria, ground truth, training sets, and expert evaluations for AI/ML performance are not present because the device described is a physical implant, not an AI/ML product.

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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)

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.

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