(108 days)
The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
The Parcus AcTiFlip and GFS Ultimate Hip devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture and are provided sterile.
This FDA 510(k) summary provides limited information regarding the acceptance criteria and study data for the Parcus Medical AcTiFlip and GFS Ultimate Hip devices.
Here's an analysis based on the provided text, highlighting where information is available and where it's missing for your specific requests:
Summary of Acceptance Criteria and Device Performance (Limited Information):
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Strength | - Meet or exceed predicate device performance for strength | - "Results were compared with test data for the predicate device and demonstrated substantial equivalency." (Specifically for strength under cycle loading and ultimate failure conditions) |
| Elongation | - Meet or exceed predicate device performance for elongation | - "Results were compared with test data for the predicate device and demonstrated substantial equivalency." (Specifically for elongation under cycle loading and ultimate failure conditions) |
| Pyrogenicity / Endotoxin | - Meet endotoxin limit specifications | - "It was concluded that both the Parcus AcTiFlip and the GFS Ultimate Hip devices meet endotoxin limit specifications and do not raise any additional concerns regarding pyrogenicity." |
Detailed Responses to Specific Questions:
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A table of acceptance criteria and the reported device performance:
- See the table above. The document primarily states that the devices demonstrate "substantial equivalency" to predicate devices for mechanical properties (strength and elongation) and meet endotoxin specifications. Specific numerical acceptance criteria for strength and elongation are not
provided in this summary, nor are the precise numerical results of the testing.
- See the table above. The document primarily states that the devices demonstrate "substantial equivalency" to predicate devices for mechanical properties (strength and elongation) and meet endotoxin specifications. Specific numerical acceptance criteria for strength and elongation are not
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document states that "testing was conducted on the worst case configurations," but does not specify the sample size (N) for these tests.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. It describes laboratory testing, not clinical studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the summary describes mechanical and biocompatibility laboratory testing of a medical device (fixation fasteners), not a diagnostic or AI-driven device requiring expert-established ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for mechanical and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving human assessment of data.
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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:
- This is not applicable. The device (fixation fasteners) is not an AI/diagnostic device that would involve human readers or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical tests, the "ground truth" (or more accurately, the reference standard for comparison) was the performance of the predicate device. The testing aimed to show that the new device's performance was "substantially equivalent" to this established predicate.
- For pyrogenicity, the "ground truth" was established based on endotoxin limit specifications, which are regulatory standards.
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing described is for physical properties and biocompatibility.
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How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.
In summary, the provided FDA 510(k) letter and summary focus on demonstrating substantial equivalence of a physical medical device (bone/soft tissue fixation fasteners) to already cleared predicate devices through mechanical testing and biocompatibility assessments. It does not involve AI, diagnostic algorithms, or human interpretation studies.
§ 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.