(267 days)
The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.
The Fixone Meniscal Repair are all-inside meniscal repair devices. Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter. The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage. The device is provided sterile for single use only.
This document describes the performance testing for the "Fixone Meniscal Repair" device. Primarily, it focuses on bench testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.
Here's a breakdown based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various performance tests and their corresponding requirements. However, it does not provide specific numerical results or pass/fail outcomes for each criteria within the summary. It generally states that the tests "demonstrated that the device performs in a substantially equivalent manner to the prior related devices."
| Test Item | Requirements | Reported Device Performance |
|---|---|---|
| Biocompatibility | Leveraged from K203523 and K230892 for anchor/suture; ISO 10993-1 for other components. | Demonstrated substantial equivalence (implied pass) |
| Extraction Test | Visual clarity/no foreign particles, pH difference ≤ 1.5, potassium permanganate difference ≤ 2.0 mL, residue after evaporation ≤ 1.0mg, UV spectrum (250-350nm) max absorbance ≤ 0.1, heavy metals not exceeding standard lead solution. | Demonstrated substantial equivalence (implied pass) |
| Extractable Color (Suture) | MFDS guideline 2021-3 10.non-absorbable suture. | Demonstrated substantial equivalence (implied pass) |
| EO Residual | ISO 10993-7, Ethylene oxide Sterilization residuals. | Demonstrated substantial equivalence (implied pass) |
| Sterility Test | ISO 10993-7, Ethylene oxide Sterilization residuals. | Demonstrated substantial equivalence (implied pass) |
| Comparison Test (Pull-out) | Not explicitly stated, but compared to FAST-FIX Meniscal Repair System and Fixone Meniscal Repair. | Demonstrated substantial equivalence (implied pass) |
| Comparison Test (Fatigue) | Not explicitly stated, but compared to FAST-FIX Meniscal Repair System and Fixone Meniscal Repair. | Demonstrated substantial equivalence (implied pass) |
| Shelf Life Testing | Real-time equivalent (RTE) and Accelerated aging temperature, Taa as per AAMI TIR17 and ASTM F 1980-02; Aging temperature: 55±2°C, aging time: 225 days. | Demonstrated substantial equivalence (implied pass) |
| Comparison Test (Benchtop performance simulating clinical usage) | Not explicitly stated. | Demonstrated substantial equivalence (implied pass) |
| External Surface | No damage to appearance in visual inspection. | Demonstrated substantial equivalence (implied pass) |
| Length (Suture) | Not less than 95.0% of 750mm when laid out smooth without tension. | Demonstrated substantial equivalence (implied pass) |
| Diameter (Suture) | According to MFDS Notification No.2020-20, "Nonabsorbable Surgical Suture, 4. Diameter" with Table 1. | Demonstrated substantial equivalence (implied pass) |
| Needle Attachment | Meet test requirements of MFDS notification No.2020-97 for "Surgical suture, non-absorbable, with/without needle". | Demonstrated substantial equivalence (implied pass) |
| Tensile Strength (Knot) | Meet test requirements of MFDS notification No.2020-97 for "Surgical suture, non-absorbable, with/without needle". | Demonstrated substantial equivalence (implied pass) |
| Endotoxin Test | USP 42 , Bacterial endotoxin test (LAL). | Conducted for each batch; batches not passing are discarded. |
| Pyrogen Test | USP 42 : 2019, Pyrogen test. | Demonstrated substantial equivalence (implied pass) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing, not clinical studies with human subjects or test sets in the context of diagnostic accuracy. Therefore, information about patient sample size, country of origin, or retrospective/prospective nature of data for a "test set" is not applicable. The samples used for mechanical and material testing would be device prototypes/production units.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable as the studies described are bench tests of mechanical and material properties, not studies requiring expert interpretation of clinical data to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies where expert consensus on interpretations is needed.
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:
This information is not provided because an MRMC study is not mentioned. The device is a meniscal repair device, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the bench tests would be established through objective engineering and material science standards and measurements. For example, the "ground truth" for tensile strength is a numerical value measured by a testing machine according to a defined protocol. For biocompatibility, it's adherence to ISO 10993 standards and a lack of adverse biological reactions in defined tests.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.